An interventional study of Open, Robotic, or Laparoscopic and Transvaginal Native Tissue Repair in Visceral Prolapse, sponsored by NICHD Pelvic Floor Disorders Network. Active, not recruiting at 10 sites in United States. Open to female participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by NICHD Pelvic Floor Disorders Network · Not applicable, Interventional, and Treatment
The study is a multi-center, randomized, surgical trial of women with symptomatic post-hysterectomy apical (cuff) prolapse desiring surgical treatment. This study will compare the three available surgical treatments performed in usual practice. The purpose of this study is to compare two commonly performed mesh apical repair (sacral colpopexy vs. Apical Transvaginal Mesh) and vaginal native tissue apical repairs with mesh reinforced repairs. The primary outcome is measured over time (up to 60 months) using a survival analysis approach. Participants will be followed for at least 36-months (3-years) post surgery and up to a maximum of 60-months (5-years) during the primary trial. Participants who complete the primary trial will be approached for consent for long-term follow-up as part of a study extension and will be followed up to a maximum of 120-months (10-years).
The investigators hypothesize that treatment failure will not differ between vaginally and abdominally placed mesh for vault vaginal prolapse, and mesh repairs (regardless of route of implantation) will be superior to native tissue apical suspension.
The primary purpose of this three arm randomized clinical trial is to determine if apical transvaginal mesh placement is non-inferior to sacral colpopexy for anatomic correction of post-hysterectomy vaginal vault prolapse and to determine if mesh reinforced repairs performed by abdominal or vaginal approach are superior to native tissue vaginal repair. This trial has the following primary aims:
1. To determine if Apical Transvaginal Mesh is non-inferior to Sacral Colpopexy for anatomic correction of post-hysterectomy vaginal vault prolapse at time points through 3 years.
1A. In the case where Apical Transvaginal Mesh is shown to be statistically significantly non-inferior to Sacral Colpopexy for anatomic correction of post-hysterectomy vaginal vault prolapse at time points through 3 years, to determine if Apical Transvaginal Mesh is superior to Sacral Colpopexy for anatomic correction of post-hysterectomy vaginal vault prolapse at time points through 3 years.
2. To determine if Sacral Colpopexy is superior to Native Tissue Repair for anatomic correction of post-hysterectomy vaginal vault prolapse at time points through 3 years.
3. To determine if Apical Transvaginal Mesh is superior to Native Tissue Repair for anatomic correction of post-hysterectomy vaginal vault prolapse at time points through 3 years.
Additional secondary aims include:
509 studies on the registry are indexed under Pelvic Organ Prolapse; 81 are open to participants now.
This study's enrollment of 360 is above the median of 80 across 330 interventional studies indexed under Pelvic Organ Prolapse.
Browse Pelvic Organ Prolapse studies →NICHD Pelvic Floor Disorders Network is the lead sponsor of 17 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Contraindication to any of the index surgical procedures
Shortened vaginal length (\<6 cm TVL)
NOTE:
Sacral Colpopexy performed via open, robotic, or laparoscopic procedure.
Procedure: Open, Robotic, or Laparoscopic
Transvaginal Native Tissue Repair: Sacrospinous Ligament Suspension (SSLS) and Uterosacral Ligament Suspension (USLS)
Procedure: Transvaginal Native Tissue Repair
Uphold™ LITE
Procedure: Uphold™ LITE
Sacral Colpopexy is a surgery performed either through an incision in the abdomen or through several small incisions with the help of a laparoscope (a slender tube) or robot. The surgery is done with a permanent synthetic (man-made) mesh. The mesh is sutured (stitched) to the vagina and sacrum (tail bone) and is used as reinforcement. It provides additional support to weakened tissues and/or muscles.
Transvaginal Native Tissue Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done using both permanent and absorbable sutures (stitches), to support weakened tissue and/or muscles, and attach the top of the vagina to ligaments in the pelvis (either to the sacrospinous ligament or uterosacral ligament).
Transvaginal Mesh Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done with a permanent synthetic (man-made) mesh. The mesh is attached to ligaments in the pelvis and is used to reinforce natural tissue and/or muscles, which are no longer able to provide support to the vagina.
Number of Participants Considered Failures
Failure was defined as any of the following: retreatment for prolapse, any POP-Q measure beyond the hymen, or presence of bother on PFDI vaginal bulge question. Under the permanent failure state assumption, the number of participants shown at each visit includes all participants who were still participating in the study or had a failure outcome prior their withdrawal. Similarly, the denominator number of participants for the cumulative failure at each visit includes all participants who were still participating in the study and attended the visit or had any failure outcome prior their withdrawal or missed visit.
Time frame: 6 months through 60 Months
Change From Baseline PFDI Score
The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1. Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2. Colorectal Anal Distress Inventory (range: 0-100), and 3. Urinary Distress Inventory (range: 0-100). The range of responses for all questions is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Subscale scores are calculated by multiplying the mean value of all questions answered by 25 for the subscale. The range of score for each subscale is: 0-100 with 0 (least distress) to 100 (most distress). The PFDI is calculated as the sum of the three subscales. Lower scores indicate better function / fewer symptoms for the PFDI scale, POPDI subscale, CRADI subscale, and UDI subscale. Change from baseline = (Month \[12, 24, 36\] Score - Baseline Score).
Time frame: 6 months through 60 Months
Change From Baseline CRADI Score
The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1. Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2. Colorectal Anal Distress Inventory (range: 0-100), and 3. Urinary Distress Inventory (range: 0-100). The range of responses for all questions is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Subscale scores are calculated by multiplying the mean value of all questions answered by 25 for the subscale. The range of score for each subscale is: 0-100 with 0 (least distress) to 100 (most distress). The PFDI is calculated as the sum of the three subscales. Lower scores indicate better function / fewer symptoms for the PFDI scale, POPDI subscale, CRADI subscale, and UDI subscale. Change from baseline = (Month \[12, 24, 36\] Score - Baseline Score).
Time frame: 6 months through 60 Months
Change From Baseline POPDI Score
The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1. Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2. Colorectal Anal Distress Inventory (range: 0-100), and 3. Urinary Distress Inventory (range: 0-100). The range of responses for all questions is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Subscale scores are calculated by multiplying the mean value of all questions answered by 25 for the subscale. The range of score for each subscale is: 0-100 with 0 (least distress) to 100 (most distress). The PFDI is calculated as the sum of the three subscales. Lower scores indicate better function / fewer symptoms for the PFDI scale, POPDI subscale, CRADI subscale, and UDI subscale. Change from baseline = (Month \[12, 24, 36\] Score - Baseline Score).
Time frame: 6 months through 60 Months
Change From Baseline UDI Score
The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1. Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2. Colorectal Anal Distress Inventory (range: 0-100), and 3. Urinary Distress Inventory (range: 0-100). The range of responses for all questions is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Subscale scores are calculated by multiplying the mean value of all questions answered by 25 for the subscale. The range of score for each subscale is: 0-100 with 0 (least distress) to 100 (most distress). The PFDI is calculated as the sum of the three subscales. Lower scores indicate better function / fewer symptoms for the PFDI scale, POPDI subscale, CRADI subscale, and UDI subscale. Change from baseline = (Month \[12, 24, 36\] Score - Baseline Score).
Time frame: 6 months through 60 Months
Change From Baseline PFIQ Score
The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of an overall score (range 0-300), 3 subscales (7 questions each): the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). The range of responses on all questions is 0-3 with (0) Not at all ... (3), Quite a bit. Subscale scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of scores for each subscale is: 0-100 with 0 (least negative impact) to 100 (most negative impact). The PFIQ is the sum of the three subscales. Lower scores indicate better function / fewer symptoms for the PFIQ score, UIQ score, POPIQ score, and CRAIQ score. Change = (Week \[12, 24\] Score - Baseline Score).
Time frame: 6 months through 60 Months
Change From Baseline CRAIQ Score
The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of an overall score (range 0-300), 3 subscales (7 questions each): the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). The range of responses on all questions is 0-3 with (0) Not at all ... (3), Quite a bit. Subscale scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of scores for each subscale is: 0-100 with 0 (least negative impact) to 100 (most negative impact). The PFIQ is the sum of the three subscales. Lower scores indicate better function / fewer symptoms for the PFIQ score, UIQ score, POPIQ score, and CRAIQ score. Change = (Week \[12, 24\] Score - Baseline Score).
Time frame: 6 months through 60 Months
Change From Baseline POPIQ Score
The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of an overall score (range 0-300), 3 subscales (7 questions each): the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). The range of responses on all questions is 0-3 with (0) Not at all ... (3), Quite a bit. Subscale scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of scores for each subscale is: 0-100 with 0 (least negative impact) to 100 (most negative impact). The PFIQ is the sum of the three subscales. Lower scores indicate better function / fewer symptoms for the PFIQ score, UIQ score, POPIQ score, and CRAIQ score. Change = (Week \[12, 24\] Score - Baseline Score).
Time frame: 6 months through 60 Months
Change From Baseline UIQ Score
The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of an overall score (range 0-300), 3 subscales (7 questions each): the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). The range of responses on all questions is 0-3 with (0) Not at all ... (3), Quite a bit. Subscale scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of scores for each subscale is: 0-100 with 0 (least negative impact) to 100 (most negative impact). The PFIQ is the sum of the three subscales. Lower scores indicate better function / fewer symptoms for the PFIQ score, UIQ score, POPIQ score, and CRAIQ score. Change = (Week \[12, 24\] Score - Baseline Score).
Time frame: 6 months through 60 Months
Change From Baseline Functional Activity Scale
Functional Activity Scale measuring the impact of incontinence symptoms on a woman's daily activities is composed of 13 questions about normal and physically strenuous daily activities. The range of responses on the individual questions is (1) No difficulty,... (5) Not able to do it. Scores are calculated by subtracting from the maximum sum (5\*13=65) the product of the mean response and number of questions, then dividing by the total range of sums (65 - 13 = 52) and multiplying by 100. The range of responses is: 0-100 with 0 (worse functionality) to 100 (Better functionality). Change = (Month \[6, 12, 18, 24, and 36\] Score - Baseline Score).
Time frame: 6 months through 60 Months
Change From Baseline Body Part Pain Scale
The Body Part Pain Scale measuring the pain experienced in the lower abdomen and pelvic region of the body is composed of 7 questions, each with a yes (1) or no (0) questions about experiencing pain followed by an intensity rating: 0 (No pain),..., 10 (Most intense). The score is calculated as the average of the responses. The range of responses is: 0-10 with 0 (No pain) to 10 (most intense pain). Lower scores indicate better function / fewer symptoms. Change = (Month \[6, 12, 18, 24, and 36\] Score - Baseline Score).
Time frame: 6 months through 60 Months
Change From Baseline Surgical Pain Scale Rest Score
The Surgical Pain Scale measuring the post-surgical pain experienced by a subject is composed of 4 questions: Pain at Rest (range 0-10), Pain with Normal Activities (range 0-10), Pain with Exercise (range 0-10), and Intensity of Worst Pain (range 0-10). Lower scores indicate better less pain for the Rest subscale, Normal subscale, Exercise Subscale, and Worst Subscale. Change = (Month \[6, 12, 18, 24, and 36\] Score - Baseline Score).
Time frame: 6 months through 60 Months
Change From Baseline Surgical Pain Scale Normal Score
The Surgical Pain Scale measuring the post-surgical pain experienced by a subject is composed of 4 questions: Pain at Rest (range 0-10), Pain with Normal Activities (range 0-10), Pain with Exercise (range 0-10), and Intensity of Worst Pain (range 0-10). Lower scores indicate better less pain for the Rest subscale, Normal subscale, Exercise Subscale, and Worst Subscale. Change = (Month \[6, 12, 18, 24, and 36\] Score - Baseline Score).
Time frame: 6 months through 60 Months
Change From Baseline Surgical Pain Scale Exercise Score
The Surgical Pain Scale measuring the post-surgical pain experienced by a subject is composed of 4 questions: Pain at Rest (range 0-10), Pain with Normal Activities (range 0-10), Pain with Exercise (range 0-10), and Intensity of Worst Pain (range 0-10). Lower scores indicate better less pain for the Rest subscale, Normal subscale, Exercise Subscale, and Worst Subscale. Change = (Month \[6, 12, 18, 24, and 36\] Score - Baseline Score).
Time frame: 6 months through 60 Months
Change From Baseline Surgical Pain Scale Worst Score
The Surgical Pain Scale measuring the post-surgical pain experienced by a subject is composed of 4 questions: Pain at Rest (range 0-10), Pain with Normal Activities (range 0-10), Pain with Exercise (range 0-10), and Intensity of Worst Pain (range 0-10). Lower scores indicate better less pain for the Rest subscale, Normal subscale, Exercise Subscale, and Worst Subscale. Change = (Month \[6, 12, 18, 24, and 36\] Score - Baseline Score).
Time frame: 6 months through 60 Months
Change From Baseline PISQ-IR Sexually Active Average Score
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. The PISQ-IR Sexually Active-Average Score (SA-AVG) ranges from 0 to 5 with higher scores indicating better function/satisfaction. The change from baseline outcome is calculated as the difference in score at 6, 12, 18, 24, and 36 months and the score at baseline.
Time frame: 6 months through 60 Months
Change From Baseline POP-Q Ba Measurement
POPQ Point Ba represents the most distal (i.e. most dependent) position of any part of the upper anterior vaginal wall (between the vaginal cuff or anterior vaginal fornix and Point Aa). Point Ba coincides with Point Aa (-3 cm) in a woman who has no anterior POP. In a woman with severe POP, Ba coincides with Point C.
Time frame: 6 months through 60 Months
Change From Baseline POP-Q Bp Measurement
POP-Q Point Bp represents the most distal position of any part of the upper posterior vaginal wall (between the vaginal cuff or posterior vaginal fornix and Point Ap).
Time frame: 6 months through 60 Months
Change From Baseline POP-Q C Measurement
POP-Q Point C is measured in cm relative to the hymen with negative values being proximal to the hymen and positive values distal to the hymen. Point C represents either the most distal edge of the cervix or the leading edge of the vaginal cuff after total hysterectomy.
Time frame: 6 months through 60 Months
Change From Baseline POP-Q TVL Measurement
POP-Q Total Vaginal Length (TVL) is measured in cm. It is the length of the vagina from posterior fornix to the hymen when Point C or D is reduced to its full normal position.
Time frame: 6 months through 60 Months
Number of Participants With PGI-I Reported Improvement
The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse). Included here are participants who had improvement as indicated by a rating of 1 (very much better), 2 (much better).
Time frame: 6 months through 60 Months
| Milestone | Native Tissue | Sacral Colpopexy | Transvaginal Mesh |
|---|---|---|---|
| Started | 123 | 121 | 116 |
| Completed | 104 | 100 | 92 |
| Not completed | 19 | 21 | 24 |
| Withdrew: Withdrawal by subject | 9 | 8 | 11 |
| Withdrew: Lost to follow-up | 8 | 12 | 8 |
| Withdrew: Death | 2 | 1 | 5 |
Failure was defined as any of the following: retreatment for prolapse, any POP-Q measure beyond the hymen, or presence of bother on PFDI vaginal bulge question. Under the permanent failure state assumption, the number of participants shown at each visit includes all participants who were still participating in the study or had a failure outcome prior their withdrawal. Similarly, the denominator number of participants for the cumulative failure at each visit includes all participants who were still participating in the study and attended the visit or had any failure outcome prior their withdrawal or missed visit.
| Participants | Native Tissue | Sacral Colpopexy | Transvaginal Mesh |
|---|---|---|---|
| 06 Months — Failure | 19 | 6 | 11 |
| 06 Months — Non-failure | 93 | 108 | 100 |
| 12 Months — Failure | 31 | 13 | 18 |
| 12 Months — Non-failure | 81 | 96 | 89 |
| 18 Months — Failure | 38 | 18 | 19 |
| 18 Months — Non-failure | 68 | 86 | 84 |
| 24 Months — Failure | 43 | 21 | 27 |
| 24 Months — Non-failure | 62 | 83 | 80 |
| 30 Months — Failure | 49 | 24 | 30 |
| 30 Months — Non-failure | 53 | 75 | 75 |
| 36 Months — Failure | 53 | 31 | 30 |
| 36 Months — Non-failure | 53 | 69 | 70 |
| 42 Months — Failure | 55 | 33 | 31 |
| 42 Months — Non-failure | 40 | 57 | 62 |
| 48 Months — Failure | 55 | 36 | 31 |
| 48 Months — Non-failure | 38 | 50 | 53 |
| 54 Months — Failure | 55 | 36 | 35 |
| 54 Months — Non-failure | 29 | 30 | 39 |
| 60 Months — Failure | 55 | 38 | 37 |
| 60 Months — Non-failure | 21 | 25 | 23 |
The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1. Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2. Colorectal Anal Distress Inventory (range: 0-100), and 3. Urinary Distress Inventory (range: 0-100). The range of responses for all questions is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Subscale scores are calculated by multiplying the mean value of all questions answered by 25 for the subscale. The range of score for each subscale is: 0-100 with 0 (least distress) to 100 (most distress). The PFDI is calculated as the sum of the three subscales. Lower scores indicate better function / fewer symptoms for the PFDI scale, POPDI subscale, CRADI subscale, and UDI subscale. Change from baseline = (Month \[12, 24, 36\] Score - Baseline Score).
| units on a scale | Native Tissue | Sacral Colpopexy | Transvaginal Mesh |
|---|---|---|---|
| 06 Months | -75.8 (-85.10 to -66.50) | -80.2 (-91.10 to -69.20) | -79.6 (-91.30 to -68.00) |
| 12 Months | -79.7 (-89.00 to -70.40) | -85.6 (-96.80 to -74.40) | -79.4 (-90.70 to -68.10) |
| 18 Months | -111.7 (-122.90 to -100.60) | -111.8 (-123.60 to -100.00) | -109 (-121.70 to -96.40) |
| 24 Months | -79.8 (-90.40 to -69.20) | -84.9 (-96.90 to -72.90) | -79.9 (-90.30 to -69.50) |
| 30 Months | -106.7 (-117.80 to -95.60) | -112 (-124.50 to -99.50) | -103.8 (-116.60 to -90.90) |
| 36 Months | -78.1 (-89.10 to -67.10) | -83.9 (-96.20 to -71.50) | -79.7 (-91.00 to -68.40) |
| 42 Months | -102.4 (-114.40 to -90.30) | -114.6 (-128.40 to -100.80) | -103.2 (-116.10 to -90.40) |
| 48 Months | -75.8 (-87.80 to -63.80) | -78.4 (-92.60 to -64.10) | -73.9 (-88.90 to -58.80) |
| 54 Months | -109.9 (-124.90 to -95.00) | -109.5 (-127.70 to -91.30) | -107 (-122.80 to -91.20) |
| 60 Months | -68.7 (-86.00 to -51.30) | -84.1 (-101.20 to -67.10) | -67.5 (-87.80 to -47.30) |
The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1. Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2. Colorectal Anal Distress Inventory (range: 0-100), and 3. Urinary Distress Inventory (range: 0-100). The range of responses for all questions is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Subscale scores are calculated by multiplying the mean value of all questions answered by 25 for the subscale. The range of score for each subscale is: 0-100 with 0 (least distress) to 100 (most distress). The PFDI is calculated as the sum of the three subscales. Lower scores indicate better function / fewer symptoms for the PFDI scale, POPDI subscale, CRADI subscale, and UDI subscale. Change from baseline = (Month \[12, 24, 36\] Score - Baseline Score).
| units on a scale | Native Tissue | Sacral Colpopexy | Transvaginal Mesh |
|---|---|---|---|
| 06 Months | -12.3 (-15.70 to -8.90) | -13.1 (-16.80 to -9.40) | -14.2 (-18.00 to -10.30) |
| 12 Months | -12.9 (-16.30 to -9.40) | -14.6 (-18.50 to -10.70) | -14.2 (-17.80 to -10.50) |
| 24 Months | -12.8 (-16.70 to -9.00) | -14.8 (-18.90 to -10.60) | -14 (-17.50 to -10.60) |
| 36 Months | -11.9 (-16.20 to -7.60) | -14.3 (-18.70 to -9.90) | -13.5 (-17.60 to -9.30) |
| 48 Months | -12.3 (-16.90 to -7.80) | -12.2 (-17.10 to -7.30) | -12.7 (-18.10 to -7.20) |
| 60 Months | -7.8 (-13.20 to -2.40) | -10.5 (-17.00 to -4.10) | -13.1 (-19.70 to -6.40) |
The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1. Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2. Colorectal Anal Distress Inventory (range: 0-100), and 3. Urinary Distress Inventory (range: 0-100). The range of responses for all questions is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Subscale scores are calculated by multiplying the mean value of all questions answered by 25 for the subscale. The range of score for each subscale is: 0-100 with 0 (least distress) to 100 (most distress). The PFDI is calculated as the sum of the three subscales. Lower scores indicate better function / fewer symptoms for the PFDI scale, POPDI subscale, CRADI subscale, and UDI subscale. Change from baseline = (Month \[12, 24, 36\] Score - Baseline Score).
| units on a scale | Native Tissue | Sacral Colpopexy | Transvaginal Mesh |
|---|---|---|---|
| 06 Months | -36.3 (-40.40 to -32.10) | -38 (-42.10 to -33.90) | -37.2 (-41.50 to -33.00) |
| 12 Months | -37.3 (-41.60 to -33.00) | -39.8 (-44.20 to -35.40) | -38.4 (-42.60 to -34.20) |
| 18 Months | -40.9 (-46.10 to -35.60) | -44.2 (-48.70 to -39.60) | -41.8 (-47.00 to -36.60) |
| 24 Months | -40.1 (-44.50 to -35.80) | -40.7 (-45.00 to -36.30) | -37.8 (-42.20 to -33.50) |
| 30 Months | -39.3 (-45.00 to -33.60) | -44.6 (-49.40 to -39.80) | -37.6 (-43.80 to -31.50) |
| 36 Months | -38.1 (-43.10 to -33.20) | -39.3 (-43.90 to -34.70) | -38.2 (-42.60 to -33.90) |
| 42 Months | -36.8 (-42.80 to -30.90) | -45.3 (-50.80 to -39.80) | -40.3 (-45.80 to -34.80) |
| 48 Months | -36.6 (-41.80 to -31.40) | -38.2 (-42.90 to -33.50) | -37.1 (-42.40 to -31.80) |
| 54 Months | -40.9 (-48.20 to -33.50) | -46.5 (-52.80 to -40.10) | -39.8 (-46.30 to -33.30) |
| 60 Months | -33.6 (-41.90 to -25.30) | -42.2 (-49.10 to -35.40) | -32.2 (-40.40 to -24.00) |
The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1. Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2. Colorectal Anal Distress Inventory (range: 0-100), and 3. Urinary Distress Inventory (range: 0-100). The range of responses for all questions is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Subscale scores are calculated by multiplying the mean value of all questions answered by 25 for the subscale. The range of score for each subscale is: 0-100 with 0 (least distress) to 100 (most distress). The PFDI is calculated as the sum of the three subscales. Lower scores indicate better function / fewer symptoms for the PFDI scale, POPDI subscale, CRADI subscale, and UDI subscale. Change from baseline = (Month \[12, 24, 36\] Score - Baseline Score).
| units on a scale | Native Tissue | Sacral Colpopexy | Transvaginal Mesh |
|---|---|---|---|
| 06 Months | -27.3 (-32.10 to -22.40) | -29.3 (-35.10 to -23.40) | -28.2 (-34.10 to -22.30) |
| 12 Months | -29.5 (-34.10 to -25.00) | -31.2 (-36.80 to -25.70) | -26.9 (-32.70 to -21.10) |
| 24 Months | -26.8 (-32.10 to -21.50) | -29.5 (-35.40 to -23.50) | -28 (-33.30 to -22.70) |
| 36 Months | -28 (-33.00 to -23.00) | -30.2 (-36.00 to -24.40) | -28 (-33.70 to -22.30) |
| 48 Months | -26.9 (-33.10 to -20.60) | -27.9 (-35.40 to -20.50) | -24.1 (-31.40 to -16.80) |
| 60 Months | -27.3 (-36.40 to -18.20) | -31.4 (-40.40 to -22.30) | -22.2 (-32.10 to -12.40) |
The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of an overall score (range 0-300), 3 subscales (7 questions each): the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). The range of responses on all questions is 0-3 with (0) Not at all ... (3), Quite a bit. Subscale scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of scores for each subscale is: 0-100 with 0 (least negative impact) to 100 (most negative impact). The PFIQ is the sum of the three subscales. Lower scores indicate better function / fewer symptoms for the PFIQ score, UIQ score, POPIQ score, and CRAIQ score. Change = (Week \[12, 24\] Score - Baseline Score).
| units on a scale | Native Tissue | Sacral Colpopexy | Transvaginal Mesh |
|---|---|---|---|
| 06 Months | -43.9 (-54.20 to -33.50) | -46.6 (-56.80 to -36.50) | -47 (-58.40 to -35.50) |
| 12 Months | -45.8 (-57.40 to -34.30) | -46.9 (-57.10 to -36.70) | -46.8 (-59.60 to -34.10) |
| 24 Months | -41.1 (-53.10 to -29.00) | -46.4 (-57.40 to -35.50) | -45.4 (-56.90 to -33.90) |
| 36 Months | -46.2 (-57.90 to -34.40) | -45.9 (-57.30 to -34.50) | -40.3 (-52.60 to -28.10) |
| 48 Months | -39.2 (-50.70 to -27.60) | -42.5 (-57.20 to -27.70) | -32.2 (-46.70 to -17.80) |
| 60 Months | -32.4 (-54.00 to -10.80) | -46.9 (-66.70 to -27.10) | -21.8 (-37.60 to -5.90) |
The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of an overall score (range 0-300), 3 subscales (7 questions each): the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). The range of responses on all questions is 0-3 with (0) Not at all ... (3), Quite a bit. Subscale scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of scores for each subscale is: 0-100 with 0 (least negative impact) to 100 (most negative impact). The PFIQ is the sum of the three subscales. Lower scores indicate better function / fewer symptoms for the PFIQ score, UIQ score, POPIQ score, and CRAIQ score. Change = (Week \[12, 24\] Score - Baseline Score).
| units on a scale | Native Tissue | Sacral Colpopexy | Transvaginal Mesh |
|---|---|---|---|
| 06 Months | -10.1 (-13.80 to -6.50) | -9.1 (-12.00 to -6.10) | -9.2 (-12.90 to -5.50) |
| 12 Months | -10.2 (-14.30 to -6.10) | -9.4 (-12.50 to -6.30) | -9.7 (-14.10 to -5.30) |
| 24 Months | -7.1 (-11.50 to -2.70) | -9.8 (-13.40 to -6.10) | -9.2 (-13.10 to -5.40) |
| 36 Months | -7.6 (-11.50 to -3.80) | -9.4 (-13.00 to -5.80) | -6.3 (-10.50 to -2.10) |
| 48 Months | -5.2 (-9.50 to -0.90) | -9.3 (-14.10 to -4.40) | -4.3 (-9.30 to 0.80) |
| 60 Months | -3.8 (-11.40 to 3.80) | -6.8 (-13.10 to -0.50) | -2.4 (-9.40 to 4.50) |
The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of an overall score (range 0-300), 3 subscales (7 questions each): the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). The range of responses on all questions is 0-3 with (0) Not at all ... (3), Quite a bit. Subscale scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of scores for each subscale is: 0-100 with 0 (least negative impact) to 100 (most negative impact). The PFIQ is the sum of the three subscales. Lower scores indicate better function / fewer symptoms for the PFIQ score, UIQ score, POPIQ score, and CRAIQ score. Change = (Week \[12, 24\] Score - Baseline Score).
| units on a scale | Native Tissue | Sacral Colpopexy | Transvaginal Mesh |
|---|---|---|---|
| 06 Months | -19 (-23.60 to -14.30) | -19 (-23.80 to -14.10) | -19.1 (-23.80 to -14.30) |
| 12 Months | -18.6 (-23.40 to -13.80) | -19.5 (-24.10 to -14.90) | -18.2 (-23.40 to -13.00) |
| 24 Months | -18.3 (-23.50 to -13.10) | -20 (-24.50 to -15.50) | -18.4 (-23.20 to -13.60) |
| 36 Months | -20.9 (-26.20 to -15.60) | -18.8 (-23.50 to -14.10) | -17.9 (-22.60 to -13.10) |
| 48 Months | -17.9 (-24.10 to -11.70) | -17.3 (-23.20 to -11.40) | -17 (-22.80 to -11.20) |
| 60 Months | -17.1 (-26.80 to -7.30) | -22.3 (-31.30 to -13.30) | -10.9 (-16.90 to -4.90) |
The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of an overall score (range 0-300), 3 subscales (7 questions each): the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). The range of responses on all questions is 0-3 with (0) Not at all ... (3), Quite a bit. Subscale scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of scores for each subscale is: 0-100 with 0 (least negative impact) to 100 (most negative impact). The PFIQ is the sum of the three subscales. Lower scores indicate better function / fewer symptoms for the PFIQ score, UIQ score, POPIQ score, and CRAIQ score. Change = (Week \[12, 24\] Score - Baseline Score).
| units on a scale | Native Tissue | Sacral Colpopexy | Transvaginal Mesh |
|---|---|---|---|
| 06 Months | -15 (-19.40 to -10.60) | -18.7 (-23.40 to -14.10) | -18.9 (-23.90 to -13.90) |
| 12 Months | -17 (-21.50 to -12.60) | -18.3 (-22.80 to -13.80) | -18.5 (-23.20 to -13.70) |
| 24 Months | -15.7 (-20.30 to -11.00) | -17 (-22.00 to -11.90) | -17.8 (-22.50 to -13.00) |
| 36 Months | -17.6 (-22.70 to -12.60) | -17.7 (-22.90 to -12.50) | -16.3 (-21.60 to -11.00) |
| 48 Months | -16.3 (-21.20 to -11.30) | -15.9 (-22.00 to -9.90) | -11 (-16.90 to -5.00) |
| 60 Months | -11.5 (-19.70 to -3.30) | -17.8 (-26.30 to -9.20) | -8.4 (-14.70 to -2.00) |
Functional Activity Scale measuring the impact of incontinence symptoms on a woman's daily activities is composed of 13 questions about normal and physically strenuous daily activities. The range of responses on the individual questions is (1) No difficulty,... (5) Not able to do it. Scores are calculated by subtracting from the maximum sum (5\*13=65) the product of the mean response and number of questions, then dividing by the total range of sums (65 - 13 = 52) and multiplying by 100. The range of responses is: 0-100 with 0 (worse functionality) to 100 (Better functionality). Change = (Month \[6, 12, 18, 24, and 36\] Score - Baseline Score).
| units on a scale | Native Tissue | Sacral Colpopexy | Transvaginal Mesh |
|---|---|---|---|
| 06 Months | 3.9 (1.60 to 6.20) | 6.2 (3.10 to 9.30) | 6.6 (3.50 to 9.70) |
| 12 Months | 4.6 (2.20 to 7.00) | 5.3 (2.20 to 8.40) | 6.1 (3.00 to 9.30) |
| 24 Months | 3.5 (0.60 to 6.50) | 6.1 (2.70 to 9.50) | 5.7 (2.70 to 8.70) |
| 36 Months | 2.6 (-0.40 to 5.50) | 7 (3.50 to 10.40) | 4.9 (1.50 to 8.30) |
| 48 Months | 2.4 (-1.50 to 6.40) | 5.3 (1.90 to 8.70) | 2.7 (-1.30 to 6.60) |
| 60 Months | -0.8 (-3.80 to 2.10) | 7.3 (2.20 to 12.30) | -0.7 (-5.20 to 3.90) |
The Body Part Pain Scale measuring the pain experienced in the lower abdomen and pelvic region of the body is composed of 7 questions, each with a yes (1) or no (0) questions about experiencing pain followed by an intensity rating: 0 (No pain),..., 10 (Most intense). The score is calculated as the average of the responses. The range of responses is: 0-10 with 0 (No pain) to 10 (most intense pain). Lower scores indicate better function / fewer symptoms. Change = (Month \[6, 12, 18, 24, and 36\] Score - Baseline Score).
| units on a scale | Native Tissue | Sacral Colpopexy | Transvaginal Mesh |
|---|---|---|---|
| 06 Months | -0.4 (-0.60 to -0.10) | -0.5 (-0.70 to -0.20) | -0.6 (-0.90 to -0.40) |
| 12 Months | -0.4 (-0.60 to -0.20) | -0.5 (-0.70 to -0.20) | -0.7 (-1.00 to -0.40) |
| 24 Months | -0.4 (-0.70 to -0.20) | -0.5 (-0.80 to -0.20) | -0.7 (-0.90 to -0.40) |
| 36 Months | -0.3 (-0.50 to -0.10) | -0.6 (-0.90 to -0.20) | -0.7 (-1.00 to -0.40) |
| 48 Months | -0.2 (-0.40 to 0.00) | -0.5 (-0.80 to -0.10) | -0.5 (-0.70 to -0.20) |
| 60 Months | -0.3 (-0.50 to 0.00) | -0.7 (-1.10 to -0.30) | -0.2 (-0.60 to 0.20) |
The Surgical Pain Scale measuring the post-surgical pain experienced by a subject is composed of 4 questions: Pain at Rest (range 0-10), Pain with Normal Activities (range 0-10), Pain with Exercise (range 0-10), and Intensity of Worst Pain (range 0-10). Lower scores indicate better less pain for the Rest subscale, Normal subscale, Exercise Subscale, and Worst Subscale. Change = (Month \[6, 12, 18, 24, and 36\] Score - Baseline Score).
| units on a scale | Native Tissue | Sacral Colpopexy | Transvaginal Mesh |
|---|---|---|---|
| 06 Months | -0.6 (-1.00 to -0.20) | -0.5 (-0.90 to -0.10) | -0.7 (-1.10 to -0.30) |
| 12 Months | -0.5 (-1.00 to -0.10) | -0.4 (-0.80 to 0.10) | -0.8 (-1.20 to -0.40) |
| 24 Months | -0.5 (-1.00 to 0.00) | -0.4 (-0.90 to 0.10) | -0.6 (-1.10 to -0.20) |
| 36 Months | -0.5 (-0.90 to 0.00) | -0.6 (-1.10 to -0.20) | -0.2 (-0.70 to 0.30) |
| 48 Months | -0.9 (-1.40 to -0.40) | -0.5 (-1.00 to 0.10) | -0.2 (-0.80 to 0.50) |
| 60 Months | -0.7 (-1.50 to 0.00) | -1.1 (-2.00 to -0.30) | 0.2 (-0.70 to 1.00) |
The Surgical Pain Scale measuring the post-surgical pain experienced by a subject is composed of 4 questions: Pain at Rest (range 0-10), Pain with Normal Activities (range 0-10), Pain with Exercise (range 0-10), and Intensity of Worst Pain (range 0-10). Lower scores indicate better less pain for the Rest subscale, Normal subscale, Exercise Subscale, and Worst Subscale. Change = (Month \[6, 12, 18, 24, and 36\] Score - Baseline Score).
| units on a scale | Native Tissue | Sacral Colpopexy | Transvaginal Mesh |
|---|---|---|---|
| 06 Months | -0.5 (-0.90 to -0.10) | -0.7 (-1.20 to -0.20) | -0.9 (-1.40 to -0.40) |
| 12 Months | -0.5 (-0.90 to -0.10) | -0.5 (-1.00 to -0.10) | -1 (-1.50 to -0.50) |
| 24 Months | -0.6 (-1.00 to -0.20) | -0.8 (-1.30 to -0.30) | -1 (-1.50 to -0.40) |
| 36 Months | -0.5 (-1.00 to 0.10) | -0.7 (-1.20 to -0.20) | -0.5 (-1.00 to 0.10) |
| 48 Months | -0.4 (-1.10 to 0.20) | -0.6 (-1.10 to 0.00) | -0.6 (-1.30 to 0.10) |
| 60 Months | -0.4 (-1.10 to 0.30) | -1 (-2.00 to 0.00) | 0.5 (-0.70 to 1.60) |
The Surgical Pain Scale measuring the post-surgical pain experienced by a subject is composed of 4 questions: Pain at Rest (range 0-10), Pain with Normal Activities (range 0-10), Pain with Exercise (range 0-10), and Intensity of Worst Pain (range 0-10). Lower scores indicate better less pain for the Rest subscale, Normal subscale, Exercise Subscale, and Worst Subscale. Change = (Month \[6, 12, 18, 24, and 36\] Score - Baseline Score).
| units on a scale | Native Tissue | Sacral Colpopexy | Transvaginal Mesh |
|---|---|---|---|
| 06 Months | -0.6 (-1.40 to 0.20) | -1.5 (-2.40 to -0.50) | -1.7 (-2.50 to -0.80) |
| 12 Months | -0.8 (-1.40 to -0.20) | -1.4 (-2.30 to -0.50) | -1.3 (-2.20 to -0.50) |
| 24 Months | -1.3 (-2.20 to -0.40) | -0.4 (-1.50 to 0.70) | -1.6 (-2.60 to -0.60) |
| 36 Months | -1.1 (-2.00 to -0.10) | -1.2 (-2.10 to -0.20) | -1.7 (-2.70 to -0.70) |
| 48 Months | -1.3 (-2.60 to -0.10) | -0.7 (-1.80 to 0.50) | -1.4 (-2.70 to 0.00) |
| 60 Months | -0.6 (-1.70 to 0.50) | -2.9 (-4.40 to -1.50) | 0.4 (-1.60 to 2.40) |
The Surgical Pain Scale measuring the post-surgical pain experienced by a subject is composed of 4 questions: Pain at Rest (range 0-10), Pain with Normal Activities (range 0-10), Pain with Exercise (range 0-10), and Intensity of Worst Pain (range 0-10). Lower scores indicate better less pain for the Rest subscale, Normal subscale, Exercise Subscale, and Worst Subscale. Change = (Month \[6, 12, 18, 24, and 36\] Score - Baseline Score).
| units on a scale | Native Tissue | Sacral Colpopexy | Transvaginal Mesh |
|---|---|---|---|
| 06 Months | -0.7 (-1.10 to -0.20) | -1.1 (-1.70 to -0.50) | -0.9 (-1.40 to -0.40) |
| 12 Months | -0.8 (-1.20 to -0.40) | -0.9 (-1.50 to -0.40) | -1.1 (-1.60 to -0.60) |
| 24 Months | -0.6 (-1.20 to 0.00) | -1.2 (-1.80 to -0.60) | -1 (-1.50 to -0.50) |
| 36 Months | -0.4 (-1.00 to 0.20) | -1.1 (-1.80 to -0.50) | -0.4 (-1.00 to 0.10) |
| 48 Months | -0.3 (-1.00 to 0.50) | -1 (-1.60 to -0.30) | -0.2 (-0.80 to 0.40) |
| 60 Months | -0.6 (-1.30 to 0.20) | -1.7 (-2.70 to -0.70) | 0.8 (-0.10 to 1.60) |
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. The PISQ-IR Sexually Active-Average Score (SA-AVG) ranges from 0 to 5 with higher scores indicating better function/satisfaction. The change from baseline outcome is calculated as the difference in score at 6, 12, 18, 24, and 36 months and the score at baseline.
| units on a scale | Native Tissue | Sacral Colpopexy | Transvaginal Mesh |
|---|---|---|---|
| 06 Months | 0.4 (0.20 to 0.50) | 0.4 (0.20 to 0.60) | 0.5 (0.40 to 0.70) |
| 12 Months | 0.4 (0.20 to 0.60) | 0.4 (0.20 to 0.70) | 0.6 (0.50 to 0.80) |
| 24 Months | 0.4 (0.20 to 0.60) | 0.4 (0.20 to 0.70) | 0.5 (0.30 to 0.70) |
| 36 Months | 0.4 (0.10 to 0.60) | 0.4 (0.10 to 0.70) | 0.6 (0.40 to 0.80) |
| 48 Months | 0.3 (0.10 to 0.50) | 0.3 (0.10 to 0.60) | 0.4 (0.20 to 0.70) |
| 60 Months | 0.2 (0.00 to 0.50) | 0.6 (0.00 to 1.10) | 0.3 (0.00 to 0.70) |
POPQ Point Ba represents the most distal (i.e. most dependent) position of any part of the upper anterior vaginal wall (between the vaginal cuff or anterior vaginal fornix and Point Aa). Point Ba coincides with Point Aa (-3 cm) in a woman who has no anterior POP. In a woman with severe POP, Ba coincides with Point C.
| cm | Native Tissue | Sacral Colpopexy | Transvaginal Mesh |
|---|---|---|---|
| 06 Months | -3.9 (-4.3 to -3.4) | -4.5 (-4.9 to -4.1) | -4.6 (-5.1 to -4.2) |
| 12 Months | -3.7 (-4.2 to -3.3) | -4.5 (-4.9 to -4.1) | -4.3 (-4.8 to -3.8) |
| 18 Months | -3.7 (-4.2 to -3.2) | -4.5 (-4.9 to -4.0) | -4.5 (-5.0 to -3.9) |
| 24 Months | -3.8 (-4.3 to -3.3) | -4.3 (-4.7 to -3.8) | -4.4 (-4.9 to -3.9) |
| 30 Months | -3.6 (-4.1 to -3.1) | -4.6 (-5.0 to -4.1) | -4.2 (-4.8 to -3.7) |
| 36 Months | -3.5 (-4.0 to -3.0) | -4.6 (-5.2 to -4.1) | -4.4 (-5.0 to -3.9) |
| 42 Months | -3.7 (-4.3 to -3.0) | -4.4 (-5.0 to -3.8) | -4.3 (-4.9 to -3.7) |
| 48 Months | -3.7 (-4.3 to -3.1) | -4.6 (-5.3 to -3.9) | -4.4 (-5.1 to -3.7) |
| 54 Months | -3.5 (-4.2 to -2.7) | -4.5 (-5.2 to -3.8) | -4.4 (-5.3 to -3.5) |
| 60 Months | -3.8 (-4.6 to -3.0) | -4.3 (-5.0 to -3.7) | -3.6 (-4.6 to -2.7) |
POP-Q Point Bp represents the most distal position of any part of the upper posterior vaginal wall (between the vaginal cuff or posterior vaginal fornix and Point Ap).
| cm | Native Tissue | Sacral Colpopexy | Transvaginal Mesh |
|---|---|---|---|
| 06 Months | -2.6 (-3.2 to -2.0) | -2.8 (-3.3 to -2.2) | -3.2 (-3.7 to -2.6) |
| 12 Months | -2.6 (-3.2 to -2.0) | -2.9 (-3.5 to -2.3) | -3 (-3.5 to -2.4) |
| 18 Months | -2.4 (-3.0 to -1.7) | -2.8 (-3.5 to -2.2) | -3.1 (-3.8 to -2.4) |
| 24 Months | -2.5 (-3.2 to -1.9) | -2.5 (-3.1 to -1.8) | -2.9 (-3.5 to -2.2) |
| 30 Months | -2.8 (-3.5 to -2.1) | -2.5 (-3.2 to -1.9) | -2.8 (-3.5 to -2.1) |
| 36 Months | -2.3 (-3.0 to -1.7) | -2.5 (-3.2 to -1.8) | -2.8 (-3.5 to -2.2) |
| 42 Months | -2.1 (-2.9 to -1.3) | -2.8 (-3.5 to -2.0) | -3 (-3.8 to -2.3) |
| 48 Months | -2.6 (-3.5 to -1.8) | -2.6 (-3.4 to -1.8) | -3.4 (-4.2 to -2.6) |
| 54 Months | -2.7 (-3.7 to -1.7) | -2.5 (-3.5 to -1.5) | -3.1 (-4.0 to -2.2) |
| 60 Months | -2.6 (-3.8 to -1.5) | -2.3 (-3.3 to -1.3) | -3.1 (-4.1 to -2.1) |
POP-Q Point C is measured in cm relative to the hymen with negative values being proximal to the hymen and positive values distal to the hymen. Point C represents either the most distal edge of the cervix or the leading edge of the vaginal cuff after total hysterectomy.
| cm | Native Tissue | Sacral Colpopexy | Transvaginal Mesh |
|---|---|---|---|
| 06 Months | -5.1 (-5.8 to -4.3) | -6.9 (-7.6 to -6.3) | -6.1 (-6.8 to -5.3) |
| 12 Months | -5.1 (-5.8 to -4.4) | -6.8 (-7.6 to -6.1) | -5.8 (-6.5 to -5.1) |
| 18 Months | -4.9 (-5.7 to -4.2) | -6.8 (-7.5 to -6.1) | -5.9 (-6.7 to -5.0) |
| 24 Months | -5 (-5.8 to -4.2) | -6.5 (-7.2 to -5.8) | -5.7 (-6.4 to -4.9) |
| 30 Months | -4.7 (-5.5 to -3.9) | -7.1 (-7.8 to -6.3) | -5.4 (-6.2 to -4.6) |
| 36 Months | -4.6 (-5.4 to -3.9) | -7.1 (-7.9 to -6.3) | -5.7 (-6.5 to -4.9) |
| 42 Months | -4.5 (-5.4 to -3.5) | -7 (-7.9 to -6.1) | -5.6 (-6.6 to -4.7) |
| 48 Months | -4.5 (-5.5 to -3.6) | -6.4 (-7.4 to -5.4) | -6.1 (-7.2 to -5.0) |
| 54 Months | -4.5 (-5.7 to -3.3) | -6.6 (-7.9 to -5.4) | -5.8 (-7.1 to -4.6) |
| 60 Months | -5.2 (-6.5 to -3.9) | -6.5 (-7.5 to -5.4) | -5.5 (-6.6 to -4.3) |
POP-Q Total Vaginal Length (TVL) is measured in cm. It is the length of the vagina from posterior fornix to the hymen when Point C or D is reduced to its full normal position.
| cm | Native Tissue | Sacral Colpopexy | Transvaginal Mesh |
|---|---|---|---|
| 06 Months | -0.9 (-1.1 to -0.7) | 0.1 (-0.2 to 0.4) | -0.9 (-1.2 to -0.6) |
| 12 Months | -1 (-1.3 to -0.8) | 0 (-0.3 to 0.3) | -0.8 (-1.1 to -0.6) |
| 18 Months | -1.1 (-1.4 to -0.8) | 0 (-0.3 to 0.3) | -0.9 (-1.2 to -0.6) |
| 24 Months | -0.9 (-1.2 to -0.7) | 0 (-0.4 to 0.3) | -0.9 (-1.3 to -0.6) |
| 30 Months | -1.2 (-1.5 to -0.9) | 0.2 (-0.1 to 0.6) | -0.9 (-1.2 to -0.6) |
| 36 Months | -0.9 (-1.2 to -0.6) | 0.2 (-0.1 to 0.5) | -1 (-1.3 to -0.7) |
| 42 Months | -1 (-1.3 to -0.6) | -0.1 (-0.4 to 0.3) | -1.1 (-1.5 to -0.7) |
| 48 Months | -1.1 (-1.5 to -0.7) | 0 (-0.5 to 0.5) | -0.8 (-1.2 to -0.5) |
| 54 Months | -1 (-1.5 to -0.4) | -0.1 (-0.8 to 0.5) | -0.9 (-1.3 to -0.4) |
| 60 Months | -0.8 (-1.2 to -0.3) | -0.3 (-0.8 to 0.2) | -0.8 (-1.3 to -0.3) |
The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse). Included here are participants who had improvement as indicated by a rating of 1 (very much better), 2 (much better).
| Participants | Native Tissue | Sacral Colpopexy | Transvaginal Mesh |
|---|---|---|---|
| 06 Months — Improvement | 96 | 108 | 98 |
| 06 Months — No improvement | 16 | 6 | 11 |
| 12 Months — Improvement | 101 | 100 | 96 |
| 12 Months — No improvement | 9 | 8 | 8 |
| 24 Months — Improvement | 87 | 90 | 97 |
| 24 Months — No improvement | 10 | 5 | 7 |
| 36 Months — Improvement | 79 | 88 | 84 |
| 36 Months — No improvement | 12 | 5 | 5 |
| 48 Months — Improvement | 58 | 68 | 67 |
| 48 Months — No improvement | 15 | 4 | 6 |
| 60 Months — Improvement | 33 | 33 | 34 |
| 60 Months — No improvement | 8 | 4 | 3 |
Collected over 60 Months. Non-serious events are listed at a 0.00% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Native Tissue | 2/123 (1.6%) | 14/123 (11.4%) | 100/123 (81.3%) |
| Sacral Colpopexy | 1/121 (0.8%) | 24/121 (19.8%) | 88/121 (72.7%) |
| Transvaginal Mesh | 5/116 (4.3%) | 25/116 (21.6%) | 91/116 (78.4%) |
| Event | Native Tissue | Sacral Colpopexy | Transvaginal Mesh |
|---|---|---|---|
| Bladder injuryInjury, poisoning and procedural complications | 5/123 | 5/121 | 4/116 |
| Stress urinary incontinenceRenal and urinary disorders | 1/123 | 3/121 | 0/116 |
| Urinary retentionRenal and urinary disorders | 1/123 | 0/121 | 2/116 |
| Small intestinal obstructionGastrointestinal disorders | 0/123 | 2/121 | 0/116 |
| DiverticulitisInfections and infestations | 1/123 | 2/121 | 0/116 |
| PneumoniaInfections and infestations | 0/123 | 2/121 | 0/116 |
| Bladder neck suspensionSurgical and medical procedures | 1/123 | 2/121 | 0/116 |
| ConstipationGastrointestinal disorders | 2/123 | 0/121 | 0/116 |
| HospitalisationSurgical and medical procedures | 2/123 | 1/121 | 1/116 |
| Atrial fibrillationCardiac disorders | 0/123 | 1/121 | 1/116 |
| Event | Native Tissue | Sacral Colpopexy | Transvaginal Mesh |
|---|---|---|---|
| Urinary tract infectionInfections and infestations | 58/123 | 35/121 | 60/116 |
| Urge incontinenceRenal and urinary disorders | 30/123 | 34/121 | 24/116 |
| Stress urinary incontinenceRenal and urinary disorders | 10/123 | 22/121 | 17/116 |
| Excessive granulation tissueSkin and subcutaneous tissue disorders | 16/123 | 2/121 | 7/116 |
| Urinary retentionRenal and urinary disorders | 10/123 | 7/121 | 13/116 |
| Faecal incontinenceGastrointestinal disorders | 13/123 | 9/121 | 12/116 |
| Vaginal infectionInfections and infestations | 5/123 | 4/121 | 11/116 |
| Medical device site reactionGeneral disorders | 11/123 | 5/121 | 8/116 |
| ConstipationGastrointestinal disorders | 6/123 | 10/121 | 6/116 |
| Pelvic painReproductive system and breast disorders | 6/123 | 8/121 | 5/116 |
| Age, Continuous(years) | Native Tissue | Sacral Colpopexy | Transvaginal Mesh | Total |
|---|---|---|---|---|
| Mean | 66.4 ± 8.5 | 65.4 ± 8.6 | 66.4 ± 9.0 | 66.1 ± 8.7 |
| Sex/Gender, Customized(Participants) | Native Tissue | Sacral Colpopexy | Transvaginal Mesh | Total |
|---|---|---|---|---|
| Female | 123 | 121 | 116 | 360 |
| Race/Ethnicity, Customized(Participants) | Native Tissue | Sacral Colpopexy | Transvaginal Mesh | Total |
|---|---|---|---|---|
| American Indian/Alaskan Native | 5 | 1 | 0 | 6 |
| Asian | 1 | 1 | 1 | 3 |
| Black/African American | 10 | 13 | 12 | 35 |
| More than one race | 2 | 0 | 1 | 3 |
| Other | 4 | 4 | 3 | 11 |
| White | 101 | 102 | 99 | 302 |
| Race/Ethnicity, Customized(Participants) | Native Tissue | Sacral Colpopexy | Transvaginal Mesh | Total |
|---|---|---|---|---|
| Hispanic or Latino | 21 | 15 | 12 | 48 |
| Not Hispanic or Latino | 98 | 103 | 104 | 305 |
| Unknown/ Not Reported | 4 | 3 | 0 | 7 |
| Marital Status(Participants) | Native Tissue | Sacral Colpopexy | Transvaginal Mesh | Total |
|---|---|---|---|---|
| Divorced/ Separated | 26 | 21 | 12 | 59 |
| MARRIED, HUSBAND IN LOUISIANA | 0 | 1 | 0 | 1 |
| Married /Living with partner | 82 | 77 | 85 | 244 |
| Single (never been married) | 7 | 8 | 4 | 19 |
| Widowed | 8 | 14 | 15 | 37 |
| Education(Participants) | Native Tissue | Sacral Colpopexy | Transvaginal Mesh | Total |
|---|---|---|---|---|
| 4-Year College Degree | 24 | 23 | 23 | 70 |
| Associate College Degree | 28 | 34 | 35 | 97 |
| Graduate Degree | 11 | 12 | 5 | 28 |
| High School/GED | 47 | 39 | 40 | 126 |
| Less than High School | 10 | 9 | 11 | 30 |
| Unknown/ Not Reported | 3 | 4 | 2 | 9 |
| Body Mass Index(kg/m^2) | Native Tissue | Sacral Colpopexy | Transvaginal Mesh | Total |
|---|---|---|---|---|
| Mean | 27.9 ± 5.5 | 29.5 ± 6.4 | 28.7 ± 5.1 | 28.7 ± 5.8 |
| Current Smoker(Participants) | Native Tissue | Sacral Colpopexy | Transvaginal Mesh | Total |
|---|---|---|---|---|
| No | 90 | 92 | 78 | 260 |
| Unknown | 25 | 22 | 27 | 74 |
| Yes | 8 | 7 | 11 | 26 |
2 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
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NICHD Pelvic Floor Disorders Network