An interventional study of Enrollment video and SSLF in Pelvic Organ Prolapse, sponsored by NICHD Pelvic Floor Disorders Network. Completed at 7 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-28.
Sponsored by NICHD Pelvic Floor Disorders Network · Not applicable, Interventional, and Other
Women will be invited to participate in E-OPTIMAL at their last clinical follow-up visit for OPTIMAL (at 24 months post surgery). E-OPTIMAL is an extension of the ongoing OPTIMAL study and no new study treatment interventions will be given. Rather an enrollment intervention will be investigated with potential E-OPTIMAL participants randomly assigned to watch a standardized video prior to consent or undergo the standard informed consent process. The standardized video will review the rationale for women's health research, the importance of long-term follow-up and a detailed invitation to participate in E-OPTIMAL. The video has undergone review by potential subjects, coordinators and physician researchers to ensure that the relevance and importance of issues potentially impacting on long-term participation in studies such as E-OPTIMAL are covered. Participation in E-OPTIMAL will occur up to three additional years. Women will be strongly encouraged to participate in annual examinations and annual telephone surveys but may participate in only one of these study parts if needed.
We propose to test the following null hypotheses:
The goal of this long-term follow-up study is to extend the follow-up of women in the OPTIMAL study up to 5 years from the time of surgery and to compare the success and complication rates of the two surgical treatment groups over this extended time period. The Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) study is a randomized trial designed to compare sacrospinous ligament fixation (SSLF) to uterosacral vaginal vault ligament suspension (ULS) and to assess the role of perioperative behavioral therapy/pelvic muscle training (PMT) in women undergoing vaginal surgery for apical or uterine prolapse and stress urinary incontinence (SUI).
The OPTIMAL study includes a two-year follow up from the time of surgery, which is too short to evaluate the long-term sequelae of the surgical procedures. A further goal of E-OPTIMAL is to investigate a strategy for improving enrollment and retention in long-term studies of women undergoing surgery for pelvic organ prolapse and SUI, by randomizing subjects to two different recruitment methods.
The primary aims of this extension study are to compare SSLF and ULS for the following outcomes up to 5 years after surgery in women with Stage 2-4 prolapse involving the vaginal apex or uterus and stress urinary incontinence:
An additional primary aim (aim 4) is to determine whether exposure to a standardized video detailing the importance of long-term follow-up studies for pelvic organ prolapse prior to the informed consent process will improve enrollment and/or retention in E-OPTIMAL. We will utilize a conceptual framework that assesses three concepts (motivation, barriers and pragmatic issues) at two levels (study level and personal/individual level). This conceptual framework was developed following a review of the scant available literature on the topic, as well as during discussions with investigators who are experienced in recruiting and retaining participants in pelvic floor disorders studies.
676 studies on the registry are indexed under Prolapse; 79 are open to participants now.
This study's enrollment of 285 is above the median of 74 across 435 interventional studies indexed under Prolapse.
Browse 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:
Criteria for termination of participation:
(Due to evidence or likelihood that the subject can no longer consent for herself)
Note: Subjects that are unable to complete telephone interviews (for example, because of hearing loss) may complete the interview portion of the survey in person, either at the site or in the home.
Arm of subjects that will be shown a standardized video detailing the importance of long-term follow-up studies for pelvic organ prolapse prior to the informed consent process.
Behavioral: Enrollment video
This group of subjects will not view a standardized video detailing the importance of long-term follow-up studies for pelvic organ prolapse prior to the informed consent process.
Uterosacral Ligament Suspension was one of the randomized surgical treatments in the OPTIMAL study
Procedure: ULS
Sacrospinous Ligament Fixation was one of the randomized surgical treatments in the OPTIMAL study.
Procedure: SSLF
Perioperative Behavioral Therapy/Pelvic Muscle Training was one of the randomized non-surgical (behavioral) interventions in the OPTIMAL study.
Behavioral: PMT
No Perioperative Behavioral Therapy/Pelvic Muscle Training (i.e., usual care) was one of the randomized non-surgical (behavioral) interventions in the OPTIMAL study.
Other: Usual Care
Standardized video detailing the importance of long-term follow-up studies for pelvic organ prolapse prior to the informed consent process
sacrospinous ligament fixation to suspend the vaginal apex
uterosacral ligament suspension to suspend the vaginal apex
perioperative behavioral therapy / pelvic muscle training with formal individualized PMT program that begins two to four weeks prior to surgery and continues for three months after surgery
usual care both before and after prolapse surgery with respect to pelvic muscle training
Surgical Failure
Surgical failure was defined as Pelvic Organ Prolapse Quantification (POP-Q) point C descended more than one-third of total vaginal length; POPQ points Aa, Ba, Ap, or Bp were beyond the hymen; bothersome vaginal bulge symptoms were reported by the participant; or the participant received retreatment. The apex is point C (cervix), and posteriorly is point D (pouch of Douglas). In women after hysterectomy, point C is the vaginal cuff and point D is omitted. This outcome measure is cumulatively across the original OPTIMAL trial and continued through the E-OPTIMAL follow-up with non-failures tracked either until failure or until study completion/dropping out of the study (lost to follow-up, withdrawal, etc.)
Time frame: 6 months and 1, 2, 3, 4, and 5 years
Recruitment Into E-OPTIMAL
Eligible OPTIMAL participants were to receive a video (or no video) about the importance of follow-up in clinical trials. The outcome is measured as the number of OPTIMAL participants that consented to participate in E-OPTIMAL.
Time frame: At 24 Months post OPTIMAL Treatment
Retention in E-OPTIMAL
Retention is defined as those participants who consented to participate in E-OPTIMAL that remained in the E-OPTIMAL study (i.e. completed follow-up visits and were not otherwise dropped from the study).
Time frame: 3, 4, and 5 Years Post OPTIMAL Treatment
Anatomic Failure
Anatomic failure was defined as POPQ system point C descended more than one-third of total vaginal length; POPQ points Aa, Ba, Ap, or Bp were beyond the hymen; or the participant received retreatment during follow-up. This outcome measure is cumulative across the original OPTIMAL trial and continued through the E-OPTIMAL follow-up with non-failures tracked either until failure or until study completion/dropping out of the study (lost to follow-up, withdrawal, etc.)
Time frame: 6 months and 1, 2, 3, 4, and 5 years
Bothersome Bulge Symptoms
Bothersome bulge symptoms were reported by the participant in response to the questions, 'Do you usually have a sensation of bulging or protrusion from the vaginal area?' or 'Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?' on the Pelvic Floor Disorders Inventory. An answer of "Yes" to either question indicates a failure while an answer to "No" for both questions indicates a non-failure.This outcome measure is cumulative across the original OPTIMAL trial and continued through the E-OPTIMAL follow-up with non-failures tracked either until failure or until study completion/dropping out of the study (lost to follow-up, withdrawal, etc.)
Time frame: 6 months and 1, 2, 3, 4, and 5 years
Retreatment for Pelvic Organ Prolapse
Retreatment is defined as any additional POP surgery or the use of pessary. This outcome measure is cumulative across the original OPTIMAL trial and continued through the E-OPTIMAL follow-up with non-retreatments tracked either until retreatment or until study completion/dropping out of the study (lost to follow-up, withdrawal, etc.)
Time frame: 6 months and 1, 2, 3, 4, and 5 years
Number of Participants With Granulation Tissue
Cumulative number of participants with granulation tissue. Granulation tissue was reported on the adverse event log.
Time frame: 2, 3, 4, and 5 years
Number of Participants With Suture Exposure
Cumulative number of participants with suture exposure. Suture exposure was reported on the adverse event log.
Time frame: 2, 3, 4, and 5 years
Number of Participants With Midurethral Sling Erosion or Exposure
Cumulative number of participants with mesh erosion or exposure. Mesh erosion and exposure was reported on the adverse event log.
Time frame: 2, 3, 4, and 5 years
Number of Participants With Pelvic Organ Prolapse Surgery
Cumulative number of participants with pelvic organ prolapse. Pelvic organ prolapse was reported on the adverse event log.
Time frame: 2, 3, 4, and 5 years
PGI-I
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).This outcome measure is shows results from the original OPTIMAL trial as well as results from the E-OPTIMAL trial (for those that consented to the extended follow-up)
Time frame: 6 months, and 1, 2, 3, 4, and 5 years
Change From Baseline CRAIQ Score
The Pelvic Floor Impact Questionnaire measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales: the Urinary Impact Questionnaire (UIQ; 4 subscales, range 0-400), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; 4 subscales, range 0-400), and the Colorectal-Anal Impact Questionnaire (CRAIQ; 4 subscales, range 0-400). Scores are calculated by multiplying the mean value of all answered questions for a subscale by 100 divided by 3. The subscales are then added together. The range of responses is: 0-400 with 0 (least negative impact) to 400 (most negative impact). Change = (Year \[0.5, 1, 2, 3, 4, 5\] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Time frame: 6 months, and 1, 2, 3, 4, and 5 years
Change From Baseline POPIQ Score
The Pelvic Floor Impact Questionnaire measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales: the Urinary Impact Questionnaire (UIQ; 4 subscales, range 0-400), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; 4 subscales, range 0-400), and the Colorectal-Anal Impact Questionnaire (CRAIQ; 4 subscales, range 0-400). Scores are calculated by multiplying the mean value of all answered questions for a subscale by 100 divided by 3. The subscales are then added together. The range of responses is: 0-400 with 0 (least negative impact) to 400 (most negative impact). Change = (Year \[0.5, 1, 2, 3, 4, 5\] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Time frame: 6 months, and 1, 2, 3, 4, and 5 years
Change From Baseline UIQ Score
The Pelvic Floor Impact Questionnaire measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales: the Urinary Impact Questionnaire (UIQ; 4 subscales, range 0-400), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; 4 subscales, range 0-400), and the Colorectal-Anal Impact Questionnaire (CRAIQ; 4 subscales, range 0-400). Scores are calculated by multiplying the mean value of all answered questions for a subscale by 100 divided by 3. The subscales are then added together. The range of responses is: 0-400 with 0 (least negative impact) to 400 (most negative impact). Change = (Year \[0.5, 1, 2, 3, 4, 5\] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Time frame: 6 months, and 1, 2, 3, 4, and 5 years
Change From Baseline CRADI Score
The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (with 3 subscales), 2. Colorectal Anal Distress Inventory (with 4 subscales), and 3. Urinary Distress Inventory (with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of responses for the CRADI is: 0-400 with 0 (least distress) to 400 (most distress). Change = (Year \[0.5, 1, 2, 3, 4, 5\] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Time frame: 6 months, and 1, 2, 3, 4, and 5 years
Change From Baseline POPDI Score
The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (with 3 subscales), 2. Colorectal Anal Distress Inventory (with 4 subscales), and 3. Urinary Distress Inventory (with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of POPDI responses is: 0-300 with 0 (least distress) to 300 (most distress). Change = (Year \[0.5, 1, 2, 3, 4, 5\] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Time frame: 6 months, and 1, 2, 3, 4, and 5 years
Change From Baseline UDI Score
The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (with 3 subscales), 2. Colorectal Anal Distress Inventory (with 4 subscales), and 3. Urinary Distress Inventory (with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of UDI responses is: 0-300 with 0 (least distress) to 300 (most distress). Change = (Year \[0.5, 1, 2, 3, 4, 5\] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Time frame: 6 months, and 1, 2, 3, 4, and 5 years
Change From Baseline Hunskaar Score
The Hunskaar Urinary Incontinence assessment measures the severity of a participant's urinary incontinence. Scores range from 1 to 8 with higher score indicating more severe incontinence. Change = (Year \[0.5, 1, 2, 3, 4, 5\] Score - Baseline Score).
Time frame: 6 months, and 1, 2, 3, 4, and 5 years
Change From Baseline SF-36 Physical Health Score
The health assessment questionnaire Short Form 36 Version (SF-36) determines participants' overall quality of life by assessing 1. limitations in physical functioning due to health problems; 2. limitations in usual role because of physical health problems; 3. bodily pain; 4. general health perceptions; 5. vitality; 6. limitations in social functioning because of physical or emotional problems; 7. limitations in usual role due to emotional problems; and 8. general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 "worst" - 100 "best"). Change = (Year \[0.5, 1, 2, 3, 4, 5\] Score - Baseline Score).
Time frame: 6 months, and 1, 2, 3, 4, and 5 years
Change From Baseline SF-36 Mental Health Score
The health assessment questionnaire Short Form 36 Version (SF-36) determines participants' overall quality of life by assessing 1. limitations in physical functioning due to health problems; 2. limitations in usual role because of physical health problems; 3. bodily pain; 4. general health perceptions; 5. vitality; 6. limitations in social functioning because of physical or emotional problems; 7. limitations in usual role due to emotional problems; and 8. general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 "worst" - 100 "best"). Change = (Year \[0.5, 1, 2, 3, 4, 5\] Score - Baseline Score).
Time frame: 6 months, and 1, 2, 3, 4, and 5 years
Change From Baseline Brink Score
The Brink scale considers three pelvic floor muscle contraction variables: vaginal pressure or muscle force, elevation or vertical displacement of the examiner fingers, and duration of contraction. The score ranges from 3 to 12 with higher scores indicating greater PFM function. Change = (Year \[0.5, 2, 3, 4, 5\] Score - Baseline Score).
Time frame: 6 months, and 2, 3, 4, and 5 years
POP-Q Point Ba
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). The range for point Ba is -3 to total vaginal length (TVL). 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. For Point Ba, better vaginal support is assigned a negative value (ie, if there is no prolapse, point Ba is -3 cm by definition). Vaginal prolapse beyond the hymen, indicating worse vaginal support, is assigned a positive value (this may be equal to the total vaginal length at the maximum).
Time frame: 6 months, and 1, 2, 3, 4, and 5 years
POP-Q Point Bp
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). It ranges from -3 to total vaginal length (TVL). Negative values indicate vaginal support above the hymen, so the more negative number the closer to normal/perfect support; positive values show prolapse beyond the hymen, so larger positive numbers are worse prolapse.
Time frame: 6 months, and 1, 2, 3, 4, and 5 years
POP-Q Point C
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. It ranges from -TVL to +TVL. Negative values indicate vaginal support above the hymen, so the more negative number the closer to normal/perfect support; positive values show prolapse beyond the hymen, so larger positive numbers are worse prolapse.
Time frame: 6 months, and 1 2, 3, 4, and 5 years
The goal of the video/no video intervention was to gauge differences in recruitment for and retention in E-OPTIMAL, thus the video/no video randomization occurred before E-OPTIMAL consent.
| Milestone | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL |
|---|---|---|---|---|
| Started | 95 | 91 | 91 | 97 |
| Completed optimal year 2 visit | 81 | 80 | 79 | 87 |
| Randomized to video | 32 | 43 | 38 | 40 |
| Randomized to no video | 45 | 30 | 34 | 42 |
| Consented to participate e-optimal | 72 | 66 | 69 | 78 |
| Completed e-optimal year 3 visit | 70 | 66 | 66 | 77 |
| Completed e-optimal year 4 visit | 67 | 61 | 63 | 68 |
| Completed e-optimal year 5 visit | 62 | 56 | 62 | 64 |
| Completed | 90 | 87 | 87 | 92 |
| Not completed | 5 | 4 | 4 | 5 |
| Withdrew: Lost to follow-up | 3 | 2 | 2 | 2 |
| Withdrew: Withdrawal by subject | 1 | 2 | 2 | 3 |
| Withdrew: Physician decision | 1 | 0 | 0 | 0 |
Surgical failure was defined as Pelvic Organ Prolapse Quantification (POP-Q) point C descended more than one-third of total vaginal length; POPQ points Aa, Ba, Ap, or Bp were beyond the hymen; bothersome vaginal bulge symptoms were reported by the participant; or the participant received retreatment. The apex is point C (cervix), and posteriorly is point D (pouch of Douglas). In women after hysterectomy, point C is the vaginal cuff and point D is omitted. This outcome measure is cumulatively across the original OPTIMAL trial and continued through the E-OPTIMAL follow-up with non-failures tracked either until failure or until study completion/dropping out of the study (lost to follow-up, withdrawal, etc.)
| Participants | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL |
|---|---|---|---|---|
| 0.5 years — Failure | 17 | 22 | 20 | 14 |
| 0.5 years — Non-failure | 73 | 65 | 66 | 77 |
| 1 years — Failure | 28 | 35 | 30 | 29 |
| 1 years — Non-failure | 58 | 51 | 56 | 62 |
| 2 years — Failure | 31 | 45 | 39 | 37 |
| 2 years — Non-failure | 51 | 39 | 44 | 52 |
| 3 years — Failure | 37 | 52 | 46 | 41 |
| 3 years — Non-failure | 39 | 26 | 31 | 40 |
| 4 years — Failure | 41 | 55 | 49 | 43 |
| 4 years — Non-failure | 30 | 22 | 26 | 32 |
| 5 years — Failure | 47 | 57 | 49 | 45 |
| 5 years — Non-failure | 22 | 20 | 26 | 25 |
Eligible OPTIMAL participants were to receive a video (or no video) about the importance of follow-up in clinical trials. The outcome is measured as the number of OPTIMAL participants that consented to participate in E-OPTIMAL.
| Participants | Enrollment Video Arm | No Video Intervention Arm |
|---|---|---|
| Consented to E-OPTIMAL | 142 | 143 |
| Did not Consent to E-OPTIMAL | 11 | 8 |
Retention is defined as those participants who consented to participate in E-OPTIMAL that remained in the E-OPTIMAL study (i.e. completed follow-up visits and were not otherwise dropped from the study).
| Participants | Enrollment Video Arm | No Video Intervention Arm |
|---|---|---|
| 3-Year Follow-up — Retained | 139 | 135 |
| 3-Year Follow-up — Not Retained | 3 | 8 |
| 4-Year Follow-up — Retained | 131 | 124 |
| 4-Year Follow-up — Not Retained | 11 | 19 |
| 5-Year Follow-up — Retained | 124 | 120 |
| 5-Year Follow-up — Not Retained | 18 | 23 |
Anatomic failure was defined as POPQ system point C descended more than one-third of total vaginal length; POPQ points Aa, Ba, Ap, or Bp were beyond the hymen; or the participant received retreatment during follow-up. This outcome measure is cumulative across the original OPTIMAL trial and continued through the E-OPTIMAL follow-up with non-failures tracked either until failure or until study completion/dropping out of the study (lost to follow-up, withdrawal, etc.)
| Participants | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL |
|---|---|---|---|---|
| 0.5 years — Failure | 10 | 12 | 13 | 11 |
| 0.5 years — Non-failure | 80 | 74 | 72 | 80 |
| 1 years — Failure | 18 | 23 | 19 | 25 |
| 1 years — Non-failure | 67 | 61 | 65 | 66 |
| 2 years — Failure | 23 | 31 | 25 | 29 |
| 2 years — Non-failure | 59 | 50 | 55 | 58 |
| 3 years — Failure | 29 | 37 | 31 | 31 |
| 3 years — Non-failure | 46 | 33 | 40 | 47 |
| 4 years — Failure | 33 | 40 | 32 | 33 |
| 4 years — Non-failure | 36 | 29 | 36 | 38 |
| 5 years — Failure | 38 | 42 | 33 | 35 |
| 5 years — Non-failure | 28 | 26 | 34 | 31 |
Bothersome bulge symptoms were reported by the participant in response to the questions, 'Do you usually have a sensation of bulging or protrusion from the vaginal area?' or 'Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?' on the Pelvic Floor Disorders Inventory. An answer of "Yes" to either question indicates a failure while an answer to "No" for both questions indicates a non-failure.This outcome measure is cumulative across the original OPTIMAL trial and continued through the E-OPTIMAL follow-up with non-failures tracked either until failure or until study completion/dropping out of the study (lost to follow-up, withdrawal, etc.)
| Participants | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL |
|---|---|---|---|---|
| 0.5 years — Failure | 10 | 12 | 8 | 5 |
| 0.5 years — Non-failure | 80 | 73 | 76 | 88 |
| 1 years — Failure | 21 | 19 | 15 | 9 |
| 1 years — Non-failure | 68 | 64 | 67 | 81 |
| 2 years — Failure | 24 | 27 | 21 | 17 |
| 2 years — Non-failure | 61 | 56 | 58 | 69 |
| 3 years — Failure | 27 | 29 | 28 | 20 |
| 3 years — Non-failure | 47 | 45 | 43 | 55 |
| 4 years — Failure | 27 | 32 | 31 | 22 |
| 4 years — Non-failure | 45 | 40 | 39 | 46 |
| 5 years — Failure | 30 | 34 | 33 | 23 |
| 5 years — Non-failure | 36 | 34 | 35 | 42 |
Retreatment is defined as any additional POP surgery or the use of pessary. This outcome measure is cumulative across the original OPTIMAL trial and continued through the E-OPTIMAL follow-up with non-retreatments tracked either until retreatment or until study completion/dropping out of the study (lost to follow-up, withdrawal, etc.)
| Participants | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL |
|---|---|---|---|---|
| 0.5 years — Retreated | 1 | 0 | 1 | 0 |
| 0.5 years — Not retreated | 90 | 86 | 82 | 92 |
| 1 years — Retreated | 2 | 3 | 2 | 2 |
| 1 years — Not retreated | 83 | 82 | 79 | 87 |
| 2 years — Retreated | 5 | 3 | 6 | 2 |
| 2 years — Not retreated | 76 | 77 | 73 | 85 |
| 3 years — Retreated | 7 | 3 | 10 | 2 |
| 3 years — Not retreated | 61 | 59 | 55 | 68 |
| 4 years — Retreated | 7 | 4 | 10 | 5 |
| 4 years — Not retreated | 52 | 51 | 52 | 52 |
| 5 years — Retreated | 8 | 4 | 10 | 6 |
| 5 years — Not retreated | 52 | 50 | 51 | 53 |
Cumulative number of participants with granulation tissue. Granulation tissue was reported on the adverse event log.
| Participants | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL |
|---|---|---|---|---|
| 2 years — No | 58 | 60 | 52 | 63 |
| 2 years — Yes | 14 | 6 | 17 | 15 |
| 3 years — No | 54 | 54 | 48 | 56 |
| 3 years — Yes | 14 | 6 | 17 | 15 |
| 4 years — No | 49 | 49 | 43 | 50 |
| 4 years — Yes | 14 | 6 | 18 | 16 |
| 5 years — No | 43 | 48 | 41 | 45 |
| 5 years — Yes | 15 | 6 | 19 | 16 |
Cumulative number of participants with suture exposure. Suture exposure was reported on the adverse event log.
| Participants | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL |
|---|---|---|---|---|
| 2 years — No | 57 | 55 | 60 | 60 |
| 2 years — Yes | 15 | 11 | 9 | 18 |
| 3 years — No | 53 | 50 | 57 | 52 |
| 3 years — Yes | 16 | 11 | 9 | 19 |
| 4 years — No | 49 | 44 | 51 | 46 |
| 4 years — Yes | 17 | 12 | 10 | 20 |
| 5 years — No | 42 | 42 | 49 | 40 |
| 5 years — Yes | 17 | 12 | 11 | 20 |
Cumulative number of participants with mesh erosion or exposure. Mesh erosion and exposure was reported on the adverse event log.
| Participants | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL |
|---|---|---|---|---|
| 2 years — No | 70 | 66 | 68 | 78 |
| 2 years — Yes | 1 | 0 | 1 | 0 |
| 3 years — No | 65 | 59 | 63 | 70 |
| 3 years — Yes | 2 | 1 | 1 | 0 |
| 4 years — No | 60 | 53 | 58 | 63 |
| 4 years — Yes | 3 | 1 | 1 | 0 |
| 5 years — No | 53 | 51 | 54 | 57 |
| 5 years — Yes | 3 | 1 | 2 | 0 |
Cumulative number of participants with pelvic organ prolapse. Pelvic organ prolapse was reported on the adverse event log.
| Participants | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL |
|---|---|---|---|---|
| 2 years — No | 72 | 64 | 67 | 76 |
| 2 years — Yes | 0 | 2 | 2 | 2 |
| 3 years — No | 64 | 59 | 58 | 68 |
| 3 years — Yes | 1 | 2 | 5 | 2 |
| 4 years — No | 55 | 51 | 55 | 53 |
| 4 years — Yes | 1 | 3 | 5 | 4 |
| 5 years — No | 55 | 50 | 54 | 54 |
| 5 years — Yes | 2 | 3 | 5 | 5 |
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).This outcome measure is shows results from the original OPTIMAL trial as well as results from the E-OPTIMAL trial (for those that consented to the extended follow-up)
| Participants | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL |
|---|---|---|---|---|
| 0.5 years — A little better | 12 | 11 | 10 | 12 |
| 0.5 years — A little worse | 5 | 2 | 5 | 5 |
| 0.5 years — Much better | 23 | 22 | 17 | 20 |
| 0.5 years — Much worse | 1 | 1 | 1 | 1 |
| 0.5 years — No change | 2 | 1 | 2 | 3 |
| 0.5 years — Very much better | 26 | 26 | 29 | 31 |
| 0.5 years — Very much worse | 0 | 1 | 1 | 2 |
| 1 years — A little better | 13 | 10 | 6 | 6 |
| 1 years — A little worse | 4 | 1 | 2 | 6 |
| 1 years — Much better | 22 | 24 | 18 | 28 |
| 1 years — Much worse | 0 | 0 | 1 | 0 |
| 1 years — No change | 4 | 2 | 5 | 4 |
| 1 years — Very much better | 26 | 25 | 30 | 27 |
| 1 years — Very much worse | 1 | 0 | 2 | 1 |
| 2 years — A little better | 14 | 14 | 9 | 13 |
| 2 years — A little worse | 3 | 5 | 6 | 3 |
| 2 years — Much better | 20 | 20 | 20 | 25 |
| 2 years — Much worse | 3 | 0 | 0 | 1 |
| 2 years — No change | 4 | 1 | 3 | 4 |
| 2 years — Very much better | 21 | 21 | 25 | 23 |
| 2 years — Very much worse | 1 | 0 | 2 | 1 |
| 3 years — A little better | 5 | 19 | 10 | 13 |
| 3 years — A little worse | 7 | 3 | 5 | 6 |
| 3 years — Much better | 18 | 24 | 17 | 23 |
| 3 years — Much worse | 6 | 2 | 0 | 3 |
| 3 years — No change | 5 | 2 | 4 | 1 |
| 3 years — Very much better | 23 | 10 | 21 | 21 |
| 3 years — Very much worse | 0 | 0 | 3 | 1 |
| 4 years — A little better | 9 | 14 | 7 | 16 |
| 4 years — A little worse | 4 | 6 | 1 | 2 |
| 4 years — Much better | 21 | 19 | 14 | 19 |
| 4 years — Much worse | 4 | 1 | 4 | 1 |
| 4 years — No change | 3 | 2 | 4 | 2 |
| 4 years — Very much better | 13 | 12 | 19 | 19 |
| 4 years — Very much worse | 2 | 0 | 3 | 1 |
| 5 years — A little better | 13 | 16 | 13 | 11 |
| 5 years — A little worse | 2 | 4 | 4 | 5 |
| 5 years — Much better | 17 | 19 | 12 | 21 |
| 5 years — Much worse | 4 | 0 | 6 | 2 |
| 5 years — No change | 4 | 5 | 3 | 3 |
| 5 years — Very much better | 12 | 11 | 18 | 15 |
| 5 years — Very much worse | 2 | 0 | 1 | 2 |
The Pelvic Floor Impact Questionnaire measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales: the Urinary Impact Questionnaire (UIQ; 4 subscales, range 0-400), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; 4 subscales, range 0-400), and the Colorectal-Anal Impact Questionnaire (CRAIQ; 4 subscales, range 0-400). Scores are calculated by multiplying the mean value of all answered questions for a subscale by 100 divided by 3. The subscales are then added together. The range of responses is: 0-400 with 0 (least negative impact) to 400 (most negative impact). Change = (Year \[0.5, 1, 2, 3, 4, 5\] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
| units on a scale | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL |
|---|---|---|---|---|
| 0.5 years | -71.3 (-95.5 to -47.1) | -45.5 (-65.8 to -25.2) | -35 (-55.6 to -14.4) | -66.8 (-89.3 to -44.3) |
| 1 years | -73.3 (-98.3 to -48.3) | -43.4 (-63.1 to -23.7) | -37.6 (-63.5 to -11.7) | -60.5 (-83.4 to -37.6) |
| 2 years | -47.5 (-77.7 to -17.3) | -25.1 (-49 to -1.2) | -19.2 (-45.8 to 7.4) | -38.9 (-57.7 to -20.1) |
| 3 years | -54.6 (-81.7 to -27.5) | -20.9 (-38.2 to -3.5) | -12.9 (-39.3 to 13.5) | -36.1 (-56.7 to -15.6) |
| 4 years | -40 (-71.7 to -8.2) | -16.6 (-42.4 to 9.2) | -8.5 (-39.7 to 22.7) | -39.1 (-61.1 to -17) |
| 5 years | -35.7 (-62.9 to -8.5) | -14.8 (-39.2 to 9.7) | 7.4 (-21.8 to 36.5) | -22.7 (-51 to 5.7) |
The Pelvic Floor Impact Questionnaire measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales: the Urinary Impact Questionnaire (UIQ; 4 subscales, range 0-400), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; 4 subscales, range 0-400), and the Colorectal-Anal Impact Questionnaire (CRAIQ; 4 subscales, range 0-400). Scores are calculated by multiplying the mean value of all answered questions for a subscale by 100 divided by 3. The subscales are then added together. The range of responses is: 0-400 with 0 (least negative impact) to 400 (most negative impact). Change = (Year \[0.5, 1, 2, 3, 4, 5\] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
| units on a scale | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL |
|---|---|---|---|---|
| 0.5 years | -95 (-123.3 to -66.7) | -61.3 (-85.6 to -37) | -55.2 (-79.5 to -30.9) | -98.6 (-122.9 to -74.4) |
| 1 years | -100.2 (-130.5 to -70) | -68.8 (-91 to -46.6) | -58.9 (-86 to -31.8) | -95.9 (-122.1 to -69.7) |
| 2 years | -68.9 (-102.5 to -35.3) | -56.6 (-77.9 to -35.3) | -42.8 (-71.1 to -14.4) | -79.3 (-101.4 to -57.2) |
| 3 years | -82.6 (-112 to -53.2) | -48.7 (-66.6 to -30.8) | -29.3 (-57.3 to -1.3) | -76.9 (-99.2 to -54.6) |
| 4 years | -84.5 (-121.8 to -47.2) | -42.3 (-64.1 to -20.6) | -32.9 (-61.7 to -4.1) | -73 (-98.6 to -47.5) |
| 5 years | -72.1 (-103.2 to -41.1) | -50.3 (-71.8 to -28.8) | -16.8 (-43.7 to 10.2) | -71.9 (-98.2 to -45.5) |
The Pelvic Floor Impact Questionnaire measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales: the Urinary Impact Questionnaire (UIQ; 4 subscales, range 0-400), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; 4 subscales, range 0-400), and the Colorectal-Anal Impact Questionnaire (CRAIQ; 4 subscales, range 0-400). Scores are calculated by multiplying the mean value of all answered questions for a subscale by 100 divided by 3. The subscales are then added together. The range of responses is: 0-400 with 0 (least negative impact) to 400 (most negative impact). Change = (Year \[0.5, 1, 2, 3, 4, 5\] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
| units on a scale | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL |
|---|---|---|---|---|
| 0.5 years | -107.7 (-133.9 to -81.6) | -85.4 (-108.7 to -62.1) | -77.3 (-102.1 to -52.4) | -116.4 (-138.6 to -94.2) |
| 1 years | -116.3 (-143.3 to -89.3) | -92 (-113 to -71) | -84.3 (-110.2 to -58.3) | -121.8 (-146.2 to -97.4) |
| 2 years | -90.3 (-122.8 to -57.8) | -80.4 (-102.1 to -58.6) | -67.7 (-95.7 to -39.8) | -99.1 (-121.4 to -76.8) |
| 3 years | -94.3 (-120.7 to -67.9) | -69.1 (-87.6 to -50.7) | -59 (-84 to -34) | -92.3 (-116.4 to -68.2) |
| 4 years | -89.5 (-124.7 to -54.3) | -68.3 (-89.8 to -46.7) | -59.2 (-87 to -31.3) | -90.3 (-117.2 to -63.4) |
| 5 years | -75.9 (-106 to -45.7) | -72.1 (-95.2 to -49) | -47.8 (-74 to -21.7) | -84.8 (-113 to -56.6) |
The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (with 3 subscales), 2. Colorectal Anal Distress Inventory (with 4 subscales), and 3. Urinary Distress Inventory (with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of responses for the CRADI is: 0-400 with 0 (least distress) to 400 (most distress). Change = (Year \[0.5, 1, 2, 3, 4, 5\] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
| units on a scale | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL |
|---|---|---|---|---|
| 0.5 years | -72.3 (-88.2 to -56.4) | -71.8 (-88.7 to -54.8) | -69.6 (-87.8 to -51.4) | -56.3 (-73.7 to -38.9) |
| 1 years | -64.1 (-81 to -47.2) | -67.5 (-85.6 to -49.5) | -77.7 (-95.7 to -59.7) | -63.3 (-81.3 to -45.4) |
| 2 years | -46.2 (-68.8 to -23.6) | -49.1 (-70.5 to -27.6) | -62 (-81.3 to -42.8) | -50.4 (-68.9 to -31.8) |
| 3 years | -45.3 (-68.4 to -22.2) | -53.1 (-73.6 to -32.6) | -48.7 (-69.1 to -28.3) | -44.7 (-63.4 to -26.1) |
| 4 years | -35.1 (-58 to -12.2) | -54.1 (-75.8 to -32.3) | -44.8 (-69.6 to -19.9) | -48.8 (-71.2 to -26.4) |
| 5 years | -37.4 (-61.1 to -13.7) | -43.1 (-61 to -25.2) | -39.1 (-60.5 to -17.6) | -39.8 (-58.7 to -20.9) |
The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (with 3 subscales), 2. Colorectal Anal Distress Inventory (with 4 subscales), and 3. Urinary Distress Inventory (with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of POPDI responses is: 0-300 with 0 (least distress) to 300 (most distress). Change = (Year \[0.5, 1, 2, 3, 4, 5\] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
| units on a scale | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL |
|---|---|---|---|---|
| 0.5 years | -95.1 (-108.9 to -81.4) | -90.2 (-106.3 to -74.1) | -92.3 (-110.5 to -74.1) | -72.6 (-88.3 to -57) |
| 1 years | -90.6 (-106 to -75.2) | -96 (-112.6 to -79.5) | -91.9 (-110.7 to -73.1) | -81.1 (-93.7 to -68.4) |
| 2 years | -76 (-94.5 to -57.5) | -79.1 (-97.2 to -61.1) | -76.9 (-96.2 to -57.7) | -65.9 (-80.5 to -51.2) |
| 3 years | -69.5 (-86.2 to -52.8) | -77.7 (-93.9 to -61.6) | -66.9 (-87.3 to -46.5) | -61.7 (-77.6 to -45.9) |
| 4 years | -70.7 (-87.3 to -54.1) | -78.3 (-97.8 to -58.8) | -65.1 (-88.4 to -41.9) | -62.8 (-79.5 to -46.1) |
| 5 years | -64.8 (-83.7 to -45.9) | -75.8 (-91.9 to -59.6) | -63.7 (-82.3 to -45.1) | -61.1 (-76.6 to -45.5) |
The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (with 3 subscales), 2. Colorectal Anal Distress Inventory (with 4 subscales), and 3. Urinary Distress Inventory (with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of UDI responses is: 0-300 with 0 (least distress) to 300 (most distress). Change = (Year \[0.5, 1, 2, 3, 4, 5\] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
| units on a scale | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL |
|---|---|---|---|---|
| 0.5 years | -105.7 (-119.3 to -92.2) | -96 (-110 to -82) | -95 (-109.9 to -80.2) | -88.9 (-103.4 to -74.4) |
| 1 years | -102.9 (-118.4 to -87.4) | -95.9 (-110.9 to -80.8) | -94 (-110.3 to -77.7) | -96.8 (-111.3 to -82.3) |
| 2 years | -90.8 (-109 to -72.6) | -89.1 (-104 to -74.2) | -81.2 (-98.6 to -63.9) | -81.3 (-95.4 to -67.2) |
| 3 years | -84.9 (-102 to -67.8) | -75 (-90.3 to -59.7) | -70.5 (-88.2 to -52.8) | -72 (-87.6 to -56.5) |
| 4 years | -81.7 (-101.9 to -61.6) | -76.2 (-93.2 to -59.2) | -70.8 (-89.5 to -52.1) | -75.3 (-91.2 to -59.5) |
| 5 years | -73.9 (-93.3 to -54.6) | -77.9 (-94.2 to -61.5) | -69 (-85.4 to -52.7) | -74.4 (-90.1 to -58.7) |
The Hunskaar Urinary Incontinence assessment measures the severity of a participant's urinary incontinence. Scores range from 1 to 8 with higher score indicating more severe incontinence. Change = (Year \[0.5, 1, 2, 3, 4, 5\] Score - Baseline Score).
| units on a scale | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL |
|---|---|---|---|---|
| 0.5 years | -3.6 (-4.3 to -2.8) | -2.9 (-3.9 to -2) | -3.2 (-4.3 to -2.2) | -3.5 (-4.5 to -2.6) |
| 1 years | -3.6 (-4.5 to -2.6) | -3.3 (-4.2 to -2.4) | -3.4 (-4.5 to -2.4) | -3.2 (-4.1 to -2.3) |
| 2 years | -3 (-4.1 to -2) | -3.2 (-4.1 to -2.2) | -2.8 (-3.8 to -1.8) | -2.7 (-3.7 to -1.8) |
| 3 years | -2.5 (-3.5 to -1.5) | -2.6 (-3.3 to -1.9) | -2.5 (-3.6 to -1.4) | -2.8 (-3.8 to -1.9) |
| 4 years | -2.5 (-3.4 to -1.6) | -2.5 (-3.4 to -1.6) | -2.4 (-3.7 to -1.1) | -2.6 (-3.6 to -1.6) |
| 5 years | -1.6 (-2.8 to -0.4) | -2.6 (-3.4 to -1.8) | -2 (-3.2 to -0.7) | -2.4 (-3.5 to -1.3) |
The health assessment questionnaire Short Form 36 Version (SF-36) determines participants' overall quality of life by assessing 1. limitations in physical functioning due to health problems; 2. limitations in usual role because of physical health problems; 3. bodily pain; 4. general health perceptions; 5. vitality; 6. limitations in social functioning because of physical or emotional problems; 7. limitations in usual role due to emotional problems; and 8. general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 "worst" - 100 "best"). Change = (Year \[0.5, 1, 2, 3, 4, 5\] Score - Baseline Score).
| units on a scale | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL |
|---|---|---|---|---|
| 0.5 years | 7.1 (4.9 to 9.3) | 4.3 (1.4 to 7.2) | 5.6 (3.4 to 7.7) | 7.7 (5.6 to 9.7) |
| 1 years | 8 (5.5 to 10.5) | 5.6 (2.8 to 8.3) | 6.6 (3.9 to 9.3) | 6.8 (4.2 to 9.5) |
| 2 years | 7.6 (5 to 10.3) | 5.2 (2.6 to 7.8) | 4.9 (2.9 to 6.9) | 6.1 (4.1 to 8.1) |
| 3 years | 4.3 (1.8 to 6.9) | 1.1 (-1.8 to 4) | 3.5 (1 to 6) | 3.1 (0.5 to 5.7) |
| 4 years | 4.8 (2 to 7.6) | 0.3 (-2.9 to 3.5) | 2.9 (0 to 5.7) | 2.9 (0.1 to 5.6) |
| 5 years | 3.2 (0.5 to 5.9) | 0.9 (-2.1 to 3.8) | 2.5 (-0.2 to 5.1) | 2.7 (0.2 to 5.2) |
The health assessment questionnaire Short Form 36 Version (SF-36) determines participants' overall quality of life by assessing 1. limitations in physical functioning due to health problems; 2. limitations in usual role because of physical health problems; 3. bodily pain; 4. general health perceptions; 5. vitality; 6. limitations in social functioning because of physical or emotional problems; 7. limitations in usual role due to emotional problems; and 8. general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 "worst" - 100 "best"). Change = (Year \[0.5, 1, 2, 3, 4, 5\] Score - Baseline Score).
| units on a scale | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL |
|---|---|---|---|---|
| 0.5 years | 2.5 (0 to 5) | 3.1 (0.5 to 5.8) | 2.6 (0.1 to 5.2) | 1.3 (-1.6 to 4.2) |
| 1 years | 4.1 (1.5 to 6.7) | 3.4 (0.9 to 6) | 0.6 (-2.4 to 3.6) | 2.7 (-0.6 to 5.9) |
| 2 years | 0.8 (-2 to 3.7) | 2 (-0.5 to 4.4) | 3.1 (0.7 to 5.5) | 1.6 (-1.2 to 4.5) |
| 3 years | 3 (0 to 6) | 2.4 (-0.9 to 5.8) | 1.6 (-1.3 to 4.5) | 2.3 (-0.9 to 5.5) |
| 4 years | 1.4 (-1.2 to 4.1) | 1.7 (-1.3 to 4.6) | 0.5 (-2.2 to 3.1) | 1.2 (-2 to 4.5) |
| 5 years | 3.1 (-0.3 to 6.4) | 1.8 (-2 to 5.5) | 0.8 (-1.9 to 3.4) | 1.2 (-2 to 4.4) |
The Brink scale considers three pelvic floor muscle contraction variables: vaginal pressure or muscle force, elevation or vertical displacement of the examiner fingers, and duration of contraction. The score ranges from 3 to 12 with higher scores indicating greater PFM function. Change = (Year \[0.5, 2, 3, 4, 5\] Score - Baseline Score).
| units on a scale | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL |
|---|---|---|---|---|
| 0.5 years | 0.2 (-0.3 to 0.8) | 0 (-0.5 to 0.5) | 0.6 (0.1 to 1.1) | 0.4 (-0.1 to 0.9) |
| 2 years | -0.1 (-0.6 to 0.4) | 0.1 (-0.5 to 0.6) | 0.4 (0 to 0.8) | 0 (-0.4 to 0.5) |
| 3 years | 0 (-0.6 to 0.6) | -0.3 (-1 to 0.4) | 0.3 (-0.2 to 0.8) | -0.5 (-1 to 0.1) |
| 4 years | 0.1 (-0.5 to 0.8) | -0.5 (-1.1 to 0.2) | 0.2 (-0.3 to 0.8) | -0.5 (-1.1 to 0.1) |
| 5 years | 0.2 (-0.5 to 0.9) | -0.6 (-1.3 to 0.1) | 0.4 (-0.2 to 1) | -0.3 (-0.9 to 0.3) |
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). The range for point Ba is -3 to total vaginal length (TVL). 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. For Point Ba, better vaginal support is assigned a negative value (ie, if there is no prolapse, point Ba is -3 cm by definition). Vaginal prolapse beyond the hymen, indicating worse vaginal support, is assigned a positive value (this may be equal to the total vaginal length at the maximum).
| cm | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL |
|---|---|---|---|---|
| 0.5 years | -1.2 (-1.5 to -0.9) | -1.2 (-1.5 to -0.9) | -1.4 (-1.7 to -1) | -1.3 (-1.6 to -1) |
| 1 years | -0.9 (-1.3 to -0.5) | -1.2 (-1.6 to -0.8) | -1 (-1.3 to -0.7) | -1.2 (-1.5 to -0.9) |
| 2 years | -0.9 (-1.2 to -0.5) | -0.8 (-1.1 to -0.6) | -1.1 (-1.5 to -0.8) | -1.1 (-1.4 to -0.8) |
| 3 years | -1.1 (-1.4 to -0.7) | -0.7 (-1.1 to -0.4) | -0.8 (-1.2 to -0.4) | -1.1 (-1.4 to -0.7) |
| 4 years | -0.8 (-1.2 to -0.3) | -0.9 (-1.3 to -0.6) | -0.8 (-1.3 to -0.3) | -1.1 (-1.5 to -0.7) |
| 5 years | -0.8 (-1.2 to -0.3) | -1 (-1.3 to -0.6) | -0.7 (-1.2 to -0.2) | -0.9 (-1.3 to -0.4) |
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). It ranges from -3 to total vaginal length (TVL). Negative values indicate vaginal support above the hymen, so the more negative number the closer to normal/perfect support; positive values show prolapse beyond the hymen, so larger positive numbers are worse prolapse.
| cm | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL |
|---|---|---|---|---|
| 0.5 years | -2.3 (-2.5 to -2) | -2.5 (-2.7 to -2.3) | -2.2 (-2.5 to -2) | -2.2 (-2.4 to -1.9) |
| 1 years | -2.2 (-2.4 to -2) | -2.4 (-2.6 to -2.2) | -2.2 (-2.4 to -2) | -2.2 (-2.5 to -2) |
| 2 years | -2 (-2.2 to -1.7) | -2.3 (-2.5 to -2.1) | -2.2 (-2.4 to -2) | -2 (-2.3 to -1.8) |
| 3 years | -2.3 (-2.5 to -2) | -2.4 (-2.6 to -2.2) | -2.1 (-2.3 to -1.9) | -2.2 (-2.5 to -1.9) |
| 4 years | -2.2 (-2.4 to -1.9) | -2.3 (-2.5 to -2.1) | -2.2 (-2.4 to -1.9) | -2 (-2.3 to -1.7) |
| 5 years | -2.2 (-2.4 to -2) | -2.3 (-2.5 to -2.1) | -1.9 (-2.4 to -1.4) | -1.9 (-2.2 to -1.6) |
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. It ranges from -TVL to +TVL. Negative values indicate vaginal support above the hymen, so the more negative number the closer to normal/perfect support; positive values show prolapse beyond the hymen, so larger positive numbers are worse prolapse.
| cm | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL |
|---|---|---|---|---|
| 0.5 years | -7.2 (-7.5 to -6.9) | -7.3 (-7.7 to -7) | -6.5 (-7.3 to -5.7) | -7 (-7.4 to -6.7) |
| 1 years | -7 (-7.5 to -6.5) | -6.5 (-7.2 to -5.8) | -6.6 (-7 to -6.2) | -6.8 (-7.2 to -6.3) |
| 2 years | -6.8 (-7.3 to -6.3) | -6.6 (-6.9 to -6.2) | -6.5 (-6.9 to -6) | -6.8 (-7.1 to -6.5) |
| 3 years | -6.9 (-7.2 to -6.5) | -6.4 (-6.7 to -6.1) | -6.3 (-6.9 to -5.8) | -6.3 (-6.6 to -5.9) |
| 4 years | -6.3 (-6.7 to -5.9) | -6.2 (-6.5 to -5.8) | -6.4 (-7 to -5.8) | -6.6 (-7 to -6.2) |
| 5 years | -6.5 (-7.1 to -6) | -6.4 (-6.8 to -6) | -5.8 (-6.5 to -5.1) | -6.6 (-7.1 to -6.2) |
Collected over 2 years through 5 years.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SSLF+BPMT | 1/72 (1.4%) | 0/72 (0%) | 29/72 (40.3%) |
| SSLF+USUAL | 0/66 (0%) | 0/66 (0%) | 17/66 (25.8%) |
| ULS+BPMT | 2/69 (2.9%) | 0/69 (0%) | 27/69 (39.1%) |
| ULS+USUAL | 1/78 (1.3%) | 0/78 (0%) | 34/78 (43.6%) |
| Event | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL |
|---|---|---|---|---|
| Granulation tissueSkin and subcutaneous tissue disorders | 15/72 | 6/66 | 19/69 | 16/78 |
| Suture exposureInjury, poisoning and procedural complications | 17/72 | 12/66 | 11/69 | 20/78 |
| Pelvic organ prolapse surgerySurgical and medical procedures | 2/72 | 3/66 | 5/69 | 5/78 |
| Midurethral sling erosion and exposureInjury, poisoning and procedural complications | 3/72 | 1/66 | 2/69 | 0/78 |
| Age, Continuous(years) | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL | Total |
|---|---|---|---|---|---|
| Mean | 55.4 ± 10.8 | 58.6 ± 10.6 | 58.7 ± 10.5 | 56.3 ± 11.2 | 57.2 ± 10.8 |
| Sex/Gender, Customized(Participants) | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL | Total |
|---|---|---|---|---|---|
| Female | 72 | 66 | 69 | 78 | 285 |
| Race/Ethnicity, Customized(Participants) | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 0 | 0 | 2 |
| Asian | 0 | 2 | 0 | 0 | 2 |
| Black or African American | 7 | 3 | 7 | 4 | 21 |
| Other | 5 | 5 | 4 | 8 | 22 |
| White | 59 | 55 | 58 | 66 | 238 |
| Race/Ethnicity, Customized(Participants) | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL | Total |
|---|---|---|---|---|---|
| Hispanic/Latina | 15 | 10 | 13 | 18 | 56 |
| Not Hispanic/Latina | 57 | 56 | 56 | 60 | 229 |
| Insurance: Private/HMO(Participants) | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL | Total |
|---|---|---|---|---|---|
| No | 70 | 65 | 68 | 76 | 279 |
| Yes | 2 | 1 | 1 | 2 | 6 |
| Insurance: Medicare or Medicaid(Participants) | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL | Total |
|---|---|---|---|---|---|
| No | 55 | 46 | 47 | 56 | 204 |
| Yes | 17 | 20 | 22 | 22 | 81 |
| Insurance: Self-pay(Participants) | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL | Total |
|---|---|---|---|---|---|
| No | 70 | 65 | 68 | 76 | 279 |
| Yes | 2 | 1 | 1 | 2 | 6 |
| Insurance: Other(Participants) | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL | Total |
|---|---|---|---|---|---|
| No | 57 | 55 | 59 | 60 | 231 |
| Yes | 15 | 11 | 10 | 18 | 54 |
13 further baseline measures are reported on the registry.
Plan to share: No
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NICHD Pelvic Floor Disorders Network