An interventional study of synthetic monofilament polypropylene mesh in Pelvic Organ Prolapse, Uterine Prolapse and Vaginal Prolapse, sponsored by Medstar Health Research Institute. Completed at 1 site in United States. Open to female participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2022-10-12.
Sponsored by Medstar Health Research Institute · Not applicable, Interventional, and Treatment
The primary aim of this double-blind, randomized clinical trial (RCT) is to test the hypothesis that the addition of a standardized technique of interpositional synthetic polypropylene mesh placement improves the one-year outcome of vaginal reconstructive surgery for pelvic organ prolapse compared to traditional vaginal reconstructive surgery without mesh.
Minimally invasive surgical procedures using mesh have rapidly developed in the field of pelvic floor reconstruction. Unfortunately, safety and efficacy data have lagged behind the technical advancements. No randomized controlled trials of different vaginal apical suspension procedures have been reported. The use of synthetic vaginal mesh has evolved due to the 20-30% recurrence rate for conventional pelvic reconstructive surgeries. This trial will examine synthetic monofilament polypropylene mesh use in vaginal reconstructive surgery for vaginal Stage II-IV prolapse.
521 studies on the registry are indexed under Pelvic Organ Prolapse; 80 are open to participants now.
This study's enrollment of 65 is below the median of 80 across 336 interventional studies indexed under Pelvic Organ Prolapse.
Browse Pelvic Organ Prolapse studies →Medstar Health Research Institute is the lead sponsor of 161 studies on the registry; 31 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 7 (50%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
vaginal prolapse repair with mesh
Device: synthetic monofilament polypropylene mesh
vaginal prolapse repair without mesh
Device: synthetic monofilament polypropylene mesh
Vaginal prolapse repair with mesh
Also known as: Prolift
Number of Participants With Anatomic Cure at 3 Years
3 different measures for Anatomic cure using POPQ measurements: 1. POP-Q at Stage I or less\* (POP-Q points Ba, Bp or C -1 or less); 2. no prolapse beyond the hymen (Ba, Bp or C 0 or less); 3. no prolapse beyond the hymen (Ba, Bp 0 or less) with adequate apical support above the midvagina (C to TVL/2 or less) No bulge symptoms using Pelvic Floor Distress Inventory, PFDI question 3; do you see or feel a bulge in the vaginal area with response of no. Patient Satisfaction using Patient Global Impression of Improvement with response of very much better or much better
Time frame: 3 year
Bothersome Dyspareunia
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire question 5 response of usually or always and tracked resolution, persistence, de novo dyspareunia
Time frame: 3 year
From January 3, 2007 to August 1, 2009, 238 women were identified as eligible and 65 randomized (32 to experimental group (mesh) and 33 to control group (non-mesh)). All patients completed 3 month followup. Study recruitment halted at median followup of 9.7 months due to pre-determined criteria of vaginal mesh exposure in 5/32 patients (15.6%) in the mesh arm.
| Milestone | Prolift Mesh | Prolapse Repair Without Mesh |
|---|---|---|
| Started | 32 | 33 |
| Completed | 32 | 33 |
| Not completed | 0 | 0 |
| Milestone | Prolift Mesh | Prolapse Repair Without Mesh |
|---|---|---|
| Started | 32 | 33 |
| Completed | 32 | 33 |
| Not completed | 0 | 0 |
| Milestone | Prolift Mesh | Prolapse Repair Without Mesh |
|---|---|---|
| Started | 33 | 32 |
| Completed | 25 | 26 |
| Not completed | 8 | 6 |
| Withdrew: Lost to follow-up | 4 | 4 |
| Withdrew: Death | 1 | 2 |
| Withdrew: Censored due to reoperation | 3 | 0 |
3 different measures for Anatomic cure using POPQ measurements: 1. POP-Q at Stage I or less\* (POP-Q points Ba, Bp or C -1 or less); 2. no prolapse beyond the hymen (Ba, Bp or C 0 or less); 3. no prolapse beyond the hymen (Ba, Bp 0 or less) with adequate apical support above the midvagina (C to TVL/2 or less) No bulge symptoms using Pelvic Floor Distress Inventory, PFDI question 3; do you see or feel a bulge in the vaginal area with response of no. Patient Satisfaction using Patient Global Impression of Improvement with response of very much better or much better
| Participants | Prolift Mesh | Prolapse Repair Without Mesh |
|---|---|---|
| no reoperation/retreatment | 20 | 21 |
| composite stage less than/equal 1, no bulge symptoms, satisfaction very much better or much better | 8 | 8 |
| composite no prolapse beyond hymen, no bulge symptoms, satisfaction very much better or much better | 15 | 12 |
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire question 5 response of usually or always and tracked resolution, persistence, de novo dyspareunia
| Participants | Prolift Mesh | Prolapse Repair Without Mesh |
|---|---|---|
| Persistent dyspareunia | 5 | 5 |
| resolution dyspareunia | 2 | 1 |
| de novo dyspareunia | 2 | 1 |
Collected over 3 months, 1 year, 3 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Prolift Mesh | 1/32 (3.1%) | 5/32 (15.6%) | 0/32 (0%) |
| Prolapse Repair Without Mesh | 2/33 (6.1%) | 0/33 (0%) | 5/33 (15.2%) |
| Event | Prolift Mesh | Prolapse Repair Without Mesh |
|---|---|---|
| Surgery/reoperation for mesh exposureSurgical and medical procedures | 5/32 | 0/33 |
| Event | Prolift Mesh | Prolapse Repair Without Mesh |
|---|---|---|
| suture exposureSurgical and medical procedures | 0/32 | 5/33 |
| Age, Continuous(years) | Prolift Mesh | Prolapse Repair Without Mesh | Total |
|---|---|---|---|
| Mean | 62.6 ± 10.6 | 63.1 ± 9 | 62.8 ± 9.8 |
| Sex: Female, Male(Participants) | Prolift Mesh | Prolapse Repair Without Mesh | Total |
|---|---|---|---|
| Female | 25 | 26 | 51 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Prolift Mesh | Prolapse Repair Without Mesh | Total |
|---|---|---|---|
| White | 16 | 17 | 33 |
| African American | 6 | 7 | 13 |
| Hispanic | 2 | 2 | 4 |
| Asian | 1 | 0 | 1 |
| Postmenopausal(Participants) | Prolift Mesh | Prolapse Repair Without Mesh | Total |
|---|---|---|---|
| Count of participants | 23 | 24 | 47 |
| Parity(number deliveries) | Prolift Mesh | Prolapse Repair Without Mesh | Total |
|---|---|---|---|
| Median | 2 (2 to 3) | 2 (2 to 3) | 2 (2 to 3) |
| BMI(kg/m^2) | Prolift Mesh | Prolapse Repair Without Mesh | Total |
|---|---|---|---|
| Mean | 27.6 ± 5.5 | 28.2 ± 6.4 | 27.9 ± 6.0 |
| POP-Q stage(Participants) | Prolift Mesh | Prolapse Repair Without Mesh | Total |
|---|---|---|---|
| stage 2 | 7 | 4 | 11 |
| stage 3 | 16 | 18 | 34 |
| stage 4 | 2 | 4 | 6 |
| married(Participants) | Prolift Mesh | Prolapse Repair Without Mesh | Total |
|---|---|---|---|
| Count of participants | 16 | 19 | 35 |
5 further baseline measures are reported on the registry.
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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