N/A
N=99
Anterior Colporrhaphy Versus Cystocele Repair Using Polypropylene Mesh or Porcine Dermis
Anterior Vaginal Wall Prolapse · Cystocele · Pelvic Organ Prolapse
Bottom Line
View on ClinicalTrials.gov: NCT01393171 ↗Enrolled (actual)
99
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: Prospective Randomized Trial of Anterior Colporrhaphy Vs. Cystocele Repair Using Polypropylene Mesh or Porcine Dermis — 5; 14; 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Polypropylene mesh (Polyform by Boston Scientific) (Device); Porcine Dermis (Pelvicol by CRBard) (Procedure); Anterior Colporrhaphy (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Kaiser Permanente
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Prospective Randomized Trial of Anterior Colporrhaphy Vs. Cystocele Repair Using Polypropylene Mesh or Porcine Dermis |
5; 14; 12 | — |
| SECONDARY Number of Participants With One or More Adverse Events at Two Years |
7; 4; 5 | — |
| SECONDARY Number of Participants With Overall Failure |
1; 3; 3 | — |
| SECONDARY Change in Quality of Life Measured by the Pelvic Floor Distress Inventory 20 and Pelvic Floor Impact Questionnaire 7 |
-63; -58; -77; -57; -33; -55 | — |
| SECONDARY Change in Postoperative Sexual Function Measured by Pelvic Organ Prolapse/Urinary Incontinence Questionnaire 12 |
0; 0; 1 | — |
Summary
The purpose of this study is to evaluate the success rate of cystocele repair using polypropylene mesh or porcine dermis compared to that of anterior colporrhaphy in a prospective randomized fashion. The study will be performed in a randomized, prospective, single-blinded fashion.
Eligibility Criteria
Inclusion Criteria
- Stage 2 or > anterior vaginal prolapse requiring surgical correction.
- >18 years old
- willing to return for follow-up visits.
Exclusion Criteria
- Less than stage II or > anterior vaginal prolapse,
- decline to participate,
- pregnant or contemplating future pregnancy,
- anti-incontinence procedure other than midurethral sling (ie, Burch colposuspension, pubovaginal sling, or needle suspension) is planned as part of their surgical procedures,
- any contra-indication to receiving mesh or porcine dermis.
Data sourced from ClinicalTrials.gov (NCT01393171). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.