N/A
N=44
A Randomized Controlled Trial of Permanent vs Absorbable Suture for Uterosacral Ligament Suspension
Pelvic Organ Prolapse · Cystocele · Uterine Prolapse
Bottom Line
View on ClinicalTrials.gov: NCT02888093 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Pelvic Organ Prolapse Quantification Exam (POP-Q) Point C — -7.25; -7 cm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Absorbent suture (polydioxanone) and Permanent suture (Gore-Tex CV2) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Joseph Kowalski
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pelvic Organ Prolapse Quantification Exam (POP-Q) Point C |
-7.25; -7 | — |
| SECONDARY Suture-related Complications |
17; 14; 2; 4 | — |
| SECONDARY Symptomatic Prolapse Outcomes |
1; 4 | — |
Summary
Uterosacral ligament suspension (USLS) is a commonly performed, vaginal surgery for the correction of female pelvic organ prolapse. The original description of this procedure included the use of permanent sutures. However, permanent suture use in this vaginal application can result in some minor complication such as persistent vaginal spotting, vaginal discharge and dyspareunia. Subsequent reports on this procedure have utilized delayed-absorbable sutures in order to avoid these complications. Retrospective studies are conflicting as to whether or not absorbable suture provides as durable an anatomic outcome as permanent suture. There are currently no high-quality, prospective studies that have evaluated outcomes of permanent and absorbable suture for uterosacral ligament suspension.
This study will recruit women scheduled to undergo USLS with or without other prolapse or anti-incontinence procedures. Participants will be randomized 1:1 to permanent or absorbable suture. Follow up will occur at 6 weeks and 12 months post-operatively. The primary outcome will be Pelvic Organ Prolapse Quantification Exam (POP-Q) point C as measured at the 12 month follow up visit. Subjects and assessors will be blinded.
Eligibility Criteria
Inclusion Criteria
- Scheduled for uterosacral ligament suspension (USLS)
Exclusion Criteria
- Non-English speaking
- Prisoner
- Cognitive impairment precluding informed consent
- Planned hysteropexy
Data sourced from ClinicalTrials.gov (NCT02888093). 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.