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N/A N=44 Randomized Double-blind Treatment

A Randomized Controlled Trial of Permanent vs Absorbable Suture for Uterosacral Ligament Suspension

Pelvic Organ Prolapse · Cystocele · Uterine Prolapse

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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