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

NCT02888093 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2019-12-02

Study results available
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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.

Conditions

  • Pelvic Organ Prolapse
  • Cystocele
  • Uterine Prolapse

Interventions

DEVICE

Absorbent suture (polydioxanone) and Permanent suture (Gore-Tex CV2)

Sponsors & Collaborators

  • International Urogynecological Association

    collaborator OTHER

  • Joseph Kowalski

    lead OTHER

Principal Investigators

  • Joseph T Kowalski, MD · University of Iowa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2017-11-30
Completion
2018-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02888093 on ClinicalTrials.gov