Effectiveness of Perineorrhaphy in Pelvic Organ Prolapse Surgery

Completed

• Conditions: Pelvic Organ Prolapse Vaginal Surgery; Pelvic Organ Prolapse (POP)

• Registration Number: NCT07006129
• Lead Sponsor: Lund University

Brief Summary

This is an observational registry-based study of long-term outcome after vaginal native tissue repair for pelvic organ prolapse designed to emulate a pragmatic open-label two-arm trial for which patients, in whom perineorrhaphy is not strictly indicated but clinically tenable, perioperatively are randomized to concomitant perineorrhaphy or not.

Detailed Description

This is an emulated pragmatic open-label two-arm trial in patients undergoing native tissue repair surgery for pelvic organ prolapse, in which patients are randomized perioperatively to either concomitant perineorrhaphy or not. The target population is the large group of patients for whom, at the discretion of the surgeon, this intervention is currently an option while not being strictly indicated. The investigators assumed that women were randomly assigned perioperatively to either strategy within levels of baseline co-variables: age, BMI, parity, lung disease, ASA-classification, constipation, hypermobility, prolapse in which vaginal compartment and if surgery is performed on it, year of primary surgery and region. Data was obtained from The Swedish National Quality Register of Gynaecological Surgery (GynOp), the Swedish National Patient Register, the Swedish Medical Birth Register, and the Swedish Cause of Death Register. In order to emulate a target trial, multiple imputation of missing data is followed by controlling for confounding through inverse probability weighting (IPW) in order to estimate the average treatment effect (ATE) in the primary analysis. In the secondary analysis, the primary analysis will be repeated but with overlap weights. Additional analyses: The sample will be re-weighted using IPW to estimate the average treatment effect on the treated (ATT). Restricted mean survival time (RMST) will be calculated at five years of follow-up for the primary outcome. Bias analysis: Mortality during follow up for the primary outcome will be used as a negative control.

Study Timeline

• Study Start: 2007-01-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2025-05
• Study First Submitted: 2025-05-27
• Study First Submitted QC: 2025-05-27
• Last Update Submitted: 2025-05-27
• Study First Posted: 2025-06-05
• Last Update Posted: 2025-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40646

Inclusion Criteria

• Pelvic organ prolapse surgery with vaginal native tissue repair without concomitant hysterectomy.

Exclusion Criteria

• Primary surgery with colpocleisis, use of mesh, laparoscopic or abdominal surgery, concomitant incontinence surgery (eg transvaginal tape).
• Previous hysterectomy
• Previous pelvic organ prolapse surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reoperation	5 years	Reported as absolute risk difference, with cumulative risks during five years of follow-up estimated using the Kaplan-Meier estimator.; Data obtained from the The Swedish National Quality Register of Gynaecological Surgery (GynOp) and the Swedish National Patient Register.

Secondary Outcome Measures

Name	Time	Method
Symptoms of a vaginal bulge (patient reported outcome)	At 1 year	Absolute risk difference for the outcome at 1 year follow-up with the non-inferiority margin set to 10% of the absolute risk in the comparison group. Data obtained from the The Swedish National Quality Register of Gynaecological Surgery (GynOp).
Unsatisfied (patient reported outcome)	At 1 year	Absolute risk difference for the outcome at 1 year follow-up with the non-inferiority margin set to 10% of the absolute risk in the comparison group. Data obtained from the The Swedish National Quality Register of Gynaecological Surgery (GynOp).

Trial Locations

Locations (1)

Lund University; 🇸🇪 Malmö, Sweden