Effectiveness of Perineorrhaphy in Pelvic Organ Prolapse Surgery

NCT07006129 | Completed

• 1 other identifier: EPMDnr 2023-00177-01 (Study 1)
• Study Type: observational
• Target: 40,646
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Organ Prolapse Vaginal Surgery; Pelvic Organ Prolapse (POP)

Keywords

Target Trial Emulation; Pelvic organ prolapse; Perineorrhaphy; Vaginal surgery; Cystocele; Rectocele; Apical prolapse

Outcome Measures

Primary Outcomes (1)

• Reoperation

  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.

  5 years

Secondary Outcomes (2)

• Symptoms of a vaginal bulge (patient reported outcome)

  At 1 year

• Unsatisfied (patient reported outcome)

  At 1 year

Study Arms (2)

Perineorrhaphy

Primary pelvic organ prolapse surgery (no concomitant hysterectomy) with native tissue repair including perineorrhaphy

Procedure: Perineorrhaphy

No perineorrhaphy

Primary pelvic organ prolapse surgery (no concomitant hysterectomy) with native tissue repair excluding perineorrhaphy

Procedure: No perineorrhaphy

Interventions

Perineorrhaphy PROCEDURE

Concomitant perineorrhaphy

Perineorrhaphy

No perineorrhaphy PROCEDURE

No concomitant perineorrhaphy

No perineorrhaphy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with their primary vaginal pelvic organ prolapse surgery registered in the Swedish National Quality Register of Gynaecological Surgery (GynOp).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Lund University: lead

Study Sites (1)

Lund University

Malmo, Sweden

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse; Cystocele; Rectocele

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hernia

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 5, 2025
• Study Start: January 1, 2007
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: June 5, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)