Superiority of Perineoplasty as Concomitant Surgical Procedure During Pelvic Organ Prolapse Repair

Active, not recruiting

• Conditions: Pelvic Organ Prolapse

• Registration Number: NCT05713422
• Lead Sponsor: Marjolein Spiering

Brief Summary

The goal of this study is to evaluate whether adding perineoplasty is, in comparison to performing vaginal prolapse surgery without adding perineoplasty, superior with respect to efficacy and cost-effectiveness and non-inferior with respect to morbidity, in patients undergoing vaginal surgical correction of pelvic organ prolapse at 24 months after surgery.

Detailed Description

Preoperative measurements, performed at baseline:

* Patient characteristics (age, BMI, smoking, obstetric history)

* Physical examination including POP-Q score. The genital hiatus (gh) at rest (as part of the POP-Q) will be used to assess the wideness of the vaginal introitus.

* Pelvic Floor Distress Inventory (PFDI-20) questionnaire and Patient Global Impression of Severity (PGI-S)

* Pelvic Floor Ultrasound 2DStudy measurements;

* Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-ir), Dutch Perineal Support Questionnaire (DPSQ), General Quality of Life (EQ-5D-5L), Medical Consumption Questionnaire (iMCQ) and Productivity Cost Questionnaire (iPCQ)

* Patient and surgeons considerations with respect to level III repair;

Postoperative measurements:

* Regular physical check-up will be at 4-8 weeks after procedure.

* Physical examination including POP-Q score

* Patient Global Impression of Improvement score (PGI-I)

* Pelvic Floor Ultrasound 2D

* iMCQ, iPCQ, EQ-5D-5L questionnaire

Extra follow up:

* Physical check-up 12 \& 24 months after surgery:

* Physical examination including POP-Q score

* Pelvic Floor Ultrasound 2D

* PFDI-20, PGI-I, DPSQ, PISQ-ir, iMCQ, iPCQ, EQ-5D-5L questionnaire

Study Timeline

• Study First Submitted: 2023-01-27
• Study First Submitted QC: 2023-01-27
• Study First Posted: 2023-02-06
• Study Start: 2023-04-23
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-02
• Last Update Posted: 2024-08-05
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 305

Inclusion Criteria

1. Female patient >18 years of age
2. Complaints of pelvic organ prolapse
3. Indication for prolapse surgery (level I and/or level II repair)
4. Genital hiatus (GH) according to POP-Q staging of ≥4 cm and ≤7 cm

Exclusion Criteria

1. Unable to understand the Dutch language
2. Pregnancy at baseline or intendancy to become pregnant during the study period
3. Patients with previous surgery for POP (previous mid urethral sling operations for urinary stress incontinence not excluded)
4. Unwilling and / or incapable of giving informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Surgical success	12 months	composite outcome defined as meeting the 3 following conditions: \[1\] "much improved" or "improved" in response to the patient global impression of improvement questionnaire, \[2\] no re-intervention performed in the same compartment within the first 12 months after index surgery, \[3\] no stage 2 or more POP in the operated compartment.

Secondary Outcome Measures

Name	Time	Method
Societal costs	24 months
Morbidity	24 months	complications and re-interventions due to complications, pain
Effectiveness	24 months	disease specific and general quality of life
Anatomical outcomes	24 months

Trial Locations

Locations (2)

Bergman Clinics; 🇳🇱 Hilversum, Netherlands

Spaarne Gasthuis; 🇳🇱 Haarlem, Netherlands