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

Pelvic Organ Prolapse Clinical Trial

— SUPPORT  

Official title:

Superiority of Perineoplasty as Concomitant Surgical Procedure During Pelvic Organ Prolapse Repair; a Comparative Cohort Trial (SUPPORT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05713422
• Other study ID #: NL82381.018.22
• Status: Recruiting
• Start date: April 23, 2023
• Est. completion date: December 2026

Study information

• Verified date: July 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Jan-Paul Roovers, Prof
• Phone: +31 20 5669111
• Email: onderzoeksbureauvkc[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 288
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Locations

Country	Name	City	State
Netherlands	Spaarne Gasthuis	Haarlem
Netherlands	Bergman Clinics	Hilversum

Sponsors (2)

Lead Sponsor	Collaborator
Marjolein Spiering	Spaarne Gasthuis

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical success	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.	12 months
Secondary	Morbidity	complications and re-interventions due to complications, pain	24 months
Secondary	Effectiveness	disease specific and general quality of life	24 months
Secondary	Anatomical outcomes		24 months
Secondary	Societal costs		24 months