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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pelvic Organ Prolapse

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 Type: Observational
• Enrollment (Actual): 305

Contacts and Locations

Study Locations

• Netherlands
  • Haarlem, Netherlands
    • Spaarne Gasthuis
  • Hilversum, Netherlands, 1213PA
    • Bergman Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients indicated for vaginal pelvic organ prolapse surgery.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Operative procedure; standard treatment; Vaginal level I and/or level II repair will be performed as usual (eg anterior and/or posterior colporrhaphy, sacrospinous fixation etc.) without perineoplasty as decided by surgeon and patient. This procedure is considered as the control group.
Operative procedure; standard treatment including level III repair; Vaginal level I and/or level II repair will be performed as usual, but now including perineoplasty (level III repair) as decided by surgeon and patient. The decision of a perineoplasty to vaginal level I and/or level II repair is based on a shared decision made by surgeon together with the patient. The considerations upon which this decision has been established in a consensus meeting of Dutch urogynecologists and will be collected by a questionnaire, This group is considered as the 'intervention' group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Marjolein Spiering
• Collaborators: Spaarne Gasthuis

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 27, 2023
• First Submitted That Met QC Criteria: January 27, 2023
• First Posted (Actual): February 6, 2023

Study Record Updates

• Last Update Posted (Estimated): August 5, 2024
• Last Update Submitted That Met QC Criteria: August 2, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: prolapse; POP; perineoplasty
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: NL82381.018.22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No