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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Pelvic Organ Prolapse

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patient >18 years of age Complaints of pelvic organ prolapse Indication for prolapse surgery (level I and/or level II repair) Genital hiatus (GH) according to POP-Q staging of ≥4 cm and ≤7 cm Exclusion Criteria: Unable to understand the Dutch language Pregnancy at baseline or intendancy to become pregnant during the study period Patients with previous surgery for POP (previous mid urethral sling operations for urinary stress incontinence not excluded) Unwilling and / or incapable of giving informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Operative procedure; standard treatment<br>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<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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POP, prolapse, perineoplasty