Clinical trial NCT05713422: Superiority of Perineoplasty as Concomitant Surgical Procedure During Pelvic Organ Prolapse Repair
Official title: Superiority of Perineoplasty as Concomitant Surgical Procedure During Pelvic Organ Prolapse Repair; a Comparative Cohort Trial (SUPPORT)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pelvic Organ Prolapse
Keywords: POP
prolapse
perineoplasty
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Spaarne Gasthuis
First posted: 2023-02-06
Enrollment: 305
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients indicated for vaginal pelvic organ prolapse surgery.

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

Eligibility criteria: 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

Primary outcomes:
measure: Surgical success
timeFrame: 12 months
Secondary outcomes:
measure: Morbidity
timeFrame: 24 months
measure: Effectiveness
timeFrame: 24 months
measure: Anatomical outcomes
timeFrame: 24 months
measure: Societal costs
timeFrame: 24 months
Other outcomes:
Locations:
city: Haarlem
country: Netherlands
facility: Spaarne Gasthuis
city: Hilversum
country: Netherlands
facility: Bergman Clinics
Study officials:
References: