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

Sponsor
Marjolein Spiering (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05713422
Collaborator
Spaarne Gasthuis (Other)
288
Enrollment
43
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    288 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Superiority of Perineoplasty as Concomitant Surgical Procedure During Pelvic Organ Prolapse Repair; a Comparative Cohort Trial (SUPPORT)
    Anticipated Study Start Date :
    May 1, 2023
    Anticipated Primary Completion Date :
    Dec 1, 2025
    Anticipated Study Completion Date :
    Dec 1, 2026

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Morbidity [24 months]

      complications and re-interventions due to complications, pain

    2. Effectiveness [24 months]

      disease specific and general quality of life

    3. Anatomical outcomes [24 months]

    4. Societal costs [24 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Marjolein Spiering
    • Spaarne Gasthuis

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Marjolein Spiering, MSc, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
    ClinicalTrials.gov Identifier:
    NCT05713422
    Other Study ID Numbers:
    • NL82381.018.22
    First Posted:
    Feb 6, 2023
    Last Update Posted:
    Feb 6, 2023
    Last Verified:
    Jan 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Marjolein Spiering, MSc, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
    POP
    prolapse
    perineoplasty
    Additional relevant MeSH terms:
    Prolapse
    Pelvic Organ Prolapse

    Study Results

    No Results Posted as of Feb 6, 2023