Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05713422

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Spaarne Gasthuis, Haarlem, Netherlands

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Surgical success

    Time frame: 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 outcomes

  1. Morbidity

    Time frame: 24 months

    complications and re-interventions due to complications, pain

  2. Effectiveness

    Time frame: 24 months

    disease specific and general quality of life

  3. Anatomical outcomes

    Time frame: 24 months

  4. Societal costs

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Marjolein Spiering

Other

Collaborators

  • Spaarne Gasthuis

Registry information

Official study title

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

Acronym: SUPPORT

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Feb 6, 2023
Registry last updated
Aug 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.