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

NCT ID: NCT05713422

Last Updated: 2024-08-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 305 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-23
• Study Completion Date: 2026-12-31

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

Conditions

Pelvic Organ Prolapse

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this 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.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Spaarne Gasthuis

OTHER

Sponsor Role: collaborator

Marjolein Spiering

OTHER

Sponsor Role: lead

Responsible Party

Marjolein Spiering

MSc

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Spaarne Gasthuis

Haarlem, , Netherlands

Bergman Clinics

Hilversum, , Netherlands

Countries

Netherlands

Other Identifiers

NL82381.018.22

Identifier Type: -

Identifier Source: org_study_id