Comparison of Two Apical Repair Methods in Women Undergoing Repairs for Prolapse

Not Applicable

Active, not recruiting

• Conditions: Quality of Life; Complication; Pelvic Organ Prolapse; Surgery
• Interventions: Procedure: fixation of the vaginal apex

• Registration Number: NCT03113513
• Lead Sponsor: Medical University of Graz

Brief Summary

To date no study has determined prospectively which technique is superior to prevent recurrent Pelvic Organ Prolapse (POP) after vaginal hysterectomy- a major unmet clinical need. The aim of the study is to determine objective anatomical recurrent prolapse after Sacrospinous Ligament Fixation (SLF) vs McCall.

Detailed Description

The aim of the study is to determine objective anatomical recurrent prolapse after SLF vs McCall. The study is designed as a Randomized Controlled Trial (RCT). Primary study endpoint will be at 12 months, secondary study endpoint at 24 months. The following parameters will be evaluated after one year: anatomical outcome, Quality of Life (QoL), sexual health, reoperations, and complications.

Study Timeline

• Study Start: 2016-05-01
• Study First Submitted: 2017-04-10
• Study First Submitted QC: 2017-04-10
• Study First Posted: 2017-04-13
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-23
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 312

Inclusion Criteria

• declined/ failed conservative treatment for POP
• planned vaginal hysterectomy with anterior/posterior colporrhaphy as indicated
• any symptomatic POP or stage II prolapse in any compartment
• at least stage I prolapse in the apical department
• women between 35 and 80 years of age
• good German language skills
• any concomitant prolapse surgery (anterior, posterior vaginal repair, suburethral tapes) as indicated
• concomitant salpingo-oophorectomy if indicated

Exclusion Criteria

• Unwillingness to participate
• Neurological disorders
• Previous hysterectomy
• Desire to have children
• Connective tissue disorders (i.e. Ehlers-Danlos syndrome, Marfan syndrome)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
McCall culdoplasty	fixation of the vaginal apex	The McCall culdoplasty will be performed in a modified version as described by McCall in 1957. Specifically, two long acting bioresorbable sutures are put through the specific anatomic landmarks.
Sacrospinous ligament fixation	fixation of the vaginal apex	The SLF technique will be performed as described by Richter et al (Amreich, 1951). Two long acting bioresorbable sutures are passed through the right sacrospinous ligament and then fixed to the vaginal cuff.

Primary Outcome Measures

Name	Time	Method
Number of patients with stage 2 or higher on the Pelvic Organ Prolapse Quantification System (POP-Q).	12 months after surgery	POP-Q stage 2 or higher means any point of the POP-Q system being -1 related to the hymen or below

Secondary Outcome Measures

Name	Time	Method
Subjective cure	12 months after surgery	determined by the Patient Global Impression of Improvement (PGII) index
Quality of life as determined by a questionnaire	12 months after surgery	The Kings Health Questionnaire was validated in women with stress urinary incontinence and assesses the impact of incontinence on quality of life. The eight subscales ("domains") scored between 0 (best) and 100 (worst). The Symptom Severity scale is scored from 0 (best) to 30 (worst); lower scores indicate better QoL. Success in terms of the study is defined as 10 points improvement on the total Kings Health Questionnaire score.
Reoperation rate	12 months after surgery	Number of patients with any reoperations for POP
Sexual health	12 months after surgery	The Pelvic Organ Prolapse Incontinence Sexual Questionnaire is a 20 item questionnaire and is the primary measure used to assess sexual function in women with urinary incontinence and prolapse. Mean subscale scores are calculated by summing the valid responses to items in the subscale and then divided by the number of items with valid responses. The higher the subscores, the worse the outcome.

Trial Locations

Locations (1)

MUGRAZ; 🇦🇹 Graz, Styria, Austria