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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Trial of Sacrospinous Ligament Fixation Versus McCall Culdoplasty in Women Undergoing Vaginal Hysterectomy and Repairs for Prolapse

Conditions
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Pelvic Organ Prolapse, Surgery, Quality of Life, Complication

Intervention / Treatment
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* Procedure: fixation of the vaginal apex


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study is designed as a RCT.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: McCall culdoplasty<br>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. | Procedure: fixation of the vaginal apex<br>* In the course of vaginal hysterectomy the vaginal cuff is either fixed to the sacrospinous ligament or to the uterosacral ligament.<br>|
| Active Comparator: Sacrospinous ligament fixation<br>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. | Procedure: fixation of the vaginal apex<br>* In the course of vaginal hysterectomy the vaginal cuff is either fixed to the sacrospinous ligament or to the uterosacral ligament.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective cure | determined by the Patient Global Impression of Improvement (PGII) index | 12 months after surgery | 
| Quality of life as determined by a questionnaire | 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. | 12 months after surgery | 
| Sexual health | 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. | 12 months after surgery | 
| Reoperation rate | Number of patients with any reoperations for POP | 12 months after surgery |