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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Quality of Life; Pelvic Organ Prolapse; Surgery; Complication
• Intervention / Treatment: Procedure: fixation of the vaginal apex

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 Type: Interventional
• Enrollment (Estimated): 312
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Styria
    • Graz, Styria, Austria, 8036
      • MUGRAZ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: McCall culdoplasty; 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; In the course of vaginal hysterectomy the vaginal cuff is either fixed to the sacrospinous ligament or to the uterosacral ligament.
Active Comparator: Sacrospinous ligament fixation; 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; In the course of vaginal hysterectomy the vaginal cuff is either fixed to the sacrospinous ligament or to the uterosacral ligament.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medical University of Graz

Publications and helpful links

General Publications

• Colombo M, Milani R. Sacrospinous ligament fixation and modified McCall culdoplasty during vaginal hysterectomy for advanced uterovaginal prolapse. Am J Obstet Gynecol. 1998 Jul;179(1):13-20. doi: 10.1016/s0002-9378(98)70245-5.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: April 10, 2017
• First Submitted That Met QC Criteria: April 10, 2017
• First Posted (Actual): April 13, 2017

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: V4 31.01.2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The sponsor has access to all study relevant data. In the specific centers only authorized study personnel has access to the data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No