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

Medical University of Graz312 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

312

Conditions

Pelvic Organ Prolapse Surgery Quality of Life Complication

Interventions

fixation of the vaginal apexPROCEDURE

In the course of vaginal hysterectomy the vaginal cuff is either fixed to the sacrospinous ligament or to the uterosacral ligament.

Eligibility

Sex: FEMALEMin age: 35 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

MUGRAZ

Graz, Styria, Austria

Outcomes

Primary Outcomes

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