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

Sponsor
Medical University of Graz (Other)
Overall Status
Recruiting
CT.gov ID
NCT03113513
Collaborator
(none)
312
Enrollment
1
Location
2
Arms
83.9
Anticipated Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: fixation of the vaginal apex
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
312 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The study is designed as a RCT.The study is designed as a RCT.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized Trial of Sacrospinous Ligament Fixation Versus McCall Culdoplasty in Women Undergoing Vaginal Hysterectomy and Repairs for Prolapse
Actual Study Start Date :
May 1, 2016
Anticipated Primary Completion Date :
Apr 30, 2023
Anticipated Study Completion Date :
Apr 30, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Subjective cure [12 months after surgery]

    determined by the Patient Global Impression of Improvement (PGII) index

  2. 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.

  3. 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.

  4. Reoperation rate [12 months after surgery]

    Number of patients with any reoperations for POP

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 80 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 MUGRAZ Graz Styria Austria 8036

Sponsors and Collaborators

  • Medical University of Graz

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT03113513
Other Study ID Numbers:
  • V4 31.01.2016
First Posted:
Apr 13, 2017
Last Update Posted:
Apr 6, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse

Study Results

No Results Posted as of Apr 6, 2022