UnknownNot Applicable

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

Austria312 participantsStarted 2016-05-01

Plain-language 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.

Who can participate

Age range

35 Years – 80 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of patients with stage 2 or higher on the Pelvic Organ Prolapse Quantification System (POP-Q).

Timeframe: 12 months after surgery

Trial details

NCT IDNCT03113513

SponsorMedical University of Graz

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-30

View on ClinicalTrials.gov More Pelvic Organ Prolapse trials