UnknownNot Applicable

Effectiveness Prolift+M Versus Conventional Vaginal Prolapse Surgery

Netherlands176 participantsStarted 2011-01

Plain-language summary

Pelvic organ prolapse is highly prevalent in the female population. The recurrence rate of pelvic organ prolapse after surgical treatment is high. This emphasizes the clinical need for improvement of the surgical techniques currently used. Placement of a mesh aims at reducing the recurrence rate. In this study the investigators compare the effectiveness of the Tension free Vaginal mesh + Monocryl with standard vaginal prolapse surgery without mesh.

Who can participate

Age range

45 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: * Subject has a anterior and/or posterior prolapse POP-Q stage II or more. Subjects with a middle compartment prolapse may only be included if there is a co-existing anterior or posterior defect which needs surgical correction. * Subject has agreed to undergo implantation of Prolift+MTM or fascial plication * Subject is willing to return for follow-up evaluation and QoL questionnaires completion at 6weeks, 6 months, 12 months and 24 months follow-ups. Exclusion Criteria: * Pregnancy * Age \< 45 years * Subject has had a previous surgery for pelvic organ prolapse. A previous mid-urethral sling procedure is not an exclusion criterion. * Have current urinary tract or vaginal infections * Have blood coagulation disorders * Have a compromised immune system or any other conditions that would compromise healing * Are unwilling or unable to return for evaluation * Previous irradiation * Presence of any malignancy

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

objective anatomic success (POPQ stage <2)

Timeframe: 24 months

Trial details

NCT IDNCT02231099

SponsorRadboud University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-09

View on ClinicalTrials.gov More Pelvic Organ Prolapse trials