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 range45 Years

SexFEMALE

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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

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