Status:
COMPLETED
Performance of Tension Free Vaginal Mesh (Prolift) Versus Conventional Vaginal Prolapse Surgery in Recurrent Prolapse.
Lead Sponsor:
Radboud University Medical Center
Conditions:
Pelvic Organ Prolapse
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Pelvic organ prolapse is a common problem. A lot of women have surgery for prolapse. The recurrence rate op pelvic organ prolapse after surgical treatment is high. Placement of a mesh aims at reducing...
Detailed Description
Patients with recurrent prolapse after surgery can participate in this study. A total of 194 women will be included. At random 97 patients undergo a standard prolapse operation and 97 patients undergo...
Eligibility Criteria
Inclusion
- recurrent anterior and/or posterior prolapse POP-Q stage 2 or more
- patient has agreed to undergo implantation of TVM (prolift) or fascial plication
- patient is willing to return for follow-up evaluation at 6 weeks, 6 months and 12 months
- patient is willing to complete quality of life questionnaires at 6 and 12 months
Exclusion
- patient is or wants to become pregnant
- patient has had previous synthetic mesh procedure (a previous mid-urethral sling procedure is NOT an exclusion criterion)
- patient has current urinary tract or vaginal infections
- patient has a blood coagulation disorder
- patient has a compromised immune system or any other condition that would compromise healing
- patient has renal insufficiency and/or upper urinary tract obstruction
- patient is unwilling or unable to return for evaluation
- patient has had previous irradiation
- patient has any malignancy
- patient has large ovarian cysts of large myoma
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT00372190
Start Date
August 1 2006
End Date
December 1 2015
Last Update
July 3 2017
Active Locations (13)
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1
Gelre ziekenhuizen
Apeldoorn, Netherlands
2
Slysis Zorggroep, location Rijnstate
Arnhem, Netherlands
3
Reinier de Graaf Gasthuis
Delft, Netherlands
4
Medisch Spectrum Twente
Enschede, Netherlands