N/A
N=190
Performance of Tension Free Vaginal Mesh (Prolift) Versus Conventional Vaginal Prolapse Surgery in Recurrent Prolapse.
Pelvic Organ Prolapse
Bottom Line
View on ClinicalTrials.gov: NCT00372190 ↗Enrolled (actual)
190
Serious AEs
5.3%
Results posted
Jul 2017
Primary outcome: Primary: Prolapse by "Pelvic Organ Prolapse Quantification System" (POP-Q), at 12 Months — 8; 38; 75; 46 participants — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tensionfree vaginal mesh kit (Prolift) (Device); classic vaginal prolapse surgery (fascia plication) (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Radboud University Medical Center
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Prolapse by "Pelvic Organ Prolapse Quantification System" (POP-Q), at 12 Months |
8; 38; 75; 46; 7; 13 | <0.05 sig |
| SECONDARY Mesh Exposure at 12 Months |
14; 0 | — |
| SECONDARY "Patient Global Impression of Improvement" (PGI-I) at 12 Months |
54; 54 | — |
| SECONDARY Bulge Symptoms |
6; 5 | — |
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 the recurrence rate, but mesh implants can cause complications.
This study is designed to determine the effectiveness of one type of mesh (tensionfree vaginal mesh; Prolift), compared with the standard prolapse surgery. A secondary objective is to track the complications of both procedures.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00372190). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.