Clinical trial NCT00372190: Performance of Tension Free Vaginal Mesh (Prolift) Versus Conventional Vaginal Prolapse Surgery in Recurrent Prolapse.
Official title: A Prospective and Comparative Study of the Performance of Tension Free Vaginal Mesh (Prolift) Versus Conventional Vaginal Prolapse Surgery in Recurrent Prolapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: Pelvic organ prolapse
recurrence
mesh
complications
treatment
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2006-09-06
Enrollment: 194
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 an operation with the mesh. Evaluation will take place during surgery, at the postoperative visit after six weeks, and after six months and twelve months. Quality of life, degree of vaginal prolapse, subjective effectiveness, safety and incidence of complications will be evaluated.

An amendment to the original study has been approved by the Ethical Committee to examine long term outcome of this RCT at 7 years. This study was completed in december 2015.

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

Primary outcomes:
measure: Prolapse by "Pelvic Organ Prolapse Quantification System" (POP-Q), at 12 Months
timeFrame: 12 months
Secondary outcomes:
measure: Mesh Exposure at 12 Months
timeFrame: 12 months
measure: "Patient Global Impression of Improvement" (PGI-I) at 12 Months
timeFrame: at 12 months
measure: Bulge Symptoms
timeFrame: 12 months
Other outcomes:
Locations:
city: Apeldoorn
country: Netherlands
facility: Gelre ziekenhuizen
city: Arnhem
country: Netherlands
facility: Slysis Zorggroep, location Rijnstate
city: Delft
country: Netherlands
facility: Reinier de Graaf Gasthuis
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Gouda
country: Netherlands
facility: Groene Hart Ziekenhuis
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Nijmegen
country: Netherlands
facility: UMC St Radboud
city: Rotterdam
country: Netherlands
facility: Ikazia
city: Stadskanaal
country: Netherlands
facility: Refaja
city: Tilburg
country: Netherlands
facility: St. Elisabeth hospital
city: Tilburg
country: Netherlands
facility: Twee Steden Ziekenhuis
city: Zaandam
country: Netherlands
facility: Zaans Medisch Centrum
city: Zwolle
country: Netherlands
facility: Isala klinieken
Study officials:
affiliation: UMC St Radboud
name: Mariella ij Withagen, Drs.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Withagen MI, Milani AL, den Boon J, Vervest HA, Vierhout ME. Trocar-guided mesh compared with conventional vaginal repair in recurrent prolapse: a randomized controlled trial. Obstet Gynecol. 2011 Feb;117(2 Pt 1):242-250. doi: 10.1097/AOG.0b013e318203e6a5.
citation: Milani AL, Damoiseaux A, IntHout J, Kluivers KB, Withagen MIJ. Long-term outcome of vaginal mesh or native tissue in recurrent prolapse: a randomized controlled trial. Int Urogynecol J. 2018 Jun;29(6):847-858. doi: 10.1007/s00192-017-3512-3. Epub 2017 Nov 22.
citation: Withagen MI, Milani AL, de Leeuw JW, Vierhout ME. Development of de novo prolapse in untreated vaginal compartments after prolapse repair with and without mesh: a secondary analysis of a randomised controlled trial. BJOG. 2012 Feb;119(3):354-60. doi: 10.1111/j.1471-0528.2011.03231.x.