Performance of Tension Free Vaginal Mesh (Prolift) Versus Conventional Vaginal Prolapse Surgery in Recurrent Prolapse.

Pelvic Organ Prolapse Clinical Trial

Official title:

A Prospective and Comparative Study of the Performance of Tension Free Vaginal Mesh (Prolift) Versus Conventional Vaginal Prolapse Surgery in Recurrent Prolapse

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00372190
• Other study ID #: P0609
• Status: Recruiting
• Phase: N/A
• First received: September 5, 2006
• Last updated: June 6, 2008
• Start date: August 2006

Study information

• Verified date: June 2008
• Source: Radboud University
• Contact: Mariella ij Withagen, Drs.
• Phone: 0031243614792
• Email: m.withagen[@]obgyn.umcn.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 194
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Procedure:
• Tensionfree vaginal mesh (Prolift)
surgery with Prolift mesh
• classic vaginal prolapse surgery (fascia plication)
classic surgery, fascia plication

Locations

Country	Name	City	State
Netherlands	Gelre ziekenhuizen	Apeldoorn
Netherlands	Slysis Zorggroep, location Rijnstate	Arnhem
Netherlands	Reinier de Graaf Gasthuis	Delft
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	Groene Hart Ziekenhuis	Gouda
Netherlands	St. Antonius Ziekenhuis	Nieuwegein
Netherlands	UMC St Radboud	Nijmegen
Netherlands	Ikazia	Rotterdam
Netherlands	Refaja	Stadskanaal
Netherlands	St. Elisabeth hospital	Tilburg
Netherlands	Twee Steden Ziekenhuis	Tilburg
Netherlands	Zaans Medisch Centrum	Zaandam
Netherlands	Isala klinieken	Zwolle

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prolapse by POPQ, at entry, after 6 months, after 12 months		at entry, 6 months and 12 months	No
Secondary	Complications during the procedure, after 6 weeks, after 6 months, after 12 months		during procedure, after 6 weeks, 6 months and 12 months	Yes
Secondary	Quality of life by standardised questionnaire, at entry, after 6 months, after 12 months		at entry, after 6 months and 12 months	No
Secondary	prolapse complaints by standardised questionnaires		at entry, after 6 weeks, 6 months and 12 months	No