Performance of Tension Free Vaginal Mesh (Prolift) Versus Conventional Vaginal Prolapse Surgery in Recurrent Prolapse.
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Radboud University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Radboud University
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00372190
First received: September 5, 2006
Last updated: June 6, 2008
Last verified: June 2008
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Pelvic Organ Prolapse |
Procedure: Tensionfree vaginal mesh (Prolift) Procedure: classic vaginal prolapse surgery (fascia plication) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective and Comparative Study of the Performance of Tension Free Vaginal Mesh (Prolift) Versus Conventional Vaginal Prolapse Surgery in Recurrent Prolapse |
Resource links provided by NLM:
Further study details as provided by Radboud University:
Primary Outcome Measures:
- Prolapse by POPQ, at entry, after 6 months, after 12 months [ Time Frame: at entry, 6 months and 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Complications during the procedure, after 6 weeks, after 6 months, after 12 months [ Time Frame: during procedure, after 6 weeks, 6 months and 12 months ] [ Designated as safety issue: Yes ]
- Quality of life by standardised questionnaire, at entry, after 6 months, after 12 months [ Time Frame: at entry, after 6 months and 12 months ] [ Designated as safety issue: No ]
- prolapse complaints by standardised questionnaires [ Time Frame: at entry, after 6 weeks, 6 months and 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 194 |
| Study Start Date: | August 2006 |
| Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Tensionfree vaginal mesh (Prolift)
|
Procedure: Tensionfree vaginal mesh (Prolift)
surgery with Prolift mesh
|
|
Active Comparator: 2
classic vaginal prolapse surgery (fascia plication)
|
Procedure: classic vaginal prolapse surgery (fascia plication)
classic surgery, fascia plication
|
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00372190
Contacts
| Contact: Mariella ij Withagen, Drs. | 0031243614792 | m.withagen@obgyn.umcn.nl |
| Contact: Mark e Vierhout, Prof. Dr. | 0031243614728 | m.vierhout@obgyn.umcn.nl |
Locations
| Netherlands | |
| Gelre ziekenhuizen | Recruiting |
| Apeldoorn, Netherlands | |
| Contact: W. Spaans, dr. w.spaans@gelre.nl | |
| Principal Investigator: W. Spaans, dr | |
| Slysis Zorggroep, location Rijnstate | Active, not recruiting |
| Arnhem, Netherlands | |
| Reinier de Graaf Gasthuis | Recruiting |
| Delft, Netherlands | |
| Principal Investigator: A L. Milani, Drs | |
| Medisch Spectrum Twente | Recruiting |
| Enschede, Netherlands | |
| Contact: E. Everhardt, dr. | |
| Principal Investigator: E Everhardt, dr. | |
| Groene Hart Ziekenhuis | Recruiting |
| Gouda, Netherlands | |
| Contact: I van der Wijk, drs | |
| Principal Investigator: I van der Wijk, drs | |
| St. Antonius Ziekenhuis | Recruiting |
| Nieuwegein, Netherlands | |
| Principal Investigator: H L Schagen van Leeuwen, Dr | |
| UMC St Radboud | Recruiting |
| Nijmegen, Netherlands | |
| Principal Investigator: M IJ Withagen, Drs. | |
| Ikazia | Recruiting |
| Rotterdam, Netherlands | |
| Contact: J de Leeuw, dr | |
| Principal Investigator: J de Leeuw, dr | |
| Refaja | Recruiting |
| Stadskanaal, Netherlands | |
| Contact: H de Wet dewet@refaja.nl | |
| Principal Investigator: H. de Wet | |
| Twee Steden Ziekenhuis | Recruiting |
| Tilburg, Netherlands | |
| Principal Investigator: A MW Broekman, Drs | |
| St. Elisabeth hospital | Recruiting |
| Tilburg, Netherlands | |
| Principal Investigator: H AM Vervest, Dr | |
| Zaans Medisch Centrum | Recruiting |
| Zaandam, Netherlands | |
| Contact: A.F.P. Mulder, drs | |
| Principal Investigator: A.F.P. Mulder, drs | |
| Isala klinieken | Recruiting |
| Zwolle, Netherlands | |
| Contact: J den Boon, dr | |
| Principal Investigator: J den Boon, dr | |
Sponsors and Collaborators
Radboud University
Investigators
| Principal Investigator: | Mariella ij Withagen, Drs. | UMC St Radboud |
More Information
No publications provided by Radboud University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | M.I.J. Withagen, Radboud University, department of obstetrics and gynaecology |
| ClinicalTrials.gov Identifier: | NCT00372190 History of Changes |
| Other Study ID Numbers: | P0609 |
| Study First Received: | September 5, 2006 |
| Last Updated: | June 6, 2008 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Radboud University:
|
Pelvic organ prolapse recurrence mesh complications treatment |
Additional relevant MeSH terms:
|
Prolapse Uterine Prolapse Pelvic Organ Prolapse |
Pathological Conditions, Anatomical Uterine Diseases Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 21, 2013