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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2008 by Radboud University.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00372190
First received: September 5, 2006
Last updated: June 6, 2008
Last verified: June 2008
  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

Ages Eligible for Study:   Child, Adult, Senior
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00372190

Locations
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, Netherlands
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: Mariella ij Withagen, Drs. UMC St Radboud
  More Information

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
Pelvic Organ Prolapse
Uterine Prolapse
Pathological Conditions, Anatomical
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on December 09, 2016