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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mariella Withagen, Radboud University
ClinicalTrials.gov Identifier:
NCT00372190
First received: September 5, 2006
Last updated: April 11, 2017
Last verified: April 2017
  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.


Condition Intervention
Pelvic Organ Prolapse Device: Tensionfree vaginal mesh kit (Prolift) Procedure: classic vaginal prolapse surgery (fascia plication)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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 Mariella Withagen, Radboud University:

Primary Outcome Measures:
  • Prolapse by "Pelvic Organ Prolapse Quantification System" (POP-Q), at 12 Months [ Time Frame: 12 months ]
    Number of participants with anatomic failures defined as "Pelvic Organ Prolapse" (POP) stage II or higher


Secondary Outcome Measures:
  • Mesh Exposure at 12 Months [ Time Frame: 12 months ]
    cumulative number of patients with mesh exposure at 12 months (if diagnosed at 6 weeks or 6 months and treated, the exposure is calculated at 12 months, even if the exposure was not there anymore)

  • "Patient Global Impression of Improvement" (PGI-I) at 12 Months [ Time Frame: at 12 months ]
    Number of participants with much to very much improvement compared to baseline

  • Bulge Symptoms [ Time Frame: 12 months ]

    Bulge symptoms defined as Prolapse domain score of the "Urogenital Distress Inventory" (UDI) at 12 months.

    Scores range from 0 (least/no bother) to 100 (maximum bother)



Enrollment: 194
Study Start Date: August 2006
Study Completion Date: December 2015
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mesh surgery
Trocar guided tension free vaginal mesh insertion by Prolift mesh kit
Device: Tensionfree vaginal mesh kit (Prolift)
Insertion of a tension free vaginal mesh using a Prolift mesh kit
Other Name: Prolift mesh
Active Comparator: Conventional vaginal surgery
Classical vaginal prolapse surgery (fascia plication)
Procedure: classic vaginal prolapse surgery (fascia plication)
classic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse
Other Name: Conventional

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mariella Withagen, Principal Investigator, Radboud University
ClinicalTrials.gov Identifier: NCT00372190     History of Changes
Other Study ID Numbers: P0609
Study First Received: September 5, 2006
Results First Received: September 7, 2016
Last Updated: April 11, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Mariella Withagen, 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 July 28, 2017