search
Back to results

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

Primary Purpose

Pelvic Organ Prolapse

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Tensionfree vaginal mesh kit (Prolift)
classic vaginal prolapse surgery (fascia plication)
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring Pelvic organ prolapse, recurrence, mesh, complications, treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Gelre ziekenhuizen
  • Slysis Zorggroep, location Rijnstate
  • Reinier de Graaf Gasthuis
  • Medisch Spectrum Twente
  • Groene Hart Ziekenhuis
  • St. Antonius Ziekenhuis
  • UMC St Radboud
  • Ikazia
  • Refaja
  • St. Elisabeth hospital
  • Twee Steden Ziekenhuis
  • Zaans Medisch Centrum
  • Isala klinieken

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mesh surgery

Conventional vaginal surgery

Arm Description

Trocar guided tension free vaginal mesh insertion by Prolift mesh kit

Classical vaginal prolapse surgery (fascia plication)

Outcomes

Primary Outcome Measures

Prolapse by "Pelvic Organ Prolapse Quantification System" (POP-Q), at 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
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
Number of participants with much to very much improvement compared to baseline
Bulge Symptoms
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)

Full Information

First Posted
September 5, 2006
Last Updated
April 11, 2017
Sponsor
Radboud University Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT00372190
Brief Title
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

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Radboud University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
Keywords
Pelvic organ prolapse, recurrence, mesh, complications, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
194 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mesh surgery
Arm Type
Experimental
Arm Description
Trocar guided tension free vaginal mesh insertion by Prolift mesh kit
Arm Title
Conventional vaginal surgery
Arm Type
Active Comparator
Arm Description
Classical vaginal prolapse surgery (fascia plication)
Intervention Type
Device
Intervention Name(s)
Tensionfree vaginal mesh kit (Prolift)
Other Intervention Name(s)
Prolift mesh
Intervention Description
Insertion of a tension free vaginal mesh using a Prolift mesh kit
Intervention Type
Procedure
Intervention Name(s)
classic vaginal prolapse surgery (fascia plication)
Other Intervention Name(s)
Conventional
Intervention Description
classic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse
Primary Outcome Measure Information:
Title
Prolapse by "Pelvic Organ Prolapse Quantification System" (POP-Q), at 12 Months
Description
Number of participants with anatomic failures defined as "Pelvic Organ Prolapse" (POP) stage II or higher
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Mesh Exposure at 12 Months
Description
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)
Time Frame
12 months
Title
"Patient Global Impression of Improvement" (PGI-I) at 12 Months
Description
Number of participants with much to very much improvement compared to baseline
Time Frame
at 12 months
Title
Bulge Symptoms
Description
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)
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariella ij Withagen, Drs.
Organizational Affiliation
UMC St Radboud
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gelre ziekenhuizen
City
Apeldoorn
Country
Netherlands
Facility Name
Slysis Zorggroep, location Rijnstate
City
Arnhem
Country
Netherlands
Facility Name
Reinier de Graaf Gasthuis
City
Delft
Country
Netherlands
Facility Name
Medisch Spectrum Twente
City
Enschede
Country
Netherlands
Facility Name
Groene Hart Ziekenhuis
City
Gouda
Country
Netherlands
Facility Name
St. Antonius Ziekenhuis
City
Nieuwegein
Country
Netherlands
Facility Name
UMC St Radboud
City
Nijmegen
Country
Netherlands
Facility Name
Ikazia
City
Rotterdam
Country
Netherlands
Facility Name
Refaja
City
Stadskanaal
Country
Netherlands
Facility Name
St. Elisabeth hospital
City
Tilburg
Country
Netherlands
Facility Name
Twee Steden Ziekenhuis
City
Tilburg
Country
Netherlands
Facility Name
Zaans Medisch Centrum
City
Zaandam
Country
Netherlands
Facility Name
Isala klinieken
City
Zwolle
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21252735
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.
Results Reference
result
PubMed Identifier
29167974
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.
Results Reference
derived
PubMed Identifier
22239416
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs