Transvaginal Treatment of Symptomatic Cystocele Grade II-III (BCR)

January 31, 2017 updated by: Slabbaert Koen

Transvaginal Treatment of Symptomatic Cystocele Grade II-III Using Cousin Biomesh Soft Prolaps or Allium Medical Endofast Reliant

This observational study will evaluate treatment of symptomatic cystocele grade II-III with Cousin Biomesh and Allium Medical Endofast Reliant. Data about 100 patients will be collected. Follow-up till 3 years after the procedure. Primary endpoint is absence of recurrence.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Vlaams-Brabant
      • Tienen, Vlaams-Brabant, Belgium, 3300
        • RZ Heilig Hart Tienen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients with symptomatic anterior prolapse

Description

Inclusion Criteria:

  • Patient is a woman
  • Patient is between 40 and 90 years old
  • Patient has to sign the informed consent form prior to the procedure
  • Patient has to agree with the scheduled follow-up visits on month 1, month 6, year 1, year 2 and year 3
  • Patient has symptomatic anterior prolapse

Exclusion Criteria:

  • Recurrence cystocele
  • Patient is pregnant
  • Patient has a wish to become pregnant
  • Patient is taking Plavix, Sintrom, Marcoumar, Marevan, Brilique, Efient, Ticlid, Xarelto, Eliquis or Pradaxa. If intake is stopped prior to procedure, patient is allowed to be included.
  • Patient is taking LMWH in a dose of more than 40 mg/day
  • Patient has a life expectancy < 1 year
  • Patient has a known connective tissue disease
  • Patient has a history of surgery of the anterior vaginal wall or pelvis
  • A scheduled hysterectomy during the index-procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Absence of recurrence
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical success
Time Frame: day 1
Correct positioning of the mesh as intended by the surgeon
day 1
Procedural success
Time Frame: 30 days
Technical success without complications till 30 days after the index-procedure
30 days
Peroperative complications
Time Frame: day 1
Perforation bowels, bladder or arteries
day 1
Postoperative complications
Time Frame: 3 years
Infection, bleeding, recurrence, mesh erosion, pain during sexual activities, pain, discomfort
3 years
Quality of life
Time Frame: 3 years
PFDI-20, PFIQ-7, PISQ-12
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Slabbaert Koen

Investigators

  • Principal Investigator: Koen Slabbaert, MD, RZ Heilig Hart Tienen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

October 1, 2014

First Submitted That Met QC Criteria

October 20, 2014

First Posted (Estimate)

October 22, 2014

Study Record Updates

Last Update Posted (Estimate)

February 1, 2017

Last Update Submitted That Met QC Criteria

January 31, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCR-11-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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