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BCR: Transvaginal Treatment of Symptomatic Cystocele Grade II-III

Sponsor
Slabbaert Koen (Other)
Overall Status
Unknown status
CT.gov ID
NCT02272322
Collaborator
(none)
100
Enrollment
1
Location
66
Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: cystocele repair with biomesh soft prolaps and endofast reliant

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Transvaginal Treatment of Symptomatic Cystocele Grade II-III Using Cousin Biomesh Soft Prolaps or Allium Medical Endofast Reliant
Study Start Date :
Jun 1, 2014
Anticipated Primary Completion Date :
Dec 1, 2017
Anticipated Study Completion Date :
Dec 1, 2019

Outcome Measures

Primary Outcome Measures

  1. Absence of recurrence [3 years]

Secondary Outcome Measures

  1. Technical success [day 1]

    Correct positioning of the mesh as intended by the surgeon

  2. Procedural success [30 days]

    Technical success without complications till 30 days after the index-procedure

  3. Peroperative complications [day 1]

    Perforation bowels, bladder or arteries

  4. Postoperative complications [3 years]

    Infection, bleeding, recurrence, mesh erosion, pain during sexual activities, pain, discomfort

  5. Quality of life [3 years]

    PFDI-20, PFIQ-7, PISQ-12

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 90 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 RZ Heilig Hart Tienen Tienen Vlaams-Brabant Belgium 3300

Sponsors and Collaborators

  • Slabbaert Koen

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Slabbaert Koen, MD, Regionaal Ziekenhuis Heilig Hart Tienen
ClinicalTrials.gov Identifier:
NCT02272322
Other Study ID Numbers:
  • BCR-11-01
First Posted:
Oct 22, 2014
Last Update Posted:
Feb 1, 2017
Last Verified:
Jan 1, 2017
Keywords provided by Slabbaert Koen, MD, Regionaal Ziekenhuis Heilig Hart Tienen
Anterior prolapse
Additional relevant MeSH terms:
Cystocele
Hernia

Study Results

No Results Posted as of Feb 1, 2017