Clinical Trial: Transvaginal Treatment of Symptomatic Cystocele Grade II-III

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

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

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.

Detailed Summary:
Sponsor: Slabbaert Koen

Current Primary Outcome: Absence of recurrence [ Time Frame: 3 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

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

Original Secondary Outcome: Same as current

Information By: Regionaal Ziekenhuis Heilig Hart Tienen

Dates:
Date Received: October 1, 2014
Date Started: June 2014
Date Completion: December 2019
Last Updated: January 31, 2017
Last Verified: January 2017