Transvaginal Treatment of Symptomatic Cystocele Grade II-III (BCR)
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ClinicalTrials.gov Identifier: NCT02272322
Recruitment Status : Unknown
Verified January 2017 by Slabbaert Koen, Regionaal Ziekenhuis Heilig Hart Tienen. Recruitment status was: Active, not recruiting
First Posted : October 22, 2014
Last Update Posted : February 1, 2017
Information provided by (Responsible Party):
Slabbaert Koen, Regionaal Ziekenhuis Heilig Hart Tienen
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
Device: cystocele repair with biomesh soft prolaps and endofast reliant
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Layout table for eligibility information
Ages Eligible for Study:
40 Years to 90 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with symptomatic anterior prolapse
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
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