Status:
UNKNOWN
Transvaginal Treatment of Symptomatic Cystocele Grade II-III
Lead Sponsor:
Slabbaert Koen
Conditions:
Cystocele
Eligibility:
FEMALE
40-90 years
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 til...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT02272322
Start Date
June 1 2014
End Date
December 1 2019
Last Update
February 1 2017
Active Locations (1)
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1
RZ Heilig Hart Tienen
Tienen, Vlaams-Brabant, Belgium, 3300