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

Slabbaert Koen

Status: Unknown

Conditions: Cystocele

Treatments: Device: cystocele repair with biomesh soft prolaps and endofast reliant

Study type: Observational

Funder types: Other

Identifiers

NCT02272322

BCR-11-01

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 40 to 90 years old

Volunteers: No Healthy Volunteers

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