Transvaginal Treatment of Symptomatic Cystocele Grade II-III

NCT ID: NCT02272322

Last Updated: 2017-02-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2019-12-31

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.

Conditions

Cystocele

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

cystocele repair with biomesh soft prolaps and endofast reliant

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Slabbaert Koen

OTHER

Sponsor Role: lead

Responsible Party

Slabbaert Koen

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Koen Slabbaert, MD

Role: PRINCIPAL_INVESTIGATOR

RZ Heilig Hart Tienen

Locations

RZ Heilig Hart Tienen

Tienen, Vlaams-Brabant, Belgium

Countries

Belgium

Other Identifiers

BCR-11-01

Identifier Type: -

Identifier Source: org_study_id