Transvaginal Treatment of Symptomatic Cystocele Grade II-III

• Conditions: Cystocele

• Registration Number: NCT02272322
• Lead Sponsor: Slabbaert Koen

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 Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-10-01
• Study First Submitted QC: 2014-10-20
• Study First Posted: 2014-10-22
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-31
• Last Update Posted: 2017-02-01
• Primary Completion: 2017-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Absence of recurrence	3 years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

RZ Heilig Hart Tienen; 🇧🇪 Tienen, Vlaams-Brabant, Belgium