Transvaginal Treatment of Symptomatic Cystocele Grade II-III

Cystocele Clinical Trial

— BCR  

Official title:

Transvaginal Treatment of Symptomatic Cystocele Grade II-III Using Cousin Biomesh Soft Prolaps or Allium Medical Endofast Reliant

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02272322
• Other study ID #: BCR-11-01
• Status: Active, not recruiting
• Phase: N/A
• First received: October 1, 2014
• Last updated: January 31, 2017
• Start date: June 2014
• Est. completion date: December 2019

Study information

• Verified date: January 2017
• Source: Regionaal Ziekenhuis Heilig Hart Tienen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2019
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystocele
• Hernia

Intervention

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

Locations

Country	Name	City	State
Belgium	RZ Heilig Hart Tienen	Tienen	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Slabbaert Koen

Country where clinical trial is conducted

Belgium, 

Outcome

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