Transvaginal Treatment of Symptomatic Cystocele Grade II-III

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02272322

Acronym

BCR

Enrollment

100

Registered

2014-10-22

Start date

2014-06-30

Completion date

2019-12-31

Last updated

2017-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystocele

Keywords

Anterior prolapse

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.

Interventions

DEVICEcystocele repair with biomesh soft prolaps and endofast reliant

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

40 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame
Absence of recurrence	3 years

Secondary

Measure	Time frame	Description
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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026