Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02272322
Other study ID # BCR-11-01
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT01637441 - Prosthetic Pelvic Organ Prolapse Repair N/A
Recruiting NCT04009694 - Does a High BMI Affect Supervised Pelvic Floor Muscle Training for Improving Symptoms in Women With Various Stages of Pelvic Organ Prolapse? N/A
Completed NCT04481906 - Vaginal Mesh Procedures for Female Cystocele
Completed NCT02888093 - A Randomized Controlled Trial of Permanent vs Absorbable Suture for Uterosacral Ligament Suspension N/A
Completed NCT02272361 - Trial Comparing Laparoscopic Sacropexy and Vaginal Mesh Surgery for Women Cystocele Repair. N/A
Completed NCT02255994 - UGYTEX® Mesh Versus Subvesical Plication in the Surgical Treatment of Bladder Prolapse N/A
Withdrawn NCT00942474 - Nerve Access Tool Study N/A
Completed NCT04417413 - Safety and Efficacy of Non-ablative Er:YAG Laser Therapy for the Treatment of Pelvic Organ Prolapse and Coexisting Stress Urinary Incontinence: A Retrospective Case Series.
Active, not recruiting NCT03714607 - Laser Therapy in Managing Vaginal Prolapse N/A
Completed NCT04184128 - Detrusor Underactivity and Bladder Outlet Obstruction in Women With Cystocele
Active, not recruiting NCT01097200 - Sacrocolpopexy Versus Vaginal Mesh Procedure for Pelvic Prolapse N/A
Recruiting NCT00162604 - Prophylactic Antibiotic Treatment During Vaginal Repair N/A
Completed NCT02400034 - Comparing Voiding Trials After Midurethral Sling for Stress Incontinence N/A
Completed NCT01559558 - Changes of Pad Weight Results and Urethral Pressure Profiles After Reduction of Cystocele by Vaginal Gauze Packing N/A
Not yet recruiting NCT03056586 - The Effect of Pessary Post Vaginal Prolapse Repair, for One Month, to Reduce the Recurrence Rate of Prolapse N/A
Completed NCT00557882 - Efficacy Study of Vaginal Mesh for Anterior Prolapse Phase 4
Completed NCT06410469 - A Novel Suturing Technique of Cystocele Treatment
Completed NCT04175782 - Enhanced Recovery Protocol in Urogynecologic Surgery N/A
Recruiting NCT05449054 - Continuous Stitches Versus Simple Interrupted Stitches for Anterior Colporrhaphy N/A
Recruiting NCT05688059 - Absorbable Suture vs Permanent Suture in Sacrospinous Ligament Suspension N/A