Transvaginal Treatment of Symptomatic Cystocele Grade II-III

NCT02272322 | Unknown

• 1 other identifier: BCR-11-01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Anterior prolapse

Outcome Measures

Primary Outcomes (1)

• Absence of recurrence

  3 years

Secondary Outcomes (5)

• Technical success

  day 1

• Procedural success

  30 days

• Peroperative complications

  day 1

• Postoperative complications

  3 years

• Quality of life

  3 years

Interventions

cystocele repair with biomesh soft prolaps and endofast reliant DEVICE

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic anterior prolapse

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Slabbaert Koen: lead

Study Sites (1)

RZ Heilig Hart Tienen

Tienen, Vlaams-Brabant, 3300, Belgium

Location

MeSH Terms

Conditions

Cystocele

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pelvic Organ Prolapse; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Koen Slabbaert, MD

  RZ Heilig Hart Tienen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 1, 2014
• First Posted: October 22, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2019
• Last Updated: February 1, 2017

Record last verified: 2017-01

Locations

BE (1)