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Transvaginal Treatment of Symptomatic Cystocele Grade II-III (BCR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02272322
Recruitment Status : Unknown
Verified January 2017 by Slabbaert Koen, Regionaal Ziekenhuis Heilig Hart Tienen.
Recruitment status was:  Active, not recruiting
First Posted : October 22, 2014
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):
Slabbaert Koen, Regionaal Ziekenhuis Heilig Hart Tienen

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.

Condition or disease Intervention/treatment
Cystocele Device: cystocele repair with biomesh soft prolaps and endofast reliant

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Transvaginal Treatment of Symptomatic Cystocele Grade II-III Using Cousin Biomesh Soft Prolaps or Allium Medical Endofast Reliant
Study Start Date : June 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2019



Primary Outcome Measures :
  1. Absence of recurrence [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Technical success [ Time Frame: day 1 ]
    Correct positioning of the mesh as intended by the surgeon

  2. Procedural success [ Time Frame: 30 days ]
    Technical success without complications till 30 days after the index-procedure

  3. Peroperative complications [ Time Frame: day 1 ]
    Perforation bowels, bladder or arteries

  4. Postoperative complications [ Time Frame: 3 years ]
    Infection, bleeding, recurrence, mesh erosion, pain during sexual activities, pain, discomfort

  5. Quality of life [ Time Frame: 3 years ]
    PFDI-20, PFIQ-7, PISQ-12



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with symptomatic anterior prolapse
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02272322


Locations
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Belgium
RZ Heilig Hart Tienen
Tienen, Vlaams-Brabant, Belgium, 3300
Sponsors and Collaborators
Slabbaert Koen
Investigators
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Principal Investigator: Koen Slabbaert, MD RZ Heilig Hart Tienen

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Responsible Party: Slabbaert Koen, MD, Regionaal Ziekenhuis Heilig Hart Tienen
ClinicalTrials.gov Identifier: NCT02272322    
Other Study ID Numbers: BCR-11-01
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017
Keywords provided by Slabbaert Koen, Regionaal Ziekenhuis Heilig Hart Tienen:
Anterior prolapse
Additional relevant MeSH terms:
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Cystocele
Hernia
Urinary Bladder Diseases
Urologic Diseases
Pelvic Organ Prolapse
Prolapse
Pathological Conditions, Anatomical