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Surgical Study Comparing 2 Procedures for the Treatment of a Dropped Bladder

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Geisinger Clinic.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Geisinger Clinic
ClinicalTrials.gov Identifier:
NCT00271102
First received: December 29, 2005
Last updated: July 9, 2010
Last verified: July 2010
History of Changes
  Purpose
The purpose of this study is to determine whether vaginal repair or abdominal repair is the procedure of choice for the surgical management of a prolapsed bladder.

Condition Intervention
Prolapse
 Procedure: anterior vaginal repair (colporrhaphy)
Procedure: abdominal paravaginal defect repair

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Trial Comparing Anterior Colporrhaphy to Paravaginal Defect Repair for Anterior Vaginal Wall Prolapse

Further study details as provided by Geisinger Clinic:

Primary Outcome Measures:
  • Change in the stage of prolapse of the anterior vaginal wall before and one year after surgery [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The difference in intra-operative and post-operative complications. Patient satisfaction before and one year after surgery based on quality of life and sexual function questionnaires specifically designed for patients with pelvic organ prolapse. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Estimated Enrollment: 70
Study Start Date: December 2005
Estimated Study Completion Date: February 2012
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Anterior repair (colporrhaphy) for their cystocele
 Procedure: anterior vaginal repair (colporrhaphy)
vaginal repair
Active Comparator: 2
Abdominal paravaginal defect repair for their cystocele
 Procedure: abdominal paravaginal defect repair
abdominal repair

Detailed Description:
It is not known whether anterior vaginal repair (colporrhaphy) or abdominal paravaginal defect repair is the procedure of choice for the treatment anterior vaginal wall prolapse. This randomized prospective study will attempt to answer this question by assessing the change in the stage of prolapse before and after surgery, patient satisfaction through quality of life and sexual function questionnaires before and after surgery, and peri-operative complication rates. Patients enrolled into the study will be followed up for up to 2 years after surgery.
  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women over the age of 18 seen at the urogynecology clinic at Geisinger with primary or recurrent pelvic organ prolapse including an anterior vaginal wall relaxation with or without urinary incontinence who are scheduled to have pelvic reconstructive surgery will be eligible to participate in the trial.

Exclusion Criteria:

  • Patients with at least 2 previous prolapse surgeries
  • Patients who are pregnant or planning to have a pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00271102

Locations
United States, Pennsylvania
Geisinger Health System
Danville, Pennsylvania, United States, 17822
Sponsors and Collaborators
Geisinger Clinic
Investigators
Principal Investigator: Vatche A Minassian, MD Geisinger Clinic
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Vatche Minassian, MD, Geisinger Health System
ClinicalTrials.gov Identifier: NCT00271102     History of Changes
Other Study ID Numbers: 2005-0193 
Study First Received: December 29, 2005
Last Updated: July 9, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Geisinger Clinic:
Cystocele, prolapse, anterior repair, colporrhaphy

Additional relevant MeSH terms:
Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 23, 2016