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

December 29, 2005
July 9, 2010
December 2005
February 2010   (final data collection date for primary outcome measure)
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 ]
Change in the stage of prolapse of the anterior vaginal wall before and one year after surgery
Complete list of historical versions of study NCT00271102 on ClinicalTrials.gov Archive Site
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 ]
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.
Not Provided
Not Provided
 
Surgical Study Comparing 2 Procedures for the Treatment of a Dropped Bladder
Randomized Trial Comparing Anterior Colporrhaphy to Paravaginal Defect Repair for Anterior Vaginal Wall Prolapse

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Prolapse
  • Procedure: anterior vaginal repair (colporrhaphy)
    vaginal repair
  • Procedure: abdominal paravaginal defect repair
    abdominal repair
  • Active Comparator: 1
    Anterior repair (colporrhaphy) for their cystocele
    Intervention: Procedure: anterior vaginal repair (colporrhaphy)
  • Active Comparator: 2
    Abdominal paravaginal defect repair for their cystocele
    Intervention: Procedure: abdominal paravaginal defect repair
Minassian VA, Parekh M, Poplawsky D, Gorman J, Litzy L. Randomized controlled trial comparing two procedures for anterior vaginal wall prolapse. Neurourol Urodyn. 2014 Jan;33(1):72-7. doi: 10.1002/nau.22396. Epub 2013 Mar 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
70
February 2012
February 2010   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00271102
2005-0193
No
Vatche Minassian, MD, Geisinger Health System
Geisinger Clinic
Not Provided
Principal Investigator: Vatche A Minassian, MD Geisinger Clinic
Geisinger Clinic
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP