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Completed

NCT Number: NCT00271102

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Geisinger Health System

Danville, Pennsylvania, 17822, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

anterior vaginal repair (colporrhaphy)

Procedure

vaginal repair

abdominal paravaginal defect repair

Procedure

abdominal repair

Primary outcomes

  1. Change in the Stage of Prolapse of the Anterior Vaginal Wall Before and One Year After Surgery

    Time frame: 4 years

    POP-Q (pelvic organ prolapse quantification) as measured after surgery at one year or more after surgery. If one year data not available, then the last post-op measure is reported.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Geisinger Clinic

Other

Registry information

Official study title

Randomized Trial Comparing Anterior Colporrhaphy to Paravaginal Defect Repair for Anterior Vaginal Wall Prolapse

Important dates

Study start
2006
Primary completion
2010
Study completion
2011
First posted
Dec 30, 2005
Registry last updated
Sep 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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