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Completed

NCT Number: NCT03609229

Outcomes After Sacrocolpopexy With and Without Burch to Prevent Stress Urinary Incontinence in 3rd and 4th Degree Apical Uterine Prolapse

Urinary incontinence will develop after prolapse repair in approximately one quarter of patients with advanced pelvic organ prolapse who remain continent despite significant loss of anterior vaginal and pelvic organ support. Many women with advanced pelvic organ prolapse who choose to undergo surgical management also choose to undergo continence surgery in order to prevent new onset urinary incontinence.

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Key information

Conditions

Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

40 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women with 3rd and 4th degree Apical prolapse

Exclusion criteria

  • Patients with previous failed surgical intervention
  • Patients with medical disorders that may interfere with surgical interventions .
  • Patients with apical prolapsed complaining of stress urinary incontinence

Treatment and study plan

Burch

Procedure

polyglactin suture was passed through the Cooper's ligament bilaterally with the guidance of the valve

Abdominal Sacrocolpopexy

Procedure
  • By careful dissection (to avoid large veins in this region), expose the back of the pubic bone and the lateral aspects of the urethra.
  • The right-handed operator double gloves, and places the left hand in the vagina.
  • With fingers on either side of the catheter in the vagina, define the urethrovesical junction (at the balloon).
  • Place three Ethibond J-shaped sutures on either side of the urethrovesical junction.

Primary outcomes

  1. the percentage of stress incontinence post operative

    Time frame: 3 months

    (symptoms, stress testing, or treatment)

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Outcomes After Sacrocolpopexy With and Without Burch to Prevent Stress Urinary Incontinence in 3rd and 4th Degree Apical Uterine Prolapse. Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 1, 2018
Registry last updated
Aug 12, 2020

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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