Patient-Centered Outcomes in the Surgical Treatment of Uterovaginal Prolapse
Patient-Centered Outcomes of Sacrocolpopexy Versus Uterosacral Ligament Suspension for the Treatment of Uterovaginal Prolapse
University Hospitals Cleveland Medical Center
320 participants
Dec 15, 2021
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to compare two types of surgery for the treatment of uterovaginal prolapse to determine which surgery works best from a patient's perspective and has the lowest number of short-term and long-term complications.
Eligibility
Inclusion Criteria4
- Women ≥ 18 years of age and ≤ 80 years of age
- Have diagnosis of symptomatic uterovaginal prolapse
- Have elected to undergo surgical management of uterovaginal prolapse after consultation with their physician
- Are eligible for both minimally invasive supracervical hysterectomy with sacrocolpopexy (MI-SCH+SCP) and total vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS)
Exclusion Criteria8
- Patients who wish to undergo uterine sparing procedures
- Body mass index BMI) \> 50
- Previous hysterectomy or prior uterovaginal surgery
- Have a diagnosis of neurogenic bladder, Parkinson's disease, multiple sclerosis, spinal cord injury, or cerebrovascular accident
- Chronic indwelling urinary catheter
- Urinary diversion of any type
- Any condition or disorder that, in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results
- Unable to speak, read, understand English
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Interventions
Minimally invasive robotic or laparoscopic supracervical hysterectomy will be done, and the vaginal apex (including cervix) will be suspended utilizing sacrocolpopexy mesh to the anterior spinous ligament.
The uterus will be removed vaginally and the vaginal apex will be suspended utilizing sutures in the uterosacral ligament.
Locations(7)
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NCT05063331