Clinical trial NCT05063331: Patient-Centered Outcomes in the Surgical Treatment of Uterovaginal Prolapse
Official title: Patient-Centered Outcomes of Sacrocolpopexy Versus Uterosacral Ligament Suspension for the Treatment of Uterovaginal Prolapse
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Uterine Prolapse
Keywords: Sacrocolpopexy
Uterosacral Ligament Suspension
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Case Western Reserve University
name: MetroHealth Medical Center
name: The Cleveland Clinic
name: Duke University
name: University of Pittsburgh
First posted: 2021-10-01
Enrollment: 320
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is utilizing a 1:1 randomization scheme (by site) to assign patients to one of two treatment arms: 1) minimally invasive supracervical hysterectomy with sacrocolpopexy (MI-SCH+SCP, N=160) or 2) total vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS, N=160).
Primary purpose: TREATMENT

Brief 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.

Detailed description: This is a multi-site, randomized controlled trial, where women with the confirmed diagnosis of uterovaginal prolapse will be randomized in a 1:1 ratio to either A) a minimally invasive supracervical hysterectomy with sacrocolpopexy (MI-SCH+SCP) or B) total vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS). After surgery, participants will be followed for 3 years including physical pelvic exams and validated symptom questionnaires to assess for the primary and secondary outcomes. A subset of participants will participate in semi-structured interviews, before surgery and through 2 years after surgery, that will assess patient recovery, satisfaction with care, and calibrate surveyed and clinically assessed outcomes to the daily life experiences of women.

Eligibility criteria: Inclusion Criteria:

1. Women ≥ 18 years of age and ≤ 80 years of age
2. Have diagnosis of symptomatic uterovaginal prolapse
3. Have elected to undergo surgical management of uterovaginal prolapse after consultation with their physician
4. Are eligible for both minimally invasive supracervical hysterectomy with sacrocolpopexy (MI-SCH+SCP) and total vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS)

Exclusion Criteria:

1. Patients who wish to undergo uterine sparing procedures
2. Body mass index BMI) \> 50
3. Previous hysterectomy or prior uterovaginal surgery
4. Have a diagnosis of neurogenic bladder, Parkinson's disease, multiple sclerosis, spinal cord injury, or cerebrovascular accident
5. Chronic indwelling urinary catheter
6. Urinary diversion of any type
7. 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
8. Unable to speak, read, understand English

Primary outcomes:
measure: Treatment failure
timeFrame: 36 months post-surgery
Secondary outcomes:
measure: Postoperative pain medication use
timeFrame: Post-surgery through Day 14
measure: Change in surgical pain using VAS
timeFrame: Baseline, Days 1, 7 and 14 post-surgery
measure: Postoperative anti-emetic use
timeFrame: Post-surgery through Day 14
measure: Change in nausea using VAS
timeFrame: Baseline, Days 1, 7 and 14 post-surgery
measure: Change in fatigue using MAF
timeFrame: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, and 8 post-surgery
measure: Change in bladder function using UDI-6
timeFrame: Baseline, 2, 6, 12, 24, and 36 months post-surgery
measure: Change in bladder function using IIQ-7
timeFrame: Baseline, 2, 6, 12, 24, and 36 months post-surgery
measure: Change in bowel function using CRAD-8
timeFrame: Baseline, 2, 6, 12, 24, and 36 months post-surgery
measure: Change in sexual function using PISQ-12
timeFrame: Baseline, 6, 12, 24, and 36 months post-surgery
measure: Change in sexual function using FSFI
timeFrame: Baseline, 6, 12, 24, and 36 months post-surgery
measure: Change in body image using BIPOP
timeFrame: Baseline, 6, 12, 24, and 36 months post-surgery
measure: Change in quality of life using P-QOL
timeFrame: Baseline, 2, 6, 12, 24, and 36 months post-surgery
measure: Change in satisfaction with care using PGI-I
timeFrame: Baseline, 6, 12, 24, and 36 months post-surgery
measure: Rate of Grade I-V DINDO complications in each surgical arm
timeFrame: Surgery through 36 months post-surgery
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Chicago
country: United States
facility: Northwestern Medicine
state: Illinois
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh, UPMC Magee-Womens Hospital
state: Pennsylvania
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Adonis Hijaz, MD
role: PRINCIPAL_INVESTIGATOR
References: