Patient-Centered Outcomes in the Surgical Treatment of Uterovaginal Prolapse

Uterine Prolapse Clinical Trial

— PREMIER  

Official title:

Patient-Centered Outcomes of Sacrocolpopexy Versus Uterosacral Ligament Suspension for the Treatment of Uterovaginal Prolapse

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05063331
• Other study ID #: 20210871
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2021
• Est. completion date: June 30, 2030

Study information

• Verified date: June 2024
• Source: University Hospitals Cleveland Medical Center
• Contact: Christiana Mares
• Phone: 216-286-1094
• Email: Christiana.Mares[@]uhhospitals.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: June 30, 2030
• Est. primary completion date: June 30, 2030
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Prolapse
• Uterine Prolapse

Intervention

Procedure:
• Minimally invasive supracervical hysterectomy and sacrocolpopexy (MI-SCH+SCP)
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.
• Vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS)
The uterus will be removed vaginally and the vaginal apex will be suspended utilizing sutures in the uterosacral ligament.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Duke University	Durham	North Carolina
United States	Mayo Clinic	Jacksonville	Florida
United States	University of Pittsburgh, UPMC Magee-Womens Hospital	Pittsburgh	Pennsylvania

Sponsors (6)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center	Case Western Reserve University, Duke University, MetroHealth Medical Center, The Cleveland Clinic, University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment failure	The primary outcome is treatment failure defined as the presence of at least one of the following: 1) presence of a vaginal bulge defined as lead point of prolapse beyond the hymen, 2) report of bothersome vaginal bulge symptoms irrespective of stage of prolapse, or 3) retreatment of symptomatic prolapse with pessary, or surgery.	36 months post-surgery
Secondary	Postoperative pain medication use	Postoperative pain medication use will be assessed using the total morphine equivalent dosing (MED) for narcotics and using the total dosage for non-narcotics.	Post-surgery through Day 14
Secondary	Change in surgical pain using VAS	Longitudinal pain score will be assessed using a visual analog scale (VAS) with a score of 0 to 100 where a higher score means a worse outcome.	Baseline, Days 1, 7 and 14 post-surgery
Secondary	Postoperative anti-emetic use	Postoperative anti-emetic use will be assessed using the total number of times patients take an anti-emetic.	Post-surgery through Day 14
Secondary	Change in nausea using VAS	Longitudinal nausea score will be assessed using a visual analog scale (VAS) with a score of 0 to 100 where a higher score means a worse outcome.	Baseline, Days 1, 7 and 14 post-surgery
Secondary	Change in fatigue using MAF	Fatigue will be assessed utilizing the Multi-Dimensional Assessment of Fatigue (MAF) Scale with a score of 1 to 148 where a higher score means a worse outcome.	Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, and 8 post-surgery
Secondary	Change in bladder function using UDI-6	Bladder function will be assessed using the Urinary Distress Inventory-6 (UDI-6) which is questions 15-20 of the Pelvic Floor Distress Inventory (PFDI-20) with a score of 0 to 18 where a higher score means a worse outcome.	Baseline, 2, 6, 12, 24, and 36 months post-surgery
Secondary	Change in bladder function using IIQ-7	Bladder function will be assessed using the Incontinence Impact Questionnaire-7 (IIQ-7) with a score of 0 to 21 where a higher score means a worse outcome.	Baseline, 2, 6, 12, 24, and 36 months post-surgery
Secondary	Change in bowel function using CRAD-8	Bowel function will be assessed using the Colorectal Anal Distress Inventory 8 (CRAD-8) which is questions 7-14 of the Pelvic Floor Distress Inventory (PFDI-20) with a score of 0 to 24 where a higher score means a worse outcome.	Baseline, 2, 6, 12, 24, and 36 months post-surgery
Secondary	Change in sexual function using PISQ-12	Sexual function will be assessed using the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) with a score of 0 to 48 where a higher score means a worse outcome.	Baseline, 6, 12, 24, and 36 months post-surgery
Secondary	Change in sexual function using FSFI	Sexual function will be assessed using the Female Sexual Function Inventory (FSFI) with a score of 2 to 36 where higher score where a higher score means a better outcome.	Baseline, 6, 12, 24, and 36 months post-surgery
Secondary	Change in body image using BIPOP	Body image will be assessed using the Body Image in Pelvic Organ Prolapse Questionnaire (BIPOP) with a score of 1 to 5 where a higher score means a better outcome.	Baseline, 6, 12, 24, and 36 months post-surgery
Secondary	Change in quality of life using P-QOL	General quality of life will be assessed using the Pelvic Organ Prolapse Quality of Life Questionnaire (P-QOL) with a score in each domain of 0 to 100 where a higher score means a worse outcome.	Baseline, 2, 6, 12, 24, and 36 months post-surgery
Secondary	Change in satisfaction with care using PGI-I	Satisfaction with care will be assessed using the Patient Global Impression of Improvement (PGI-I) scale with a score of 1 to 7 where higher score means a worse outcome.	Baseline, 6, 12, 24, and 36 months post-surgery
Secondary	Rate of Grade I-V DINDO complications in each surgical arm	Surgical complications will be assessed using the Clavien-Dindo standardized classification system with a grade of I to V where the higher grade means a worse outcome.	Surgery through 36 months post-surgery