PREMIER: Patient-Centered Outcomes in the Surgical Treatment of Uterovaginal Prolapse
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Sacrocolpopexy Minimally invasive supracervical hysterectomy with sacrocolpopexy (MI-SCH+SCP) |
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.
|
| Active Comparator: Uterosacral Ligament Suspension Total vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS) |
Procedure: 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.
|
Outcome Measures
Primary Outcome Measures
- Treatment failure [36 months post-surgery]
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.
Secondary Outcome Measures
- Postoperative pain medication use [Post-surgery through Day 14]
Postoperative pain medication use will be assessed using the total morphine equivalent dosing (MED) for narcotics and using the total dosage for non-narcotics.
- Change in surgical pain using VAS [Baseline, Days 1, 7 and 14 post-surgery]
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.
- Postoperative anti-emetic use [Post-surgery through Day 14]
Postoperative anti-emetic use will be assessed using the total number of times patients take an anti-emetic.
- Change in nausea using VAS [Baseline, Days 1, 7 and 14 post-surgery]
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.
- Change in fatigue using MAF [Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, and 8 post-surgery]
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.
- Change in bladder function using UDI-6 [Baseline, 2, 6, 12, 24, and 36 months post-surgery]
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.
- Change in bladder function using IIQ-7 [Baseline, 2, 6, 12, 24, and 36 months post-surgery]
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.
- Change in bowel function using CRAD-8 [Baseline, 2, 6, 12, 24, and 36 months post-surgery]
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.
- Change in sexual function using PISQ-12 [Baseline, 6, 12, 24, and 36 months post-surgery]
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.
- Change in sexual function using FSFI [Baseline, 6, 12, 24, and 36 months post-surgery]
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.
- Change in body image using BIPOP [Baseline, 6, 12, 24, and 36 months post-surgery]
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.
- Change in quality of life using P-QOL [Baseline, 2, 6, 12, 24, and 36 months post-surgery]
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.
- Change in satisfaction with care using PGI-I [Baseline, 6, 12, 24, and 36 months post-surgery]
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.
- Rate of Grade I-V DINDO complications in each surgical arm [Surgery through 36 months post-surgery]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Women ≥ 18 years of age and ≤ 80 years of age
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Have diagnosis of symptomatic uterovaginal prolapse
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Have elected to undergo surgical management of uterovaginal prolapse after consultation with their physician
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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:
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Patients who wish to undergo uterine sparing procedures
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Body mass index BMI) > 50
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Previous hysterectomy or prior uterovaginal surgery
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Have a diagnosis of neurogenic bladder, Parkinson's disease, multiple sclerosis, spinal cord injury, or cerebrovascular accident
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Chronic indwelling urinary catheter
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Urinary diversion of any type
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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
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Unable to speak, read, understand English
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Duke University | Durham | North Carolina | United States | 27707 |
| 2 | University Hospitals Cleveland Medical Center | Cleveland | Ohio | United States | 44106 |
| 3 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
| 4 | University of Pittsburgh, UPMC Magee-Womens Hospital | Pittsburgh | Pennsylvania | United States | 15213 |
Sponsors and Collaborators
- University Hospitals Cleveland Medical Center
- Case Western Reserve University
- MetroHealth Medical Center
- The Cleveland Clinic
- Duke University
- University of Pittsburgh
Investigators
- Principal Investigator: Adonis Hijaz, MD, University Hospitals Cleveland Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20210871