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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
320
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.
Mayo Clinic
Jacksonville, Florida, United States
RECRUITINGNorthwestern Medicine
Chicago, Illinois, United States
RECRUITINGDuke University
Durham, North Carolina, United States
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.
Time frame: 36 months post-surgery
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.
Time frame: Post-surgery through Day 14
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.
Time frame: Baseline, Days 1, 7 and 14 post-surgery
Postoperative anti-emetic use
Postoperative anti-emetic use will be assessed using the total number of times patients take an anti-emetic.
Time frame: Post-surgery through Day 14
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.
Time frame: Baseline, Days 1, 7 and 14 post-surgery
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.
Time frame: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, and 8 post-surgery
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University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
RECRUITINGMetroHealth Medical Center
Cleveland, Ohio, United States
RECRUITINGCleveland Clinic
Cleveland, Ohio, United States
RECRUITINGUniversity of Pittsburgh, UPMC Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States
RECRUITINGChange 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.
Time frame: Baseline, 2, 6, 12, 24, and 36 months post-surgery
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.
Time frame: Baseline, 2, 6, 12, 24, and 36 months post-surgery
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.
Time frame: Baseline, 2, 6, 12, 24, and 36 months post-surgery
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.
Time frame: Baseline, 6, 12, 24, and 36 months post-surgery
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.
Time frame: Baseline, 6, 12, 24, and 36 months post-surgery
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.
Time frame: Baseline, 6, 12, 24, and 36 months post-surgery
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.
Time frame: Baseline, 2, 6, 12, 24, and 36 months post-surgery
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.
Time frame: Baseline, 6, 12, 24, and 36 months post-surgery
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.
Time frame: Surgery through 36 months post-surgery