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| Name | Class |
|---|---|
| Case Western Reserve University | OTHER |
| MetroHealth Medical Center | OTHER |
| The Cleveland Clinic | OTHER |
| Duke University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sacrocolpopexy | Active Comparator | Minimally invasive supracervical hysterectomy with sacrocolpopexy (MI-SCH+SCP) |
|
| Uterosacral Ligament Suspension | Active Comparator | Total vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimally invasive supracervical hysterectomy and sacrocolpopexy (MI-SCH+SCP) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in surgical pain using VAS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adonis Hijaz, MD | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Jacksonville | Florida | 32224 | United States | ||
| Northwestern Medicine |
All of the individual participant data collected during the trial will be made available after de-identification.
Beginning 9 months and ending 36 months following publication.
Researchers who provide a methodologically sound proposal may use the data for any purpose.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 29, 2025 | Apr 24, 2026 |
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| OTHER |
| University of Pittsburgh | OTHER |
| Mayo Clinic | OTHER |
| Northwestern Medicine | OTHER |
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).
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Participants will be masked to the surgical randomization prior to surgery and will be informed of their surgical assignment (unmasked) after waking up from surgery and prior to discharge.
|
| Vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS) | Procedure | The uterus will be removed vaginally and the vaginal apex will be suspended utilizing sutures in the uterosacral ligament. |
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Duke University | Durham | North Carolina | 27707 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| University of Pittsburgh, UPMC Magee-Womens Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D014596 | Uterine Prolapse |
| ID | Term |
|---|---|
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D056887 | Pelvic Organ Prolapse |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007045 | Hysterectomy, Vaginal |
| ID | Term |
|---|---|
| D007044 | Hysterectomy |
| D013509 | Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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