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Patient-Centered Outcomes in the Surgical Treatment of Uterovaginal Prolapse (PREMIER)

Primary Purpose

Uterine Prolapse

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Minimally invasive supracervical hysterectomy and sacrocolpopexy (MI-SCH+SCP)
Vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS)
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Prolapse focused on measuring Sacrocolpopexy, Uterosacral Ligament Suspension

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Duke UniversityRecruiting
  • University Hospitals Cleveland Medical CenterRecruiting
  • Cleveland ClinicRecruiting
  • University of Pittsburgh, UPMC Magee-Womens HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Sacrocolpopexy

Uterosacral Ligament Suspension

Arm Description

Minimally invasive supracervical hysterectomy with sacrocolpopexy (MI-SCH+SCP)

Total vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Postoperative anti-emetic use
Postoperative anti-emetic use will be assessed using the total number of times patients take an anti-emetic.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
August 4, 2021
Last Updated
September 28, 2023
Sponsor
University Hospitals Cleveland Medical Center
Collaborators
Case Western Reserve University, MetroHealth Medical Center, The Cleveland Clinic, Duke University, University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT05063331
Brief Title
Patient-Centered Outcomes in the Surgical Treatment of Uterovaginal Prolapse
Acronym
PREMIER
Official Title
Patient-Centered Outcomes of Sacrocolpopexy Versus Uterosacral Ligament Suspension for the Treatment of Uterovaginal Prolapse
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
September 30, 2028 (Anticipated)
Study Completion Date
September 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Cleveland Medical Center
Collaborators
Case Western Reserve University, MetroHealth Medical Center, The Cleveland Clinic, Duke University, University of Pittsburgh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Prolapse
Keywords
Sacrocolpopexy, Uterosacral Ligament Suspension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sacrocolpopexy
Arm Type
Active Comparator
Arm Description
Minimally invasive supracervical hysterectomy with sacrocolpopexy (MI-SCH+SCP)
Arm Title
Uterosacral Ligament Suspension
Arm Type
Active Comparator
Arm Description
Total vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS)
Intervention Type
Procedure
Intervention Name(s)
Minimally invasive supracervical hysterectomy and sacrocolpopexy (MI-SCH+SCP)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS)
Intervention Description
The uterus will be removed vaginally and the vaginal apex will be suspended utilizing sutures in the uterosacral ligament.
Primary Outcome Measure Information:
Title
Treatment failure
Description
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
Secondary Outcome Measure Information:
Title
Postoperative pain medication use
Description
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
Title
Change in surgical pain using VAS
Description
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
Title
Postoperative anti-emetic use
Description
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
Title
Change in nausea using VAS
Description
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
Title
Change in fatigue using MAF
Description
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
Title
Change in bladder function using UDI-6
Description
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
Title
Change in bladder function using IIQ-7
Description
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
Title
Change in bowel function using CRAD-8
Description
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
Title
Change in sexual function using PISQ-12
Description
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
Title
Change in sexual function using FSFI
Description
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
Title
Change in body image using BIPOP
Description
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
Title
Change in quality of life using P-QOL
Description
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
Title
Change in satisfaction with care using PGI-I
Description
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
Title
Rate of Grade I-V DINDO complications in each surgical arm
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women ≥ 18 years of age and ≤ 80 years of age Have diagnosis of symptomatic uterovaginal prolapse Have elected to undergo surgical management of uterovaginal prolapse after consultation with their physician 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: Patients who wish to undergo uterine sparing procedures Body mass index BMI) > 50 Previous hysterectomy or prior uterovaginal surgery Have a diagnosis of neurogenic bladder, Parkinson's disease, multiple sclerosis, spinal cord injury, or cerebrovascular accident Chronic indwelling urinary catheter Urinary diversion of any type 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 Unable to speak, read, understand English
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ellen Divoky
Phone
216-844-8092
Email
ellen.divoky@uhhospitals.org
First Name & Middle Initial & Last Name or Official Title & Degree
Christiana Mares
Phone
216-286-1094
Email
Christiana.Mares@uhhospitals.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adonis Hijaz, MD
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27707
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Summer Granger
Phone
919-401-1015
Email
summer.mcmasterbennett@duke.edu
First Name & Middle Initial & Last Name & Degree
Eric Jelovsek, MD
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ellen Divoky
Phone
216-844-8092
Email
ellen.divoky@uhhospitals.org
First Name & Middle Initial & Last Name & Degree
Christiana Mares
Phone
216-286-1094
Email
christiana.mares@uhhospitals.org
First Name & Middle Initial & Last Name & Degree
Adonis Hijaz, MD
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lynn Borzi
Phone
216-445-3158
Email
borzil@ccf.org
First Name & Middle Initial & Last Name & Degree
Annette Graham
Phone
216-445-2597
Email
GRAHAMA2@ccf.org
First Name & Middle Initial & Last Name & Degree
Cecile A. Ferrando, MD MPH
Facility Name
University of Pittsburgh, UPMC Magee-Womens Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Judy Gruss
Phone
412-641-5388
Email
grusja@upmc.edu
First Name & Middle Initial & Last Name & Degree
G Sarah Napoe, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All of the individual participant data collected during the trial will be made available after de-identification.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following publication.
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal may use the data for any purpose.

Learn more about this trial

Patient-Centered Outcomes in the Surgical Treatment of Uterovaginal Prolapse

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