Uterine ProlapsePREMIERNCT05063331
Patient-Centered Outcomes in the Surgical Treatment of Uterovaginal Prolapse
A study testing Minimally invasive supracervical hysterectomy and sacrocolpopexy (MI-SCH+SCP) and Vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS) in people with Uterine Prolapse, run by University Hospitals Cleveland Medical Center at 7 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Uterine Prolapse
- What is being tested?
- Minimally invasive supracervical hysterectomy and sacrocolpopexy (MI-SCH+SCP) and Vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 7 sitesUnited States
- Study dates
- 15 Dec 2021to 31 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Northwestern Medicine
Chicago, Illinois, 60611
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
MetroHealth Medical Center
Cleveland, Ohio, 44109
Cleveland Clinic
Cleveland, Ohio, 44195
Duke University
Durham, North Carolina, 27707
Mayo Clinic
Jacksonville, Florida, 32224
University of Pittsburgh, UPMC Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Patient-Centered Outcomes of Sacrocolpopexy Versus Uterosacral Ligament Suspension for the Treatment of Uterovaginal Prolapse
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.
Read the 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.
- Conditions
- Uterine Prolapse
- Being tested
- Minimally invasive supracervical hysterectomy and sacrocolpopexy (MI-SCH+SCP), Vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS)
- Keywords
- Sacrocolpopexy, Uterosacral Ligament Suspension
- Medical subject headings
- Uterine Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive supracervical hysterectomy and sacrocolpopexy (MI-SCH+SCP)Procedure or surgery
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)Procedure or surgery
The uterus will be removed vaginally and the vaginal apex will be suspended utilizing sutures in the uterosacral ligament.
| Study group | Role | What they receive |
|---|---|---|
| Sacrocolpopexy | Active comparator | Minimally invasive supracervical hysterectomy with sacrocolpopexy (MI-SCH+SCP) Receives: Procedure: Minimally invasive supracervical hysterectomy and sacrocolpopexy (MI-SCH+SCP) |
| Uterosacral Ligament Suspension | Active comparator | Total vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS) Receives: Procedure: Vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 months post-surgery
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Surgery through 36 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start15 Dec 2021
- Primary completion31 May 2029 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine ProlapseStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Case Western Reserve University, MetroHealth Medical Center, The Cleveland Clinic, Duke University, University of Pittsburgh, Mayo Clinic, Northwestern Medicine
- Responsible party
- Principal investigator, Adonis Hijaz, MD, University Hospitals Cleveland Medical Center
- Investigators
- Adonis Hijaz, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05063331
- Sponsor's protocol ID
- 20210871
- Acronym
- PREMIER
- Status last verified
- Sep 2026
- First submitted
- 4 Aug 2021
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial will be made available after de-identification.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Centered Outcomes of Sacrocolpopexy Versus Uterosacral Ligament Suspension for the Treatment of Uterovaginal Prolapse
- ClinicalTrials.gov ID
- NCT05063331
- Acronym / sponsor ID
- PREMIER / 20210871
- Conditions
- Uterine Prolapse
- Keywords
- Sacrocolpopexy, Uterosacral Ligament Suspension
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Case Western Reserve University, MetroHealth Medical Center, The Cleveland Clinic, Duke University, University of Pittsburgh, Mayo Clinic, Northwestern Medicine
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 1 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Sacrocolpopexy | Active comparator | Procedure: Minimally invasive supracervical hysterectomy and sacrocolpopexy (MI-SCH+SCP)Minimally invasive supracervical hysterectomy with sacrocolpopexy (MI-SCH+SCP) |
| Uterosacral Ligament Suspension | Active comparator | Procedure: Vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS)Total vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Sacrocolpopexy |
| 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. | Procedure or surgery | Uterosacral Ligament Suspension |
Primary outcome
Treatment failure
Time frame: 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.
14 secondary outcomes
Postoperative pain medication use
Time frame: Post-surgery through Day 14
Change in surgical pain using VAS
Time frame: Baseline, Days 1, 7 and 14 post-surgery
Postoperative anti-emetic use
Time frame: Post-surgery through Day 14
Change in nausea using VAS
Time frame: Baseline, Days 1, 7 and 14 post-surgery
Change in fatigue using MAF
Time frame: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, and 8 post-surgery
Change in bladder function using UDI-6
Time frame: Baseline, 2, 6, 12, 24, and 36 months post-surgery
Change in bladder function using IIQ-7
Time frame: Baseline, 2, 6, 12, 24, and 36 months post-surgery
Change in bowel function using CRAD-8
Time frame: Baseline, 2, 6, 12, 24, and 36 months post-surgery
Change in sexual function using PISQ-12
Time frame: Baseline, 6, 12, 24, and 36 months post-surgery
Change in sexual function using FSFI
Time frame: Baseline, 6, 12, 24, and 36 months post-surgery
Change in body image using BIPOP
Time frame: Baseline, 6, 12, 24, and 36 months post-surgery
Change in quality of life using P-QOL
Time frame: Baseline, 2, 6, 12, 24, and 36 months post-surgery
Change in satisfaction with care using PGI-I
Time frame: Baseline, 6, 12, 24, and 36 months post-surgery
Rate of Grade I-V DINDO complications in each surgical arm
Time frame: Surgery through 36 months post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial will be made available after de-identification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adonis Hijaz, MD principal investigator
University Hospitals Cleveland Medical Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally invasive supracervical hysterectomy and sacrocolpopexy (MI-SCH+SCP) and Vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS) in people with Uterine Prolapse, run by University Hospitals Cleveland Medical Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment failure (time frame: 36 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.