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Surgery Techniques for Uterine Prolapse (PREMIER Trial)

N/A

Recruiting

Led By Adonis Hijaz, MD

Research Sponsored by University Hospitals Cleveland Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women aged 18 to 80

Diagnosis of symptomatic uterovaginal prolapse

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 2, 6, 12, 24, and 36 months post-surgery

Awards & highlights

PREMIER Trial Summary

This trial will compare two types of surgery for uterovaginal prolapse to determine which is better for patients, in terms of complications.

Who is the study for?

This trial is for women aged 18-80 with symptomatic uterovaginal prolapse who've chosen surgical treatment and can undergo either MI-SCH+SCP or TVH+USLS. It's not for those with a BMI over 50, previous related surgeries, urinary conditions, certain neurological disorders, or non-English speakers.Check my eligibility

What is being tested?

The study compares two surgeries for uterovaginal prolapse: minimally invasive supracervical hysterectomy with sacrocolpopexy (MI-SCH+SCP) versus vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS), focusing on patient outcomes and complication rates.See study design

What are the potential side effects?

Potential side effects from the surgeries may include pain at the incision site, bleeding, infection risk, possible damage to nearby organs like the bladder or intestines, and general anesthesia risks such as nausea and allergic reactions.

PREMIER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman aged between 18 and 80.

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I have been diagnosed with a prolapse of my uterus or vagina.

PREMIER Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 2, 6, 12, 24, and 36 months post-surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 2, 6, 12, 24, and 36 months post-surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2, 6, 12, 24, and 36 months post-surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Treatment failure

Secondary outcome measures

Change in bladder function using IIQ-7

Change in bladder function using UDI-6

Change in body image using BIPOP

+11 more

PREMIER Trial Design

2Treatment groups

Active Control

Group I: SacrocolpopexyActive Control1 Intervention

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

Group II: Uterosacral Ligament SuspensionActive Control1 Intervention

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Hospitals Cleveland Medical CenterLead Sponsor

317 Previous Clinical Trials

339,937 Total Patients Enrolled

Case Western Reserve UniversityOTHER

299 Previous Clinical Trials

259,630 Total Patients Enrolled

MetroHealth Medical CenterOTHER

114 Previous Clinical Trials

21,069 Total Patients Enrolled

Media Library

Minimally invasive supracervical hysterectomy and sacrocolpopexy (MI-SCH+SCP) Clinical Trial Eligibility Overview. Trial Name: NCT05063331 — N/A

Uterine Prolapse Research Study Groups: Sacrocolpopexy, Uterosacral Ligament Suspension

Uterine Prolapse Clinical Trial 2023: Minimally invasive supracervical hysterectomy and sacrocolpopexy (MI-SCH+SCP) Highlights & Side Effects. Trial Name: NCT05063331 — N/A

Minimally invasive supracervical hysterectomy and sacrocolpopexy (MI-SCH+SCP) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05063331 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any remaining slots available in this medical study?

"According to the clinicaltrials.gov platform, this research is in need of participants. The trial was initially posted on December 15th 2021 and was most recently amended on July 29th 2022."

Answered by AI

Is there an age requirement for recruitment into this trial?

"According to the clinical trial's eligibility requirements, eligible volunteers are expected to be between 18 and 80 years of age. Additionally, there are 3 specific studies for minors and 73 seperate trials available to those over 65."

Answered by AI

Is my profile suitable to join this experiment?

"This study is allowing 320 adults aged 18-80 to join in order to investigate the efficacy of minimally invasive supracervical hysterectomy with sacrocolpopexy (MI-SCP+SCH) and total vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS). Qualified candidates must have decided, after speaking with their doctor, that a surgical procedure for uterovaginal prolapse is necessary."

Answered by AI

What is the current sample size for this research project?

"This trial seeks to recruit 320 qualified candidates. Patients can partake in the study at University of Pittsburgh, UPMC Magee-Womens Hospital and Duke University located in Pennsylvania and North carolina respectively."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Patient-Centered Outcomes in the Surgical Treatment of Uterovaginal Prolapse

Adonis Hijaz, MD 2021. "Patient-Centered Outcomes in the Surgical Treatment of Uterovaginal Prolapse". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05063331.