Surgery Techniques for Uterine Prolapse

(PREMIER Trial)

Recruiting in Palo Alto (17 mi)

+6 other locations

Overseen by Adonis Hijaz, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University Hospitals Cleveland Medical Center

Disqualifiers: BMI > 50, Neurogenic bladder, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment for uterine prolapse?

Research shows that minimally invasive sacrocolpopexy (SCP) and uterosacral ligament suspension (USLS) are effective treatments for uterine prolapse, with studies indicating high levels of patient satisfaction and improvement. Additionally, laparoscopic sacrocolpopexy combined with supracervical hysterectomy has shown positive outcomes in managing pelvic organ prolapse. ^{1 2 3 4 5}

Is surgery for uterine prolapse generally safe?

Research comparing different surgical techniques for uterine prolapse, such as sacrocolpopexy and uterosacral ligament suspension, has looked at complications and patient satisfaction. These studies suggest that while there are some risks, such as mesh-related complications, the procedures are generally considered safe with careful surgical technique. ^{2 3 4 6 7}

How does the treatment for uterine prolapse differ from other treatments?

This treatment combines minimally invasive techniques like supracervical hysterectomy (removal of the uterus while keeping the cervix) and sacrocolpopexy (surgical support for the vagina) to address uterine prolapse. It is unique because it offers a less invasive option with the potential for uterine preservation, which may be important for women who wish to maintain their uterus for personal or medical reasons. ^{1 8 9 10 11}

Research Team

Adonis Hijaz, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Eligibility Criteria

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.

Inclusion Criteria

I am a woman aged between 18 and 80.

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

I have chosen surgery for uterovaginal prolapse after talking to my doctor.

Exclusion Criteria

I have had a hysterectomy or surgery on my uterus/vagina.

Any condition or disorder that might prevent the subject from completing the study or interfere with the interpretation of the study results

Chronic indwelling urinary catheter

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either a minimally invasive supracervical hysterectomy with sacrocolpopexy or a total vaginal hysterectomy with uterosacral ligament suspension

Immediate post-surgery

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for postoperative pain, anti-emetic use, and changes in nausea and fatigue

2 weeks

Multiple assessments (in-person and virtual)

Follow-up

Participants are monitored for safety and effectiveness, including physical pelvic exams and symptom questionnaires

36 months

Regular visits at 6, 12, 24, and 36 months post-surgery

Long-term Follow-up

Participants' quality of life, satisfaction with care, and other outcomes are assessed through validated questionnaires

36 months

Treatment Details

Interventions

• Minimally invasive supracervical hysterectomy and sacrocolpopexy (MI-SCH+SCP) (Surgery)
• Minimally invasive supracervical hysterectomy and sacrocolpopexy (MI-SCP+SCH) (Surgery)
• Vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS) (Surgery)

Trial Overview 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.

Participant Groups

Group I: Sacrocolpopexy Active Control 1 Intervention

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

Group II: Uterosacral Ligament Suspension Active Control 1 Intervention

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

Minimally invasive supracervical hysterectomy and sacrocolpopexy (MI-SCH+SCP) is already approved in Canada for the following indications:

Approved in Canada as Sacrocolpopexy for:

• Pelvic organ prolapse
• Uterovaginal prolapse

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Mayo Clinic Jacksonville, FL

Cleveland Clinic Cleveland, OH

Northwestern Medicine Chicago, IL

MetroHealth Medical Center Cleveland, OH

More Trial Locations

Who Is Running the Clinical Trial?

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials

348

Patients Recruited

394,000+

Case Western Reserve University

Collaborator

Trials

314

Patients Recruited

236,000+

MetroHealth Medical Center

Collaborator

Trials

125

Patients Recruited

22,600+

The Cleveland Clinic

Collaborator

Trials

1072

Patients Recruited

1,377,000+

Duke University

Collaborator

Trials

2495

Patients Recruited

5,912,000+

University of Pittsburgh

Collaborator

Trials

1820

Patients Recruited

16,360,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of outcomes of laparoscopic sacrocolpopexy with concomitant supracervical hysterectomy or uterine preservation. Sato, H., Otsuka, S., Abe, H., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic minimally invasive sacrocolpopexy or hysteropexy and transobturator tape combined with native tissue repair of the vaginal compartments in patients with advanced pelvic organ prolapse and incontinence. Ignjatovic, I., Potic, M., Basic, D., et al.[2021]

In a study of 175 women who underwent either vaginal uterosacral ligament suspension (USLS) or minimally invasive sacrocolpopexy (SCP), both groups reported high satisfaction and low regret regarding their surgical decisions, indicating that both procedures are well-received.

However, women in the SCP group perceived slightly lower postoperative improvement compared to those in the USLS group, as indicated by their Patient Global Impression of Improvement (PGI-I) scores, suggesting that while both surgeries are effective, USLS may offer a better perceived outcome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Satisfaction and Regret Following Uterosacral Ligament Suspension and Sacrocolpopexy: A Prospective Multicenter Analysis From the Fellows' Pelvic Research Network. Bastawros, D., Rabon, H., Noor, N., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaginal hysterectomy, vaginal salpingoophorectomy and uterosacral ligament colpopexy: a view from above (in English and Spanish). Siff, LN., Jallad, K., Pizarro-Berdichevsky, J., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative Outcomes of Minimally Invasive Sacrocolpopexy Based on Route of Concurrent Hysterectomy: A Secondary Analysis of the National Surgical Quality Improvement Program Database. Cardenas-Trowers, O., Stewart, JR., Meriwether, KV., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transvaginal Versus Transabdominal Placement of Synthetic Mesh at Time of Sacrocolpopexy. Nosti, PA., Carter, CM., Sokol, AI., et al.[2019]

Women who underwent total vaginal hysterectomy with uterosacral ligament suspension experienced a decrease in total vaginal length post-surgery, while those who had robotic hysterectomy with colpopexy saw an increase in vaginal length, indicating a significant difference in surgical outcomes (p < .001).

Despite the differences in vaginal length changes, both surgical groups reported similar levels of sexual function and pelvic floor function postoperatively, with no significant differences in prolapse recurrence rates between the two methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaginal versus robotic hysterectomy and concomitant pelvic support surgery: a comparison of postoperative vaginal length and sexual function. De La Cruz, JF., Myers, EM., Geller, EJ.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hysteropexy: Evidence and Insights. Ridgeway, BM., Cadish, L.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic colposuspension for total vaginal prolapse. Ostrzenski, A.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A New Combined Laparoscopic-Vaginal Lateral Suspension Procedure for the Treatment of Pelvic Organ Prolapse. Miele, GM., Marra, PM., Cefalì, K., et al.[2022]

In a study involving 208 women with uterine prolapse, uterus-preserving vaginal sacrospinous hysteropexy was found to be non-inferior to vaginal hysterectomy with uterosacral ligament suspension, showing no significant difference in surgical failure rates after 12 months.

Both surgical methods resulted in similar outcomes regarding anatomical recurrences, functional recovery, quality of life, and complications, indicating that sacrospinous hysteropexy is a safe and effective alternative to hysterectomy for treating uterine prolapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sacrospinous hysteropexy versus vaginal hysterectomy with suspension of the uterosacral ligaments in women with uterine prolapse stage 2 or higher: multicentre randomised non-inferiority trial. Detollenaere, RJ., den Boon, J., Stekelenburg, J., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Comparison of outcomes of laparoscopic sacrocolpopexy with concomitant supracervical hysterectomy or uterine preservation. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Laparoscopic minimally invasive sacrocolpopexy or hysteropexy and transobturator tape combined with native tissue repair of the vaginal compartments in patients with advanced pelvic organ prolapse and incontinence. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Satisfaction and Regret Following Uterosacral Ligament Suspension and Sacrocolpopexy: A Prospective Multicenter Analysis From the Fellows' Pelvic Research Network. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Vaginal hysterectomy, vaginal salpingoophorectomy and uterosacral ligament colpopexy: a view from above (in English and Spanish). [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Perioperative Outcomes of Minimally Invasive Sacrocolpopexy Based on Route of Concurrent Hysterectomy: A Secondary Analysis of the National Surgical Quality Improvement Program Database. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Transvaginal Versus Transabdominal Placement of Synthetic Mesh at Time of Sacrocolpopexy. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Vaginal versus robotic hysterectomy and concomitant pelvic support surgery: a comparison of postoperative vaginal length and sexual function. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Hysteropexy: Evidence and Insights. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Laparoscopic colposuspension for total vaginal prolapse. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

A New Combined Laparoscopic-Vaginal Lateral Suspension Procedure for the Treatment of Pelvic Organ Prolapse. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Sacrospinous hysteropexy versus vaginal hysterectomy with suspension of the uterosacral ligaments in women with uterine prolapse stage 2 or higher: multicentre randomised non-inferiority trial. [2018]