Surgery Techniques for Uterine Prolapse

(PREMIER Trial)

Recruiting at 6 trial locations

Overseen By Grace Pelfrey

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University Hospitals Cleveland Medical Center

Disqualifiers: BMI > 50, Neurogenic bladder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: Immediate post-surgery

320 Participants Needed

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

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

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 United States, European Union, Canada for the following indications:

Approved in United States as Sacrocolpopexy for:

• Pelvic organ prolapse
• Uterovaginal prolapse

Approved in European Union as Sacrocolpopexy for:

• Pelvic organ prolapse
• Uterovaginal prolapse

Approved in Canada as Sacrocolpopexy for:

• Pelvic organ prolapse
• Uterovaginal prolapse

Who Is Running the Clinical Trial?

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials

348

Recruited

394,000+

Case Western Reserve University

Collaborator

Trials

314

Recruited

236,000+

MetroHealth Medical Center

Collaborator

Trials

125

Recruited

22,600+

The Cleveland Clinic

Collaborator

Trials

1,072

Recruited

1,377,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

University of Pittsburgh

Collaborator

Trials

1,820

Recruited

16,360,000+

Findings from Research

In a study of 274 patients undergoing laparoscopic sacrocolpopexy, those who preserved their uterus had a lower composite failure rate (3.6%) compared to those who had a supracervical hysterectomy (10.7%), suggesting that uterine preservation may be a safer option for reducing the risk of prolapse recurrence.

The study found that higher preoperative body mass index and specific anatomical measurements were associated with an increased risk of composite failure, highlighting the importance of patient factors in surgical outcomes.

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]

In a study of 81 patients with pelvic organ prolapse (POP), both laparoscopic sacrohysteropexy (LSHP) and minimally invasive sacrocolpopexy (LMSCP) combined with transobturator tape (TOT) showed significant anatomical and symptomatic improvements, indicating their effectiveness in treating POP and urinary incontinence.

There were no significant differences in surgical duration, hospital stay, or complication rates between the two surgical methods, suggesting that both approaches are equally safe and effective for patients with different types of prolapse.

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]

The video demonstrates key procedural steps for performing vaginal hysterectomy (TVH), vaginal salpingoophorectomy, and uterosacral ligament colpopexy, filmed from both vaginal and abdominal perspectives to enhance understanding of the anatomy involved.

By highlighting critical anatomical landmarks and techniques to avoid injury during the procedure, the video aims to improve the safety and confidence of surgeons performing these gynecological surgeries.

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]

In a study of 524 women undergoing minimally invasive sacrocolpopexy (MISCP) with concurrent hysterectomy, the route of hysterectomy (vaginal, laparoscopic-assisted, laparoscopic supracervical, or total laparoscopic) did not significantly affect the rates of 30-day postoperative complications, reoperation, or readmission.

The total laparoscopic hysterectomy (TLH) group had the shortest operative time, but overall, all routes demonstrated low complication rates, indicating that MISCP is a safe option regardless of the hysterectomy method used.

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]

In a study of 182 patients undergoing pelvic surgery, the rate of mesh-related complications was very low and similar between total vaginal hysterectomy with laparoscopic sacrocolpopexy (TVH-LSC) and laparoscopic supracervical hysterectomy with sacrocolpopexy mesh (LSH-LSC), at 1.6% and 1.7% respectively.

TVH-LSC resulted in a significantly shorter operative time (about 1 hour less) compared to LSH-LSC, while both procedures showed no differences in intraoperative complications or success rates for treating pelvic organ prolapse.

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]

Uterine-sparing procedures for treating uterovaginal prolapse are gaining popularity, with evidence supporting techniques like sacrospinous hysteropexy, which is backed by randomized controlled trials.

These procedures require careful surgical considerations, such as assessing uterine abnormalities and the potential for future pregnancies, but show promising outcomes in various prospective trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

The modified translaparoscopic colpopexy technique for total vaginal prolapse showed promising results, with all patients in the study (27 total) experiencing no intraoperative or postoperative complications, indicating a high safety profile.

Compared to the initial technique, the modified approach demonstrated superior outcomes, effectively suspending the vaginal vault and restoring pelvic anatomy, making it a viable alternative to traditional surgical methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

The new combined vaginal-laparoscopic technique for hysteropexy aims to reduce the risks of serious complications associated with traditional methods, particularly in challenging cases like those involving obesity or anatomical variations.

This technique not only enhances safety but also improves the physiological orientation of the vaginal axis, suggesting a potential advancement in uterine-preserving surgeries for pelvic organ prolapse.

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]