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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two surgical techniques to determine which is more effective for treating uterovaginal prolapse, a condition where pelvic organs slip out of their normal position. Researchers aim to identify which surgery results in fewer complications and is preferred by patients. Women diagnosed with symptomatic uterovaginal prolapse who have decided with their doctor to undergo surgery might be suitable for this trial. Participants will receive one of two types of minimally invasive surgeries: minimally invasive supracervical hysterectomy and sacrocolpopexy (MI-SCH+SCP) or vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS).

As an unphased trial, this study provides participants the chance to contribute to valuable research that may enhance surgical outcomes for future patients.

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 prior data suggests that these surgical techniques are safe for treating uterine prolapse?

Research has shown that both surgical techniques under study are generally safe.

For the minimally invasive supracervical hysterectomy and sacrocolpopexy (MI-SCH+SCP), studies have found it effective for treating vaginal wall issues. It is considered safe, with most patients recovering well. When comparing techniques, robotic sacrocolpopexy, part of this procedure, is usually safe and successful.

The vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS) is also considered safe. Research indicates it effectively treats pelvic organ prolapse, including uterine prolapse. Although there is a higher chance of the prolapse returning, patients generally tolerate the procedure well.

Both treatments have been studied and are generally safe. However, individual experiences may vary, so discussing potential risks and benefits with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these surgical techniques for uterine prolapse because they offer minimally invasive options that may lead to quicker recovery times and less postoperative discomfort compared to traditional methods. The use of minimally invasive supracervical hysterectomy combined with sacrocolpopexy (MI-SCH+SCP) and total vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS) aims to provide effective support for pelvic organs while reducing surgical trauma. These techniques may improve overall patient outcomes by offering less invasive alternatives to standard open surgeries, potentially reducing hospital stays and improving quality of life.

What evidence suggests that these surgical techniques are effective for uterine prolapse?

This trial will compare two treatments for uterine prolapse. Research has shown that minimally invasive sacrocolpopexy, one of the treatments under study, greatly improves symptoms related to the pelvic area, body structure, and sexual function, with low rates of complications and hospital readmissions within 30 days. Meanwhile, studies on vaginal hysterectomy with uterosacral ligament suspension, the other treatment option in this trial, have shown that the condition returns in about 12.4% of cases, with less than 1% needing another surgery, which is considered low. This treatment also provides good results for body structure and function. Both options appear effective for treating pelvic organ prolapse with few complications. ^{1 2 5 6 7}

Who Is on the Research Team?

Adonis Hijaz, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Mayo Clinic

Collaborator

Trials

3,427

Recruited

3,221,000+

Northwestern Medicine

Collaborator

Trials

14

Recruited

9,500+

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+

Published Research Related to This Trial

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 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 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]

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]

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 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 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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3083043/

Supracervical Robotic-Assisted Laparoscopic ... Supracervical robotic-assisted laparoscopic sacrocolpopexy was found to be an effective repair of apical vaginal defects in patients with pelvic organ ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5070533/

One-Year Outcomes After Minimally Invasive Sacrocolpopexy Minimally invasive sacrocolpopexy is associated with significant improvement in pelvic floor symptoms, anatomy, and sexual function.

3. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/10.1111/jog.70068

Comparison of surgical outcomes between robotic and ... This study aimed to compare short- and long-term surgical outcomes between robotic sacrocolpopexy (RSC) and laparoscopic sacrocolpopexy (LSC), ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1553465019303681

Perioperative Outcomes of Minimally Invasive ... Regardless of route of concurrent hysterectomy, MISCP is associated with low rates of 30-day complications, reoperation, and readmission.

5. liebertpub.com liebertpub.com/doi/10.1089/gyn.2022.0119

Robotic-Assisted Surgery for Pelvic Organ Prolapse This article reviews surgical techniques, troubleshooting, outcomes, and ongoing areas of development regarding the use of a robotic approach to prolapse ...

6. einj.org einj.org/m/journal/view.php?number=646

Surgical Outcomes and Safety of Robotic Sacrocolpopexy ... This study aimed to investigate the surgical outcomes and safety of robotic sacrocolpopexy (RSC) in patients with uterine/vaginal vault prolapse ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2666676622001326

Outcomes of single port robotic sacrocolpopexy compared ... This retrospective study demonstrates feasibility and safety of the single-port robotic approach for sacrocolpopexy when compared with traditional multi-port ...