HUSLS vs R-SCP for Pelvic Organ Prolapse

Overseen By Christine Cota

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Loma Linda University

Disqualifiers: Dementia, Chronic pelvic pain, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Surgical procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two surgical methods—robotic sacrocolpopexy and high uterosacral ligament suspension—for treating pelvic organ prolapse, a condition where organs such as the bladder or uterus drop from their normal position. The research seeks to determine which method is more effective. Individuals with symptoms of pelvic organ prolapse who can attend all study visits might be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance treatment options for pelvic organ prolapse.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.

What prior data suggests that these techniques are safe for treating pelvic organ prolapse?

Research shows that both high uterosacral ligament suspension (HUSLS) and robotic sacrocolpopexy (R-SCP) are generally safe options for treating pelvic organ prolapse.

For high uterosacral ligament suspension, studies have found a low rate of complications. In one study, only 3.4% of 1,099 patients experienced complications. Another report showed complications during or after surgery in just 1.8% of patients, suggesting that HUSLS is well-tolerated.

Robotic sacrocolpopexy also has a strong safety record. Multiple studies indicate it is an effective surgical treatment with a high success rate and few complications. One review highlighted minimal blood loss and no reported complications, indicating the procedure is typically safe and reliable.

Both treatments have been studied and found to have low risks of complications, making them good options for those considering surgery for pelvic organ prolapse. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for pelvic organ prolapse because they offer innovative surgical options. High uterosacral ligament suspension (HUSLS) provides a vaginal approach, which can be less invasive and may lead to quicker recovery times compared to traditional abdominal surgeries. On the other hand, robotic sacrocolpopexy utilizes advanced robotic technology, offering precision and potentially reducing complications. These approaches aim to enhance patient outcomes and expand the options available beyond conventional surgical methods.

What evidence suggests that this trial's treatments could be effective for pelvic organ prolapse?

This trial will compare high uterosacral ligament suspension (HUSLS) with robotic sacrocolpopexy (R-SCP) for treating pelvic organ prolapse. Research has shown that both HUSLS and R-SCP are effective treatments. Specifically, studies on HUSLS have demonstrated excellent results, with less than 1% of patients requiring additional surgery. In contrast, R-SCP has success rates ranging from 78% to 100%, with patients reporting high satisfaction over time. Both procedures provide strong support for pelvic organs, preventing them from descending. Overall, both treatments are reliable options for managing pelvic organ prolapse. ^{1 2 3 4 6}

Who Is on the Research Team?

Sam Siddighi

Principal Investigator

Loma Linda University Health Care

Are You a Good Fit for This Trial?

This trial is for adults with symptomatic pelvic organ prolapse who can consent, attend all study visits, and have transportation within 2 hours of LLUH. It's not for those without transport or financial means, with Alzheimer's, dementia, opposition to mesh use due to beliefs or past complications, pregnancy plans during the study, chronic undetermined pelvic pain over 6 months, certain comorbidities like fibromyalgia or interstitial cystitis.

Inclusion Criteria

I feel a bulge or pressure in my pelvic area.

Signed Informed Consent

I can attend all required study visits.

Exclusion Criteria

I have had pelvic pain for over 6 months not related to my menstrual cycle and may also have fibromyalgia, interstitial cystitis, or vulvodynia.

I do not have dementia and can complete questionnaires.

You live more than 2 hours away from LLUH.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either Robotic Sacrocolpopexy or High Uterosacral Ligament Suspension for pelvic organ prolapse repair

Surgical procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment, including filling out questionnaires and POP-Q assessments

12 months

What Are the Treatments Tested in This Trial?

Interventions

• High uterosacral ligament suspension
• Robotic sacrocolpopexy

Trial Overview The trial compares two surgical methods for fixing pelvic organ prolapse: Robotic Sacrocolpopexy (R-SCP) and High Uterosacral Ligament Suspension (HUSLS). The goal is to see which one works better in terms of effectiveness.

How Is the Trial Designed?

Group I: Sacrocolpopexy Active Control 1 Intervention

Robotic sacrocolpopexy

Group II: HUSLS Active Control 1 Intervention

Vaginal high uterosacral ligament suspension

Who Is Running the Clinical Trial?

Loma Linda University

Lead Sponsor

Trials

322

Recruited

267,000+

Published Research Related to This Trial

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39154516/

Outcomes of uterosacral ligaments suspension for ... Anatomical, functional, and subjective outcomes were very satisfactory, and the reoperation rate for recurrence was below 1%.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0301211524004469

Outcomes of uterosacral ligaments suspension for ... Anatomical, functional, and subjective outcomes were very satisfactory, and the reoperation rate for recurrence was below 1%.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39277103/

Two-Year Follow-Up on Surgical Outcomes of vNOTES ... Conclusion: vNOTES-HUSLS was effective in the treatment and prophylaxis of apical prolapse, demonstrating high anatomic success rates. The procedure ...

4. journals.lww.com journals.lww.com/fpmrs/Fulltext/2018/05000/Outcomes_of_Transvaginal_High_Uterosacral.2.aspx?generateEpub=Article%7Cfpmrs:2018:05000:00002%7C10.1097/01.spv.0000533751.41539.5b%7C

Outcomes of Transvaginal High Uterosacral Ligaments ... Uterosacral ligament suspension is a safe and effective procedure in primary surgical treatment of pelvic organ prolapse. Anatomical, functional, and ...

5. mdpi.com mdpi.com/2227-9032/12/16/1611

Long-Term Outcomes (10 Years) of Sacrospinous ... The data demonstrated that SSL fixation is an effective surgical intervention for prolapse repair, with an improvement in every POP-q parameter.

6. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/10.1111/1471-0528.17565

The effectiveness and safety of laparoscopic uterosacral ... The laparoscopic uterosacral ligament suspension seems to be a promising, effective and safe technique to treat apical pelvic organ prolapse, ...