What side effects are associated with this type of intervention?

The most common side effects of Robotic Sacrocolpopexy (R-SCP) for Pelvic Organ Prolapse include mesh-related complications such as erosion or exposure, which can lead to discomfort and require additional surgery. Other potential side effects are similar to those of other robotic-assisted procedures and include increased risk of bladder and ureteral injury, delayed thermal injuries, and mechanical issues with the robotic equipment. Additionally, patients may experience general surgical risks such as infection, bleeding, and postoperative pain.

What prior FDA approvals exist?

The FDA has approved various treatments for Pelvic Organ Prolapse (POP), including surgical options that use mesh for pelvic organ support. One such treatment is the robotic-assisted sacrocolpopexy (R-SCP), which involves attaching the vaginal vault to the sacrum using a mesh. This procedure is designed to provide long-term support for pelvic organs and is performed with the assistance of robotic technology to enhance precision and reduce recovery time. Other FDA-approved treatments for POP include traditional sacrocolpopexy and transvaginal mesh procedures, although the latter has faced scrutiny and regulatory changes due to safety concerns.

What other types of research exist?

One promising alternative to R-SCP for pelvic organ prolapse is the High Uterosacral Ligament Suspension (HUSLS). This technique involves suspending the vaginal apex to the uterosacral ligaments, providing strong support without the need for mesh. Another emerging approach is the use of laparoscopic or robotic-assisted techniques for pelvic organ prolapse repair, which offer minimally invasive options with potentially quicker recovery times and fewer complications. Additionally, the development of new materials and techniques for mesh placement, such as lightweight and biologically compatible meshes, may offer improved outcomes for patients.

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Procedure

HUSLS vs R-SCP for Pelvic Organ Prolapse

N/A

Waitlist Available

Led By Sam Siddighi

Research Sponsored by Loma Linda University

Eligibility Criteria Checklist

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

Must have

Symptomatic pelvic organ prolapse

18 Years of age or older

Must not have

Dementia or considered unable to complete questionnaires

History of Alzheimer Disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 month post operative

Awards & highlights

No Placebo-Only Group

Summary

This trial compares two surgeries for treating pelvic organ prolapse: one uses a robot to place a supportive mesh, and the other uses stitches to lift and secure the organs through the vagina. The goal is to find out which method is more effective.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort at the surgery site, bleeding, infection risk from surgery or mesh used in procedures. There could also be specific complications related to each surgical method that will be monitored.

Eligibility Criteria

Inclusion Criteria

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

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I feel a bulge or pressure in my pelvic area.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have dementia and can complete questionnaires.

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I have been diagnosed with Alzheimer's Disease.

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I have had multiple strokes or another neurological condition.

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

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My surgery did not include a high uterosacral ligament suspension.

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I do not have a car or any way to get to places.

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I can't attend follow-up visits because I have no way to get there.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 month post operative

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 month post operative

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 month post operative for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pelvic Organ Prolapse Quantification (pop-q) to asses change post operatively

Secondary study objectives

questionnaires PFDI-7

questionnaires PFIQ-20

questionnaires PGI-I

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: SacrocolpopexyActive Control1 Intervention

Robotic sacrocolpopexy

Group II: HUSLSActive Control1 Intervention

Vaginal high uterosacral ligament suspension

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Pelvic Organ Prolapse (POP) treatments commonly include surgical interventions such as Sacrocolpopexy, which involves attaching the vaginal vault to the sacrum using a mesh to provide support. The mechanism of action for Sacrocolpopexy, particularly when performed robotically (R-SCP), involves the precise placement of mesh to reinforce the pelvic floor and restore normal anatomy. This is crucial for POP patients as it helps alleviate symptoms like urinary incontinence, pelvic pressure, and discomfort, thereby improving quality of life. Robotic assistance in R-SCP enhances surgical precision, reduces recovery time, and minimizes complications, making it a significant advancement in POP treatment.