Emsella for Enlarged Prostate
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of the Emsella chair, a non-invasive treatment device, for treating enlarged prostate. It focuses on the timing of treatment relative to a HoLEP procedure, a laser surgery for prostate issues. Participants are divided into three groups: one performs pelvic floor exercises, another uses the Emsella chair before surgery, and the last uses it after. The goal is to determine which timing yields the best results. Men with a prostate size of 80-150 grams who can tolerate 30-minute Emsella sessions are suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to enhance understanding of optimal treatment timing for improved outcomes.
Will I have to stop taking my current medications?
If you are taking medications like oxybutynin or mirabegron for an overactive bladder, you cannot participate in the trial. The protocol does not specify about other medications, so it's best to discuss with the trial team.
What prior data suggests that the Emsella chair treatment is safe for enlarged prostate?
Research shows that Emsella, a non-invasive treatment, is generally easy for people to tolerate. Previous studies have used Emsella for urinary incontinence and reported promising safety results. Emsella uses magnetic waves to strengthen pelvic muscles, which is safe for most people. No major reports of serious side effects have emerged from using Emsella. This suggests it is likely safe for treating an enlarged prostate.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about the use of Emsella for treating an enlarged prostate because it offers a non-invasive alternative to traditional surgical and medication approaches. Unlike standard options like medication or invasive procedures, Emsella utilizes high-intensity electromagnetic energy to stimulate the pelvic floor muscles, which may improve urinary symptoms associated with an enlarged prostate. This novel delivery method is not only painless but also allows patients to remain fully clothed during treatment. Additionally, Emsella sessions are quick, potentially making this an appealing option for those seeking efficient and convenient care.
What evidence suggests that the Emsella chair treatments could be effective for an enlarged prostate?
Research has shown that the Emsella chair might help reduce urinary symptoms in men with an enlarged prostate. Emsella uses electromagnetic waves to strengthen pelvic floor muscles, improving bladder control. In this trial, participants will receive Emsella treatment either before or after their HoLEP procedure. Some studies suggest that Emsella users have experienced better urinary function. Although limited data exists specifically for enlarged prostate, Emsella's method has shown promise in similar conditions. Overall, early findings suggest potential benefits, but more research is needed to fully understand its effectiveness for this specific condition.12678
Who Is on the Research Team?
Amy E Krambeck, MD
Principal Investigator
Northwestern University
Are You a Good Fit for This Trial?
This trial is for men with an enlarged prostate (80-150g) who can move independently, have mild urinary symptoms, are able to complete surveys, and can go home the same day after their prostate procedure.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-HoLEP Treatment
Participants complete 2 30-minute Emsella treatment sessions per week for 3 weeks leading up to their scheduled HoLEP procedure
HoLEP Procedure
Participants undergo the HoLEP procedure
Post-HoLEP Treatment
Participants complete 2 30-minute Emsella treatment sessions per week for 3 weeks following their scheduled HoLEP procedure
Follow-up
Participants are monitored for safety and effectiveness after treatment, including adverse effects and patient-reported symptoms
What Are the Treatments Tested in This Trial?
Interventions
- Emsella
Trial Overview
The study tests if Emsella chair treatments—non-invasive pelvic floor therapy—help reduce temporary stress urinary incontinence when given before or after HoLEP surgery for enlarged prostate.
How Is the Trial Designed?
3
Treatment groups
Active Control
Patients are reminded to perform pelvic floor exercises known as Kegel exercises for 3 weeks leading up to their scheduled HoLEP procedure, and continue Kegel exercises for 3 weeks following the HoLEP procedure.
Participants will complete 2 30-minute Emsella treatment sessions for 3 weeks (for a total of 6 30-minute Emsella chair treatment sessions) leading up to their scheduled HoLEP procedure. They will undergo the HoLEP 1 week after the final Emsella treatment session.
Participants will complete 2 30-minute Emsella treatment sessions for 3 weeks (for a total of 6 30-minute Emsella chair treatment sessions) following their scheduled HoLEP procedure. They will begin their first Emsella treatment session 1 week after HoLEP.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwestern University
Lead Sponsor
Citations
Update on the management of benign prostatic hyperplasia ...
Based on a Cochrane review with network meta-analysis, PUL and PAE are likely to be more effective in reducing urinary symptoms, among other minimally invasive ...
Emsella for Reducing tSUI After HOLEP
This study aims to investigate the effectiveness of the Emsella chair treatments at different timepoints. Before and after the holmium laser ...
Benign Prostatic Hyperplasia
This trial is testing a special catheter designed to treat men with an enlarged prostate. The device helps to open up the urinary passage, making it easier ...
Benign Prostatic Hyperplasia - StatPearls - NCBI Bookshelf
Meta-analysis with individual data of functional outcomes following Aquablation for lower urinary tract symptoms due to BPH in various prostate anatomies.
Landmark Studies Impacting the Medical Management ... - PMC
The primary outcome measures were improvement in symptom score and increase in peak urinary flow rate. The primary end points were consistent with the ...
42 Benign Prostatic Hyperplasia Trials Near You
Phase 1 trials are the trials to collect safety data ... Emsella for Enlarged Prostate and High Intensity Focused Ultrasound for Benign Prostatic Hyperplasia ...
Efficacy and safety of pelvic floor magnetic stimulation ...
Conclusion: PFMS combined with mirabegron markedly alleviated BPH and OAB symptoms and improved patient-reported quality of life, without.
8.
centerwatch.com
centerwatch.com/clinical-trials/listings/condition/276/benign-prostatic-hyperplasia-enlarged-prostateBenign Prostatic Hyperplasia Enlarged Prostate Clinical ...
About 50% of BPH cases can lead to moderate to severe lower urinary tract symptoms (LUTS), and even serious complications such as hydronephrosis, which greatly ...
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