Pelvic Floor Stimulation for Urinary Incontinence After Prostatectomy

JN
Overseen ByJesse N Mills, MD
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: University of California, Los Angeles
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist men experiencing urinary incontinence (difficulty controlling urination) after prostate surgery. It evaluates a new, non-invasive treatment called pelvic floor neuromuscular stimulation, which uses electromagnetic stimulation to strengthen pelvic muscles without requiring any effort from the patient. Researchers seek to determine if this treatment can alleviate symptoms and enhance the quality of life for those affected. Men who underwent prostate surgery at UCLA and experience incontinence may qualify for this trial, provided they do not have specific health conditions such as a pacemaker or active infection. As an unphased trial, this study offers participants the chance to contribute to innovative research that could improve the quality of life for many.

What prior data suggests that this pelvic floor stimulation is safe for urinary incontinence after prostatectomy?

Research shows that non-invasive pelvic floor neuromuscular stimulation is usually well-tolerated. In past studies, participants reported few side effects. For example, one study examined the safety and comfort of this therapy and found it to be both safe and practical. The treatment uses electrical stimulation to strengthen pelvic floor muscles, which can help with bladder control issues after prostate surgery. So far, reports of serious side effects have been rare. However, the data remains limited because the studies were small and did not follow participants for extended periods. More research is needed to fully understand the long-term safety of this treatment, but early results are promising.12345

Why are researchers excited about this trial?

Researchers are excited about non-invasive pelvic floor neuromuscular stimulation for urinary incontinence after prostatectomy because it offers a new, non-invasive approach compared to traditional treatments like pelvic floor exercises or medications. Unlike these standard treatments, this method uses targeted electrical stimulation to strengthen the pelvic floor muscles without the need for surgery or drugs. This unique delivery method has the potential to provide effective relief with fewer side effects and a more convenient treatment experience for patients.

What evidence suggests that non-invasive pelvic floor neuromuscular stimulation is effective for urinary incontinence?

Research has shown that pelvic floor neuromuscular stimulation, a non-invasive method, can improve urinary incontinence after prostate surgery. Participants in this trial will undergo an 8-week intervention using this technique. Some studies have found that pelvic floor neuromuscular stimulation strengthens pelvic muscles and enhances bladder control without requiring active effort from the patient. Specifically, high-intensity electromagnetic stimulation has improved bladder control and reduced the need for pads in both women and men. Although the research is promising, it often involves small participant groups and short follow-up periods. The FDA has cleared this method for improving bladder control, highlighting its potential benefits.56789

Are You a Good Fit for This Trial?

Inclusion Criteria

I am a man who is 18 years old or older.
Able to provide informed consent
I am having or have had prostate surgery at UCLA.

Exclusion Criteria

Hematuria of unknown origin
Any condition deemed by the investigator to make participation unsafe
I do not have a fever or active inflammatory condition right now.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo an 8-week intervention of non-invasive pelvic floor neuromuscular stimulation, consisting of 12 sessions in total

8 weeks
12 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness, with outcomes assessed at baseline, end of treatment, and follow-up within three months of starting the intervention

3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Non-invasive pelvic floor neuromuscular stimulation

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Non-invasive pelvic floor neuromuscular stimulationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials
1,594
Recruited
10,430,000+

Citations

Evaluation of Non-Invasive Pelvic Floor Neuromuscular ...

This prospective study aims to evaluate feasibility, safety, and patient-reported continence outcomes associated with non-invasive pelvic floor ...

Effectiveness of electrical stimulation for treating male urinary ...

Randomized, placebo controlled study of electrical stimulation with pelvic floor muscle training for severe urinary incontinence after radical prostatectomy.

Effectiveness of pelvic floor rehabilitation after radical ...

While a recent meta-analysis (2023) suggested that RARP may lead to better functional outcomes compared to laparoscopic radical prostatectomy ( ...

FDA clears neuromuscular stimulation device for post- ...

FDA 510(k) clearance enables use of external neuromuscular stimulation to strengthen pelvic floor musculature and improve bladder control in men ...

The Effect of Pelvic Floor Muscle Training On Incontinence ...

Pelvic muscle floor exercises are suitable for patients experiencing incontinence after radical prostatectomy.

Pelvic Floor Rehabilitation After Prostatectomy - PMC - NIH

Participants who lost > 50 g of urine during the PT and/or displayed sensory deficits received adjunct neuromuscular electrostimulation, ...

Effectiveness of electrical stimulation for treating male...

Randomized, placebo controlled study of electrical stimulation with pelvic floor muscle training for severe urinary incontinence after radical prostatectomy.

Incontinence after Prostate Treatment: AUA/GURS/SUFU ...

This guideline on incontinence after prostate treatment (IPT) is intended to facilitate care decisions and aid clinicians in the management of patients.

Updates to Incontinence After Prostate Treatment

RP and radiation therapy (RT) for prostate cancer are both associated with urinary incontinence after treatment, with urinary incontinence more ...