Pelvic Floor Physical Therapy for Stress Urinary Incontinence

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of California, Irvine

Disqualifiers: Non-English speaker, Indwelling catheter, Neurological disorders, Neurogenic bladder, Lumbosacral spine pathology, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether starting pelvic floor physical therapy (PFPT) before prostate surgery can better prevent stress urinary incontinence (SUI) afterward. Participants will be divided into two groups: one will begin PFPT before surgery and continue after, while the other will start only after surgery. The study aims to determine if early PFPT aids in faster bladder control recovery. Men with bothersome urinary symptoms due to benign prostatic hyperplasia (BPH) who plan to undergo surgery at UC Irvine might be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance recovery outcomes for future patients.

Will I have to stop taking my current medications?

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 pelvic floor physical therapy is safe for stress urinary incontinence?

Research has shown that pelvic floor physical therapy (PFPT) is a safe and well-tolerated treatment for stress urinary incontinence (SUI). Studies have found that PFPT can effectively improve the quality of life for individuals with urinary incontinence. It is a recommended treatment with minimal risk. No major reports of harmful effects from PFPT exist, making it a low-risk option for managing SUI. Participants in trials have generally responded well to the exercises, indicating it is a safe choice for those considering joining a clinical trial involving PFPT. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for stress urinary incontinence, which often include medications or surgery, pelvic floor physical therapy (PFPT) offers a non-invasive approach that strengthens the pelvic muscles. Researchers are excited about this technique because it can be started before surgery in some patients, potentially improving surgical outcomes and recovery. This proactive approach addresses muscle strength and control, which are crucial for managing incontinence, providing a holistic avenue for treatment that could complement existing options.

What evidence suggests that pelvic floor physical therapy is effective for stress urinary incontinence?

Research shows that pelvic floor physical therapy (PFPT) can help treat stress urinary incontinence (SUI). Studies have found that PFPT improves or even cures SUI by strengthening the pelvic floor muscles. These muscles control urine flow, so stronger muscles lead to better control. In various studies, participants who underwent PFPT achieved better results than those who did not. This trial will compare two approaches: Arm 1 will receive PFPT both preoperatively and postoperatively, while Arm 2 will receive PFPT only postoperatively. Although limited evidence exists specifically for using PFPT before prostate surgery like HoLEP, the overall benefits for SUI are well-supported. ^{1 6 7 8 9}

Who Is on the Research Team?

Akhil Das, MD

Principal Investigator

University of California, Irvine

Are You a Good Fit for This Trial?

This trial is for men who are scheduled to undergo a surgical procedure called HoLEP to treat benign prostatic hyperplasia (BPH), which causes urinary issues. Participants should not have started any pelvic floor physical therapy before the study and must be willing to follow the assigned therapy schedule.

Inclusion Criteria

I am a man with urinary problems due to an enlarged prostate and considering/undergoing HoLEP.

Exclusion Criteria

I have a neurological condition that could affect my muscle function.

I have a condition affecting my lower spine.

I have a condition where my bladder doesn't empty properly due to nerve problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Pelvic Floor Physical Therapy

Pelvic floor physical therapy (PFPT) is initiated 1 month before surgery for patients in the experimental group

4 weeks

Weekly visits (in-person)

Surgery

Holmium laser enucleation of the prostate (HoLEP) is performed

Day of surgery

1 visit (in-person)

Postoperative Pelvic Floor Physical Therapy

Pelvic floor physical therapy (PFPT) is initiated 1-3 days after surgery for all participants and continues until urinary continence is regained

Up to 6 months

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of urinary continence and other outcomes

6 months

Regular follow-up visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Pelvic Floor Physical Therapy

Trial Overview The trial tests if starting pelvic floor physical therapy before surgery can help patients recover faster from stress urinary incontinence after their prostate surgery, compared to starting it only after surgery as per current practice.

How Is the Trial Designed?

Group I: Arm 1: Preoperative and postoperative pelvic floor physical therapy Experimental Treatment 1 Intervention

Pelvic floor physical therapy (PFPT) will be initiated 1 month before surgery in patients randomized to Arm 1.

Group II: Arm 2: Postoperative pelvic floor physical therapy only. Active Control 1 Intervention

At 1-3 days follow-up after surgery pelvic floor physical therapy (PFPT) will be initiated in the post-operative PFPT-only group as part of standard of care.

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10301414/

Effectiveness of Pelvic Floor Muscle Training on Quality ... This study confirmed the effectiveness of PFMT on the QoL in women with UI, mainly for patients with stress urinary incontinence.

2. aafp.org aafp.org/pubs/afp/issues/2020/0401/p393.html

Pelvic Floor Muscle Training vs. Control for Urinary ... Use of pelvic floor muscle training to treat women with all subtypes of urinary incontinence results in improvement or cure vs. no treatment.

3. openurologyandnephrologyjournal.com openurologyandnephrologyjournal.com/VOLUME/15/ELOCATOR/e1874303X2208181/

Pelvic Floor Muscle Training for Stress Urinary ... This meta-analysis showed that BPFMT had a better outcome in improving PFM strength, while nighttime micturition was, on the contrary, better in PFMT only.

4. bmj.com bmj.com/content/371/bmj.m3719

Effectiveness of pelvic floor muscle training with and ... To assess the effectiveness of pelvic floor muscle training (PFMT) plus electromyographic biofeedback or PFMT alone for stress or mixed urinary incontinence in ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04122898

Pelvic Floor Muscle Training in Gymnasts With Stress ... Additionally, the pelvic floor facilitates intercourse, vaginal birth, storage of stool and urine and voluntary defecation and urination. A dysfunctional pelvic ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07212478

Pelvic Floor Muscle Training vs. Pilates Exercises ... Objective: To compare the effects of 3 months of muscle training, through PFMT and Pilates exercises, on improving UI in postmenopausal women.

7. cochranelibrary.com cochranelibrary.com/cdsr/doi/10.1002/14651858.CD009508.pub2/abstract

Comparisons of approaches to pelvic floor muscle training ... Pelvic floor muscle training (PFMT) is a recommended treatment for female stress, urgency, and mixed urinary incontinence. Training varies in ...

8. journals.humankinetics.com journals.humankinetics.com/view/journals/ijatt/30/6/article-p305.xml

Effectiveness of Pelvic Floor Muscle Training for Treating ... Objective: To investigate the effectiveness of pelvic floor muscle training in treating urinary incontinence in female athletes aged over 13

9. bmjopen.bmj.com bmjopen.bmj.com/content/13/4/e069874

Efficacy of supervised pelvic floor muscle training with a ... Effectiveness and cost-effectiveness of basic versus biofeedback-mediated intensive pelvic floor muscle training for female stress or mixed urinary incontinence ...