Pelvic Floor Exercises for Prostate Cancer

Recruiting at 6 trial locations

Overseen By Felix Cheung, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Previous radiotherapy, Urinary incontinence, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

33 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if exercises to strengthen pelvic floor muscles can reduce urinary leakage after prostate surgery. Participants will either follow a special exercise program with professional guidance or receive standard care instructions. The study will assess adherence to the exercises and participants' perceptions. Men with prostate cancer planning to undergo prostate surgery and who do not already experience urinary leakage might be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance post-surgery care 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 focuses on pelvic floor exercises for prostate cancer patients.

What prior data suggests that this pelvic floor muscle exercise program is safe for prostate cancer patients?

A previous study demonstrated that exercises to strengthen the pelvic floor muscles, combined with biofeedback, significantly reduced urinary incontinence after prostate surgery. The benefits appeared as soon as three months post-surgery and lasted up to a year. Research has shown that these exercises are generally well-tolerated, with no major safety concerns. Some men even experienced improved sexual function. Overall, these exercises appear to be a safe and effective way to manage incontinence following prostate surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new approach to improving recovery after prostate cancer surgery using pelvic floor muscle exercises (PFME) with biofeedback. Unlike the usual care, which typically involves basic instructions for Kegel exercises, this study involves a structured PFME program supervised by trained physical therapists, both before and after surgery. The unique feature here is the use of biofeedback, which helps patients better understand and control their pelvic floor muscles, potentially leading to faster and more effective recovery. This method could enhance patients’ quality of life by improving continence and other pelvic functions more efficiently than traditional methods.

What evidence suggests that pelvic floor muscle exercises might be an effective treatment for urinary incontinence after prostate surgery?

Research shows that pelvic floor muscle exercises can greatly help with urinary leakage after prostate surgery. In this trial, participants in the intervention group will undergo a Pelvic Floor Muscle Exercise (PFME) program with biofeedback. One study found that these exercises can improve control over leakage by nearly three times. Another study found that performing these exercises with real-time feedback before surgery can significantly reduce leakage for several months afterward. This evidence suggests that strengthening pelvic muscles before and after surgery could help manage or shorten the duration of leakage. Participants in the control group will receive usual care, which includes standardized instructions about Kegel exercises. ^{1 2 3 6 7}

Who Is on the Research Team?

James Eastham, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with prostate cancer who are scheduled to undergo or have recently had a radical prostatectomy. The study aims to help participants reduce urinary incontinence post-surgery through pelvic floor muscle exercises.

Inclusion Criteria

I am over 18 and scheduled for prostate removal surgery at MSK.

Exclusion Criteria

I can participate in all study activities without issues related to health, location, or communication.

I have had radiotherapy for prostate cancer.

I had urinary incontinence before my prostate surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgery PFME Training

Participants undergo PFME training with a physical therapist 2 times before surgery

4-6 weeks

2 visits (in-person)

Post-surgery PFME Training

Participants undergo PFME training with a physical therapist 2 times after surgery

1.5 months

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Pelvic Floor Muscle Exercise Program

Trial Overview

The study tests a Pelvic Floor Muscle Exercise (PFME) Program, which includes Kegel exercises and biofeedback before and after surgery. Participants' experiences will be evaluated via interviews, and their quality of life measured by questionnaires.

How Is the Trial Designed?

Group I: intervention group (PFME program with biofeedback) Experimental Treatment 3 Interventions

Consented patients randomized to the intervention group will be referred to SPEAR Physical Therapy to undergo the study PFME training program. The team at SPEAR Physical Therapy regularly sees patients undergoing radical prostatectomy and is specially trained in PFME training for male patients. Patients in the intervention arm will undergo PFME training with a physical therapist 2 times before surgery (4-6 weeks \[in person\] and 3-4 weeks \[in person\], before surgery) (within ±1 week is considered acceptable to avoid protocol violations). Patients in the intervention group will also undergo 2 PFME training sessions after surgery (3 weeks and 1.5 months after surgery).

Group II: control group (usual care) Active Control 2 Interventions

Consented patients randomized to the control group will receive usual care at MSK. This will comprise standardized verbal (and sometimes also written) instructions about Kegel exercises from the nurse and/or urologist before the operation. All patients will complete the Prostate Quality of Life Survey at baseline and at 1.5, 3, and 6 months after radical prostatectomy (within ±2 weeks is considered acceptable to avoid protocol violations). This is part of the standard of care for patients undergoing prostatectomy.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

In a study of 60 prostate cancer patients undergoing radiotherapy, those who performed Kegel exercises showed a lower incidence of urinary incontinence compared to the control group, with only 3.3% developing 2nd-grade urinary incontinence by the end of the 8th week versus 10% in the control group.

Kegel exercises not only helped prevent urinary incontinence but also significantly improved quality of life measures, including social function and global health status, while reducing fatigue and gastrointestinal symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Kegel exercises on the prevention of urinary and fecal incontinence in patients with prostate cancer undergoing radiotherapy. Urvaylıoğlu, AE., Kutlutürkan, S., Kılıç, D.[2021]

Supervised pelvic floor muscle exercises (PFME) significantly improve urinary incontinence remission rates in men after prostate surgery, especially within the first 6 months, with risk differences of 12 to 25% compared to no exercise.

Unsupervised PFME does not provide the same benefits as supervised training and is similar to no exercise at all, highlighting the importance of structured rehabilitation programs for effective recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supervised pelvic floor muscle exercise is more effective than unsupervised pelvic floor muscle exercise at improving urinary incontinence in prostate cancer patients following radical prostatectomy - a systematic review and meta-analysis. Baumann, FT., Reimer, N., Gockeln, T., et al.[2022]

A systematic analysis of 150 YouTube videos on pelvic floor muscle training after prostate cancer surgery revealed that the overall quality of these videos is high, with average scores of 3.35 on the DISCERN Scale and 3.38 on the Global Quality Score.

The videos had a significant reach, averaging over 124,000 views, indicating that they are widely accessed by patients seeking information on postoperative exercises, highlighting the need for health professionals to ensure the accuracy and reliability of online health resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality Analysis of YouTube Videos Presenting Pelvic Floor Exercises after Prostatectomy Surgery. Rodriguez-Rodriguez, AM., Blanco-Diaz, M., Lopez-Diaz, P., et al.[2021]

Pelvic floor muscle training (PFMT) is recommended for prostate cancer patients to help reduce urinary incontinence, and preoperative PFMT can lead to better postoperative outcomes.

Nurses can play a crucial role in teaching PFMT techniques both before and after surgery, focusing on individualized training that enhances motor learning and targets the specific pelvic floor muscles involved in maintaining continence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pelvic Floor Muscle Training in Radical Prostatectomy and Recent Understanding of the Male Continence Mechanism: A Review. Sayner, A., Nahon, I.[2021]

This randomized clinical trial will involve 363 men undergoing radical prostatectomy for prostate cancer, comparing a new preoperative pelvic floor muscle training method against conventional training and no training, aiming to reduce urinary incontinence post-surgery.

The study will assess various outcomes, including the effectiveness of the training on urinary continence and quality of life, using objective measures like the 24-hour pad weight test and neuromuscular control assessments over a 12-month period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a personalised pelvic floor muscle training programme on urinary incontinence after radical prostatectomy (MaTchUP): protocol for a randomised controlled trial. Hodges, P., Stafford, R., Coughlin, GD., et al.[2021]

Preoperative pelvic floor muscle training (PFMT) significantly increased the cross-sectional area of muscle fibers in the external urethral sphincter and improved contraction pressure of the levator ani in patients undergoing radical prostatectomy, suggesting enhanced muscle function.

After surgery, a higher percentage of patients who underwent PFMT experienced urinary continence compared to the control group, indicating that PFMT may help prevent incontinence associated with radical prostatectomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-operative training induces changes in the histomorphometry and muscle function of the pelvic floor in patients with indication of radical prostatectomy. Ocampo-Trujillo, A., Carbonell-González, J., Martínez-Blanco, A., et al.[2014]

Pelvic floor muscle exercises (PFME) significantly reduce the incidence of urinary incontinence (UI) in the first six months after radical prostatectomy, with odds ratios indicating a strong benefit compared to no PFME.

Preoperative PFME does not provide additional benefits for recovery from UI compared to postoperative PFME alone, suggesting that focusing on PFME after surgery is sufficient for improving outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of perioperative pelvic floor muscle exercise on urinary incontinence after radical prostatectomy: a meta-analysis. Geng, E., Yin, S., Yang, Y., et al.[2023]

In a randomized controlled trial involving 60 patients, pelvic floor muscle exercises (PFME/Kegel) significantly reduced post-surgery incontinence problems after robot-assisted radical prostatectomy, with notable improvements observed at 3 and 6 months.

The study demonstrated that PFME is an effective intervention for enhancing quality of life in patients suffering from incontinence following prostate surgery, indicating its suitability as a rehabilitation strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Pelvic Floor Muscle Training On Incontinence Problems After Radical Prostatectomy. Aydın Sayılan, A., Özbaş, A.[2019]

Pelvic floor muscle exercises (PFME) significantly improve urinary continence in patients recovering from prostate surgery, with an odds ratio of 2.971 indicating a higher likelihood of achieving continence compared to those who do not perform PFME.

The study suggests that adding assistant interventions to PFME further enhances recovery, with an odds ratio of 2.128, but emphasizes the need for more high-quality research to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Pelvic Floor Exercise for Post-prostatectomy Incontinence: Systematic Review and Meta-analysis. Park, JJ., Kwon, A., Park, JY., et al.[2022]

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sciencedirect.com

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PFMT with preoperative biofeedback significantly reduced postprostatectomy incontinence up to 3 mo, at 3–<6 mo, and at 6–<12 mo following RP, compared with the ...

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frontiersin.org

frontiersin.org/journals/public-health/articles/10.3389/fpubh.2023.1186067/full

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Preoperative pelvic floor muscle exercise can improve postoperative urinary incontinence at 3rd months after radical prostatectomy.

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prostatecanceruk.org

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Pelvic floor muscle exercises

Some men find pelvic floor muscle exercises help with problems getting or keeping an erection after treatment for prostate cancer.