Pelvic Floor Exercises for Prostate Cancer

Recruiting in Palo Alto (17 mi)

+6 other locations

Overseen by James Eastham, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Previous radiotherapy, Urinary incontinence, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

The researchers are doing this study to find out if a PFME program to reduce urinary incontinence after radical prostatectomy is feasible for people with prostate cancer. The researchers will track how many participants join the study, follow the program, and stay in the study. They will also evaluate how people feel about their experience and satisfaction with participating in this program through interviews. They will also measure participants' quality of life by filling out questionnaires, and we will study whether the program shows promise in reducing urinary incontinence. Radical prostatectomy sometimes causes incontinence after the surgery. The researchers think that by teaching PFME and strengthening and improving control of the pelvic floor muscles, PFME training before and after radical prostatectomy may help reduce incontinence and/or reduce how long incontinence lasts.

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 data supports the effectiveness of the treatment Pelvic Floor Muscle Exercise Program for prostate cancer?

Research shows that pelvic floor muscle exercises can significantly reduce urinary incontinence in men after prostate surgery, improving their quality of life. Studies found that patients who performed these exercises experienced a notable decrease in incontinence symptoms over time compared to those who did not.

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Are pelvic floor exercises safe for humans?

Pelvic floor exercises, also known as Kegel exercises, are generally considered safe for humans and are often recommended for improving urinary incontinence, especially after prostate surgery.

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How do pelvic floor exercises differ from other treatments for prostate cancer?

Pelvic floor exercises are unique because they focus on strengthening the muscles that support the bladder and bowel, helping to reduce urinary incontinence after prostate surgery. Unlike medications or surgical interventions, these exercises are a non-invasive, physical therapy approach that can significantly improve quality of life by addressing incontinence issues.

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Eligibility Criteria

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.

Trial Timeline

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)

Participant Groups

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.

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities) Basking Ridge, NJ

Memorial Sloan Kettering Monmouth (Limited Protocol Activities) Middletown, NJ

Memorial Sloan Kettering Bergen (Limited Protocol Activities) Montvale, NJ

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) Commack, NY

More Trial Locations

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

The Effect of Pelvic Floor Muscle Training On Incontinence Problems After Radical Prostatectomy. [2019] The aim of the current study was to determine the effect of pelvic floor muscle exercises (PFME/Kegel) training administered to patients scheduled for robot-assisted radical prostatectomy on postprocedural incontinence problems. This study was a randomized controlled trial. Pelvic floor muscle exercises were applied to the procedure group three times a day for 6 months. No exercises were applied to the control group. Incontinence and quality-of-life assessments of the 60 patients in the experimental and control groups were performed on months 0 (10 days after removal of the urinary catheter), 1, 3, and 6 through face-to-face and telephone interviews. Total Incontinence Consultation on Incontinence-Short Form scores, which provide an objective criterion for the evaluation of individuals with incontinence problems, decreased over time. This decrease was statistically highly significant in the third and sixth months. Pelvic muscle floor exercises are suitable for patients experiencing incontinence after radical prostatectomy.

2. Switzerland pubmed.ncbi.nlm.nih.gov

Quality Analysis of YouTube Videos Presenting Pelvic Floor Exercises after Prostatectomy Surgery. [2021] Prostate cancer (PC) is a major cause of disease and mortality among men. Surgical treatment involving the removal of the prostate may result in temporary or permanent erectile dysfunction (ED) and urinary incontinence (UI), with considerable impact on quality of life. Pelvic floor muscle training (PFMT) is one of the recommended techniques for the prevention, treatment, and rehabilitation of postoperative complications. The aim of this observational study was to assess the quality of YouTube videos-accessible to any patient-related to exercises after prostatectomy surgery.

3. United States pubmed.ncbi.nlm.nih.gov

Pelvic Floor Muscle Training in Radical Prostatectomy and Recent Understanding of the Male Continence Mechanism: A Review. [2021] Pelvic floor muscle training (PFMT) is recommended as part of supportive care for patients with prostate cancer. It can assist in reducing treatment-related symptoms such as urinary incontinence. This literature review aims to discuss recent innovative findings on the pathophysiology of the male continence mechanism and implications for PFMT in radical prostatectomy.

4. Spain 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. [2014] To evaluate the efficacy of preoperative pelvic floor muscle training (PFMT) on histomorphometry, muscle function, urinary continence and quality of life of patients undergoing radical prostatectomy (RP).

5. England 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. [2021] Prostate cancer is the most common cancer in men. Prostatectomy is the most common treatment. Morbidity from prostatectomy is high-80% of men experience urinary incontinence which negatively impacts the quality of life. Postsurgical pelvic floor muscle training is commonly prescribed but recent systematic reviews found no evidence of efficacy. We propose a new treatment that commences preoperatively and targets functional training of specific pelvic floor muscles that contribute to urinary continence. Assessment and biofeedback using transperineal ultrasound imaging assists in training. This will be compared against conventional training (maximal pelvic floor muscle contraction assessed by digital rectal examination) and no training. Embedded physiological studies will allow the investigation of moderation and mediation of the treatment effect on the outcomes.

6. England 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. [2022] Urinary incontinence is one of the most clinically relevant side effects in the treatment of prostate cancer patients. The aim of this systematic review and meta-analysis was to analyze the specific exercise effects of supervised versus unsupervised pelvic floor muscle exercise (PFME) and exercise volume on urinary incontinence status after radical prostatectomy.

7. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Pelvic Floor Exercise for Post-prostatectomy Incontinence: Systematic Review and Meta-analysis. [2022] To determine the effect of pelvic floor muscle exercise (PFME) for post-prostatectomy urinary incontinence (PPUI), which has a major impact on the quality of life of patients undergone radical prostatectomy (RP).

8. Scotland pubmed.ncbi.nlm.nih.gov

Effect of Kegel exercises on the prevention of urinary and fecal incontinence in patients with prostate cancer undergoing radiotherapy. [2021] This is a nonrandomized experimental study conducted to evaluate the effect of Kegel exercises on the prevention of urinary and fecal incontinence in prostate cancer patients undergoing radiotherapy.

9. Brazil pubmed.ncbi.nlm.nih.gov

The effect of perioperative pelvic floor muscle exercise on urinary incontinence after radical prostatectomy: a meta-analysis. [2023] Pelvic floor muscle exercise (PFME) is the most common conservative management for urinary incontinence (UI) after radical prostatectomy (RP). We performed this meta-analysis to investigate whether PFME during the entire perioperative period, including before and after RP, can significantly improve the recovery of postoperative UI.