Pelvic Floor Physical Therapy for Stress Urinary Incontinence

Overseen By Smita De

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Disqualifiers: Neurologic disorders, Urologic conditions, Pelvic radiation, others

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

Compensation: Varies

Number of Visits: 1

36 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to allow us to assess the effectiveness (or success) of starting pelvic floor physical therapy (i.e. exercises for your pelvic muscles) prior to HoLEP (holmium laser enucleation of the prostate) surgery for enlarged prostates in order to manage or prevent urinary incontinence (i.e. leaking) after surgery (i.e. post-operatively). Your pelvic floor refers to the muscles under your bladder along your pelvic bones that prevent you from leaking urine or stool. Traditionally, pelvic floor physical therapy is started after surgery and continued until urinary continence (i.e. no leaking of urine) is regained. We want to assess if beginning pelvic floor physical therapy prior to surgery (and continuing afterwards) reduces the time required to regain urinary continence following HoLEP.

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.

Is pelvic floor physical therapy safe for humans?

Pelvic floor physical therapy is considered a safe, first-line treatment for various pelvic disorders, with no significant safety concerns reported in the studies. ^{1 2 3 4 5}

How is preoperative pelvic floor physical therapy different from other treatments for stress urinary incontinence?

Preoperative pelvic floor physical therapy is unique because it involves exercises to strengthen the pelvic muscles before surgery, which can improve outcomes and quality of life after procedures like prolapse repairs. Unlike other treatments that may focus on medication or surgery alone, this therapy emphasizes muscle training to enhance recovery and function. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Preoperative Pelvic Floor Physical Therapy for Stress Urinary Incontinence?

Research shows that pelvic floor physical therapy, which involves exercises to strengthen the muscles that support the bladder, is commonly recommended for women with stress urinary incontinence and can improve symptoms. It is also used to enhance recovery and quality of life after pelvic surgeries. ^{5 7 10 11 12}

Eligibility Criteria

This trial is for individuals with an enlarged prostate experiencing symptoms like bedwetting, urinary retention, or incontinence. Participants should be scheduled for HoLEP surgery but haven't started pelvic floor physical therapy yet. Specific eligibility details are not provided.

Inclusion Criteria

I am a male with a prostate.

Ethnic background: all ethnicities

I am scheduled for a HoLEP procedure due to prostate enlargement symptoms.

Exclusion Criteria

I have never had radiation therapy to my pelvis.

I have a history of neurological disorders that could affect my muscle function or bladder.

I am unable to give consent by myself.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Pelvic Floor Physical Therapy

Participants in the experimental group start pelvic floor physical therapy 1 month before surgery

4 weeks

Weekly visits (in-person)

Surgery

Participants undergo HoLEP surgery for enlarged prostates

1 day

1 visit (in-person)

Postoperative Pelvic Floor Physical Therapy

Participants start pelvic floor physical therapy after surgery to manage or prevent urinary incontinence

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

Monthly visits (in-person)

Treatment Details

Interventions

• Preoperative Pelvic Floor Physical Therapy

Trial Overview The study tests if starting pelvic floor physical therapy before HoLEP surgery helps patients regain bladder control faster post-surgery compared to the traditional method of beginning therapy after surgery.

Participant Groups

Group I: Preoperative PFPT Experimental Treatment 1 Intervention

This group of patients will be instructed to start pelvic floor physical therapy 1 month before surgery.

Group II: Postoperative PFPT Active Control 1 Intervention

This group of patients will be instructed to start pelvic floor physical therapy after surgery (standard of care).

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Findings from Research

In a study of 49 women undergoing vaginal reconstructive surgery, pelvic floor physical therapy (PFPT) was shown to improve muscle function as indicated by intravaginal EMG measurements, although it did not lead to significant differences in quality of life compared to standard care.

Both groups experienced improvements in pelvic symptoms after surgery, but the lack of subjective differences suggests that while PFPT may enhance muscle function, its impact on overall quality of life may require longer-term evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of physical therapy on quality of life and function after vaginal reconstructive surgery. Pauls, RN., Crisp, CC., Novicki, K., et al.[2022]

In a study of 49 women undergoing vaginal reconstruction, pelvic floor physical therapy (PFPT) showed initial improvements in muscle function at 12 weeks, but these benefits did not persist by the 24-week follow-up.

Overall quality of life and bladder symptoms improved for all participants by 24 weeks post-surgery, indicating that while PFPT did not provide additional long-term benefits, patients experienced ongoing improvements in their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pelvic floor physical therapy: impact on quality of life 6 months after vaginal reconstructive surgery. Pauls, RN., Crisp, CC., Novicki, K., et al.[2022]

Intensive group physical therapy significantly reduced daytime urinary frequency by 22% after 4 weeks and 19% after 3 months, while biofeedback training showed minimal improvement in daytime frequency, indicating that physical therapy may be more effective for this aspect of urinary stress incontinence.

Both therapies improved nocturnal urinary frequency, but biofeedback training resulted in a higher percentage of patients reporting complete resolution of incontinence episodes (62% vs. 28% in the physical therapy group), suggesting that while physical therapy is effective, biofeedback may offer better subjective outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative analysis of biofeedback and physical therapy for treatment of urinary stress incontinence in women. Pages, IH., Jahr, S., Schaufele, MK., et al.[2019]

In a study of 447 women with stress urinary incontinence, only 49% found pelvic floor muscle training successful, indicating that while it can be beneficial, many patients may not experience significant improvement.

Three key predictors of treatment failure were identified: having two or more leakages per day before treatment, chronic use of psychotropic medication, and a positive stress test result, which drastically reduced the odds of successful treatment to just 15%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Who will benefit from pelvic floor muscle training for stress urinary incontinence? Cammu, H., Van Nylen, M., Blockeel, C., et al.[2005]

In a review of 21 trials involving 1490 women, pelvic floor muscle training with regular supervision (weekly or bi-weekly group sessions) significantly improved outcomes for women with stress urinary incontinence, with only 10% reporting no improvement compared to 43% in the individual supervision group.

Despite the positive findings, the evidence is not strong enough to recommend a specific training approach, highlighting the need for more consistent and well-defined training protocols in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Hay-Smith, EJ., Herderschee, R., Dumoulin, C., et al.[2022]

A survey of 53 physical therapists in a rural healthcare setting revealed that 58% received less than 2 hours of training in pelvic floor physical therapy (PFPT) during their graduate education, indicating a significant gap in initial training.

Despite the low training levels, 95% of therapists pursued additional post-graduate training in PFPT, suggesting a strong commitment to improving their skills to better serve patients with pelvic floor dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training of Physical Therapists in Pelvic Floor Techniques: Is Care Available in the Rural Midwest? Biach, V., van Oosbree, A., Cookson, N., et al.[2023]

Approximately 66% of women prescribed pelvic floor physical therapy (PFPT) initiated treatment, but only 29% completed the full course, indicating a significant drop-off in adherence.

The study suggests potential racial disparities in PFPT attendance, as Hispanic patients were less likely to initiate therapy compared to non-Hispanic patients, highlighting a need for targeted interventions to improve access and adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attendance at Prescribed Pelvic Floor Physical Therapy in a Diverse, Urban Urogynecology Population. Shannon, MB., Genereux, M., Brincat, C., et al.[2019]

In a study of 26 women with high-tone pelvic floor dysfunction, 22 completed 6 sessions of pelvic floor physical therapy (PFPT), which led to significant improvements in genitourinary symptoms, pain, and quality of life, despite no significant change in vaginal closure force.

After 6 weeks of PFPT, the levator hiatal area increased, indicating muscle lengthening, but this did not translate into a measurable increase in pelvic floor muscle strength as assessed by intravaginal closure force.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Objective Changes in Pelvic Floor Muscle Strength and Length in Women With High-Tone Pelvic Floor Dysfunction After Pelvic Floor Physical Therapy (RELAX Trial). Volpe, LJ., Zugelder, M., Kotarinos, R., et al.[2023]

Pelvic floor physical therapy (PFPT) is an effective first-line conservative treatment for various pelvic floor disorders, including urinary incontinence and pelvic organ prolapse, with evidence supporting its ability to improve or cure symptoms.

While PFPT shows strong benefits for many conditions, the effectiveness of PFPT in the context of surgery for pelvic floor disorders remains unclear, highlighting the need for more standardized treatment protocols and larger trials to assess long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pelvic floor physical therapy in the treatment of pelvic floor dysfunction in women. Wallace, SL., Miller, LD., Mishra, K.[2020]

Pelvic floor muscle training (PFMT) significantly improves outcomes for women with urinary incontinence, leading to higher rates of reported cure or improvement compared to control groups, based on a review of 14 trials involving 836 women.

PFMT also enhances quality of life related to continence and reduces the number of incontinence episodes, with minimal adverse effects reported, supporting its recommendation as a first-line treatment for stress, urge, or mixed urinary incontinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Dumoulin, C., Hay-Smith, J.[2022]

Pelvic floor muscle training is an effective first-line treatment for women with stress, urge, or mixed urinary incontinence, based on a review of 13 trials involving 714 women.

The review supports the inclusion of pelvic floor muscle training in conservative management programs, although formal meta-analysis was not performed due to study heterogeneity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pelvic floor muscle training versus no treatment for urinary incontinence in women. A Cochrane systematic review. Dumoulin, C., Hay-Smith, J.[2018]

Pelvic floor muscle training (PFMT) is effective for women with urinary incontinence, showing that those who participated in PFMT were more likely to report improvement or cure compared to those who did not, based on a review of 13 trials involving 714 women.

While PFMT generally resulted in about one fewer incontinence episode per day, the studies showed significant variability in methods and outcomes, suggesting that younger women with stress urinary incontinence may benefit the most from longer, supervised training programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Hay-Smith, EJ., Dumoulin, C.[2022]

References

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

Impact of physical therapy on quality of life and function after vaginal reconstructive surgery. [2022]

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

Pelvic floor physical therapy: impact on quality of life 6 months after vaginal reconstructive surgery. [2022]

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

Comparative analysis of biofeedback and physical therapy for treatment of urinary stress incontinence in women. [2019]

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

Who will benefit from pelvic floor muscle training for stress urinary incontinence? [2005]

5. England pubmed.ncbi.nlm.nih.gov

Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. [2022]

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

Training of Physical Therapists in Pelvic Floor Techniques: Is Care Available in the Rural Midwest? [2023]

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

Attendance at Prescribed Pelvic Floor Physical Therapy in a Diverse, Urban Urogynecology Population. [2019]

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

Objective Changes in Pelvic Floor Muscle Strength and Length in Women With High-Tone Pelvic Floor Dysfunction After Pelvic Floor Physical Therapy (RELAX Trial). [2023]

9. England pubmed.ncbi.nlm.nih.gov

Pelvic floor physical therapy in the treatment of pelvic floor dysfunction in women. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. [2022]

11. Italy pubmed.ncbi.nlm.nih.gov

Pelvic floor muscle training versus no treatment for urinary incontinence in women. A Cochrane systematic review. [2018]

12. England pubmed.ncbi.nlm.nih.gov

Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. [2022]