36 Participants Needed

Pelvic Floor Physical Therapy for Stress Urinary Incontinence

SD
Overseen BySmita De
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: The Cleveland Clinic
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?

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.12345

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.678910

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.57101112

Are You a Good Fit for This Trial?

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.
See 1 more

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.
See 2 more

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Preoperative PFPTExperimental Treatment1 Intervention
Group II: Postoperative PFPTActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials
1,072
Recruited
1,377,000+

Published Research Related to This Trial

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

Citations

Impact of physical therapy on quality of life and function after vaginal reconstructive surgery. [2022]
Pelvic floor physical therapy: impact on quality of life 6 months after vaginal reconstructive surgery. [2022]
Comparative analysis of biofeedback and physical therapy for treatment of urinary stress incontinence in women. [2019]
Who will benefit from pelvic floor muscle training for stress urinary incontinence? [2005]
Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. [2022]
Training of Physical Therapists in Pelvic Floor Techniques: Is Care Available in the Rural Midwest? [2023]
Attendance at Prescribed Pelvic Floor Physical Therapy in a Diverse, Urban Urogynecology Population. [2019]
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]
Pelvic floor physical therapy in the treatment of pelvic floor dysfunction in women. [2020]
Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. [2022]
Pelvic floor muscle training versus no treatment for urinary incontinence in women. A Cochrane systematic review. [2018]
Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. [2022]
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