Your session is about to expire
← Back to Search
Behavioral Intervention
Pelvic Floor Physical Therapy for Stress Urinary Incontinence
N/A
Recruiting
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age: >=18 years of age
Sex: male sex assigned at birth (needs to have a prostate)
Must not have
Neurological disorders: patients with a history of a neurologic disorder that could affect muscle function, neurogenic bladder, lumbosacral spine pathology
History of pelvic radiation: patient with prior pelvic radiation will be excluded
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days after surgery
Awards & highlights
No Placebo-Only Group
Summary
This trial is being conducted to see if starting pelvic floor physical therapy before prostate surgery can help manage or prevent urinary incontinence (leaking) after the surgery. Pelvic floor physical therapy involves exercises
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Pelvic floor physical therapy is generally safe but may include temporary soreness or fatigue from exercises. There's no mention of other specific side effects related to this intervention.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am a male with a prostate.
Select...
I am scheduled for a HoLEP procedure due to prostate enlargement symptoms.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of neurological disorders that could affect my muscle function or bladder.
Select...
I have never had radiation therapy to my pelvis.
Select...
I am unable to give consent by myself.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day of surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day of surgery
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Time to continence
Secondary study objectives
Post void residual
Uroflow
catheter duration
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Preoperative PFPTExperimental Treatment1 Intervention
This group of patients will be instructed to start pelvic floor physical therapy 1 month before surgery.
Group II: Postoperative PFPTActive Control1 Intervention
This group of patients will be instructed to start pelvic floor physical therapy after surgery (standard of care).
Find a Location
Who is running the clinical trial?
The Cleveland ClinicLead Sponsor
1,057 Previous Clinical Trials
1,371,724 Total Patients Enrolled