Preoperative Pelvic Floor Physical Therapy to Minimize Stress Urinary Incontinence After Holmium Laser Enucleation of the Prostate

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorThe Cleveland Clinic

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: >=18 years of age

Sex: male sex assigned at birth (needs to have a prostate)

BMI: all BMI

Ethnic background: all ethnicities

Disqualifiers

Neurological disorders: patients with a history of a neurologic disorder that could affect muscle function, neurogenic bladder, lumbosacral spine pathology

Specific urologic conditions: patients with pre-operative indwelling catheter, urethral stricture greater than 1 centimeter in length or requiring dilation/incision, indwelling ureteral stent

History of pelvic radiation: patient with prior pelvic radiation will be excluded

Patients unable to give consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • Preoperative pelvic floor physical therapy

    Behavioral

    Pelvic floor physical therapy to start before prostate surgery rather than after surgery.

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Preoperative PFPTExperimental treatment 1 intervention
Group B: Postoperative PFPTNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Time to continence

Time to recover from transient postoperative stress urinary incontinence

Time frame
6 months after surgery

Secondary outcomes

1

Uroflow

urine flow rate (milliliters/second)

Time frame
6 months after surgery
2

Post void residual

Residual urine after voiding (milliliters)

Time frame
6 months after surgery
3

international prostate symptom score

validated questionnaire on urination symptoms

Time frame
6 months after surgery
4

operative time

length of surgery (minutes)

Time frame
day of surgery

Other outcomes

Sponsors and contacts

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