Evaluation of the Impact of Preoperative Pelvic Floor Exercise on Incontinence After Laser Enucleation of the Prostate: a Feasibility Study. (PPP)

March 11, 2026 updated by: Centre hospitalier de l'Université de Montréal (CHUM)

Evaluation of the Impact of Preoperative Pelvic Floor Exercise on Incontinence After Laser Enucleation of the Prostate: a Prospective Feasibility Study.

The purpose of this study is to assess the acceptability and feasibility of including a pelvic floor muscle exercise program into the care provided to patients undergoing prostate enucleation, studying both patients and clinicians perpsectives. A second part of the study will be to compare two groups, one receiving pelvic floor muscle exercise before surgery and and the other receiving the standard treatment, which is surgery. We will evaluate patients' perceptions of integrating physiotherapy sessions before surgery and attempt to identify facilitators and barriers to pelvic floor muscle exercise among both patients and clinicians.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

NATURE AND OBJECTIVES OF THE PROJECT

With aging, prostate enlargement, or benign prostatic hyperplasia (BPH), is very common in men. BPH can obstruct the urinary tract and result in urinary dysfunction. While some patients affected by BPH do not experience symptoms, others may have difficulty urinating or lose control of the bladder. To reduce these bothersome symptoms, patients may undergo a procedure called prostate enucleation, which involves using a laser to remove the portion of the prostate that obstructs the urinary tract.

Unfortunately, in some cases, patients may develop urinary incontinence after surgery. The rate of incontinence can vary greatly from person to person. Several risk factors may increase this likelihood, such as advanced age, diabetes, obesity, or a large prostate.

In general, the majority of patients recover and no longer have incontinence after 6 months (<1%). However, some patients who develop incontinence after surgery may still experience an impact on quality of life. Pelvic floor physiotherapy is often recommended for patients with incontinence after prostate surgery. However, very few studies have evaluated the effectiveness of preoperative pelvic floor physiotherapy in preventing urinary incontinence.

The purpose of this study is to assess the acceptability and feasibility of including a pelvic floor muscle exercise program in the care provided to patients undergoing prostate enucleation by studying both patient and clinician perspectives. A second part of the study will compare two groups: one receiving pelvic floor muscle exercises before surgery and the other receiving standard treatment (surgery only).

The investigators will evaluate participants' perceptions of integrating physiotherapy sessions before surgery and attempt to identify facilitators and barriers to pelvic floor muscle exercises among both participants and clinicians.

NUMBER OF PARTICIPANTS AND DURATION OF PARTICIPATION

A total of thirty (30) participants will be included in the study and randomly assigned (through an envelope draw) to one of the following groups:

G-PPP: Group receiving perineal physiotherapy before surgery

G-S: Group receiving surgery only

Participants will have a one-in-two (1/2) chance of being assigned to either group. Participation duration will be approximately one year, and the expected duration of the entire project is two years.

The study will take place at the Centre hospitalier de l'Université de Montréal.

NATURE OF THE REQUESTED PARTICIPATION

By agreeing to participate in the study, participants consent to undergo a randomization process before assignment to either group (G-PPP or G-S). No member of the research team can guarantee group assignment. After signing informed consent, an envelope will be opened indicating the participant's group.

If assigned to the intervention group (G-PPP), participants will be asked to engage in a perineal physiotherapy program and provide feedback on this program. The investigators will also collect information from participants' medical records related to evaluation, intervention, and care surrounding the surgery. Participants assigned to the standard treatment group (G-S) will complete the usual questionnaires and receive standard surgical treatment.

PROJECT PROCEDURES

Participants eligible for this study are those whose medical condition (BPH) requires surgical management through endoscopic prostate enucleation. Standard clinical care includes endoscopic prostate enucleation regardless of study participation. For research purposes only, participants in the G-PPP group will undergo pre- and postoperative pelvic physiotherapy sessions. Both groups will complete questionnaires.

A table of study visits and procedures appears at the end of the consent form.

This study includes three phases:

  1. Eligibility Determination Phase (both groups)

    During this phase, participants will be evaluated by a urologist to verify whether laser enucleation of the prostate is the appropriate treatment. The following tests and procedures will be conducted:

    Review of medical history associated with BPH

    Review and documentation of current medications

    Blood sample: A 5 mL sample will be drawn for laboratory tests, including PSA

    Measurement of urinary flow: Participants will urinate into a special device to evaluate urinary difficulties

    Completion of questionnaires: IPSS, IIEF, SESPPFE, ICIQ-SF

    Completion of a 3-day micturition diary

    These evaluations are part of standard care. The appointment will last approximately 15-20 minutes, about 5 minutes longer than usual.

    If results indicate that a participant is not eligible, laser enucleation will not be performed as part of the research protocol, and clinical treatment options will be discussed with the treating physician.

    Eligible participants will proceed to randomization.

  2. Training Phase (G-PPP only)

    Participants in G-PPP will undergo three 30-minute pelvic floor physiotherapy sessions (two before surgery, one after surgery) with a specialized physiotherapist.

    Session #1:

    Teaching pelvic floor exercises (theoretical and practical)

    Manual methods (digital or probe-based resistance)

    Hypopressive abdominal exercises

    Biofeedback, including evaluation of muscle endurance and contraction quality

    Illustrated instructions for at-home practice

    Session #2:

    Evaluation of progress

    Reinforcement of exercises

    Review of first session's teachings

    Session #3:

    Postoperative evaluation

    Progress assessment

    Reinforcement and review

  3. Follow-Up Phase (both groups)

Participants will meet with the medical team approximately four times (1, 3, 6, and 12 months after surgery) to evaluate progress. These assessments are part of standard care. Information collected in the medical record will be used for the research project.

One month after surgery, participants will complete a brief questionnaire (5 items) evaluating appreciation of the physiotherapy intervention.

RISKS AND INCONVENIENCES

Risks associated with physiotherapy sessions:

Potential temporary effects may include:

Mild pelvic muscle soreness

Ineffective results or muscle strain from incorrect technique

Increased urinary urgency or frequency

Pelvic pain (rare)

Mild rectal discomfort

These effects are generally temporary and can be minimized with proper technique and gradual progression.

BENEFITS

Personal benefits cannot be guaranteed. However, participation may provide valuable insights, and findings will contribute to scientific knowledge.

CONFIDENTIALITY

During participation, the investigators and research staff will collect necessary information in a research file. This may include medical history, current health status, habits, and test results. The file may contain identifying information (name, gender, date of birth, ethnic origin).

All information will remain confidential within legal limits. Participants will be identified only by a code. The key linking the name to the code will be kept by the responsible researcher.

Data will be retained for at least 10 years. Research results may be published, but participant identity will not be disclosed.

Participants have the right to access their research file and request corrections.

DISSEMINATION OF GENERAL RESULTS

General study results will be available to participants upon request at the end of the study.

OPEN SCIENCE AND DATA DEPOSIT

To promote accessibility and scientific reuse, de-identified research data may be deposited in a secure institutional or public repository. All identifiers will be removed.

By signing consent, participants authorize data deposition in accordance with applicable laws.

PROJECT FUNDING

Neither the responsible researcher nor the institution receives funding for this project.

COMPENSATION

Participants will not receive financial compensation.

IN CASE OF HARM

Participants will receive all necessary care in the event of harm caused by research procedures. Participation does not waive legal rights or release investigators or the institution from liability.

VOLUNTARY PARTICIPATION AND RIGHT TO WITHDRAW

Participation is voluntary. Participants may withdraw at any time without consequences for care or their relationship with healthcare providers.

The responsible researcher or ethics committee may also withdraw participants if necessary for safety, protocol adherence, or administrative reasons.

Participants are encouraged to attend a final assessment before withdrawing. Data already collected will continue to be used to preserve study integrity.

Any new information relevant to participation will be promptly communicated.

ETHICS APPROVAL

The CHUM Research Ethics Committee has approved and will monitor this study.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2X 0A9
        • Centre Hospitalier de l'Universite de Montreal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with symptomatic BPH who are candidates for prostate enucleation, including: urinary retention, post-renal AKI, refractory hematuria, recurrent UTIs, symptoms refractory to medical therapies, IPSS > 8, urinary flow rate < 15 mL/sec.
  • Patients able to perform pelvic floor physiotherapy exercises independently.
  • Patients who agree to additional outpatient physiotherapy visits.
  • Patients who provide consent to participate in the study.

Exclusion Criteria:

  • Patients with severe central or peripheral neurological diseases and gait disorders
  • Patients with a history of prostate or bladder cancer, prior prostate surgery, neurogenic bladder, or urethral stricture
  • Patients with bladder atony
  • Patients unable to continue pelvic floor muscle training independently

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of care
No intervention, standard of care administrated.
Experimental: Intervention - Pelvic Floor Muscle Exercise

Three sessions of 30 minutes will be scheduled (2 before the surgery and one after the surgery) with a specialized pelvic rehabilitation physiotherapist.

Teaching pelvic floor physiotherapy exercises.
Other: Pelvic Floor Muscle Exercise before and after surgery

Teaching pelvic floor physiotherapy exercises:

  • Theoretical part.
  • Practical part, including various modalities:

Manual method, where the therapist inserts a finger or a probe into the rectum to apply resistance to the muscle while asking the patient to contract and then relax the pelvic floor.

Hypopressive abdominals, which involve breathing exercises to strengthen the deep abdominal muscles and support internal organs.

Biofeedback, which allows the patient to visualize real-time muscle contractions.

Teaching through biofeedback enables a better assessment of pelvic floor muscle endurance and contraction quality, respiratory coordination, and correction of incorrect physical postures.

All patients will be provided with illustrated instructions to continue the exercises on their own.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Acceptability of the Perineal Physiotherapy Program as Measured by Patient Acceptability of a Postoperative Pelvic Floor Physiotherapy Program After Endoscopic Prostate Enucleation Questionnaire (PPP-EEP) and Percentage of Session Attendance
Time Frame: From enrollment to 3-5 months after surgery

Patient Acceptability of a Postoperative Pelvic Floor Physiotherapy Program After Endoscopic Prostate Enucleation Questionnaire (PPP-EEP). A majority (>50%) of patients should agree with the 6 items on the questionnaire (score >3/5 on the Likert scale, as lowest score is 1 = strongly disagree to highest score being 5 = strongly agree, for a total score range of 6 to 30. Higher score meaning better outcome).

Attendance of ≥60% at physiotherapy sessions will be considered acceptable.
From enrollment to 3-5 months after surgery
Clinician-Reported Feasibility of a Preoperative Pelvic Floor Physiotherapy Program (Urologists and Physiotherapists) Assessed by the Program Integration and Perceived Continence Benefit Questionnaire
Time Frame: From enrollment to 3-5 months after surgery

Program Integration and Perceived Continence Benefit Questionnaire. A majority (>50%) of clinicians are expected to agree with the 6 questionnaire items (>3/5 on the Likert scale, as lowest score is 1 = strongly disagree to highest score being 5 = strongly agree, for a total score range of 6 to 30. Higher score meaning better outcome.)

At least 60% of preoperative pelvic floor physiotherapy (PPP) sessions will be delivered to participants prior to surgery.
From enrollment to 3-5 months after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical changes between the preoperative and postoperative periods for each patient assessed by PSA dosage in ng/mL
Time Frame: From enrollment to 3-5 months after surgery
Blood tests performed before surgery and after surgery (>3 months)
From enrollment to 3-5 months after surgery
Evaluation of urinary incontinence assessed by a miction diary done on 3 days and number of incontinence pads used per day
Time Frame: From enrollment to 3-5 months after surgery
From enrollment to 3-5 months after surgery
Urinary flow rate measured by Urinary Peak Flow Rate (Qmax) in mL/s
Time Frame: From enrollment to 3-5 months after surgery
From enrollment to 3-5 months after surgery
Evaluation of patient satisfaction regarding urinary voiding and storage symptoms assessed by the International Prostate Symptom Score (IPSS) questionnaire
Time Frame: From enrollment to 3-5 months after surgery
International Prostate Symptom Score (IPSS) questionnaire, from 0 (lowest/asymptomatic) to 35 (highest/severe symptoms), higher score meaning worse outcome.
From enrollment to 3-5 months after surgery
Evaluation of erectile function assessed by International Index of Erectile Function (IIEF) Questionnaire
Time Frame: From enrollment to 3-5 months after surgery
International Index of Erectile Function (IIEF) Questionnaire, lowest score of 5 to a maximum of 25, with higher scores indicating less severe erectile dysfunction and better outcome.
From enrollment to 3-5 months after surgery
Frequency, severity, and impact on quality of life of urinary incontinence assessed by the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)
Time Frame: From enrollment to 3-5 months after surgery
International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF), total score range of 0 to 21, where 0 represents no leakage and 21 represents the maximum severity. Higher scores indicate a worse outcome.
From enrollment to 3-5 months after surgery
Evaluation of patient self-efficacy in the perineal physiotherapy program assessed by Self-Efficacy Scale For Practicing Pelvic Floor Exercise Questionnaire (SESPPFE)
Time Frame: From enrollment to 3-5 months after surgery

Self-Efficacy Scale For Practicing Pelvic Floor Exercise Questionnaire (SESPPFE), score range from 0 to 100, where 0 represents no self-efficacy and 100 represents stronger belief in personal competence. Higher scores indicating better outcome.

Patients in the Intervention group have to answer the questionnaire only.
From enrollment to 3-5 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Investigators

  • Principal Investigator: Naeem Bohjani, MD, Centre de recherche du Centre Hospitalier de l'Universite de Montreal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2024

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

March 4, 2026

First Posted (Actual)

March 6, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23.137

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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