NCT07456345

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• BPH (Benign Prostatic Hyperplasia)
• Incontinence, Urinary
• HoLEP
• Pelvic Floor Muscle Exercise

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-04-29
• Primary completion: 2026-04-01
• Completion: 2026-05-01
• First posted: 2026-03-06
• Last updated: 2026-03-12

Locations

1 site across 1 country: Canada