Evaluation of the Impact of Preoperative Pelvic Floor Exercise on Incontinence After Laser Enucleation of the Prostate: a Prospective Feasibility Study.
| Registry | NCT07456345, acronym PPP |
|---|---|
| Status | Active not recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, prevention |
| Enrollment | 30 (Estimated) |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) (Other) |
| Conditions | BPH (Benign Prostatic Hyperplasia), Incontinence, Urinary, HoLEP, Pelvic Floor Muscle Exercise |
| Interventions | Pelvic Floor Muscle Exercise before and after surgery (Other) |
| Dates | start 2024-04-29, primary completion 2026-04-01 (estimated), completion 2026-05-01 (estimated), first posted 2026-03-06, last updated 2026-03-12 |
| Locations | 1 site in Canada |
Related Papers Related Patents Related Grants Related Experts
All trials for BPH (Benign Prostatic Hyperplasia) All trials for Incontinence, Urinary All trials of Pelvic Floor Muscle Exercise before and after surgery
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Standard of care | No intervention | No intervention, standard of care administrated. | |
| Intervention - Pelvic Floor Muscle Exercise | Experimental | Other: Pelvic Floor Muscle Exercise before and after surgery | 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. |
Sex: Male, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Centre Hospitalier de l'Université de Montréal | Montreal, Quebec | Canada |