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

NCT07456345 | Active Not Recruiting

• 1 other identifier: 23.137
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

BPH; HoLEP; Urinary incontinence; Pelvic Floor Muscle Exercise

Outcome Measures

Primary Outcomes (2)

• 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

  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

  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 Outcomes (7)

• Evaluation of patient satisfaction regarding urinary voiding and storage symptoms assessed by the International Prostate Symptom Score (IPSS) questionnaire

  From enrollment to 3-5 months after surgery

• Clinical changes between the preoperative and postoperative periods for each patient assessed by PSA dosage in ng/mL

  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

  From enrollment to 3-5 months after surgery

Study Arms (2)

Standard of care

NO INTERVENTION

No intervention, standard of care administrated.

Intervention - Pelvic Floor Muscle Exercise

EXPERIMENTAL

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

Interventions

Pelvic Floor Muscle Exercise before and after surgery OTHER

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.

Intervention - Pelvic Floor Muscle Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 0A9, Canada

Location

Related Publications (10)

• Park JJ, Kwon A, Park JY, Shim SR, Kim JH. Efficacy of Pelvic Floor Exercise for Post-prostatectomy Incontinence: Systematic Review and Meta-analysis. Urology. 2022 Oct;168:175-182. doi: 10.1016/j.urology.2022.04.023. Epub 2022 May 5.

  PMID: 35526757 RESULT

• Chang JI, Lam V, Patel MI. Preoperative Pelvic Floor Muscle Exercise and Postprostatectomy Incontinence: A Systematic Review and Meta-analysis. Eur Urol. 2016 Mar;69(3):460-7. doi: 10.1016/j.eururo.2015.11.004. Epub 2015 Nov 21.

  PMID: 26610857 RESULT

• Nam JK, Kim HW, Lee DH, Han JY, Lee JZ, Park SW. Risk Factors for Transient Urinary Incontinence after Holmium Laser Enucleation of the Prostate. World J Mens Health. 2015 Aug;33(2):88-94. doi: 10.5534/wjmh.2015.33.2.88. Epub 2015 Aug 19.

  PMID: 26331125 RESULT

• Cho MC, Park JH, Jeong MS, Yi JS, Ku JH, Oh SJ, Kim SW, Paick JS. Predictor of de novo urinary incontinence following holmium laser enucleation of the prostate. Neurourol Urodyn. 2011 Sep;30(7):1343-9. doi: 10.1002/nau.21050. Epub 2011 Apr 28.

  PMID: 21538499 RESULT

• Anan G, Kaiho Y, Iwamura H, Ito J, Kohada Y, Mikami J, Sato M. Preoperative pelvic floor muscle exercise for early continence after holmium laser enucleation of the prostate: a randomized controlled study. BMC Urol. 2020 Jan 23;20(1):3. doi: 10.1186/s12894-019-0570-5.

  PMID: 31973706 RESULT

• Houssin V, Olivier J, Brenier M, Pierache A, Laniado M, Mouton M, Theveniaud PE, Baumert H, Mallet R, Marquette T, Villers A, Robert G, Rizk J. Predictive factors of urinary incontinence after holmium laser enucleation of the prostate: a multicentric evaluation. World J Urol. 2021 Jan;39(1):143-148. doi: 10.1007/s00345-020-03169-0. Epub 2020 Mar 26.

  PMID: 32219512 RESULT

• Elmansy HM, Kotb A, Elhilali MM. Holmium laser enucleation of the prostate: long-term durability of clinical outcomes and complication rates during 10 years of followup. J Urol. 2011 Nov;186(5):1972-6. doi: 10.1016/j.juro.2011.06.065. Epub 2011 Sep 23.

  PMID: 21944127 RESULT

• Bozzini G, Berti L, Aydogan TB, Maltagliati M, Roche JB, Bove P, Besana U, Calori A, Pastore AL, Muller A, Micali S, Sighinolfi MC, Rocco B, Buizza C. A prospective multicenter randomized comparison between Holmium Laser Enucleation of the Prostate (HoLEP) and Thulium Laser Enucleation of the Prostate (ThuLEP). World J Urol. 2021 Jul;39(7):2375-2382. doi: 10.1007/s00345-020-03468-6. Epub 2020 Sep 30.

  PMID: 32997262 RESULT

• Elterman D, Aube-Peterkin M, Evans H, Elmansy H, Meskawi M, Zorn KC, Bhojani N. UPDATE - Canadian Urological Association guideline: Male lower urinary tract symptoms/benign prostatic hyperplasia. Can Urol Assoc J. 2022 Aug;16(8):245-256. doi: 10.5489/cuaj.7906. No abstract available.

  PMID: 35905485 RESULT

• Lerner LB, McVary KT, Barry MJ, Bixler BR, Dahm P, Das AK, Gandhi MC, Kaplan SA, Kohler TS, Martin L, Parsons JK, Roehrborn CG, Stoffel JT, Welliver C, Wilt TJ. Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA GUIDELINE PART II-Surgical Evaluation and Treatment. J Urol. 2021 Oct;206(4):818-826. doi: 10.1097/JU.0000000000002184. Epub 2021 Aug 13.

  PMID: 34384236 RESULT

MeSH Terms

Conditions

Prostatic Hyperplasia; Urinary Incontinence

Interventions

Postoperative Period

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Perioperative Period; Surgical Procedures, Operative; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Naeem Bohjani, MD

  Centre de Recherche du Centre Hospitalier de l'Université de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: March 6, 2026
• Study Start: April 29, 2024
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)