Effect of Group Preoperative Pelvic Floor Training for HoLEP

NCT05719220 | Recruiting

• 1 other identifier: 23-38400
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The main goal of this study is to see if group pelvic floor training before surgery can help prevent urinary incontinence after Holmium laser enucleation of the prostate (HoLEP) surgery. The study has the potential to inform preoperative intervention strategies for managing incontinence after HoLEP.

Conditions

BPH; Urinary Incontinence

Keywords

benign prostatic hyperplasia; pelvic floor training; group therapy; holmium laser enucleation of the prostate; urinary incontinence

Outcome Measures

Primary Outcomes (2)

• Incidence of urinary incontinence at 1 month

  Urinary incontinence (present/absent) will be defined according to the guidelines of the International Continence Society as involuntary loss of urine experienced during the bladder storage phase using self-report measures at regular intervals postoperatively.

  1 month after the operation

• Incidence of urinary incontinence at 3 months

  Urinary incontinence (present/absent) will be defined according to the guidelines of the International Continence Society as involuntary loss of urine experienced during the bladder storage phase using self-report measures at regular intervals postoperatively.

  3 months after the operation

Secondary Outcomes (7)

• The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form at 1 month

  1 month after the operation

• The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form at 3 months

  3 months after the operation

• The International Prostate Symptom Score at 1 month

  1 month after the operation

• The International Prostate Symptom Score at 3 months

  3 months after the operation

• Pelvic floor muscle strength at 1 month

  1 month after the operation

Study Arms (2)

Group preoperative pelvic floor training

Patients will receive group preoperative PFT, 4 weeks prior to HoLEP.

Behavioral: Group preoperative pelvic floor training

No preoperative pelvic floor training

The control group will receive standard care, which may include patient education about postoperative care and pelvic floor muscle exercises, but will not receive structured group PFT.

Interventions

Group preoperative pelvic floor training BEHAVIORAL

Patients will receive PFT from a trained physical therapist delivered in a group setting of 8-10 people. The investigators allow patients in the PFT group to attend group classes as many times as they want prior to surgery to see if the frequency of training has an effect on outcomes. The treatment group could be required to go to at least 1 group class 4 weeks prior to their procedure, but they could be welcome to attend more if they want further practice and review of the material. A 45-minute group class with basic PFT guidelines could be presented weekly during the study.

Group preoperative pelvic floor training

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The investigators will recruit a cohort of patients scheduled to undergo HoLEP at the UCSF Urology Clinic. Well-informed consent will be obtained from every patient after giving balanced information about the options of group preoperative PFT and no training before recruitment in the study. The investigators will offer the group class to everyone and use the patients who decline the group class as the control group (N = 50: 50 each arm).

You may qualify if:

• Consecutive patients with a diagnosis of BPH with a plan to undergo HoLEP.
• Between the age of 50-90.
• Ability to understand and provide informed consent.

You may not qualify if:

• Patients whom inability to carry out PFT protocol.
• Patients unwilling or unable to complete follow up care.
• Severe urinary incontinence due to a history of neurological diseases such as a cerebrovascular accident or spinal cord injuries.
• Patients whom inability to read and understand the English language.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

Related Publications (19)

• Gilling PJ, Wilson LC, King CJ, Westenberg AM, Frampton CM, Fraundorfer MR. Long-term results of a randomized trial comparing holmium laser enucleation of the prostate and transurethral resection of the prostate: results at 7 years. BJU Int. 2012 Feb;109(3):408-11. doi: 10.1111/j.1464-410X.2011.10359.x. Epub 2011 Aug 23.

  PMID: 21883820 BACKGROUND

• Sun F, Sun X, Shi Q, Zhai Y. Transurethral procedures in the treatment of benign prostatic hyperplasia: A systematic review and meta-analysis of effectiveness and complications. Medicine (Baltimore). 2018 Dec;97(51):e13360. doi: 10.1097/MD.0000000000013360.

  PMID: 30572440 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Shigemura K, Tanaka K, Yamamichi F, Chiba K, Fujisawa M. Comparison of Predictive Factors for Postoperative Incontinence of Holmium Laser Enucleation of the Prostate by the Surgeons' Experience During Learning Curve. Int Neurourol J. 2016 Mar;20(1):59-68. doi: 10.5213/inj.1630396.198. Epub 2016 Mar 9.

  PMID: 27032559 BACKGROUND

• 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 BACKGROUND

• Pan LH, Lin MH, Pang ST, Wang J, Shih WM. Improvement of Urinary Incontinence, Life Impact, and Depression and Anxiety With Modified Pelvic Floor Muscle Training After Radical Prostatectomy. Am J Mens Health. 2019 May-Jun;13(3):1557988319851618. doi: 10.1177/1557988319851618.

  PMID: 31092098 BACKGROUND

• MacDonald R, Fink HA, Huckabay C, Monga M, Wilt TJ. Pelvic floor muscle training to improve urinary incontinence after radical prostatectomy: a systematic review of effectiveness. BJU Int. 2007 Jul;100(1):76-81. doi: 10.1111/j.1464-410X.2007.06913.x. Epub 2007 Apr 13.

  PMID: 17433028 BACKGROUND

• Centemero A, Rigatti L, Giraudo D, Lazzeri M, Lughezzani G, Zugna D, Montorsi F, Rigatti P, Guazzoni G. Preoperative pelvic floor muscle exercise for early continence after radical prostatectomy: a randomised controlled study. Eur Urol. 2010 Jun;57(6):1039-43. doi: 10.1016/j.eururo.2010.02.028. Epub 2010 Mar 1.

  PMID: 20227168 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Dumoulin C, Morin M, Danieli C, Cacciari L, Mayrand MH, Tousignant M, Abrahamowicz M; Urinary Incontinence and Aging Study Group. Group-Based vs Individual Pelvic Floor Muscle Training to Treat Urinary Incontinence in Older Women: A Randomized Clinical Trial. JAMA Intern Med. 2020 Oct 1;180(10):1284-1293. doi: 10.1001/jamainternmed.2020.2993.

  PMID: 32744599 BACKGROUND

• Pereira VS, Correia GN, Driusso P. Individual and group pelvic floor muscle training versus no treatment in female stress urinary incontinence: a randomized controlled pilot study. Eur J Obstet Gynecol Reprod Biol. 2011 Dec;159(2):465-71. doi: 10.1016/j.ejogrb.2011.09.003. Epub 2011 Oct 1.

  PMID: 21962461 BACKGROUND

• Lamb SE, Pepper J, Lall R, Jorstad-Stein EC, Clark MD, Hill L, Fereday-Smith J. Group treatments for sensitive health care problems: a randomised controlled trial of group versus individual physiotherapy sessions for female urinary incontinence. BMC Womens Health. 2009 Sep 14;9:26. doi: 10.1186/1472-6874-9-26.

  PMID: 19751517 BACKGROUND

• D'Ancona C, Haylen B, Oelke M, Abranches-Monteiro L, Arnold E, Goldman H, Hamid R, Homma Y, Marcelissen T, Rademakers K, Schizas A, Singla A, Soto I, Tse V, de Wachter S, Herschorn S; Standardisation Steering Committee ICS and the ICS Working Group on Terminology for Male Lower Urinary Tract & Pelvic Floor Symptoms and Dysfunction. The International Continence Society (ICS) report on the terminology for adult male lower urinary tract and pelvic floor symptoms and dysfunction. Neurourol Urodyn. 2019 Feb;38(2):433-477. doi: 10.1002/nau.23897. Epub 2019 Jan 25.

  PMID: 30681183 BACKGROUND

• Avery K, Donovan J, Peters TJ, Shaw C, Gotoh M, Abrams P. ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn. 2004;23(4):322-30. doi: 10.1002/nau.20041.

  PMID: 15227649 BACKGROUND

• Barry MJ. Evaluation of symptoms and quality of life in men with benign prostatic hyperplasia. Urology. 2001 Dec;58(6 Suppl 1):25-32; discussion 32. doi: 10.1016/s0090-4295(01)01300-0.

  PMID: 11750246 BACKGROUND

• Beattie PF, Pinto MB, Nelson MK, Nelson R. Patient satisfaction with outpatient physical therapy: instrument validation. Phys Ther. 2002 Jun;82(6):557-65.

  PMID: 12036397 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence; Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

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

Study Officials

• Thomas Chi, M.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Victoria Hogue

CONTACT

415-302-7443; victoria.hogue@ucsf.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: February 8, 2023
• Study Start: February 7, 2024
• Primary Completion: December 31, 2025
• Study Completion: March 30, 2026
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)