Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05719220
Other study ID # 23-38400
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 2023
Est. completion date June 2024

Study information

Verified date January 2023
Source University of California, San Francisco
Contact Thomas Chi, M.D.
Phone 415-353-2480
Email tom.chi@ucsf.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Preoperative pelvic floor training (PFT) may improve early urinary incontinence after prostate surgery. Group-based training potentially provides additional benefits such as cost-benefit, social support, and motivation. However, the efficacy of group preoperative PFT has not been reported. This study aims to determine the effect of group preoperative PFT on transient urinary incontinence after HoLEP in a prospective cohort of patients and to identify any potential predictors of transient urinary incontinence after HoLEP. In this study, the investigators will recruit approximately 50 patients in each cohort (total 100) and will be followed over time to collect data on both the exposure (group PFT) and the outcome (incidence of urinary incontinence 1 month and 3 months after HoLEP). Potential confounding variables, such as patient demographics, preoperative imaging, and operative data, will be collected and analyzed. The results of this study have the potential to inform the development of effective preoperative interventions for the management of transient urinary incontinence after HoLEP.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender Male
Age group 50 Years to 90 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Group preoperative pelvic floor training
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.

Locations

Country Name City State
United States University of California, San Francisco San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (19)

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. — View Citation

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. — View Citation

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. — View Citation

Beattie PF, Pinto MB, Nelson MK, Nelson R. Patient satisfaction with outpatient physical therapy: instrument validation. Phys Ther. 2002 Jun;82(6):557-65. Erratum In: Phys Ther 2002 Aug;82(8):827. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: J Urol. 2022 Mar;207(3):743. J Urol. 2022 Oct;208(4):939. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 19 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form at 1 month The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) is a self-administered questionnaire used to measure the severity of urinary incontinence symptoms, such as frequency, urgency, and amount of urine loss, as well as the impact of urinary incontinence on daily activities and emotional well-being. The total score ranges from 0 to 21, with higher scores indicating more severe urinary incontinence and greater impact on quality of life. 1 month after the operation
Secondary The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form at 3 months The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) is a self-administered questionnaire used to measure the severity of urinary incontinence symptoms, such as frequency, urgency, and amount of urine loss, as well as the impact of urinary incontinence on daily activities and emotional well-being. The total score ranges from 0 to 21, with higher scores indicating more severe urinary incontinence and greater impact on quality of life. 3 months after the operation
Secondary The International Prostate Symptom Score at 1 month The International Prostate Symptom Score (IPSS) is a self-administered questionnaire that assesses the severity of lower urinary tract symptoms (LUTS) in men. The questionnaire consists of 7 items that assess symptoms such as frequency, urgency, nocturia, weak stream, straining, incomplete emptying, and terminal dribbling. Each item is scored on a scale of 0-5. The total score ranges from 0 to 35, with higher scores indicating more severe symptoms and the last question for measuring the effect of LUTS on quality of life. 1 month after the operation
Secondary The International Prostate Symptom Score at 3 months The International Prostate Symptom Score (IPSS) is a self-administered questionnaire that assesses the severity of lower urinary tract symptoms (LUTS) in men. The questionnaire consists of 7 items that assess symptoms such as frequency, urgency, nocturia, weak stream, straining, incomplete emptying, and terminal dribbling. Each item is scored on a scale of 0-5. The total score ranges from 0 to 35, with higher scores indicating more severe symptoms and the last question for measuring the effect of LUTS on quality of life. 3 months after the operation
Secondary Pelvic floor muscle strength at 1 month Preoperative and postoperative pelvic floor muscle strength measured by perineometer (the output in cmH2O) will be compared to determine whether the strength gain or maintenance, which could be a repeated measure at baseline, 1 month, and 3 months. 1 month after the operation
Secondary Pelvic floor muscle strength at 3 months Preoperative and postoperative pelvic floor muscle strength measured by perineometer (the output in cmH2O) will be compared to determine whether the strength gain or maintenance, which could be a repeated measure at baseline, 1 month, and 3 months. 3 months after the operation
Secondary Patient satisfaction Patient satisfaction after receiving group PFT will be evaluated using a patient satisfaction with outpatient physical therapy survey. Immediately after the completion of the PFT program or soon thereafter
See also
  Status Clinical Trial Phase
Recruiting NCT05534412 - A Practice-Based Intervention To Improve Care for a Diverse Population Of Women With Urinary Incontinence N/A
Recruiting NCT05515198 - Improving Care for Women With Urinary Incontinence (EMPOWER) N/A
Completed NCT04071301 - Collection of Real-life Measurement Data for TENA SmartCare Change Indicator in Subjects With Urinary Incontinence N/A
Completed NCT03623880 - Enhancing Behavioral Treatment for Women With Pelvic Floor Disorders N/A
Recruiting NCT05880862 - Comparative Effectiveness of Initial OAB Treatment Options Among Older Women at High Risk of Falls Early Phase 1
Recruiting NCT04159467 - Effect of Pelvic Floor Muscle Training on Urinary Incontinence Reports in Obese Women Undergoing a Low Calorie Diet N/A
Completed NCT05485922 - Performance of a Single-use Intermittent Micro-hole Zone Catheter N/A
Completed NCT06268782 - The Effectiveness of an Online Exercise Program on Well-being of Postpartum Women N/A
Not yet recruiting NCT03027986 - Evaluation of a Postural Rehabilitation Program Based on Sensory-motor Control in Men With Urinary Incontinence After Prostatectomy N/A
Recruiting NCT02490917 - ACT™ Balloons Versus Artificial Urinary Sphincter (AMS800™) for the Treatment of Female Stress Urinary Incontinence N/A
Enrolling by invitation NCT02529371 - Pre-Marketing Feasibility Evaluation of the UriCap-RM - Urine Collection in Hospitalized Male Patients N/A
Enrolling by invitation NCT02530372 - Feasibility of the UriCap-F for Urine Collection in Hospitalized Women N/A
Completed NCT02549729 - Effect of the Pelvic Floor Training in Postmenopausal Women With or Without Hormonal Therapy N/A
Completed NCT02338726 - Pelvic Floor Symptoms and Quality of Life in Elderly Women - a Population-based Pilot Study N/A
Completed NCT02600676 - Transcutaneous Electric Nerve Stimulation (TENS) in Children With Enuresis N/A
Completed NCT02239796 - Feasibility Controlled Trial of Tibial Nerve Stimulation for Stroke Related Urinary Incontinence N/A
Completed NCT02368262 - Prevalence of Incontinence and Risk Factors in Children With Cerebral Palsy N/A
Completed NCT01942681 - Female Patients With Signs of uRgE and Stress Urinary Incontinence Study of Propiverine Hydrochloride N/A
Recruiting NCT01804153 - Stem Cells Tratment for the Local Feminine Stress Urinary Incontinence Treatment (HULPURO) Phase 1/Phase 2
Completed NCT01520948 - Behavioral Therapy to Treat Urinary Symptoms in Parkinson Disease Phase 3