Incontinence Clinical Trial
Official title:
Additional Effects of Aerobic and Resistance Exercise Training to Pelvic Floor Muscle Training in Urinary Incontinence and Erectile Dysfunction After Radical Prostatectomy
In the literature, studies about urinary symptoms after radical prostatectomy (RP) are generally focused on urinary incontinence (UI), and studies about sexual symptoms are focused on erectile dysfunction (ED). In the management of these symptoms, the effects of pharmacological agents (duloxetine/antimuscarinics and PDE5-I) and/or local approaches (pelvic floor muscle training-PFMT, vacuum erection devices) have been emphasized. In these studies, the results are contradictory and the level of evidence is low. The effects of aerobic and resistance exercise training on urinary, sexual and general health after RP have not been revealed from a holistic and multidisciplinary perspective. Therefore, the aim of this study was to investigate the additional effects of aerobic and resistance exercise trainings to pelvic floor muscle training on urinary incontinence and erectile dysfunction after radical prostatectomy in a randomized controlled design. The study will include volunteers aged 40 years and older (Mini Mental test score of 24 and above for individuals aged 65 years and older) with symptoms of UI and/or ED after RP. The study is designed as a randomized controlled trial. Individuals who meet the inclusion criteria and agree to participate in the study will be randomly assigned to 2 separate groups. Subjects in the research group will receive patient education, PFMT, and aerobic and resistance exercise trainings; subjects in the control group will receive only patient education and PFMT. The study period is 12 weeks. Individuals will be evaluated at 2 separate time periods, at the beginning of the study and at the end of the 12th week.
Status | Not yet recruiting |
Enrollment | 38 |
Est. completion date | January 15, 2026 |
Est. primary completion date | January 15, 2026 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 40 Years and older |
Eligibility | Inclusion Criteria: - Individuals with localized prostate cancer (Stage I-II) undergoing Robot-Assisted Laparoscopic or Open Bilateral Nerve-Sparing Radical Prostatectomy - being married or having a partner - lack of cooperation problems with the assessments and interventions in the study - Being 40 years or older Exclusion Criteria: - Acute disease status (e.g. urinary tract infection, respiratory infection, presence of interstitial cystitis, bladder or gastrointestinal bleeding), - Acute surgical condition (within the first 3 weeks after prostatectomy), - Presence of neurological disease or neurogenic bladder, - Preoperative incontinence, - Bladder or other prostate surgery prior to prostatectomy, - Preoperative/postoperative pelvic radiotherapy, - Reporting preoperative ED or sexual dysfunction other than ED, - Have any medical condition that may limit their exercise training, - Individuals over 65 years of age with a Mini Mental Test score of less than 24 (a score of less than 24 indicates mild/moderate dementia) |
Country | Name | City | State |
---|---|---|---|
Turkey | Mustafa Enis Dilekmen | Ankara |
Lead Sponsor | Collaborator |
---|---|
Hacettepe University |
Turkey,
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
Bellet RN, Adams L, Morris NR. The 6-minute walk test in outpatient cardiac rehabilitation: validity, reliability and responsiveness--a systematic review. Physiotherapy. 2012 Dec;98(4):277-86. doi: 10.1016/j.physio.2011.11.003. Epub 2012 May 16. — View Citation
Chamorro C, Arancibia M, Trigo B, Arias-Poblete L, Jerez-Mayorga D. Absolute Reliability and Concurrent Validity of Hand-Held Dynamometry in Shoulder Rotator Strength Assessment: Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2021 Sep 3;18(17):9293. doi: 10.3390/ijerph18179293. — View Citation
Chamorro C, Armijo-Olivo S, De la Fuente C, Fuentes J, Javier Chirosa L. Absolute Reliability and Concurrent Validity of Hand Held Dynamometry and Isokinetic Dynamometry in the Hip, Knee and Ankle Joint: Systematic Review and Meta-analysis. Open Med (Wars). 2017 Oct 17;12:359-375. doi: 10.1515/med-2017-0052. eCollection 2017. — View Citation
Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998 May;28(3):551-8. doi: 10.1017/s0033291798006667. — View Citation
Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available. — View Citation
Giannitsi S, Bougiakli M, Bechlioulis A, Kotsia A, Michalis LK, Naka KK. 6-minute walking test: a useful tool in the management of heart failure patients. Ther Adv Cardiovasc Dis. 2019 Jan-Dec;13:1753944719870084. doi: 10.1177/1753944719870084. — View Citation
Greenstein A, Dekalo S, Chen J. Penile size in adult men-recommendations for clinical and research measurements. Int J Impot Res. 2020 Mar;32(2):153-158. doi: 10.1038/s41443-019-0157-4. Epub 2019 Jun 6. — View Citation
Henry JD, Crawford JR. The short-form version of the Depression Anxiety Stress Scales (DASS-21): construct validity and normative data in a large non-clinical sample. Br J Clin Psychol. 2005 Jun;44(Pt 2):227-39. doi: 10.1348/014466505X29657. — View Citation
Jorgensen L, Lose G, Andersen JT. One-hour pad-weighing test for objective assessment of female urinary incontinence. Obstet Gynecol. 1987 Jan;69(1):39-42. — View Citation
Kwon YS, Farber N, Yu JW, Rhee K, Han C, Ney P, Hong JH, Lee P, Gupta N, Kim WJ, Kim IY. Longitudinal recovery patterns of penile length and the underexplored benefit of long-term phosphodiesterase-5 inhibitor use after radical prostatectomy. BMC Urol. 2018 May 9;18(1):37. doi: 10.1186/s12894-018-0341-8. — View Citation
Mertoglu O, Ucer O, Ceylan Y, Bozkurt O, Gunlusoy B, Albaz AC, Demir O; Aegean Study Group of Society of Urological Surgery. Reliability and Validity of the Turkish Language Version of the International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptoms. Int Neurourol J. 2016 Jun;20(2):159-63. doi: 10.5213/inj.1630460.230. Epub 2016 Jun 24. — View Citation
Neijenhuijs KI, Holtmaat K, Aaronson NK, Holzner B, Terwee CB, Cuijpers P, Verdonck-de Leeuw IM. The International Index of Erectile Function (IIEF)-A Systematic Review of Measurement Properties. J Sex Med. 2019 Jul;16(7):1078-1091. doi: 10.1016/j.jsxm.2019.04.010. Epub 2019 May 27. — View Citation
Rasekaba T, Lee AL, Naughton MT, Williams TJ, Holland AE. The six-minute walk test: a useful metric for the cardiopulmonary patient. Intern Med J. 2009 Aug;39(8):495-501. doi: 10.1111/j.1445-5994.2008.01880.x. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | International Consultation on Incontinence Questionnaire- Short Form (ICIQ-SF) Score | The ICIQ-UI Short Form is a questionnaire for evaluating the frequency, severity and impact of urinary incontinence on quality of life (QoL) in men and women in research and clinical practice. | Change in severity of incontinence from baseline to the end of the 12th week. | |
Primary | International Index of Erectil Function-15 ( IIEF-15) Score | The IIEF-15 is a multidimensional scale that can be used to evaluate ED. It has five subdomains: Erectile Function ( items 1,2,3,4,5,15), Orgasmic Function ( items 9,10), Sexual Desire (items 11,12), Intercourse Satisfaction ( items 6,7,8), Overall Satisfaction (items 13,14). | Change in severity of erectile function from baseline to the end of the 12th week. | |
Secondary | 1-hour Pad Test Score | 1-Hour Pad test is a non-invasive test that is widely used in the evaluation of objective UI severity. | Change in severity of incontinence from baseline to the end of the 12th week. | |
Secondary | Penile Length | Penile length will be measured by the therapist with the help of a ruler. This is a non-invasive objective measurement method used in the literature to measure the penile length of individuals after prostatectomy. | Change in penile length from baseline to the end of the 12th week. | |
Secondary | Peripheral Muscle Strength | Peripheral muscle strength will be evaluated with a hand-held dynamometer. The handheld dynamometer is a non-invasive and routinely used objective assessment tool preferred in the clinic for strength measurement. Studies have shown that handheld digital dynamometers are useful tools to objectively assess muscle strength before and after intervention and to demonstrate the effectiveness of treatment. In our study, within the scope of peripheral muscle strength measurement, static strength measurements will be performed in shoulder flexion-extension, shoulder abduction-adduction, elbow flexion-extension, hip flexion-extension, knee flexion-extension, and ankle dorsal and plantar flexion. | Change in strength of peripheral muscles from baseline to the end of the 12th week. | |
Secondary | Functional Exercise Capacity | Functional exercise capacity of individuals will be evaluated with the 6 Minute Walking Test (6MWT). The 6MWT is a simple and non-invasive test that evaluates the submaximal functional exercise capacity of individuals in 6 minutes on a hard and flat surface, does not require special equipment or advanced training, and has been shown to be reliable and valid in various patient populations in the literature. | Change in distance from baseline to the end of the 12th week. | |
Secondary | International Consultation On Incontinence- Male Lower Urinary Tract Symptoms (ICIQ-MLUTS) Score | The ICIQ-MLUTS is a questionnaire for evaluating male lower urinary tract symptoms and impact on quality of life (QoL) in research and clinical practice. It has four subdomains: Voiding Score (2-6 items), Incontinence Score (7-12 items), Frequency of urination during the day (13th item), Frequency of urination during the night (14th item) | Change in lower urinary system symptoms scores from baseline to the end of the 12th week. | |
Secondary | Depression Anxiety and Stress Scale-21 (DASS-21) Score | The DASS-21 is a self-report scale designed to measure the negative emotional states of depression, anxiety and stress. It contains 21 questions totally and 7 questions for each symptoms. Depression: dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest / involvement, anhedonia and inertia. (Items 3, 5, 10, 13, 16, 17, 21). Anxiety: autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. (Items 2, 4, 7, 9, 15, 19, 20). Stress: levels of chronic nonspecific arousal, difficulty relaxing, nervous arousal, and being easily upset / agitated, irritable / over-reactive and impatient (Items 1, 6, 8, 11, 12, 14, 18). | Change in level of depression, anxiety and stress level from baseline to the end of the 12th week. | |
Secondary | World Health Organization Quality of Life Brief Version (WHOQOL-BREF) Score | The World Health Organization Quality of Life Scale-Short Form (WHOQOL-BREF) will be used to question the general quality of life of individuals.The WHOQOL-BREF addresses four quality of life domains: physical health, psychological health, social relationships and environment. | Change in quality of life from baseline to the end of the 12th week. |
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