NCT06126874

Additional Effects of Aerobic and Resistance Exercises to Pelvic Floor Muscle Training After Radical Prostatectomy

Additional Effects of Aerobic and Resistance Exercise Training to Pelvic Floor Muscle Training in Urinary Incontinence and Erectile Dysfunction After Radical Prostatectomy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Hacettepe University · Academic / Other
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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 hypotheses of the study are as follows: * H1: After radical prostatectomy, aerobic and resistance exercise trainings in addition to pelvic floor muscle training (PFMT) provides greater improvement in objective UI severity, urinary symptoms and incontinence-specific quality of life. * H2: After radical prostatectomy, aerobic and resistance exercise trainings in addition to PFMT provides greater improvement in in penile length. * H3: After radical prostatectomy, aerobic and resistance exercise trainings in addition to PFMT provides greater improvement in erectile function and sexual health. * H4: After radical prostatectomy, aerobic and resistance exercise trainings in addition to PFMT provides greater improvement in peripheral muscle strength. * H5: After radical prostatectomy, aerobic and resistance exercise trainings in addition to PFMT provides greater improvement in functional exercise capacity. * H6: After radical prostatectomy, aerobic and resistance exercise trainings in addition to PFMT provides greater improvement in general health and quality of life. 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. Subjective severity of incontinence and its impact on life will be assessed with the International Consultation Incontinence Questionnaire-Short Form (ICIQ-SF). The International Consultation on Incontinence Questionnaire-Male Lower Urinary Tract Symptoms (ICIQ-MLUTS) scale will be used to question the severity of lower urinary tract symptoms. Erectile function and sexual function will be questioned with the International Erectile Function Form -15 (IIEF-15). Depression Anxiety Stress Scale-21 (DASS-21) will be used to evaluate the depression, anxiety and stress levels of the patients. The World Health Organization Quality of Life Questionnaire-Short Form (WHOQOL-BREF) will be used to question the general quality of life of the individuals. Objective severity of incontinence will be evaluated with a 1-hour pad test. Peripheral muscle strength will be evaluated with a hand-held dynamometer and functional exercise capacity of the individuals will be evaluated by 6-Minute Walking Test (6-MWT).

Conditions

• Incontinence
• Erectile Dysfunction Following Radical Prostatectomy

Interventions

Type	Name	Description
OTHER	Patient Education	Individuals in both study groups will be provided with patient education through verbal and visual presentations. In the content of patient education; information about the importance of the research topic and the content of the study through anatomical models and short animations, lifestyle recommendations for urinary incontinence symptoms (avoiding bladder irritants such as alcohol, caffeine, tea, spicy foods, acidic foods and chocolate, regulating water / fluid consumption, recommendations for attention to bowel regularity and increasing physical activity levels) and recommendations for sexual functioning (coitus positions that facilitate erection, recommendations for reshaping the sexual schema, recommendations for the physical dimension of sexual health) will be given.
OTHER	Pelvic Floor Muscle Training	In PFMT, voluntary maximal and submaximal contractions for strength and endurance training of pelvic floor muscles will be taught and individuals will continue PFMT as a home exercise program. In the first 2 weeks of PFMT, individuals will perform 3 sessions of exercise per day. In each 2-week control, the number of sessions will be increased by 1 session and PFMT application will be completed with 5 sessions per day in the study.
OTHER	Aerobic Exercise Training	Aerobic exercise training will be planned 3 days a week, 1 day on the routine clinic day with a treadmill ergometer and 2 days as a home program in the form of brisk walking outside the clinic (e.g. outdoors or in a suitable environment).The intensity of aerobic exercise training will be planned according to the Maximal Heart Rate (MHR) method and Modified Borg Scale (MBS). In the first 2 weeks in the clinic, training will be started with 50 min (+10 min warm-up and cool-down) at 60% of the MHR, the exercise intensity will be increased by 5% every 2 weeks, and the program will be terminated by providing exercise training at 85% of the MHR in the 10th-12th week. Patients will be asked to adjust the intensity of aerobic exercise outside the clinic to correspond to the 12-14 (slightly difficult) degree of perceived fatigue according to the MBS.
OTHER	Resistance Exercise Training	Resisted exercise training will be planned 2 days a week, 1 day in the clinic and 1 day outside the clinic as a home program, and 12 different exercises for large muscle groups with dumbbells and weight sets, resistance bands (therabands) will be used in the training. These exercises are leg press, leg extension, leg curl, squat, seated row, lateral pull down, biceps curl, triceps extension, dumble fly, lateral raises, bench press and abdominal crunch. Exercises will be performed with free weights (dumbbells), resistance bands (therabands) or body weight.

Timeline

• Start date: 2024-03-15
• Primary completion: 2026-01-15
• Completion: 2026-01-15
• First posted: 2023-11-13
• Last updated: 2024-03-04

Locations

1 site across 1 country: Turkey (Türkiye)