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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Incontinence, Erectile Dysfunction Following Radical Prostatectomy

Intervention / Treatment
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* Other: Patient Education
* Other: Pelvic Floor Muscle Training
* Other: Aerobic Exercise Training
* Other: Resistance Exercise Training


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient education, Pelvic floor muscle training, Aerobic and Resistance exercise trainings<br>Patient Education: Individuals in both study groups will be provided with patient education through verbal and visual presentations. Pelvic Floor Muscle Training (PFMT): 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. 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). 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. | Other: Patient Education<br>* 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.<br>Other: Pelvic Floor Muscle Training<br>* 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.<br>Other: Aerobic Exercise Training<br>* 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.<br>Other: Resistance Exercise Training<br>* 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.<br>|
| Active Comparator: Patient education and Pelvic floor muscle training<br>Patient Education: Individuals in both study groups will be provided with patient education through verbal and visual presentations. Pelvic Floor Muscle Training (PFMT): 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. | Other: Patient Education<br>* 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.<br>Other: Pelvic Floor Muscle Training<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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men's health, radical prostatectomy, urinary incontinence, erectile dysfunction, pelvic floor muscle training, aerobic exercise, resistance exercise, Kegel exercise