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

Hacettepe University

Status: Not yet enrolling

Conditions: Erectile Dysfunction Following Radical Prostatectomy; Incontinence

Treatments: Other: Resistance Exercise Training; Other: Aerobic Exercise Training; Other: Patient Education; Other: Pelvic Floor Muscle Training

Study type: Interventional

Funder types: Other

Identifiers

NCT06126874

KA-23054

Details and patient eligibility

About

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.

Full 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).

Enrollment: 38 estimated patients

Sex: Male

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

Patient education, Pelvic floor muscle training, Aerobic and Resistance exercise trainings

Experimental group

Description:

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.

Treatment:

Other: Resistance Exercise Training

Other: Patient Education

Other: Pelvic Floor Muscle Training

Other: Aerobic Exercise Training

Patient education and Pelvic floor muscle training

Active Comparator group

Description:

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.

Treatment:

Other: Patient Education

Other: Pelvic Floor Muscle Training