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

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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Erectile Dysfunction
• Erectile Dysfunction Following Radical Prostatectomy
• Incontinence

• NCT number: NCT06126874
• Study type: Interventional
• Source: Hacettepe University
• Contact: Serap Özgül, PhD
• Phone: 05339390803
• Email: serapky@yahoo.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 15, 2024
• Completion date: January 15, 2026