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

NCT06126874 | Not Yet Recruiting

• 1 other identifier: KA-23054
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Incontinence; Erectile Dysfunction Following Radical Prostatectomy

Keywords

men's health; radical prostatectomy; urinary incontinence; erectile dysfunction; pelvic floor muscle training; aerobic exercise; resistance exercise; Kegel exercise

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 1-hour Pad Test Score

  Change in severity of incontinence from baseline to the end of the 12th week.

• Penile Length

  Change in penile length from baseline to the end of the 12th week.

• Peripheral Muscle Strength

  Change in strength of peripheral muscles from baseline to the end of the 12th week.

• Functional Exercise Capacity

  Change in distance from baseline to the end of the 12th week.

• International Consultation On Incontinence- Male Lower Urinary Tract Symptoms (ICIQ-MLUTS) Score

  Change in lower urinary system symptoms scores from baseline to the end of the 12th week.

Study Arms (2)

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

EXPERIMENTAL

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; Other: Pelvic Floor Muscle Training; Other: Aerobic Exercise Training; Other: Resistance Exercise Training

Patient education and Pelvic floor muscle training

ACTIVE COMPARATOR

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; Other: Pelvic Floor Muscle Training

Interventions

Patient Education OTHER

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.

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

Pelvic Floor Muscle Training OTHER

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.

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

Aerobic Exercise Training OTHER

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.

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

Resistance Exercise Training OTHER

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.

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

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Mustafa Enis Dilekmen

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (14)

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MeSH Terms

Conditions

Urinary Incontinence; Erectile Dysfunction

Interventions

Patient Education as Topic; Resistance Training

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases, Male; Genital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Serap ÖZGÜL, Prof

  Hacettepe University, Department of Physiotherapy and Rehabilitation

  PRINCIPAL INVESTIGATOR

• Naşide MANGIR, Assoc Prof

  Hacettepe University, Department of Urology

  STUDY DIRECTOR

Central Study Contacts

Serap Özgül, PhD

CONTACT

05339390803; serapky@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 13, 2023
• Study Start: March 15, 2024
• Primary Completion: January 15, 2026
• Study Completion: January 15, 2026
• Last Updated: March 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)