Pelvic Floor Muscle Training With Aerobic Exercise and Relaxation After Radical Prostatectomy

NCT07172854 | Not Yet Recruiting

• 2 other identifiers: KA-24085TUBITAK
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

Post-prostatectomy urinary incontinence (PP-UI) and erectile dysfunction (ED) are common complications after radical prostatectomy, negatively affecting quality of life. Pelvic floor muscle training (PFMT) is widely recommended as the first-line conservative treatment, but recent evidence suggests that multimodal, structured rehabilitation may further improve recovery. This randomized controlled trial will investigate the additional effects of aerobic exercise and relaxation training combined with PFMT in men following nerve-sparing robotic-assisted radical prostatectomy. Forty-eight participants aged 40-65 years, within one year post-surgery, who demonstrate voluntary pelvic floor muscle contraction and sufficient cognitive function (MoCA), will be randomly assigned (1:1) to intervention or control groups. All participants will receive standardized education and a 12-week supervised PFMT program with biofeedback and home-based exercises. The intervention group will additionally perform treadmill-based aerobic exercise three times per week and structured relaxation training once per week. Primary outcomes include urinary symptoms (ICIQ-MLUTS), erectile function (IIEF-15), and prostate cancer-specific quality of life (EPIC). Secondary outcomes include pad test, ICIQ-SF, 6-minute walk test, MoCA, HADS, and adherence. This non-commercial study aims to provide high-quality evidence supporting physiotherapy-based multimodal rehabilitation for improved pelvic health and quality of life in men after prostate cancer surgery.

Conditions

Post Prostatectomy Incontinence; Erectile Dysfunction Following Radical Prostatectomy

Outcome Measures

Primary Outcomes (3)

• Change in urinary symptoms

  Assessment of changes in three primary domains: Lower urinary tract symptoms will be assessed using the International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptoms Module (ICIQ-MLUTS). Scores range from 0 to 48, with higher scores indicating more severe urinary symptoms. All outcomes will be measured at baseline and at the end of the 12-week intervention period.

  Baseline and at 12 weeks post-intervention

• Change in Erectile Function (IIEF-15)

  Erectile function and sexual health will be assessed using the International Index of Erectile Function (IIEF-15). Scores range from 5 to 75, with higher scores indicating better erectile function.

  Baseline and 12 weeks post-intervention

• Change in Prostate Cancer-Specific Quality of Life (EPIC)

  Prostate cancer-related quality of life will be measured using the Expanded Prostate Cancer Index Composite (EPIC). Scores range from 0 to 100, with higher scores indicating better quality of life.

  Baseline and 12 weeks post-intervention

Secondary Outcomes (6)

• Change in Montreal Cognitive Assessment (MoCA) Score

  Baseline and 12 weeks

• Change in 1-Hour Pad Test Result

  Baseline and 12 weeks

• Change in ICIQ-Short Form (ICIQ-SF) Score

  Baseline and 12 weeks

• Change in Hospital Anxiety and Depression Scale (HADS) Scores

  Baseline and 12 weeks

• Change in 6-Minute Walk Test Distance

  Baseline and 12 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

Intervention group

Other: Pelvic Floor Muscle Training; Other: Aerobic Exercise; Other: Relaxation Training; Other: Patient Education

Control Group

ACTIVE COMPARATOR

Control Group

Other: Pelvic Floor Muscle Training; Other: Patient Education

Interventions

Pelvic Floor Muscle Training OTHER

Supervised PFMT with biofeedback, 3 times per week for 12 weeks, plus home exercises.

Control Group; Intervention Group

Aerobic Exercise OTHER

Treadmill walking, moderate intensity (Borg 4-6), 60 minutes/session, 3 times per week for 12 weeks.

Intervention Group

Relaxation Training OTHER

Guided breathing, imagery, and meditation, once weekly for 12 weeks, in addition to home practice.

Intervention Group

Patient Education OTHER

Standardized education on urinary incontinence, pelvic anatomy, lifestyle modification, and stress management.

Control Group; Intervention Group

Eligibility Criteria

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

You may qualify if:

• Male participants aged 40 to 65 years
• Underwent nerve-sparing robotic radical prostatectomy within the past 12 months
• Ability to voluntarily contract pelvic floor muscles
• Cognitive capacity sufficient for cooperation with study assessments and interventions, as determined by the Montreal Cognitive Assessment (MoCA)

You may not qualify if:

• Presence of acute illness (e.g., urinary tract infection, respiratory infection, interstitial cystitis, bladder or gastrointestinal bleeding)
• Within the first 3 weeks after prostatectomy surgery (acute postoperative period)
• Neurological disorders or diagnosis of neurogenic bladder
• Diagnosed cognitive or psychiatric disorders
• Preoperative urinary incontinence or erectile dysfunction
• History of prior bladder or prostate surgery before prostatectomy
• Participation in pelvic floor muscle training within the last 6 months
• Refusal to participate or absence of signed informed consent form

Sponsors & Collaborators

• Hacettepe University: lead

MeSH Terms

Interventions

Exercise; Relaxation Therapy; Patient Education as Topic

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Ege Nur ATABEY GERLEGİZ

CONTACT

+903123052525; egenuratabey@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research asisstant

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: September 15, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-05