Pelvic Floor Muscle Training With Aerobic Exercise and Relaxation After Radical Prostatectomy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age40-65
SponsorHacettepe University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Pelvic Floor Muscle Training
Other interventionSupervised PFMT with biofeedback, 3 times per week for 12 weeks, plus home exercises.
Aerobic Exercise
Other interventionTreadmill walking, moderate intensity (Borg 4-6), 60 minutes/session, 3 times per week for 12 weeks.
Relaxation Training
Other interventionGuided breathing, imagery, and meditation, once weekly for 12 weeks, in addition to home practice.
Patient Education
Other interventionStandardized education on urinary incontinence, pelvic anatomy, lifestyle modification, and stress management.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: Intervention GroupExperimental treatment 4 interventions
Group B: Control GroupActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and at 12 weeks post-intervention2
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.
Time frame
Baseline and 12 weeks post-intervention3
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.
Time frame
Baseline and 12 weeks post-interventionSecondary outcomes
1
Change in Montreal Cognitive Assessment (MoCA) Score
Cognitive performance will be assessed using the Montreal Cognitive Assessment (MoCA). Scores range from 0 to 30, with higher scores reflecting better cognitive function.
Time frame
Baseline and 12 weeks2
Change in 1-Hour Pad Test Result
Objective severity of urinary incontinence will be measured using the 1-hour pad test. The pad is weighed before and after the test; higher weight gain indicates more leakage.
Time frame
Baseline and 12 weeks3
Change in ICIQ-Short Form (ICIQ-SF) Score
The subjective impact of urinary incontinence on daily life will be assessed using the ICIQ-Short Form (ICIQ-SF). Scores range from 0 to 21, with higher scores indicating greater impact and worse continence-related quality of life.
Time frame
Baseline and 12 weeks4
Change in Hospital Anxiety and Depression Scale (HADS) Scores
Psychological status will be assessed using the Hospital Anxiety and Depression Scale (HADS), which includes anxiety (HADS-A) and depression (HADS-D) subscales. Each subscale ranges from 0 to 21. Higher scores indicate greater emotional distress (worse outcomes).
Time frame
Baseline and 12 weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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