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Completed NCT07172854

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

Conditions: Post Prostatectomy Incontinence, Erectile Dysfunction Following Radical Prostatectomy

Sex: Male
Ages: 40 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 48
Sponsor: Hacettepe University

Location: Hacettepe University Altindağ Ankara

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.

Eligibility Criteria

Inclusion Criteria: * 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) Exclusion Criteria: * 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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07172854). StuddyBuddy aggregates publicly available trial information.