Clinical Trial

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

Study acronym: PFMTinPPUI
Not Yet Recruiting
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Record status
This record was last updated September 15, 2025 (before its estimated July 15, 2026 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT07172854
Lead Sponsor Hacettepe University
Conditions Post Prostatectomy Incontinence, Erectile Dysfunction Following Radical Prostatectomy
Enrollment 48 participants
Start Date 2025-09-15
Primary Completion 2026-07-15 (estimated)
Study Completion 2026-09-15 (estimated)
Updated on ClinicalTrials.gov 2025-09-15