Not Yet RecruitingNot Applicable

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

48 participantsStarted 2025-09-15

Plain-language 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.

Who can participate

Age range

40 Years – 65 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in urinary symptoms

Timeframe: Baseline and at 12 weeks post-intervention

Change in Erectile Function (IIEF-15)

Timeframe: Baseline and 12 weeks post-intervention

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

Timeframe: Baseline and 12 weeks post-intervention

Trial details

NCT IDNCT07172854

SponsorHacettepe University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-15

Contact for this trial

Ege Nur ATABEY GERLEGİZ

+903123052525 egenuratabey@gmail.com

View on ClinicalTrials.gov More Post Prostatectomy Incontinence trials