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

NCT07172854 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-09-15

No results posted yet for this study

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

Interventions

OTHER

Pelvic Floor Muscle Training

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

OTHER

Aerobic Exercise

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

OTHER

Relaxation Training

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

OTHER

Patient Education

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

Sponsors & Collaborators

  • Hacettepe University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2026-07-15
Completion
2026-09-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07172854 on ClinicalTrials.gov