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临床试验/NCT07172854
NCT07172854已完成不适用

Radikal Prostatektomi Sonrasında Aerobik Egzersiz ve Gevşeme Eğitimlerinin Pelvik Taban Kas Eğitimine İlave Etkileri

Hacettepe University1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2025年4月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
1
主要终点
Change in Erectile Function (IIEF-15)

研究概览

简要总结

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.

详细描述

Post-prostatectomy urinary incontinence (PP-UI) and erectile dysfunction (ED) are among the most common and distressing complications following radical prostatectomy (RP), significantly affecting the quality of life and psychosocial well-being of prostate cancer survivors. Although pelvic floor muscle training (PFMT) is widely recommended as the first-line conservative approach to manage these complications, recent evidence highlights the importance of multimodal, structured rehabilitation programs supervised by physiotherapists to optimize continence recovery and sexual function.

This randomized controlled trial aims to investigate the additional effects of aerobic exercise and relaxation training when combined with PFMT in men with urinary incontinence and erectile dysfunction following nerve-sparing robotic-assisted radical prostatectomy. The study is designed as a two-arm parallel-group, single-center trial involving 48 male participants aged between 40 and 65 years. Eligible participants must be within one year post-surgery, demonstrate voluntary pelvic floor muscle contraction, and exhibit sufficient cognitive function as assessed by the Montreal Cognitive Assessment (MoCA).

Participants will be randomly allocated (1:1) into either the intervention group or the control group using a computer-generated block randomization procedure. All participants will receive standardized patient education and a 12-week PFMT protocol guided by biofeedback. The PFMT sessions will be conducted individually by a physiotherapist three times per week and include a home-based exercise program monitored through an exercise diary.

In the intervention group, aerobic exercise and relaxation training will be added to PFMT. Aerobic exercise will consist of treadmill walking at moderate intensity (Modified Borg RPE scale 4-6) for 60 minutes (10 min warm-up, 40 min loading, 10 min cool-down), three times per week for 12 weeks. Relaxation training will be conducted once weekly and will include guided breathing, imagery, and meditation techniques in a quiet, dimly lit environment. Patients will be encouraged to practice these relaxation techniques at home using a standardized script.

Assessments will be performed at baseline and at the end of the 12-week intervention. Primary outcome measures include changes in urinary symptoms (ICIQ-MLUTS), erectile function (IIEF-15), and prostate cancer-specific quality of life (EPIC). Secondary outcomes include objective incontinence severity (1-hour pad test), subjective continence impact (ICIQ-SF), functional exercise capacity (6-minute walk test), psychological status (HADS), and exercise adherence (self-reported exercise diary).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •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)

排除标准

  • •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

研究组 & 干预措施

Intervention Group

Experimental

Intervention group

干预措施: Pelvic Floor Muscle Training (Other)

Intervention Group

Experimental

Intervention group

干预措施: Aerobic Exercise (Other)

Intervention Group

Experimental

Intervention group

干预措施: Relaxation Training (Other)

Intervention Group

Experimental

Intervention group

干预措施: Patient Education (Other)

Control Group

Active Comparator

Control Group

干预措施: Pelvic Floor Muscle Training (Other)

Control Group

Active Comparator

Control Group

干预措施: Patient Education (Other)

结局指标

主要结局

Change in Erectile Function (IIEF-15)

时间窗: Baseline and 12 weeks post-intervention

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.

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

时间窗: Baseline and 12 weeks post-intervention

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.

Change in urinary symptoms

时间窗: Baseline and at 12 weeks post-intervention

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.

次要结局

  • Change in 1-Hour Pad Test Result(Baseline and 12 weeks)
  • Change in ICIQ-Short Form (ICIQ-SF) Score(Baseline and 12 weeks)
  • Change in Hospital Anxiety and Depression Scale (HADS) Scores(Baseline and 12 weeks)
  • Change in 6-Minute Walk Test Distance(Baseline and 12 weeks)
  • Exercise Adherence(Throughout 12-week intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ege Nur ATABEY

research asisstant

Hacettepe University

研究点 (1)

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