Evaluation of Urinary Incontinence, Erectile Dysfunction, and Psychosocial Outcomes Following Radical Prostatectomy for Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Erectile dysfunction
研究概览
简要总结
This observational cross-sectional study aims to evaluate the effects of radical prostatectomy for prostate cancer on pelvic floor function and psychosocial well-being. The study will assess the prevalence and severity of urinary incontinence and erectile dysfunction, as well as their impact on quality of life, sexual health, self-esteem, and interpersonal relationships.
Adult men who underwent radical prostatectomy at least one year before enrollment will complete a series of validated questionnaires and provide demographic and clinical information through online surveys or telephone interviews. The study will also explore whether participants received pelvic floor physiotherapy before or after surgery and whether rehabilitation is associated with better functional and psychosocial outcomes. The findings may contribute to a better understanding of the long-term consequences of radical prostatectomy and help identify opportunities to improve patient care.
详细描述
Radical prostatectomy is one of the most common curative treatments for localized prostate cancer. Although surgical techniques have improved over recent decades, urinary incontinence and erectile dysfunction remain among the most frequent long-term complications after surgery. These conditions may substantially affect patients' quality of life, sexual health, self-esteem, interpersonal relationships, and psychosocial well-being. Despite the availability of conservative pelvic floor rehabilitation strategies, access to and use of pelvic floor physiotherapy before and after surgery remain variable.
This observational cross-sectional study aims to evaluate the long-term effects of radical prostatectomy on pelvic floor function and psychosocial outcomes in men who underwent surgery at least one year before study participation. Data will be collected through validated patient-reported outcome measures and a structured questionnaire including sociodemographic, clinical, and treatment-related information.
Participants will be recruited through social media, institutional dissemination, patient networks, and snowball sampling. After providing electronic informed consent, participants will complete the study questionnaires either online or, when digital literacy is limited, through a structured telephone interview conducted by a trained researcher. No interviews will be audio-recorded, and all data will be pseudonymized before analysis.
The primary objectives are to evaluate urinary incontinence and erectile dysfunction after radical prostatectomy and to describe their psychosocial consequences. Secondary objectives include determining the proportion of patients who received information about pelvic floor physiotherapy, identifying the proportion who underwent pelvic floor rehabilitation before and/or after surgery, and exploring whether rehabilitation is associated with differences in functional and psychosocial outcomes. The study also aims to improve awareness of pelvic floor rehabilitation as part of the multidisciplinary management of prostate cancer survivors.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male participants aged 18 years or older. History of radical prostatectomy for prostate cancer, regardless of the surgical technique used.
- •At least 12 months since radical prostatectomy. Able to understand the study information and provide electronic informed consent.
- •Able to complete the questionnaires in Spanish, either independently or with the support of a structured telephone interview.
- •Willing to participate voluntarily in the study.
排除标准
- •Presence of comorbidities that may independently contribute to urinary incontinence or erectile dysfunction (e.g., neurological disorders or other relevant medical conditions).
- •Severe cognitive or sensory impairment that prevents understanding the study procedures or completing the questionnaires.
- •Refusal or inability to provide informed consent.
研究组 & 干预措施
Men aged who underwent radical prostatectomy for prostate cancer
Men aged ≥18 years who underwent radical prostatectomy for prostate cancer at least one year before enrollment.
干预措施: No Interventions (Other)
结局指标
主要结局
Erectile dysfunction
时间窗: Baseline (single assessment)
Erectile function assessed using the International Index of Erectile Function-5 (IIEF-5). Higher scores indicate better erectile function.
Urinary incontinence severity
时间窗: Baseline (single assessment)
Urinary incontinence severity assessed using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-UI SF). Higher scores indicate greater symptom severity and impact on quality of life.
次要结局
- Pelvic floor physiotherapy(Baseline (single assessment))
- Sociodemographic and clinical characteristics(Baseline (single assessment))
- Prostate cancer-specific urinary symptoms and quality of life(Baseline (single assessment))
- Sexual health(Baseline (single assessment))
- Self-esteem and relationship outcomes(Baseline (single assessment))
- Health-related quality of life(Baseline (single assessment))
- Perceived influence of social taboos(Baseline (single assessment))
- Comfort discussing urinary incontinence(Baseline (single assessment))
- Comfort discussing sexual health(Baseline (single assessment))
- Honesty of questionnaire responses(Baseline (single assessment))
研究者
Noemi Moreno-Segura
Principal Investigator
University of Valencia