Clinical trial · Observational
Evaluation of Pelvic Floor Function and Psychosocial Sequelae Following Radical Prostatectomy for Prostate Cancer
Evaluation of Urinary Incontinence, Erectile Dysfunction, and Psychosocial Outcomes Following Radical Prostatectomy for Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Erectile Dysfunction Following Radical Prostatectomy | — | UNRESOLVED | — |
| Prostate Cancer (Adenocarcinoma) | Malignant Prostate Neoplasm | CURATED_EXACT | 0.85 |
| Radical Prostatectomy | — | UNRESOLVED | — |
| Urinary Incontinence (UI) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No Interventions | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Men aged who underwent radical prostatectomy for prostate cancer
- description
- Men aged ≥18 years who underwent radical prostatectomy for prostate cancer at least one year before enrollment.
- interventionNames
- Other: No Interventions
Primary outcomes (2)
- measure
- Erectile dysfunction
- timeFrame
- Baseline (single assessment)
- description
- Erectile function assessed using the International Index of Erectile Function-5 (IIEF-5). Higher scores indicate better erectile function.
- measure
- Urinary incontinence severity
- timeFrame
- Baseline (single assessment)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 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. Exclusion Criteria: 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.
References
Publications (0)
Data not yet available