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Enrolling By Invitation
NCT07693647
Evaluation of Pelvic Floor Function and Psychosocial Sequelae Following Radical Prostatectomy for Prostate Cancer
Conditions: Prostate Cancer (Adenocarcinoma), Radical Prostatectomy, Urinary Incontinence (UI), Erectile Dysfunction Following Radical Prostatectomy
Sex: Male
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 67
Sponsor: University of Valencia
Location: Gascó Oliag, 5 Valencia Valencia
Summary
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07693647). StuddyBuddy aggregates publicly available trial information.