Evaluation of Pelvic Floor Function and Psychosocial Sequelae Following Radical Prostatectomy for Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No Interventions.
- Who it may be relevant to
- Registry conditions: Prostate Cancer (Adenocarcinoma), Radical Prostatectomy, Urinary Incontinence (UI), Erectile Dysfunction Following Radical Prostatectomy. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Urinary Incontinence, Erectile Dysfunction, and Psychosocial Outcomes Following Radical Prostatectomy for Prostate Cancer
Overview
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.
Detailed description
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.
Interventions
- Other No Interventions
No intervention
Primary outcome measures
- Erectile dysfunction [Time frame: Baseline (single assessment)]
- Urinary incontinence severity [Time frame: Baseline (single assessment)]
Secondary outcome measures (9)
- Prostate cancer-specific urinary symptoms and quality of life [Time frame: Baseline (single assessment)]
- Sexual health [Time frame: Baseline (single assessment)]
- Self-esteem and relationship outcomes [Time frame: Baseline (single assessment)]
- Health-related quality of life [Time frame: Baseline (single assessment)]
- Pelvic floor physiotherapy [Time frame: Baseline (single assessment)]
- Comfort discussing urinary incontinence [Time frame: Baseline (single assessment)]
- Comfort discussing sexual health [Time frame: Baseline (single assessment)]
- Perceived influence of social taboos [Time frame: Baseline (single assessment)]
- Honesty of questionnaire responses [Time frame: Baseline (single assessment)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Spain · 1 center
- Gascó Oliag, 5 — Valencia
Identifiers
NCT: NCT07693647 · Prostatectomy_ED