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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Prostate Cancer (Adenocarcinoma); Radical Prostatectomy; Erectile Dysfunction Following Radical Prostatectomy; Urinary Incontinence (UI)
• Intervention / Treatment: Other: No Interventions

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.

• Study Type: Observational
• Enrollment (Estimated): 67

Contacts and Locations

Study Locations

• Spain
  • Valencia
    • Valencia, Valencia, Spain, 46010
      • Gascó Oliag, 5

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adult men who underwent radical prostatectomy for prostate cancer at least 12 months before enrollment. Participants will be recruited from the community through social media, institutional advertisements, patient networks, and snowball sampling. Eligible individuals will voluntarily contact the research team and, after providing electronic informed consent, will complete the study questionnaires online or, when necessary, through a structured telephone interview.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: No Interventions; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Erectile dysfunction	Erectile function assessed using the International Index of Erectile Function-5 (IIEF-5). Higher scores indicate better erectile function.	Baseline (single assessment)
Urinary incontinence severity	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.	Baseline (single assessment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pelvic floor physiotherapy	Self-reported information regarding receipt of information about pelvic floor physiotherapy and participation in pelvic floor rehabilitation before and/or after radical prostatectomy.	Baseline (single assessment)
Prostate cancer-specific urinary symptoms and quality of life	Urinary symptoms and prostate cancer-specific quality of life assessed using the EORTC QLQ-PR25 questionnaire. European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Prostate Cancer Module (EORTC QLQ-PR25). Scores for each scale are transformed to a 0-100 scale. Higher scores indicate greater symptom burden for symptom scales and better functioning for functional scales.	Baseline (single assessment)
Sexual health	Sexual health assessed using the EORTC Sexual Health Questionnaire (EORTC SH22). Scores are transformed to a 0-100 scale. Higher scores indicate better sexual functioning for functional scales and worse symptoms or problems for symptom scales.	Baseline (single assessment)
Self-esteem and relationship outcomes	Self-esteem and relationship functioning assessed using the Self-Esteem and Relationship Questionnaire (SEAR).Total score ranges from 0 to 100, with higher scores indicating better self-esteem and relationship functioning.	Baseline (single assessment)
Health-related quality of life	Health-related quality of life assessed using the Short Form-36 Health Survey (SF-36). Scores for each domain range from 0 to 100, with higher scores indicating better health-related quality of life.	Baseline (single assessment)
Comfort discussing urinary incontinence	Participant-rated comfort discussing urinary incontinence using a 10-point Likert scale (1 = very uncomfortable to 10 = very comfortable). Higher scores indicate greater comfort.	Baseline (single assessment)
Comfort discussing sexual health	Participant-rated comfort discussing sexual health using a 10-point Likert scale (1 = very uncomfortable to 10 = very comfortable). Higher scores indicate greater comfort.	Baseline (single assessment)
Perceived influence of social taboos	Perceived influence of social taboos on discussing urinary incontinence and sexual health assessed using a 10-point Likert scale (1 = no influence to 10 = very strong influence). Higher scores indicate greater perceived influence of social taboos.	Baseline (single assessment)
Honesty of questionnaire responses	Self-reported honesty when answering questionnaires assessed using a 10-point Likert scale (1 = not honest at all to 10 = completely honest). Higher scores indicate greater perceived honesty.	Baseline (single assessment)

Collaborators and Investigators

• Sponsor: University of Valencia

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: July 2, 2026
• First Submitted That Met QC Criteria: July 2, 2026
• First Posted (Actual): July 9, 2026

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Rehabilitation; Pelvic floor muscle training; Quality of life; Urinary incontinence; Prostate cancer; Radical prostatectomy; Erectile dysfunction; Pelvic floor; Sexual health; Psychosocial outcomes; Pelvic floor physiotherapy
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Mental Disorders; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Prostatic Neoplasms; Urinary Incontinence; Adenocarcinoma; Erectile Dysfunction
• Other Study ID Numbers: Prostatectomy_ED

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No