Evaluation of Pelvic Floor Function and Psychosocial Sequelae Following Radical Prostatectomy for Prostate Cancer

NCT07693647 | Enrolling By Invitation

• 1 other identifier: Prostatectomy_ED
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Urinary Incontinence (UI); Prostate Cancer (Adenocarcinoma); Radical Prostatectomy; Erectile Dysfunction Following Radical Prostatectomy

Keywords

Prostate cancer; Radical prostatectomy; Urinary incontinence; Erectile dysfunction; Pelvic floor; Pelvic floor muscle training; Pelvic floor physiotherapy; Rehabilitation; Sexual health; Quality of life; Psychosocial outcomes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• 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)

• Pelvic floor physiotherapy

  Baseline (single assessment)

Study Arms (1)

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

Interventions

No Interventions OTHER

No intervention

Men aged who underwent radical prostatectomy for prostate cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Gascó Oliag, 5

Valencia, Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Adenocarcinoma; Urinary Incontinence; Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 9, 2026
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)