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

9 juli 2026 uppdaterad av: Noemi Moreno-Segura, University of Valencia

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.

Studieöversikt

Status

Anmälan via inbjudan

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

67

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Spanien
    • Valencia
      • Valencia, Valencia, Spanien, 46010
        • Gascó Oliag, 5

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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.
Övrig: Inga ingripanden
Inget ingripande

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Erectile dysfunction
Tidsram: Baseline (single assessment)
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
Tidsram: Baseline (single assessment)
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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Pelvic floor physiotherapy
Tidsram: Baseline (single assessment)
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
Tidsram: Baseline (single assessment)
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
Tidsram: Baseline (single assessment)
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
Tidsram: Baseline (single assessment)
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
Tidsram: Baseline (single assessment)
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
Tidsram: Baseline (single assessment)
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
Tidsram: Baseline (single assessment)
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
Tidsram: Baseline (single assessment)
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
Tidsram: Baseline (single assessment)
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)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Valencia

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 januari 2025

Primärt slutförande (Beräknad)

31 december 2027

Avslutad studie (Beräknad)

31 december 2027

Studieregistreringsdatum

Först inskickad

2 juli 2026

Först inskickad som uppfyllde QC-kriterierna

2 juli 2026

Första postat (Faktisk)

9 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

13 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

9 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • Prostatectomy_ED

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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