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

9 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Iscrizione su invito

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

67

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Spagna
    • Valencia
      • Valencia, Valencia, Spagna, 46010
        • Gascó Oliag, 5

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.
Altro: Nessun intervento
Nessun intervento

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Erectile dysfunction
Lasso di tempo: 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
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pelvic floor physiotherapy
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Valencia

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 gennaio 2025

Completamento primario (Stimato)

31 dicembre 2027

Completamento dello studio (Stimato)

31 dicembre 2027

Date di iscrizione allo studio

Primo inviato

2 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

2 luglio 2026

Primo Inserito (Effettivo)

9 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • Prostatectomy_ED

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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