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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究場所
-
-
Valencia
-
Valencia、Valencia、スペイン、46010
- Gascó Oliag, 5
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
|
介入なし
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Erectile dysfunction
時間枠：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
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pelvic floor physiotherapy
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- Prostatectomy_ED
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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