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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
연락처 및 위치
연구 장소
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Valencia
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Valencia, Valencia, 스페인, 46010
- Gascó Oliag, 5
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
그룹/코호트 수
코호트 및 개입
그룹/코호트그룹/코호트 |
개입 / 치료개입 / 치료 |
|---|---|
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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.
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개입 없음
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Erectile dysfunction
기간: Baseline (single assessment)
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Erectile function assessed using the International Index of Erectile Function-5 (IIEF-5).
Higher scores indicate better erectile function.
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Baseline (single assessment)
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Urinary incontinence severity
기간: Baseline (single assessment)
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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.
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Baseline (single assessment)
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pelvic floor physiotherapy
기간: Baseline (single assessment)
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Self-reported information regarding receipt of information about pelvic floor physiotherapy and participation in pelvic floor rehabilitation before and/or after radical prostatectomy.
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Baseline (single assessment)
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Prostate cancer-specific urinary symptoms and quality of life
기간: Baseline (single assessment)
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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.
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Baseline (single assessment)
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Sexual health
기간: Baseline (single assessment)
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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.
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Baseline (single assessment)
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Self-esteem and relationship outcomes
기간: Baseline (single assessment)
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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.
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Baseline (single assessment)
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Health-related quality of life
기간: Baseline (single assessment)
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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.
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Baseline (single assessment)
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Comfort discussing urinary incontinence
기간: Baseline (single assessment)
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Participant-rated comfort discussing urinary incontinence using a 10-point Likert scale (1 = very uncomfortable to 10 = very comfortable).
Higher scores indicate greater comfort.
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Baseline (single assessment)
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Comfort discussing sexual health
기간: Baseline (single assessment)
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Participant-rated comfort discussing sexual health using a 10-point Likert scale (1 = very uncomfortable to 10 = very comfortable).
Higher scores indicate greater comfort.
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Baseline (single assessment)
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Perceived influence of social taboos
기간: Baseline (single assessment)
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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.
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Baseline (single assessment)
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Honesty of questionnaire responses
기간: Baseline (single assessment)
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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.
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Baseline (single assessment)
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- Prostatectomy_ED
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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