Sexual Quality of Patients After Bladder Cancer Cystectomy

Study Overview
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Brief Summary
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Bladder cancer is the second most prevalent urological cancer in France. About 1 in 5 new cases of bladder cancer infiltrate the muscles. The standard treatment is neoadjuvant chemotherapy followed by radical cystectomy associated with reconstruction of the urinary tract. The short-term effects on well-being and quality of life are well known. The long-term effects are, on the other hand, poorly understood, particularly sexual function. This study aim to asses the quality of sexual life in patients with cystectomy for bladder cancer. This will be done via various questionnaires given before and after surgery.

Detailed Description
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The study is a prospective observational cohort study of the quality of sexual life in patients with cystectomy for bladder cancer. Data is collected via Qlq-C30, EORTC-Shq22, MSHQ if male, Female Sexual Function Index (FSFI) questionnaires that the patients complete by themselves. They are given before surgery and then 8 months after surgery. The study consists of the compilation of relevant clinical data and questionnaire results.

Official Title
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Sexual Quality of Patients After Bladder Cancer Cystectomy : A Prospective Observational Study

Conditions
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Sexual Dysfunction

Intervention / Treatment
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* Other: Questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any adult patient who had a cystectomy for bladder cancer Affiliated with a social security scheme Exclusion Criteria: No Cystectomy Cystectomy for neurological etiology Pregnant or breastfeeding women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective observational study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: patients with cystectomy<br> | Other: Questionnaires<br>* Patients will fill in multiple questionnaires for this study : EORTC quality of life questionnaire (QLQ) QLQ-C30, EORTC Shq22, Male Sexual Health Questionnaire (MSHQ) only for Men, FSFI (only for women)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the decrease in the quality of sexual life of patients who had a cystectomy | EORTC SHQ C22 score before surgery | T0 : before surgery | 
| Evaluation of the decrease in the quality of sexual life of patients who had a cystectomy | EORTC SHQ C22 score 8 months after surgery | T1 : 8 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the decrease in the quality of life of patients who had a cystectomy | QLQ-C30 score before surgery | T0 : before surgery | 
| Evaluation of the decrease in the quality of life of patients who had a cystectomy | QLQ-C30 score 8 months after surgery | T1 : 8 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bladder cancer, cystectomy, sex life, sex quality