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NCT04964895 Clinical Trial

Sexual Quality of Patients After Bladder Cancer Cystectomy

Sexual Dysfunction Clinical Trial

— QSCO  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04964895
Other study ID # RC31/21/0113
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 20, 2021
Est. completion date January 1, 2023

Study information
Verified date September 2023
Source University Hospital, Toulouse
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date January 1, 2023
Est. primary completion date September 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Questionnaires
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)

Locations
Country Name City State
France University Hospital Toulouse Toulouse

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Evaluation of the decrease in the quality of life of patients who had a cystectomy QLQ-C30 score before surgery T0 : before surgery
Secondary 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
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