Sexual Quality of Patients After Bladder Cancer Cystectomy

Not Applicable

Completed

• Conditions: Sexual Dysfunction
• Interventions: Other: Questionnaires

• Registration Number: NCT04964895
• Lead Sponsor: University Hospital, Toulouse

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-07-06
• Study First Submitted QC: 2021-07-06
• Study First Posted: 2021-07-16
• Study Start: 2021-09-20
• Primary Completion: 2022-09-01
• Study Completion: 2023-01-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-04
• Last Update Posted: 2023-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients with cystectomy	Questionnaires	-

Primary Outcome Measures

Name	Time	Method
Evaluation of the decrease in the quality of sexual life of patients who had a cystectomy	T1 : 8 months after surgery	EORTC SHQ C22 score 8 months after surgery

Secondary Outcome Measures

Name	Time	Method
Evaluation of the decrease in the quality of life of patients who had a cystectomy	T1 : 8 months after surgery	QLQ-C30 score 8 months after surgery

Trial Locations

Locations (1)

University Hospital Toulouse; 🇫🇷 Toulouse, France