Back to resultsSexual Quality of Patients After Bladder Cancer Cystectomy (QSCO)
Primary Purpose
Sexual Dysfunction
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Questionnaires
Sponsored by
About this trial
This is an interventional supportive care trial for Sexual Dysfunction focused on measuring bladder cancer, cystectomy, sex life, sex quality
Eligibility Criteria
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
Sites / Locations
- University Hospital Toulouse
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
patients with cystectomy
Arm Description
Outcomes
Primary Outcome Measures
Evaluation of the decrease in the quality of sexual life of patients who had a cystectomy
EORTC SHQ C22 score 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
Secondary Outcome Measures
Evaluation of the decrease in the quality of life of patients who had a cystectomy
QLQ-C30 score before surgery
Evaluation of the decrease in the quality of life of patients who had a cystectomy
QLQ-C30 score 8 months after surgery
Full Information
NCT ID
NCT04964895
First Posted
July 6, 2021
Last Updated
September 4, 2023
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT04964895
Brief Title
Sexual Quality of Patients After Bladder Cancer Cystectomy
Acronym
QSCO
Official Title
Sexual Quality of Patients After Bladder Cancer Cystectomy : A Prospective Observational Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
September 20, 2021 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
January 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Dysfunction
Keywords
bladder cancer, cystectomy, sex life, sex quality
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective observational study
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patients with cystectomy
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Questionnaires
Intervention Description
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)
Primary Outcome Measure Information:
Title
Evaluation of the decrease in the quality of sexual life of patients who had a cystectomy
Description
EORTC SHQ C22 score before surgery
Time Frame
T0 : before surgery
Title
Evaluation of the decrease in the quality of sexual life of patients who had a cystectomy
Description
EORTC SHQ C22 score 8 months after surgery
Time Frame
T1 : 8 months after surgery
Secondary Outcome Measure Information:
Title
Evaluation of the decrease in the quality of life of patients who had a cystectomy
Description
QLQ-C30 score before surgery
Time Frame
T0 : before surgery
Title
Evaluation of the decrease in the quality of life of patients who had a cystectomy
Description
QLQ-C30 score 8 months after surgery
Time Frame
T1 : 8 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Huyghe, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Toulouse
City
Toulouse
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Sexual Quality of Patients After Bladder Cancer Cystectomy
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