QSCO: Sexual Quality of Patients After Bladder Cancer Cystectomy

Sponsor
University Hospital, Toulouse (Other)
Overall Status
Recruiting
CT.gov ID
NCT04964895
Collaborator
(none)
50
1
1
15.4
3.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Questionnaires
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Prospective observational studyProspective observational study
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Sexual Quality of Patients After Bladder Cancer Cystectomy : A Prospective Observational Study
Actual Study Start Date :
Sep 20, 2021
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: patients with cystectomy

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)

Outcome Measures

Primary Outcome Measures

  1. Evaluation of the decrease in the quality of sexual life of patients who had a cystectomy [T0 : before surgery]

    EORTC SHQ C22 score before surgery

  2. 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

  1. Evaluation of the decrease in the quality of life of patients who had a cystectomy [T0 : before surgery]

    QLQ-C30 score before surgery

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Toulouse Toulouse France

Sponsors and Collaborators

  • University Hospital, Toulouse

Investigators

  • Principal Investigator: Eric Huyghe, MD, University Hospital, Toulouse

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT04964895
Other Study ID Numbers:
  • RC31/21/0113
First Posted:
Jul 16, 2021
Last Update Posted:
Oct 29, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Toulouse
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 29, 2021