Sexual Quality of Patients After Bladder Cancer Cystectomy (QSCO)

December 9, 2025 updated by: University Hospital, Toulouse

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France
        • University Hospital Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Any patient who underwent cystectomy for bladder cancer during the study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)

What is the study measuring?

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2021

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

January 1, 2023

Study Registration Dates

First Submitted

July 6, 2021

First Submitted That Met QC Criteria

July 6, 2021

First Posted (Actual)

July 16, 2021

Study Record Updates

Last Update Posted (Estimated)

December 17, 2025

Last Update Submitted That Met QC Criteria

December 9, 2025

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/21/0113

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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