Sexual DysfunctionQSCONCT04964895
Sexual Quality of Patients After Bladder Cancer Cystectomy
An observational study of Sexual Dysfunction, run by University Hospital, Toulouse at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Sexual Dysfunction
- What is being tested?
- Questionnaires
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 20 Sep 2021to 1 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patient who underwent cystectomy for bladder cancer during the study.
Who may be able to join
- Any adult patient who had a cystectomy for bladder cancer
- Affiliated with a social security scheme
Who cannot join
- No Cystectomy
- Cystectomy for neurological etiology
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Sexual Dysfunction
- Being tested
- Questionnaires
- Keywords
- bladder cancer, cystectomy, sex life, sex quality
- Medical subject headings
- Sexual Dysfunction, Physiological, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
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)
| Study group | Role | What they receive |
|---|---|---|
| patients with cystectomy | Not described Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the decrease in the quality of sexual life of patients who had a cystectomy
EORTC SHQ C22 score before surgery
Measured: T0 : 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
Measured: T1 : 8 months after surgery
Secondary outcomes (2)
Evaluation of the decrease in the quality of life of patients who had a cystectomy
QLQ-C30 score before surgery
Measured: T0 : before surgery
Evaluation of the decrease in the quality of life of patients who had a cystectomy
QLQ-C30 score 8 months after surgery
Measured: T1 : 8 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start20 Sep 2021
- Primary completion1 Sep 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual DysfunctionStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Huyghe, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04964895
- Sponsor's protocol ID
- RC31/21/0113
- Acronym
- QSCO
- Status last verified
- Sep 2023
- First submitted
- 6 Jul 2021
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexual Quality of Patients After Bladder Cancer Cystectomy : A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04964895
- Acronym / sponsor ID
- QSCO / RC31/21/0113
- Conditions
- Sexual Dysfunction
- Keywords
- bladder cancer, cystectomy, sex life, sex quality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 16 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with cystectomy | – | Other: Questionnaires |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient who underwent cystectomy for bladder cancer during the study.
Key inclusion criteria (2 listed)
- Any adult patient who had a cystectomy for bladder cancer
- Affiliated with a social security scheme
Key exclusion criteria (3 listed)
- No Cystectomy
- Cystectomy for neurological etiology
- Pregnant or breastfeeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesPatients 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) | Other | patients with cystectomy |
Primary outcome
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
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
2 secondary outcomes
Evaluation of the decrease in the quality of life of patients who had a cystectomy
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Huyghe, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sexual Dysfunction, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the decrease in the quality of sexual life of patients who had a cystectomy (time frame: T0 : before surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.