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OpenTrials
Completed

NCT Number: NCT04964895

Sexual Quality of Patients After Bladder Cancer Cystectomy

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.

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Key information

Conditions

Sexual Dysfunction Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Male Urogenital Diseases Neoplasms Neoplasms by Site Sexual Dysfunction, Physiological Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Toulouse

Toulouse, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

questionnaires

Other

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 outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: QSCO

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jul 16, 2021
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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