Sexual Quality of Patients After Bladder Cancer Cystectomy

NCT04964895 | Completed

• 1 other identifier: RC31/21/0113
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Sexual Dysfunction

Keywords

bladder cancer; cystectomy; sex life; sex quality

Outcome Measures

Primary Outcomes (2)

• Evaluation of the decrease in the quality of sexual life of patients who had a cystectomy

  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

  EORTC SHQ C22 score 8 months after surgery

  T1 : 8 months after surgery

Secondary Outcomes (2)

• Evaluation of the decrease in the quality of life of patients who had a cystectomy

  T0 : before surgery

• Evaluation of the decrease in the quality of life of patients who had a cystectomy

  T1 : 8 months after surgery

Study Arms (1)

patients with cystectomy

Other: Questionnaires

Interventions

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)

patients with cystectomy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Any adult patient who had a cystectomy for bladder cancer
• Affiliated with a social security scheme

You may not qualify if:

• No Cystectomy
• Cystectomy for neurological etiology
• Pregnant or breastfeeding women

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

Sexual Dysfunction, Physiological; Urinary Bladder Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Eric Huyghe, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: July 16, 2021
• Study Start: September 20, 2021
• Primary Completion: September 1, 2022
• Study Completion: January 1, 2023
• Last Updated: December 17, 2025

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)