Sexual Function in Patients Suspected of Non-muscle Invasive Bladder Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 11 April 2016
• Main ID: NCT02381912
• Date of registration: 05/03/2015
• Prospective Registration: No
• Primary sponsor: Herlev Hospital
• Public title: Sexual Function in Patients Suspected of Non-muscle Invasive Bladder Cancer
• Scientific title: Sexual Function in Patients Suspected of Non-muscle Invasive Bladder Cancer
• Date of first enrolment: March 2015
• Target sample size: 210
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02381912
• Study type: Observational
• Study design: Observational Model: Case Control, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

Denmark

Contacts

• Name: Peter B Østergren, MD
• Affiliation: Herlev Hospital, Department of Urology

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with primary hematuria, both gross and microscopic

- Men and women older or equal to 40 years of age

- Signed informed consent statement

Exclusion Criteria:

- Men and women younger than 40 years of age

- Patients with recurrent hematuria and known causative disease

- Already known urogenital cancer

- Previous massive pelvic surgery or pelvic radiotherapy

- TUR-P within the last 2 months

- Participants diagnosed with tumors originating from the ureters, renal pelvis and
kidney, and bladder tumors at T stage more than or equal to T1b.



Age minimum: 40 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Urinary Bladder Neoplasms

Erectile Dysfunction

Hematuria

Sexual Dysfunction, Physiological

Sexual Dysfunctions, Psychological

Intervention(s)

Other: EORTC QLQ-C30 and EORTC BLS-24 questionnaire

Primary Outcome(s)

Change in sexual function [Time Frame: 4 months]

Secondary Outcome(s)

Change in erectile function [Time Frame: 4 months]

Secondary ID(s)

SSBC-2015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors