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

Completed

• Conditions: Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Urinary Bladder Neoplasms; Hematuria; Erectile Dysfunction
• Interventions: Other: EORTC QLQ-C30 and EORTC BLS-24 questionnaire

• Registration Number: NCT02381912
• Lead Sponsor: Herlev Hospital

Brief Summary

The purpose of the study is to investigate sexual function in patients suspected of non muscle invasive bladder cancer (NMIBC). The investigators hypothesis is that reduced sexual function is underdiagnosed in patients with non-muscle invasive bladder cancer and that active examination and treatment may worsen the sexual function.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-05
• Study First Submitted QC: 2015-03-05
• Study First Posted: 2015-03-06
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-08
• Last Update Posted: 2016-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hematuria - NMIBC	EORTC QLQ-C30 and EORTC BLS-24 questionnaire	Primary hematuria due to NMIBC.
Hematuria - other cause	EORTC QLQ-C30 and EORTC BLS-24 questionnaire	Other non-malignant cause of hematuria.

Primary Outcome Measures

Name	Time	Method
Change in sexual function	4 months	Change in sexual function measured by the "EORTC QLQ-BLS24 sexual functioning questions"

Secondary Outcome Measures

Name	Time	Method
Change in erectile function	4 months	Change in erectile function measured by the Erection Hardness Scale

Trial Locations

Locations (1)

Herlev Hospital; 🇩🇰 Herlev, Denmark