Sexual Function in Patients Suspected of Non-muscle Invasive Bladder Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Hematuria - NMIBC Primary hematuria due to NMIBC. |
Other: EORTC QLQ-C30 and EORTC BLS-24 questionnaire
Questionnaires answered at baseline and 4 months follow up.
|
| Hematuria - other cause Other non-malignant cause of hematuria. |
Other: EORTC QLQ-C30 and EORTC BLS-24 questionnaire
Questionnaires answered at baseline and 4 months follow up.
|
Outcome Measures
Primary Outcome Measures
- Change in sexual function [4 months]
Change in sexual function measured by the "EORTC QLQ-BLS24 sexual functioning questions"
Secondary Outcome Measures
- Change in erectile function [4 months]
Change in erectile function measured by the Erection Hardness Scale
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Herlev Hospital | Herlev | Denmark | 2730 |
Sponsors and Collaborators
- Herlev Hospital
Investigators
- Principal Investigator: Peter B Østergren, MD, Herlev Hospital, Department of Urology
Study Documents (Full-Text)
None provided.More Information
Publications
- Goossens-Laan CA, Kil PJ, Ruud Bosch JL, De Vries J. Pre-diagnosis quality of life (QoL) in patients with hematuria: comparison of bladder cancer with other causes. Qual Life Res. 2013 Mar;22(2):309-15. doi: 10.1007/s11136-012-0163-1. Epub 2012 Mar 30.
- Kowalkowski MA, Chandrashekar A, Amiel GE, Lerner SP, Wittmann DA, Latini DM, Goltz HH. Examining sexual dysfunction in non-muscle-invasive bladder cancer: results of cross-sectional mixed-methods research. Sex Med. 2014 Aug;2(3):141-51. doi: 10.1002/sm2.24.
- van der Aa MN, Bekker MD, van der Kwast TH, Essink-Bot ML, Steyerberg EW, Zwarthoff EC, Sen FE, Elzevier HW. Sexual function of patients under surveillance for bladder cancer. BJU Int. 2009 Jul;104(1):35-40. doi: 10.1111/j.1464-410X.2008.08333.x. Epub 2009 Jan 14.
- SSBC-2015