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

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02381912
• Other study ID #: SSBC-2015
• Status: Completed
• Phase: N/A
• First received: March 5, 2015
• Last updated: March 8, 2016
• Start date: March 2015
• Est. completion date: January 2016

Study information

• Verified date: March 2016
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Erectile Dysfunction
• Hematuria
• Sexual Dysfunction, Physiological
• Sexual Dysfunctions, Psychological
• Urinary Bladder Neoplasms

Intervention

Other:
• EORTC QLQ-C30 and EORTC BLS-24 questionnaire
Questionnaires answered at baseline and 4 months follow up.

Locations

Country	Name	City	State
Denmark	Herlev Hospital	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in sexual function	Change in sexual function measured by the "EORTC QLQ-BLS24 sexual functioning questions"	4 months	No
Secondary	Change in erectile function	Change in erectile function measured by the Erection Hardness Scale	4 months	No