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

NCT ID: NCT02381912

Last Updated: 2016-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

210 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-01-31

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Hematuria - NMIBC

Primary hematuria due to NMIBC.

EORTC QLQ-C30 and EORTC BLS-24 questionnaire

Intervention Type OTHER

Questionnaires answered at baseline and 4 months follow up.

Hematuria - other cause

Other non-malignant cause of hematuria.

EORTC QLQ-C30 and EORTC BLS-24 questionnaire

Intervention Type OTHER

Questionnaires answered at baseline and 4 months follow up.

Interventions

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EORTC QLQ-C30 and EORTC BLS-24 questionnaire

Questionnaires answered at baseline and 4 months follow up.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Herlev Hospital

OTHER

Sponsor Role lead

Responsible Party

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Peter Busch Østergren

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter B Østergren, MD

Role: PRINCIPAL_INVESTIGATOR

Herlev Hospital, Department of Urology

Locations

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Herlev Hospital

Herlev, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type BACKGROUND
PMID: 25356311 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19154473 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22461137 (View on PubMed)

Other Identifiers

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SSBC-2015

Identifier Type: -

Identifier Source: org_study_id

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