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

March 8, 2016 updated by: Peter Busch Østergren, Herlev Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

210

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Herlev, Denmark, 2730
        • Herlev Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with primary hematuria.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in sexual function
Time Frame: 4 months
Change in sexual function measured by the "EORTC QLQ-BLS24 sexual functioning questions"
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in erectile function
Time Frame: 4 months
Change in erectile function measured by the Erection Hardness Scale
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herlev Hospital

Investigators

  • Principal Investigator: Peter B Østergren, MD, Herlev Hospital, Department of Urology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

March 5, 2015

First Submitted That Met QC Criteria

March 5, 2015

First Posted (Estimate)

March 6, 2015

Study Record Updates

Last Update Posted (Estimate)

March 9, 2016

Last Update Submitted That Met QC Criteria

March 8, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSBC-2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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