NCT02381912

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 6, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

March 9, 2016

Status Verified

March 1, 2016

Enrollment Period

10 months

First QC Date

March 5, 2015

Last Update Submit

March 8, 2016

Conditions

Urinary Bladder NeoplasmsSexual Dysfunction, PhysiologicalSexual Dysfunctions, PsychologicalErectile DysfunctionHematuria

Outcome Measures

Primary Outcomes (1)

  • Change in sexual function

    Change in sexual function measured by the "EORTC QLQ-BLS24 sexual functioning questions"

    4 months

Secondary Outcomes (1)

  • Change in erectile function

    4 months

Study Arms (2)

Hematuria - NMIBC

Primary hematuria due to NMIBC.

Other: EORTC QLQ-C30 and EORTC BLS-24 questionnaire

Hematuria - other cause

Other non-malignant cause of hematuria.

Other: EORTC QLQ-C30 and EORTC BLS-24 questionnaire

Interventions

EORTC QLQ-C30 and EORTC BLS-24 questionnaireOTHER

Questionnaires answered at baseline and 4 months follow up.

Hematuria - NMIBCHematuria - other cause

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with primary hematuria.

You may qualify if:

  • Patients with primary hematuria, both gross and microscopic
  • Men and women older or equal to 40 years of age
  • Signed informed consent statement

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herlev Hospital

Herlev, 2730, Denmark

Location

Related Publications (3)

  • 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.

    PMID: 25356311BACKGROUND

  • 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.

    PMID: 19154473BACKGROUND

  • 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.

    PMID: 22461137BACKGROUND

MeSH Terms

Conditions

Urinary Bladder NeoplasmsSexual Dysfunction, PhysiologicalSexual Dysfunctions, PsychologicalErectile DysfunctionHematuria

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesGenital DiseasesMental DisordersGenital Diseases, MaleUrination DisordersHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Peter B Østergren, MD

    Herlev Hospital, Department of Urology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 5, 2015

First Posted

March 6, 2015

Study Start

March 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

March 9, 2016

Record last verified: 2016-03

Locations

DK(1)