Urinary Bladder NeoplasmsNCT02381912
Sexual Function in Patients Suspected of Non-muscle Invasive Bladder Cancer
An observational study of Urinary Bladder Neoplasms and Sexual Dysfunction, Physiological, run by Herlev Hospital at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Urinary Bladder Neoplasms, Sexual Dysfunction, Physiological, Sexual Dysfunctions, Psychological
- What is being tested?
- EORTC QLQ-C30 and EORTC BLS-24 questionnaire
- How many people
- 210 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2015to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with primary hematuria.
Who may be able to join
- Patients with primary hematuria, both gross and microscopic
- Men and women older or equal to 40 years of age
- Signed informed consent statement
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Urinary Bladder Neoplasms, Sexual Dysfunction, Physiological, Sexual Dysfunctions, Psychological, Erectile Dysfunction, Hematuria
- Being tested
- EORTC QLQ-C30 and EORTC BLS-24 questionnaire
- Medical subject headings
- Urinary Bladder Neoplasms, Sexual Dysfunction, Physiological, Sexual Dysfunctions, Psychological, Erectile Dysfunction, Hematuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EORTC QLQ-C30 and EORTC BLS-24 questionnaireOther
Questionnaires answered at baseline and 4 months follow up.
| Study group | Role | What they receive |
|---|---|---|
| Hematuria - NMIBC | Primary hematuria due to NMIBC. Receives: Other: EORTC QLQ-C30 and EORTC BLS-24 questionnaire | |
| Hematuria - other cause | Other non-malignant cause of hematuria. Receives: Other: EORTC QLQ-C30 and EORTC BLS-24 questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sexual function
Change in sexual function measured by the "EORTC QLQ-BLS24 sexual functioning questions"
Measured: 4 months
Secondary outcomes (1)
Change in erectile function
Change in erectile function measured by the Erection Hardness Scale
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Urinary Bladder NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Busch Østergren, Herlev Hospital
- Investigators
- Peter B Østergren, MD, Principal investigator, Herlev Hospital, Department of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02381912
- Sponsor's protocol ID
- SSBC-2015
- Status last verified
- Mar 2016
- First submitted
- 5 Mar 2015
- Last updated
- 9 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25356311van 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.
PubMed 19154473Goossens-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.
PubMed 22461137
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexual Function in Patients Suspected of Non-muscle Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT02381912
- Acronym / sponsor ID
- SSBC-2015
- Conditions
- Urinary Bladder Neoplasms, Sexual Dysfunction, Physiological, Sexual Dysfunctions, Psychological, Erectile Dysfunction, Hematuria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 6 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hematuria - NMIBC | – | Other: EORTC QLQ-C30 and EORTC BLS-24 questionnairePrimary hematuria due to NMIBC. |
| Hematuria - other cause | – | Other: EORTC QLQ-C30 and EORTC BLS-24 questionnaireOther non-malignant cause of hematuria. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with primary hematuria.
Key inclusion criteria (3 listed)
- Patients with primary hematuria, both gross and microscopic
- Men and women older or equal to 40 years of age
- Signed informed consent statement
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EORTC QLQ-C30 and EORTC BLS-24 questionnaireQuestionnaires answered at baseline and 4 months follow up. | Other | Hematuria - NMIBC, Hematuria - other cause |
Primary outcome
Change in sexual function
Time frame: 4 months
Change in sexual function measured by the "EORTC QLQ-BLS24 sexual functioning questions"
1 secondary outcome
Change in erectile function
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2016.
- Background: PubMed 25356311Kowalkowski 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.
- Background: PubMed 19154473van 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.
- Background: PubMed 22461137Goossens-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter B Østergren, MD principal investigator
Herlev Hospital, Department of Urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Bladder Neoplasms and Sexual Dysfunction, Physiological, run by Herlev Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sexual function (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02381912, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2016; AzTrials last refreshed its copy on 7 Nov 2026.