Clinical trial · Observational
Sexual Function in Patients Suspected of Non-muscle Invasive Bladder Cancer
NCT02381912CI-TRIAL-00021271completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Erectile Dysfunction | — | UNRESOLVED | — |
| Hematuria | — | UNRESOLVED | — |
| Sexual Dysfunction, Physiological | — | UNRESOLVED | — |
| Sexual Dysfunctions, Psychological | — | UNRESOLVED | — |
| Urinary Bladder Neoplasms | Bladder Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EORTC QLQ-C30 and EORTC BLS-24 questionnaire | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Hematuria - NMIBC
- description
- Primary hematuria due to NMIBC.
- interventionNames
- Other: EORTC QLQ-C30 and EORTC BLS-24 questionnaire
- label
- Hematuria - other cause
- description
- Other non-malignant cause of hematuria.
- interventionNames
- Other: EORTC QLQ-C30 and EORTC BLS-24 questionnaire
Primary outcomes (1)
- measure
- Change in sexual function
- timeFrame
- 4 months
- description
- Change in sexual function measured by the "EORTC QLQ-BLS24 sexual functioning questions"
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
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.
References
Publications (3)
- BACKGROUNDKowalkowski 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 25356311
- BACKGROUNDvan 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 19154473
- BACKGROUNDGoossens-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 22461137