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

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.

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Key information

Conditions

Urinary Bladder Neoplasms Erectile Dysfunction Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Hematuria Hemorrhage Male Urogenital Diseases Mental Disorders Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urinary Bladder Diseases Urination Disorders Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Herlev Hospital

Herlev, 2730, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EORTC QLQ-C30 and EORTC BLS-24 questionnaire

Other

Questionnaires answered at baseline and 4 months follow up.

Primary outcomes

Change in sexual function

Time frame: 4 months

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

Secondary outcomes

Change in erectile function

Time frame: 4 months

Change in erectile function measured by the Erection Hardness Scale

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Mar 6, 2015
Registry last updated: Mar 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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