Flexible Cystoscopy
Conditions
Brief summary
Flexible cystoscopy is routinely performed by urologists. Many patients have concerns to undergo this procedure and expect it to be unpleasant or even painful. Thus, reduction of pain and discomfort during cystoscopy is of great interest, but there is not sufficient evidence regarding the most appropriate conduct of cystoscopy. In this study the impact of lidocaine gel, patient counseling and monitoring regarding pain perception during flexible cystoscopy are investigated.
Interventions
DEVICELidocaine gel
10 ml 2% lidocaine gel is instilled with a syringe through the length of the urethra and kept in site at least 5 minutes prior the introduction of the cystoscope.
OTHERCounselling
Patients receive a brochure in the waiting room explaining the procedure in details.
OTHERMonitor
Patients are allowed to view and follow the procedure on a monitor connected to the cystoscope's camera.
DEVICELubricating gel
10 ml plain lubrificant gel is instilled with a syringe through the length of the urethra and kept in site at least 5 minutes prior the introduction of the cystoscope.
OTHERNo counselling
Patients won't receive a brochure in the waiting room explaining the procedure in details.
OTHERNo monitor
Patients are not allowed to view and follow the procedure on a monitor connected to the cystoscope's camera.
Sponsors
Ajet Hyseni
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Men 18 - 80 years * Given indication for flexible cystoscopy * Written informed consent
Exclusion criteria
* Allergy to amid anesthetics * Urinary tract infection * Use of analgesics in the previous 24 hours and chronic intake of analgesics * Dementia * Presence of a sensory disorder such as or spinal cord injury * Indwelling catheter carrier
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain based on a numeric rating scale | During flexible cystoscopy | The pain scale ranging from 0 (no pain) to 10 (worst possible pain). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain based on a numeric rating scale | Immediately before flexible cystoscopy | The pain scale ranging from 0 (no pain) to 10 (worst possible pain). |
| Pain based on a verbal rating scale | Immediately after flexible cystoscopy | The pain scale ranging from 0 (it was not unpleasant) to 5 (the investigation was almost unbearable). |
Countries
Switzerland
Contacts
Primary ContactAjet Hyseni, Dr.med.univ.RKS
Backup ContactCarlo Di Bona
Outcome results
None listed