Clinical trial NCT02196987: Does the Act of Urination During Urethral Catheterisation in Males Reduce Pain?
Official title: Pain Level During Male Urethral Catheterisation - Does Patient Attempted Urination During Catheterisation Reduce Pain? A Prospective Randomized Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain
Keywords: Pain
Catheter
Urethra
Urination
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-07-22
Enrollment: 96
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men who will be referred to Urodynamic study

Brief summary: Currently, there are no specific guidelines or best practice suggestions for best male catheterization as fat as insertion technique. There is however, information as to reducing infection, and as to recommended lubricant.

From our experience, the investigators have noticed that when requesting the patient to attempt urination while inserting a urethral catheter, the level of pain and discomfort is reduced. In this study, the investigators will evaluate the pain level during male urethral catheterization in each technique.

Our hypothesis is that the level of pain will be much less if the in the study group where the act of urination will be requested from the patient.

Detailed description: This is a randomized prospective study that will compare the pain levels of urethral catheterization in men randomized to requesting to urinate while inserting a urethral catheter to normal catheter insertion.

Males aged 18 years and older who will be referred for multichannel Urodynamic study in order to evaluate lower urinary tract symptoms will be included.

Patients will be randomized to 2 groups: (1) Patients who will be requested to urinate while catheterising the urethra to its full length; (2), Patients who will be requested to lie while catheterising the urethra, without further instructions from the medical professional. In both groups, prior to catheterisation, 10 ml of lidocaine gel will be inserted into the urethra. The randomization technique will be employed by a computerized random number generator.

A 12F Tieman urethral catheter will be introduced in order to measure post-void residual volumes. Subsequently, multichannel Urodynamic testing (Duet Encompass System - Mediwatch Group Plc) will be performed using a dual lumen 6F urethral and 9F rectal catheters. Filling will be carried out using room temperature saline at a filling rate of 50 ml/min.

Patients will be requested to fill out a 0 (no pain) to 10 (worst imaginable pain) visual analog pain scale (VAS) in different time points: before the procedure (baseline), immediately after gel instillation, immediately after the introduction of the Tieman catheter, 15 minutes after the catheter will be taken out.

Time frame of the study: 30 minutes before the test and 1 hour after the test. Since the study evaluates pain during the procedure the time frame of the study and assessment is very short. longer follow-up is not needed.

Eligibility criteria: Inclusion Criteria:

* men aged 18 years and older who will be referred for multichannel Urodynamic study in order to evaluate lower urinary tract symptoms.

Exclusion Criteria:

* use of any analgesics within the previous 24 hours, known urethral stricture, active urinary tract infection, indwelling urethral catheter, pre-existing urethral pain (e.g. patients with chronic pelvic pain syndromes and interstitial cystitis), inability to cooperate with pain assessment due to mental disorders.

Primary outcomes:
measure: Change from baseline in visual analog pain scales
timeFrame: Before catheterisation, during catheterisation, 15 minutes after catheterisation
Secondary outcomes:
Other outcomes:
Locations:
city: Beer Yaakov, Zeriffin
country: Israel
facility: Assaf Harofe Medical Center
Study officials:
affiliation: Assaf Harofe Medical Center
name: Kobi Stav, MD
role: PRINCIPAL_INVESTIGATOR
References: