Does the Act of Urination During Urethral Catheterisation in Males Reduce Pain?

Pain Clinical Trial

Official title:

Pain Level During Male Urethral Catheterisation - Does Patient Attempted Urination During Catheterisation Reduce Pain? A Prospective Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02196987
• Other study ID #: 109/14
• Status: Recruiting
• Phase: N/A
• First received: July 18, 2014
• Last updated: July 21, 2014
• Start date: July 2014
• Est. completion date: July 2015

Study information

• Verified date: July 2014
• Source: Assaf-Harofeh Medical Center
• Contact: Kobi Stav, MD
• Phone: 972-8-9778461
• Email: stavkobi[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• Urination during urethral catheterisation
Requesting the patient to urinate while inserting urethral catheter
• Urethral catheterisation, without further guidance
Lying, inserting urethral catheter, without further guidance from health care professional

Locations

Country	Name	City	State
Israel	Assaf Harofe Medical Center	Beer Yaakov, Zeriffin

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in visual analog pain scales	A 0 to 10 visual analog pain scale (VAS)	Before catheterisation, during catheterisation, 15 minutes after catheterisation	No