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

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

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.

Study Overview

• Status: Unknown
• Conditions: Pain
• Intervention / Treatment: Other: Urination during urethral catheterisation; Other: Urethral catheterisation, without further guidance

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.

• Study Type: Observational
• Enrollment (Anticipated): 96

Contacts and Locations

Study Locations

• Israel
  • Beer Yaakov, Zeriffin, Israel, 70300
    • Recruiting
    • Assaf Harofe Medical Center
    • Contact: Kobi Stav, MD; Phone Number: 972-8-9778461; Email: stavkobi@gmail.com
    • Principal Investigator: Kobi Stav, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Men who will be referred to Urodynamic study

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Urination, urethral catheterisation; Act of urination during urethral catheterisation in males	Other: Urination during urethral catheterisation; Requesting the patient to urinate while inserting urethral catheter
Lie, catheterisation, urethra; Urethral catheterisation without medical professional guidance	Other: Urethral catheterisation, without further guidance; Lying, inserting urethral catheter, without further guidance from health care professional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assaf-Harofeh Medical Center
• Investigators: Principal Investigator: Kobi Stav, MD, Assaf Harofe Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Anticipated): July 1, 2015
• Study Completion (Anticipated): July 1, 2015

Study Registration Dates

• First Submitted: July 18, 2014
• First Submitted That Met QC Criteria: July 21, 2014
• First Posted (Estimate): July 22, 2014

Study Record Updates

• Last Update Posted (Estimate): July 22, 2014
• Last Update Submitted That Met QC Criteria: July 21, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Pain; Catheter; Urethra; Urination
• Other Study ID Numbers: 109/14