Female Urethral Catheterization - Instillation of the Lubricating Gel Into the Urethra or Pouring it on the Catheter's Tip?

Pain Clinical Trial

Official title:

Pain Level During Female Urethral Catheterization - Should we Instill the Lubrication Gel Into the Urethra or Just Lubricate the Catheter's Tip? a Prospective Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01985516
• Other study ID #: 132/13
• Status: Recruiting
• Phase: N/A
• First received: October 20, 2013
• Last updated: November 10, 2013
• Start date: October 2013
• Est. completion date: September 2014

Study information

• Verified date: November 2013
• 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: Interventional

Clinical Trial Summary

Currently, there are no specific guidelines or best practice suggestions for female catheterization. However, there is a consensus that an anesthetic lubricating gel should be routinely used in women as well.

Urethral lubrication can be performed in two different techniques: instillation of the gel directly into the urethra or pouring the gel on the catheter's tip. In this study, we will evaluate the pain level during female urethral catheterization in each technique.

Our hypothesis is that the level of pain will be much less if the lubrication agent will be instilled directely to the urethra.

Description:

This is a randomized prospective study that will compare the pain levels of urethral catheterization in women randomized to intraurethral lidocaine gel instillation or lubrication of the catheter's tip with lidocaine gel.

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

Patients will be randomized to 2 groups: (1) 5mL of 2% lidocaine gel instilled directly into the urethra 5 minutes before catheterization; (2), 5mL of 2% lidocaine gel poured on the distal part of the catheter. The randomization technique will be employed by a computerized random number generator.

A 12F Nelaton 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: prior to gel instillation (baseline), immediately after gel instillation (only in group 1), immediately after the introduction of the Nelaton catheter, 5 and 30 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: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

women 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), known allergy to lidocaine or inability to cooperate with pain assessment due to mental disorders.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• Instillation into the urethra
5mL of 2% lidocaine gel will be instilled directly into the urethra 5 minutes before catheterization
• pouring the gel on the catheter's tip
5mL of 2% lidocaine gel will be poured on the distal part of the catheter (from the distal tip to 10 cm proximally).

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 instillation, During Instillation of the lubricants, After Urethral Catheterization, 5 and 30 minutes after the catheter removal	No