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

NCT01985516 | Unknown

• 1 other identifier: 132/13
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain

Keywords

Pain; Urethra; Catheter

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Instillation into the urethra

EXPERIMENTAL

5mL of 2% lidocaine gel will be instilled directly into the urethra 5 minutes before catheterization

Other: Instillation into the urethra

Pouring the gel on the tip of the catheter

ACTIVE COMPARATOR

5mL of 2% lidocaine gel will be poured on the distal part of the catheter (from the distal tip to 10 cm proximally)

Other: pouring the gel on the catheter's tip

Interventions

Instillation into the urethra OTHER

5mL of 2% lidocaine gel will be instilled directly into the urethra 5 minutes before catheterization

Instillation into the urethra

pouring the gel on the catheter's tip OTHER

5mL of 2% lidocaine gel will be poured on the distal part of the catheter (from the distal tip to 10 cm proximally).

Pouring the gel on the tip of the catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

Assaf Harofe Medical Center

Beer Yaakov, Zeriffin, 70300, Israel

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kobi Stav, MD

  Assaf Harofe Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kobi Stav, MD

CONTACT

972-8-9778461; stavkobi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Kobi Stav

Study Record Dates

• First Submitted: October 20, 2013
• First Posted: November 15, 2013
• Study Start: October 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: November 15, 2013

Record last verified: 2013-11

Locations

IL (1)