Double Blinded Randomized Trial Between Lidocaine And Plain Gel For Urethral Straight Catheterization And The Q-Tip Test

NCT00883103 | Completed Phase 4 Results DMC

• 1 other identifier: 07-091
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the pain perception between lidocaine and plain aqueous gel during assessment of postvoid residual volume and the Q-tip test.

Conditions

Pain

Keywords

female urethral catheterization; Lidocaine; lubricant; Q-tip test; Q tip test; K-Y jelly; pain perception; straight catheterization

Outcome Measures

Primary Outcomes (1)

• Patient's Perception of Pain Using the Wong-Baker FACES Visual Scale: 0 - no Pain; 5 - Worst Imaginable Pain

  A sterile catheter lubricated with the allocated gel was placed transurethrally into the bladder to measure the postvoid residual volume. After removal of the catheter, a cotton swab, coated with the same allocated gel, was advanced to the urethrovesical junction until resistance was felt. The angle of the swab with the horizontal plane was measured at rest and with a Valsalva maneuver. Immediately following the Q-tip test, the patient's perception of pain level was measured by Wong-Baker FACES Pain Scale, a visual scale where 0 represents no pain and 5 represents worst imaginable pain.

  Immediately after the examination

Study Arms (2)

Lidocaine

ACTIVE COMPARATOR

2% Lidocaine jelly will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.

Drug: 2% Lidocaine jelly

Aqueous gel

PLACEBO COMPARATOR

Plain aqueous gel as placebo will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.

Drug: Plain aqueous gel

Interventions

2% Lidocaine jelly DRUG

2% Lidocaine jelly will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.

Lidocaine

Plain aqueous gel DRUG

Plain aqueous gel will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.

Also known as: Surgilube

Aqueous gel

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All women who presented to a single urogynecologist's office for an initial consultation with a complaint of urinary incontinence and/or pelvic organ prolapse

You may not qualify if:

• Being a minor
• Pregnancy
• Allergy to Lidocaine or aqueous lubricant gel
• Any current use of analgesia
• Structural abnormalities of the urethra
• Active genital Herpes or other vulvovaginal infections or inability to cooperate with pain assessment due to mental disorders.

Sponsors & Collaborators

• Baystate Medical Center: lead

Study Sites (1)

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

Related Publications (1)

• Harmanli OH, Okafor O, Ayaz R, Knee A. Lidocaine jelly and plain aqueous gel for urethral straight catheterization and the Q-tip test: a randomized controlled trial. Obstet Gynecol. 2009 Sep;114(3):547-550. doi: 10.1097/AOG.0b013e3181b43808.

  PMID: 19701033 RESULT

MeSH Terms

Conditions

Pain

Interventions

phenylmercury borate

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Oz Harmanli, MD
• Organization: Baystate Medical Center

oz.harmanli@baystatehealth.org

4137945608

Study Officials

• Oz Harmanli, MD

  Baystate Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 15, 2009
• First Posted: April 17, 2009
• Study Start: November 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: September 13, 2011
• Results First Posted: September 13, 2011

Record last verified: 2011-08

Locations

US (1)