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Comparison of Body and Room Temperature Saline in Urodynamics
This study is currently recruiting participants.
Verified by Tripler Army Medical Center, July 2006
First Received: July 20, 2006   No Changes Posted
Sponsored by: Tripler Army Medical Center
Information provided by: Tripler Army Medical Center
ClinicalTrials.gov Identifier: NCT00355433
  Purpose

The purpose of this study is to compare first urge, strong urge, and maximum capacity, and perception of discomfort during urodynamic testing between room temperature and body temperate saline. Twenty-four non-pregnant females referred to the urogynecology clinic for bladder testing will be enrolled into the study.

Each patient will serve as her own control, undergoing the bladder testing with both room temperature and body temperature saline.


Condition Intervention Phase
Urinary Incontinence
Procedure: Urodymanics
Phase IV

Study Type: Interventional
Study Design: Diagnostic, Randomized, Double-Blind, Active Control, Single Group Assignment, Efficacy Study
Official Title: Comparison of Urodynamic Volume Measurements Using Room and Body Temperature Saline

Resource links provided by NLM:


Further study details as provided by Tripler Army Medical Center:

Primary Outcome Measures:
  • first urge
  • strong urge
  • maximum urge

Secondary Outcome Measures:
  • patient comfort (Likert scale)

Estimated Enrollment: 24
Study Start Date: July 2006
Estimated Study Completion Date: July 2006
Detailed Description:

This is a prospective observational study. Patient scheduled to undergo evaluation of urinary incontinence by urodynamics in the gynecology clinic will be asked to participate. Patients will be counseled and consent forms signed. The nurse will open the envelope which randomizes the order of instillation and set up the first fluid.

Normal saline in 1000ml bags are used for instillation. The bags being used for body temperature fluid will be heated using an Olympic Warmette to between 98 and 99 degrees as determined by 3M Tempadot Thermometers.

Urodynamics will be performed using standard clinic protocol recording first sensation, first urge, and maximum capacity. The patient will ask to comment on the discomfort of the test using a 5 point Lickert scale for both pain and urgency (see attached questions). Patients will be allowed to void. The bladder will be filled again with the second solution with identical questions used to determine first sensation, first urge and maximum capacity. During each filling the patient will be tested for stress incontinence at 200 and 300 mls as per our protocol. Following the instillation of the second solution the patient will again be asked her perception of pain and urgency an identical scale. Maximum bladder capacities from each temperature saline tested will then be compared against maximum bladder capacity as estimated from the patients’ bladder diary. The patient will then be managed as is appropriate for her test results.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Females referred to gynecology clinic for urodynamics evaluation with an appropriate indication for bladder testing

Exclusion Criteria:

  • Male subjects and pregnant females
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00355433

Contacts
Contact: micah j hill, D.O. 808-433-5943 micah.hill@haw.tamc.amedd.army.mil
Contact: grant d mcwilliams, D.O. 808-433-5950 grant.mcwilliams@haw.tamc.amedd.army.mil

Locations
United States, Hawaii
Tripler Army Medical Center Recruiting
TAMC, Hawaii, United States, 96859
Principal Investigator: Micah J Hill, D.O.            
Sponsors and Collaborators
Tripler Army Medical Center
  More Information

Publications:
1. Klevmark, B, Volume threshold for micturation: Influence of filing rate on sensory and motor bladder function, Scandanavian Journal of Urology and Nephrology Supplementum 2002; 210:6-10 2. Wyandaele, J, The normal pattern of perception of bladder filling during cystometry studied in 38 young healthy volunteers, Journal of Urology 1998; 160(2):479-81 3. Pauwels, E, DeWatcher, S, Wyndaele, J, Normality of bladder filling studied in symptom-free middle-aged woman, Clinical Urology 2004; 171(4):1567-70 4. Chin-peuckert, L, Komlos, M, Rennick, J, Jednak, R, Capolicchio, J, Salle, J, What is the variability between two concescutive cystometries in the same child?, Clinical Urology 2003; 170(4):1614-7 5. Goodman, T, Kilborn, T, Pearce, R. Warm or cold contrast medium in the micturating cystourethrogram: which is best?, Clinical Radiology 2003; 58(7):551-4

Study ID Numbers: TAMC 11H06
Study First Received: July 20, 2006
Last Updated: July 20, 2006
ClinicalTrials.gov Identifier: NCT00355433     History of Changes
Health Authority: United States: Federal Government

Keywords provided by Tripler Army Medical Center:
urinary incontinence
urodynamics
temperature

Study placed in the following topic categories:
Signs and Symptoms
Urologic Diseases
Urination Disorders
Urinary Incontinence

Additional relevant MeSH terms:
Signs and Symptoms
Urological Manifestations
Urologic Diseases
Urination Disorders
Urinary Incontinence

ClinicalTrials.gov processed this record on September 11, 2009