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Comparison of Body and Room Temperature Saline in Urodynamics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00355433
Recruitment Status : Unknown
Verified July 2006 by Tripler Army Medical Center.
Recruitment status was:  Recruiting
First Posted : July 24, 2006
Last Update Posted : July 24, 2006
Information provided by:
Tripler Army Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Urinary Incontinence Procedure: Urodymanics Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Diagnostic
Official Title: Comparison of Urodynamic Volume Measurements Using Room and Body Temperature Saline
Study Start Date : July 2006
Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. first urge
  2. strong urge
  3. maximum urge

Secondary Outcome Measures :
  1. patient comfort (Likert scale)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • Male subjects and pregnant females

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00355433

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Contact: micah j hill, D.O. 808-433-5943
Contact: grant d mcwilliams, D.O. 808-433-5950

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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
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

Layout table for additonal information Identifier: NCT00355433    
Other Study ID Numbers: TAMC 11H06
First Posted: July 24, 2006    Key Record Dates
Last Update Posted: July 24, 2006
Last Verified: July 2006
Keywords provided by Tripler Army Medical Center:
urinary incontinence
Additional relevant MeSH terms:
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Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders