Comparison of Body and Room Temperature Saline in Urodynamics
Primary Purpose
Urinary Incontinence
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Urodymanics
Sponsored by
About this trial
This is an interventional diagnostic trial for Urinary Incontinence focused on measuring urinary incontinence, urodynamics, temperature
Eligibility 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
Sites / Locations
- Tripler Army Medical CenterRecruiting
Outcomes
Primary Outcome Measures
first urge
strong urge
maximum urge
Secondary Outcome Measures
patient comfort (Likert scale)
Full Information
NCT ID
NCT00355433
First Posted
July 20, 2006
Last Updated
July 20, 2006
Sponsor
Tripler Army Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00355433
Brief Title
Comparison of Body and Room Temperature Saline in Urodynamics
Official Title
Comparison of Urodynamic Volume Measurements Using Room and Body Temperature Saline
Study Type
Interventional
2. Study Status
Record Verification Date
July 2006
Overall Recruitment Status
Unknown status
Study Start Date
July 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Tripler Army Medical Center
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
urinary incontinence, urodynamics, temperature
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
24 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Urodymanics
Primary Outcome Measure Information:
Title
first urge
Title
strong urge
Title
maximum urge
Secondary Outcome Measure Information:
Title
patient comfort (Likert scale)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
micah j hill, D.O.
Phone
808-433-5943
Email
micah.hill@haw.tamc.amedd.army.mil
First Name & Middle Initial & Last Name or Official Title & Degree
grant d mcwilliams, D.O.
Phone
808-433-5950
Email
grant.mcwilliams@haw.tamc.amedd.army.mil
Facility Information:
Facility Name
Tripler Army Medical Center
City
Tamc
State/Province
Hawaii
ZIP/Postal Code
96859
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Micah J Hill, D.O.
12. IPD Sharing Statement
Citations:
Citation
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
Results Reference
background
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Comparison of Body and Room Temperature Saline in Urodynamics
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