NCT00355433

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2006

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 24, 2006

Completed
Last Updated

July 24, 2006

Status Verified

July 1, 2006

First QC Date

July 20, 2006

Last Update Submit

July 20, 2006

Conditions

Keywords

urinary incontinenceurodynamicstemperature

Outcome Measures

Primary Outcomes (3)

  • first urge

  • strong urge

  • maximum urge

Secondary Outcomes (1)

  • patient comfort (Likert scale)

Interventions

UrodymanicsPROCEDURE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Male subjects and pregnant females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tripler Army Medical Center

TAMC, Hawaii, 96859, United States

RECRUITING

Related Publications (1)

  • 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

    BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

July 20, 2006

First Posted

July 24, 2006

Study Start

July 1, 2006

Study Completion

July 1, 2006

Last Updated

July 24, 2006

Record last verified: 2006-07

Locations