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Overactive Bladder (OAB) Drink Advice Study

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.
 
ClinicalTrials.gov Identifier: NCT00982241
Recruitment Status : Withdrawn (Difficulty in enrolling participants)
First Posted : September 23, 2009
Last Update Posted : July 24, 2012
Sponsor:
Information provided by (Responsible Party):
Radboud University

Tracking Information
First Submitted Date  ICMJE September 22, 2009
First Posted Date  ICMJE September 23, 2009
Last Update Posted Date July 24, 2012
Study Start Date  ICMJE July 2009
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2009)
  • urine osmolality [ Time Frame: 2 days ]
  • PPIUS urge-score [ Time Frame: 2 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2009)
  • urine pH [ Time Frame: 2 days ]
  • PPIUS urge score [ Time Frame: 2 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Overactive Bladder (OAB) Drink Advice Study
Official Title  ICMJE Prospective Intervention Study of Drink Advice in Overactive Bladder Syndrome (OAB)
Brief Summary The researchers want to investigate how fluid intake influences the symptoms of OAB. The researchers will recruit 45 patients with OAB and randomize them (blind) in 3 groups (low/normal/high fluid intake). Patients will follow this drink pattern for 2-5 days, while filling in an standard micturation diary for 2 days. This micturation diary is coupled to: collection of multiple urine samples, urine pH measurements, and a Perception of Intensity of Urgency Scale (PPIUS) scoring table. All this is collected by the patients themselves. Urine samples will be analysed for osmolality by the clinical chemistry department.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Overactive Bladder Syndrome
Intervention  ICMJE Dietary Supplement: water
drinking water / normal dietary fluids for oral intake
Study Arms  ICMJE
  • Active Comparator: normal fluid intake
    1500 ml /day (+/- 300 ml) for 2,5 days
    Intervention: Dietary Supplement: water
  • Active Comparator: high fluid intake
    2400 ml/day (+/- 300 ml )for 2,5 days
    Intervention: Dietary Supplement: water
  • Active Comparator: low fluid intake
    fluid intake 900 ml/day (+/- 300ml) for 2,5 days
    Intervention: Dietary Supplement: water
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: July 23, 2012)
0
Original Estimated Enrollment  ICMJE
 (submitted: September 22, 2009)
45
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • OAB patients

Exclusion Criteria:

  • benign prostatic hyperplasia
  • neurogenic detrusor overactivity
  • urine tract infection
  • anticholinergics
  • intravesical botulin toxin
  • cardiac failure
  • renal insufficiency
  • sacral neurostimulation
  • percutaneous neurostimulation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00982241
Other Study ID Numbers  ICMJE OABdrinkstudy
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Radboud University
Study Sponsor  ICMJE Radboud University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: John Heesakkers, dr. MD dept of Urology, Radboud University Nijmegen Medical Centre
PRS Account Radboud University
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP