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Overactive Bladder (OAB) Drink Advice Study

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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Recruitment Status : Withdrawn (Difficulty in enrolling participants)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

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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Syndrome Dietary Supplement: water Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Prospective Intervention Study of Drink Advice in Overactive Bladder Syndrome (OAB)
Study Start Date : July 2009
Actual Primary Completion Date : December 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: normal fluid intake
1500 ml /day (+/- 300 ml) for 2,5 days
Dietary Supplement: water
drinking water / normal dietary fluids for oral intake

Active Comparator: high fluid intake
2400 ml/day (+/- 300 ml )for 2,5 days
Dietary Supplement: water
drinking water / normal dietary fluids for oral intake

Active Comparator: low fluid intake
fluid intake 900 ml/day (+/- 300ml) for 2,5 days
Dietary Supplement: water
drinking water / normal dietary fluids for oral intake




Primary Outcome Measures :
  1. urine osmolality [ Time Frame: 2 days ]
  2. PPIUS urge-score [ Time Frame: 2 days ]

Secondary Outcome Measures :
  1. urine pH [ Time Frame: 2 days ]
  2. PPIUS urge score [ Time Frame: 2 days ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT00982241


Locations
Netherlands
Dept. of Urology, Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Investigators
Study Chair: John Heesakkers, dr. MD dept of Urology, Radboud University Nijmegen Medical Centre

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT00982241     History of Changes
Other Study ID Numbers: OABdrinkstudy
First Posted: September 23, 2009    Key Record Dates
Last Update Posted: July 24, 2012
Last Verified: September 2009

Keywords provided by Radboud University:
OAB
urine
osmolality
urge
fluid intake
PPIUS
urge score
bladder

Additional relevant MeSH terms:
Syndrome
Urinary Bladder, Overactive
Disease
Pathologic Processes
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms