Overactive Bladder (OAB) Drink Advice Study

July 23, 2012 updated by: Radboud University Medical Center

Prospective Intervention Study of Drink Advice in Overactive Bladder Syndrome (OAB)

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6500 HB
        • Dept. of Urology, Radboud University Nijmegen Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
urine osmolality
Time Frame: 2 days
2 days
PPIUS urge-score
Time Frame: 2 days
2 days

Secondary Outcome Measures

Outcome Measure
Time Frame
urine pH
Time Frame: 2 days
2 days
PPIUS urge score
Time Frame: 2 days
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

  • Study Chair: John Heesakkers, dr. MD, dept of Urology, Radboud University Nijmegen Medical Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

September 22, 2009

First Submitted That Met QC Criteria

September 22, 2009

First Posted (Estimate)

September 23, 2009

Study Record Updates

Last Update Posted (Estimate)

July 24, 2012

Last Update Submitted That Met QC Criteria

July 23, 2012

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OABdrinkstudy

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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