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Overactive Bladder (OAB) Drink Advice Study

NCT ID: NCT00982241

Last Updated: 2012-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Brief Summary

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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

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Conditions

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Overactive Bladder Syndrome

Keywords

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OAB urine osmolality urge fluid intake PPIUS urge score bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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normal fluid intake

1500 ml /day (+/- 300 ml) for 2,5 days

Group Type ACTIVE_COMPARATOR

water

Intervention Type DIETARY_SUPPLEMENT

drinking water / normal dietary fluids for oral intake

high fluid intake

2400 ml/day (+/- 300 ml )for 2,5 days

Group Type ACTIVE_COMPARATOR

water

Intervention Type DIETARY_SUPPLEMENT

drinking water / normal dietary fluids for oral intake

low fluid intake

fluid intake 900 ml/day (+/- 300ml) for 2,5 days

Group Type ACTIVE_COMPARATOR

water

Intervention Type DIETARY_SUPPLEMENT

drinking water / normal dietary fluids for oral intake

Interventions

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water

drinking water / normal dietary fluids for oral intake

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Heesakkers, dr. MD

Role: STUDY_CHAIR

dept of Urology, Radboud University Nijmegen Medical Centre

Locations

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Dept. of Urology, Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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OABdrinkstudy

Identifier Type: -

Identifier Source: org_study_id