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The Effect of Urox™ in the Treatment of Overactive Bladder and Urinary Incontinence

NCT02396160 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2016-05-05

Study results available
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Summary

This study aims to assess the efficacy of a specialized herbal formula, Urox, versus control over 8 weeks, in a double blind, placebo controlled trial. 150 participants are being recruited, randomized and administered treatment or placebo for the period of 8 weeks after initial eligibility screening. Outcome measures include previously validated tools such as the 3 day symptom diary measuring self-recorded day frequency, nocturia, urgency and incontinence episodes. Quality of life improvements are being measured using the Incontinence Impact Questionnaire, Urinary Distress Inventory and the short version of the OverActive Bladder survey.

Conditions

Interventions

DIETARY_SUPPLEMENT

Urox

Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs

OTHER

Placebo

Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment

Sponsors & Collaborators

  • University of Tasmania

    collaborator OTHER

  • Seipel Group Pty Ltd

    collaborator INDUSTRY

  • Endeavour College of Natural Health

    collaborator UNKNOWN

  • The University of Queensland

    lead OTHER

Principal Investigators

  • Niikee Schoendorfer, PhD · The University of Queensland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2014-12-31
Completion
2015-05-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02396160 on ClinicalTrials.gov