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

Primary Purpose

Overactive Bladder, Urinary Incontinence, Urinary Frequency or Urgency Adverse Event

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Urox
Placebo
Sponsored by
The University of Queensland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring overactive bladder, urinary incontinence, nocturia, urinary frequency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Inclusion criteria include symptoms of urinary frequency (at least ten times per day) and/or incontinence (at least nine episodes per week), provided they have experienced symptoms of OAB for at least 6 months.

Exclusion Criteria:

  1. Recent surgery particularly hysterectomy or prolapse repair (within the last 12 months)
  2. Recently undergone childbirth (within the last 12 months), or currently pregnant.
  3. Use of any natural therapies for bladder symptoms in the last month.
  4. Concomitant health conditions such as uncontrolled diabetes mellitus, heart disease, pancreatic, hepatic or renal disease, recurrent urinary tract infections, and chronic inflammatory conditions, which may otherwise affect outcomes.
  5. Currently being treated for mental health issues or psychiatric disturbances.
  6. Any individuals who are presently taking prescribed medication for incontinence or OAB.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Treatment

    Placebo

    Arm Description

    2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root

    identical placebo vegetarian capsule containing color-matched cellulose

    Outcomes

    Primary Outcome Measures

    Day Urinary Frequency
    Day urinary frequency as defined as the number of voluntary diurnal micturitions per day, recorded in a validated urinary diary
    Nocturia Frequency
    Night time urinary frequency as defined as the number of voluntary nocturnal micturition's per day recorded in a validated urinary diary

    Secondary Outcome Measures

    Urinary Urgency Frequency
    Urinary urgency as defined by number of urgency episodes per day recorded in a validated urinary diary
    Urge Incontinence Frequency
    Urge incontinence as defined by number of incontinence episodes per day resulting from urinary urgency, recorded in a validated urinary diary
    Stress Incontinence Frequency
    Stress incontinence as defined by number of episodes of incontinence per day related to stress, recorded in a validated urinary diary

    Full Information

    First Posted
    March 17, 2015
    Last Updated
    April 3, 2016
    Sponsor
    The University of Queensland
    Collaborators
    University of Tasmania, Seipel Group Pty Ltd, Endeavour College of Natural Health
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02396160
    Brief Title
    The Effect of Urox™ in the Treatment of Overactive Bladder and Urinary Incontinence
    Official Title
    The Effect of Urox™(Crateva, Horsetail and Lindera Combination) in the Treatment of Overactive Bladder and Urinary Incontinence
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2013 (undefined)
    Primary Completion Date
    December 2014 (Actual)
    Study Completion Date
    May 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The University of Queensland
    Collaborators
    University of Tasmania, Seipel Group Pty Ltd, Endeavour College of Natural Health

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    Detailed Description
    Initial consultations were held at either the Brisbane campus of the Endeavour College of Natural Medicine Naturopathic clinic or at Kelvin Grove Natural Medicine clinic, Brisbane. Follow up interviews are being conducted via telephone. To minimize dropout rates, participants are telephoned (as a reminder for the call and to complete the micturition diaries) approximately 1 week before the scheduled interview time and were intermittently called over the week following if they were unable to be reached at the scheduled interview time. Three attending clinicians interviewed trial participants, all having participated in interview training prior to any interviews being taken. The training was designed to ensure utility of a uniform and consistent approach regarding how questions were asked and how data was recorded. The week prior to an initial consultation participants were requested to complete a micturition diary and health related quality of life surveys, to serve as baseline measures. The attending clinician then also completed a clinical data sheet, at the time of the initial consultation, containing a range of questions including demographics, exercise, health history and habits, which will be used to control and correlate data variables. Any incomplete quality of life surveys at the outset were also completed at the first interview. Micturition diaries are collected by post at 2, 4 and 8 week intervals along with the completion of quality of life surveys and follow up clinical data sheet via telephone. Participants were asked to keep the micturition diary for 3 days prior to each consultation and were provided reply paid envelopes to return the surveys and unused capsules to assess compliance. For the primary outcome (day frequency) measure it was calculated that 90 participants equally divided into placebo and control were required to detect a difference of 1.6 urinary frequency episodes per day (2.7SD) between treatment and placebo groups, with a two-tailed alpha of 0.05 and a power of 80%. For total incontinence, 53 participants were required equally divided into each group to detect a difference of 1.2 episodes per day (2.2SD), while for urgency 54 was required in each group to detect a difference of 2 per day (3.7SD). To account for potential drop-outs and variations in presenting symptoms, a total of 150 participants were recruited. Data for the two treatments will be compared using mixed effects ordered logistic regression adjusted for repeated measures (Stata, version 13.1, StataCorp, TX, USA). GraphPad Prism (version 6.00 for Windows, GraphPad Software, La Jolla California, USA) will be used to plot the data. Data (day frequency, night frequency, urgency and incontinence) will be evaluated by intention to treat analysis, with the last result brought forward for people who dropped out or were lost to follow-up. Variables selected for adjustment using backward stepwise regression from list including age, sex, water intake and diuretic use (p<0.22 for covariate inclusion). Holm estimation test will be used to adjust p-values for repeated measures. Each analysis will only included participants who are symptomatic at baseline. For example, in relation to daytime urinary frequency - only participants with baseline of ≥10 will be included in the analyses.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overactive Bladder, Urinary Incontinence, Urinary Frequency or Urgency Adverse Event, Nocturia
    Keywords
    overactive bladder, urinary incontinence, nocturia, urinary frequency

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    150 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment
    Arm Type
    Active Comparator
    Arm Description
    2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    identical placebo vegetarian capsule containing color-matched cellulose
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Urox
    Intervention Description
    Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment
    Primary Outcome Measure Information:
    Title
    Day Urinary Frequency
    Description
    Day urinary frequency as defined as the number of voluntary diurnal micturitions per day, recorded in a validated urinary diary
    Time Frame
    8 weeks
    Title
    Nocturia Frequency
    Description
    Night time urinary frequency as defined as the number of voluntary nocturnal micturition's per day recorded in a validated urinary diary
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    Urinary Urgency Frequency
    Description
    Urinary urgency as defined by number of urgency episodes per day recorded in a validated urinary diary
    Time Frame
    8 weeks
    Title
    Urge Incontinence Frequency
    Description
    Urge incontinence as defined by number of incontinence episodes per day resulting from urinary urgency, recorded in a validated urinary diary
    Time Frame
    8 weeks
    Title
    Stress Incontinence Frequency
    Description
    Stress incontinence as defined by number of episodes of incontinence per day related to stress, recorded in a validated urinary diary
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Inclusion criteria include symptoms of urinary frequency (at least ten times per day) and/or incontinence (at least nine episodes per week), provided they have experienced symptoms of OAB for at least 6 months. Exclusion Criteria: Recent surgery particularly hysterectomy or prolapse repair (within the last 12 months) Recently undergone childbirth (within the last 12 months), or currently pregnant. Use of any natural therapies for bladder symptoms in the last month. Concomitant health conditions such as uncontrolled diabetes mellitus, heart disease, pancreatic, hepatic or renal disease, recurrent urinary tract infections, and chronic inflammatory conditions, which may otherwise affect outcomes. Currently being treated for mental health issues or psychiatric disturbances. Any individuals who are presently taking prescribed medication for incontinence or OAB.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Niikee Schoendorfer, PhD
    Organizational Affiliation
    The University of Queensland
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    As data was analysed de-identified, it is not possible to have individual participant data available associated with their name and details.
    Citations:
    PubMed Identifier
    29385990
    Citation
    Schoendorfer N, Sharp N, Seipel T, Schauss AG, Ahuja KDK. Urox containing concentrated extracts of Crataeva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root, in the treatment of symptoms of overactive bladder and urinary incontinence: a phase 2, randomised, double-blind placebo controlled trial. BMC Complement Altern Med. 2018 Jan 31;18(1):42. doi: 10.1186/s12906-018-2101-4.
    Results Reference
    derived

    Learn more about this trial

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

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