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

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ClinicalTrials.gov Identifier: NCT02396160
Recruitment Status : Completed
First Posted : March 24, 2015
Results First Posted : May 5, 2016
Last Update Posted : May 5, 2016
Sponsor:
Collaborators:
University of Tasmania
Seipel Group Pty Ltd
Endeavour College of Natural Health
Information provided by (Responsible Party):
Dr Niikee Schoendorfer, The University of Queensland

Tracking Information
First Submitted Date  ICMJE March 17, 2015
First Posted Date  ICMJE March 24, 2015
Results First Submitted Date  ICMJE December 22, 2015
Results First Posted Date  ICMJE May 5, 2016
Last Update Posted Date May 5, 2016
Study Start Date  ICMJE August 2013
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2016)
  • Day Urinary Frequency [ Time Frame: 8 weeks ]
    Day urinary frequency as defined as the number of voluntary diurnal micturitions per day, recorded in a validated urinary diary
  • Nocturia Frequency [ Time Frame: 8 weeks ]
    Night time urinary frequency as defined as the number of voluntary nocturnal micturition's per day recorded in a validated urinary diary
Original Primary Outcome Measures  ICMJE
 (submitted: March 23, 2015)
Reduction in diurnal and nocturnal micturitions (urinary frequency as defined as the number of voluntary diurnal and nocturnal micturitions recorded in a validated urinary diary) [ Time Frame: 8 weeks ]
The primary outcome measure will be urinary frequency as defined as the number of voluntary diurnal and nocturnal micturitions recorded in a validated urinary diary
Change History Complete list of historical versions of study NCT02396160 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2016)
  • Urinary Urgency Frequency [ Time Frame: 8 weeks ]
    Urinary urgency as defined by number of urgency episodes per day recorded in a validated urinary diary
  • Urge Incontinence Frequency [ Time Frame: 8 weeks ]
    Urge incontinence as defined by number of incontinence episodes per day resulting from urinary urgency, recorded in a validated urinary diary
  • Stress Incontinence Frequency [ Time Frame: 8 weeks ]
    Stress incontinence as defined by number of episodes of incontinence per day related to stress, recorded in a validated urinary diary
Original Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2015)
  • Reduction in urinary urgency (measures recorded in a validated urinary diary) [ Time Frame: 8 weeks ]
    Reduction in urinary urgency as defined by
  • Reduction in urinary incontinence (measures recorded in a validated urinary diary) [ Time Frame: 8 weeks ]
    Reduction in urinary incontinence as defined by measures recorded in a validated urinary diary
  • Improvement of quality of life [ Time Frame: 8 weeks ]
    Improvement in quality of life as measured by the validated quality of life surveys (OAB-SF, IIQ and UDI)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Urox™ in the Treatment of Overactive Bladder and Urinary Incontinence
Official Title  ICMJE The Effect of Urox™(Crateva, Horsetail and Lindera Combination) in the Treatment of Overactive Bladder and Urinary Incontinence
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Overactive Bladder
  • Urinary Incontinence
  • Urinary Frequency or Urgency Adverse Event
  • Nocturia
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Treatment
    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
    Intervention: Dietary Supplement: Urox
  • Placebo Comparator: Placebo
    identical placebo vegetarian capsule containing color-matched cellulose
    Intervention: Other: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 23, 2015)
150
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02396160
Other Study ID Numbers  ICMJE SG-04
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: As data was analysed de-identified, it is not possible to have individual participant data available associated with their name and details.
Responsible Party Dr Niikee Schoendorfer, The University of Queensland
Study Sponsor  ICMJE The University of Queensland
Collaborators  ICMJE
  • University of Tasmania
  • Seipel Group Pty Ltd
  • Endeavour College of Natural Health
Investigators  ICMJE
Principal Investigator: Niikee Schoendorfer, PhD The University of Queensland
PRS Account The University of Queensland
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP