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
About this trial
This is an interventional treatment trial for Overactive Bladder focused on measuring overactive bladder, urinary incontinence, nocturia, urinary frequency
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.
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
NCT ID
NCT02396160
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
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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