Clinical trial NCT02396160: 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
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder
Urinary Incontinence
Urinary Frequency or Urgency Adverse Event
Nocturia
Keywords: overactive bladder
urinary incontinence
nocturia
urinary frequency
Lead sponsor: The University of Queensland
Sponsor class: OTHER
Collaborators: name: University of Tasmania
name: Seipel Group Pty Ltd
name: Endeavour College of Natural Health
First posted: 2015-03-24
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

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.

Primary outcomes:
measure: Day Urinary Frequency
timeFrame: 8 weeks
measure: Nocturia Frequency
timeFrame: 8 weeks
Secondary outcomes:
measure: Urinary Urgency Frequency
timeFrame: 8 weeks
measure: Urge Incontinence Frequency
timeFrame: 8 weeks
measure: Stress Incontinence Frequency
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: The University of Queensland
name: Niikee Schoendorfer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.