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

NCT ID: NCT02396160

Last Updated: 2016-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2015-05-31

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.

Conditions

Overactive Bladder; Urinary Incontinence; Urinary Frequency or Urgency Adverse Event; Nocturia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Urox

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

identical placebo vegetarian capsule containing color-matched cellulose

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

Urox

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Tasmania

OTHER

Sponsor Role: collaborator

Seipel Group Pty Ltd

INDUSTRY

Sponsor Role: collaborator

Endeavour College of Natural Health

UNKNOWN

Sponsor Role: collaborator

The University of Queensland

OTHER

Sponsor Role: lead

Responsible Party

Dr Niikee Schoendorfer

Research Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Niikee Schoendorfer, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Queensland

References

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.

Reference Type: DERIVED

PMID: 29385990 (View on PubMed)

Other Identifiers

SG-04

Identifier Type: -

Identifier Source: org_study_id