N/A
N=150
The Effect of Urox™ in the Treatment of Overactive Bladder and Urinary Incontinence
Overactive Bladder · Urinary Incontinence · Urinary Frequency or Urgency Adverse Event · Nocturia
Bottom Line
View on ClinicalTrials.gov: NCT02396160 ↗Enrolled (actual)
150
Serious AEs
0.0%
Results posted
May 2016
Primary outcome: Primary: Day Urinary Frequency — 7.68; 10.95 number of diurnal micturitions per day
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Urox (Dietary_supplement); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Queensland
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Day Urinary Frequency |
7.68; 10.95 | — |
| PRIMARY Nocturia Frequency |
2.16; 3.11 | — |
| SECONDARY Urinary Urgency Frequency |
1.49; 3.92 | — |
| SECONDARY Urge Incontinence Frequency |
1.21; 2.36 | — |
| SECONDARY Stress Incontinence Frequency |
0.67; 1.6 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02396160). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.