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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Overactive Bladder
Urinary Incontinence
Urinary Frequency or Urgency Adverse Event
Nocturia
Interventions Dietary Supplement: Urox
Other: Placebo
Enrollment 150
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment Placebo
Hide Arm/Group 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

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

identical placebo vegetarian capsule containing color-matched cellulose

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

Period Title: Overall Study
Started 75 75
Completed 69 73
Not Completed 6 2
Arm/Group Title Treatment Placebo Total
Hide Arm/Group 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

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

identical placebo vegetarian capsule containing color-matched cellulose

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

Total of all reporting groups
Overall Number of Baseline Participants 75 75 150
Hide Baseline Analysis Population Description
This data includes all those who met criteria (minimum of 2 of the following symptoms per day for 6 months - Urinary Day Frequency ≥10 daytime micturitions; Nocturia ≥2 night time micturitions; Urinary Urgency ≥2 episodes and/or Incontinence ≥1 episode) and were entered into randomisation at the commencement of their enrollment into the study
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 75 participants 75 participants 150 participants
64.21  (12.11) 62.26  (13.87) 63.23  (13.03)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 75 participants 150 participants
Female
40
  53.3%
48
  64.0%
88
  58.7%
Male
35
  46.7%
27
  36.0%
62
  41.3%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 75 participants 75 participants 150 participants
79.90  (18.78) 79.73  (22.74) 79.82  (20.81)
Day urinary frequency   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 75 participants 75 participants 150 participants
50 57 107
[1]
Measure Description: number of participants ≥10 daytime micturitions per day
Night urinary frequency   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 75 participants 75 participants 150 participants
70 61 131
[1]
Measure Description: number of participants ≥2 nocturnal micturitions per night
Urgency   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 75 participants 75 participants 150 participants
62 62 124
[1]
Measure Description: number of participants ≥2 urgency micturitions per day
Urge incontinence   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 75 participants 75 participants 150 participants
34 35 69
[1]
Measure Description: number of participants ≥1 urge incontinent episode per day
Stress incontinence   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 75 participants 75 participants 150 participants
11 10 21
[1]
Measure Description: number of participants ≥1 stress incontinent episodes per day
Any incontinence   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 75 participants 75 participants 150 participants
35 43 78
[1]
Measure Description: number of participants ≥1 any incontinence episodes per day
2 symptoms   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 75 participants 75 participants 150 participants
24 23 47
[1]
Measure Description: number of participants reporting meeting 2 symptom criteria per day
3 symptoms   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 75 participants 75 participants 150 participants
33 29 62
[1]
Measure Description: number of participants reporting meeting 3 symptom criteria per day
4 symptoms   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 75 participants 75 participants 150 participants
18 23 41
[1]
Measure Description: number of participants reporting meeting 4 symptom criteria per day
1.Primary Outcome
Title Day Urinary Frequency
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis includes participants who met the criteria for this outcome being day urination frequency ≥10 daytime micturitions per day at baseline. Please note that not all participants in this study met the criteria for all outcomes, hence numbers in each section may seem incongruent with total study participants.
Arm/Group Title Treatment Placebo
Hide Arm/Group 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

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

identical placebo vegetarian capsule containing color-matched cellulose

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

Overall Number of Participants Analyzed 50 57
Mean (95% Confidence Interval)
Unit of Measure: number of diurnal micturitions per day
7.68
(7.46 to 7.91)
10.95
(10.70 to 11.20)
2.Primary Outcome
Title Nocturia Frequency
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis includes participants who met the criteria for this outcome being nocturnal frequency ≥2 per day at baseline. Please note that not all participants in this study met the criteria for all outcomes, hence numbers in each section may seem incongruent with total study participants.
Arm/Group Title Treatment Placebo
Hide Arm/Group 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

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

identical placebo vegetarian capsule containing color-matched cellulose

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

Overall Number of Participants Analyzed 70 61
Mean (95% Confidence Interval)
Unit of Measure: number of nocturnal micturitions
2.16
(2.02 to 2.29)
3.11
(2.98 to 3.24)
3.Secondary Outcome
Title Urinary Urgency Frequency
Hide Description Urinary urgency as defined by number of urgency episodes per day recorded in a validated urinary diary
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis includes participants who met the criteria for this outcome being urgency urination frequency ≥1 per day at baseline. Please note that not all participants in this study met the criteria for all outcomes, hence numbers in each section may seem incongruent with total study participants.
Arm/Group Title Treatment Placebo
Hide Arm/Group 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

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

identical placebo vegetarian capsule containing color-matched cellulose

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

Overall Number of Participants Analyzed 62 62
Mean (95% Confidence Interval)
Unit of Measure: number of urgency episodes
1.49
(1.28 to 1.71)
3.92
(3.65 to 4.19)
4.Secondary Outcome
Title Urge Incontinence Frequency
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis includes participants who met the criteria for this outcome being urge incontinent frequency ≥1 per day at baseline. Please note that not all participants in this study met the criteria for all outcomes, hence numbers in each section may seem incongruent with total study participants.
Arm/Group Title Treatment Placebo
Hide Arm/Group 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

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

identical placebo vegetarian capsule containing color-matched cellulose

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

Overall Number of Participants Analyzed 34 35
Mean (95% Confidence Interval)
Unit of Measure: number of urge incontinence episodes
1.21
(0.89 to 1.54)
2.36
(2.07 to 2.66)
5.Secondary Outcome
Title Stress Incontinence Frequency
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis includes participants who met the criteria for this outcome being stress incontinence frequency ≥1 per day at baseline. Please note that not all participants in this study met the criteria for all outcomes, hence numbers in each section may seem incongruent with total study participants.
Arm/Group Title Treatment Placebo
Hide Arm/Group 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

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

identical placebo vegetarian capsule containing color-matched cellulose

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

Overall Number of Participants Analyzed 11 10
Mean (95% Confidence Interval)
Unit of Measure: Number of stress incontinence episodes
0.67
(0.47 to 0.86)
1.6
(1.26 to 1.94)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment Placebo
Hide Arm/Group 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

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

identical placebo vegetarian capsule containing color-matched cellulose

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

All-Cause Mortality
Treatment Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/69 (0.00%)   0/73 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   5/69 (7.25%)   8/73 (10.96%) 
Gastrointestinal disorders     
Episodes of diarrhea   2/69 (2.90%)  2/73 (2.74%) 
Flatulence   1/69 (1.45%)  0/73 (0.00%) 
General disorders     
Facial flushing   0/69 (0.00%)  1/73 (1.37%) 
Halitosis   0/69 (0.00%)  1/73 (1.37%) 
Musculoskeletal and connective tissue disorders     
Worsened arthritic pain   0/69 (0.00%)  1/73 (1.37%) 
Psychiatric disorders     
Worsened memory   0/69 (0.00%)  1/73 (1.37%) 
Renal and urinary disorders     
Urinary tract infection   2/69 (2.90%)  1/73 (1.37%) 
Respiratory, thoracic and mediastinal disorders     
Headache and worsened asthma   0/69 (0.00%)  1/73 (1.37%) 
Indicates events were collected by systematic assessment
Limitations of this study include the relatively short duration and lack of long-term follow up. As a phase 2 clinical trial, there was no active comparator and a smaller sample size was also utilized.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Niikee Schoendorfer
Organization: University of Queensland
Phone: 0413122076
EMail: n.schoendorfer@uq.edu.au
Layout table for additonal information
Responsible Party: Dr Niikee Schoendorfer, The University of Queensland
ClinicalTrials.gov Identifier: NCT02396160     History of Changes
Other Study ID Numbers: SG-04
First Submitted: March 17, 2015
First Posted: March 24, 2015
Results First Submitted: December 22, 2015
Results First Posted: May 5, 2016
Last Update Posted: May 5, 2016