Trial Outcomes & Findings for The Effect of Urox™ in the Treatment of Overactive Bladder and Urinary Incontinence (NCT NCT02396160)
NCT ID: NCT02396160
Last Updated: 2016-05-05
Results Overview
Day urinary frequency as defined as the number of voluntary diurnal micturitions per day, recorded in a validated urinary diary
COMPLETED
NA
150 participants
8 weeks
2016-05-05
Participant Flow
Participant milestones
| Measure |
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
Urox: Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs
|
Placebo
identical placebo vegetarian capsule containing color-matched cellulose
Placebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
75
|
|
Overall Study
COMPLETED
|
69
|
73
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Urox™ in the Treatment of Overactive Bladder and Urinary Incontinence
Baseline characteristics by cohort
| Measure |
Treatment
n=75 Participants
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
|
Placebo
n=75 Participants
identical placebo vegetarian capsule containing color-matched cellulose
Placebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.21 years
STANDARD_DEVIATION 12.11 • n=99 Participants
|
62.26 years
STANDARD_DEVIATION 13.87 • n=107 Participants
|
63.23 years
STANDARD_DEVIATION 13.03 • n=206 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
88 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
Weight
|
79.90 kg
STANDARD_DEVIATION 18.78 • n=99 Participants
|
79.73 kg
STANDARD_DEVIATION 22.74 • n=107 Participants
|
79.82 kg
STANDARD_DEVIATION 20.81 • n=206 Participants
|
|
Day urinary frequency
|
50 participants
n=99 Participants
|
57 participants
n=107 Participants
|
107 participants
n=206 Participants
|
|
Night urinary frequency
|
70 participants
n=99 Participants
|
61 participants
n=107 Participants
|
131 participants
n=206 Participants
|
|
Urgency
|
62 participants
n=99 Participants
|
62 participants
n=107 Participants
|
124 participants
n=206 Participants
|
|
Urge incontinence
|
34 participants
n=99 Participants
|
35 participants
n=107 Participants
|
69 participants
n=206 Participants
|
|
Stress incontinence
|
11 participants
n=99 Participants
|
10 participants
n=107 Participants
|
21 participants
n=206 Participants
|
|
Any incontinence
|
35 participants
n=99 Participants
|
43 participants
n=107 Participants
|
78 participants
n=206 Participants
|
|
2 symptoms
|
24 participants
n=99 Participants
|
23 participants
n=107 Participants
|
47 participants
n=206 Participants
|
|
3 symptoms
|
33 participants
n=99 Participants
|
29 participants
n=107 Participants
|
62 participants
n=206 Participants
|
|
4 symptoms
|
18 participants
n=99 Participants
|
23 participants
n=107 Participants
|
41 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: 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.
Day urinary frequency as defined as the number of voluntary diurnal micturitions per day, recorded in a validated urinary diary
Outcome measures
| Measure |
Treatment
n=50 Participants
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
|
Placebo
n=57 Participants
identical placebo vegetarian capsule containing color-matched cellulose
Placebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment
|
|---|---|---|
|
Day Urinary Frequency
|
7.68 number of diurnal micturitions per day
Interval 7.46 to 7.91
|
10.95 number of diurnal micturitions per day
Interval 10.7 to 11.2
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: 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.
Night time urinary frequency as defined as the number of voluntary nocturnal micturition's per day recorded in a validated urinary diary
Outcome measures
| Measure |
Treatment
n=70 Participants
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
|
Placebo
n=61 Participants
identical placebo vegetarian capsule containing color-matched cellulose
Placebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment
|
|---|---|---|
|
Nocturia Frequency
|
2.16 number of nocturnal micturitions
Interval 2.02 to 2.29
|
3.11 number of nocturnal micturitions
Interval 2.98 to 3.24
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: 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.
Urinary urgency as defined by number of urgency episodes per day recorded in a validated urinary diary
Outcome measures
| Measure |
Treatment
n=62 Participants
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
|
Placebo
n=62 Participants
identical placebo vegetarian capsule containing color-matched cellulose
Placebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment
|
|---|---|---|
|
Urinary Urgency Frequency
|
1.49 number of urgency episodes
Interval 1.28 to 1.71
|
3.92 number of urgency episodes
Interval 3.65 to 4.19
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: 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.
Urge incontinence as defined by number of incontinence episodes per day resulting from urinary urgency, recorded in a validated urinary diary
Outcome measures
| Measure |
Treatment
n=34 Participants
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
|
Placebo
n=35 Participants
identical placebo vegetarian capsule containing color-matched cellulose
Placebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment
|
|---|---|---|
|
Urge Incontinence Frequency
|
1.21 number of urge incontinence episodes
Interval 0.89 to 1.54
|
2.36 number of urge incontinence episodes
Interval 2.07 to 2.66
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: 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.
Stress incontinence as defined by number of episodes of incontinence per day related to stress, recorded in a validated urinary diary
Outcome measures
| Measure |
Treatment
n=11 Participants
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
|
Placebo
n=10 Participants
identical placebo vegetarian capsule containing color-matched cellulose
Placebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment
|
|---|---|---|
|
Stress Incontinence Frequency
|
0.67 Number of stress incontinence episodes
Interval 0.47 to 0.86
|
1.6 Number of stress incontinence episodes
Interval 1.26 to 1.94
|
Adverse Events
Treatment
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment
n=69 participants at risk
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
|
Placebo
n=73 participants at risk
identical placebo vegetarian capsule containing color-matched cellulose
Placebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment
|
|---|---|---|
|
Gastrointestinal disorders
Episodes of diarrhea
|
2.9%
2/69
|
2.7%
2/73
|
|
Renal and urinary disorders
Urinary tract infection
|
2.9%
2/69
|
1.4%
1/73
|
|
Respiratory, thoracic and mediastinal disorders
Headache and worsened asthma
|
0.00%
0/69
|
1.4%
1/73
|
|
Psychiatric disorders
Worsened memory
|
0.00%
0/69
|
1.4%
1/73
|
|
Gastrointestinal disorders
Flatulence
|
1.4%
1/69
|
0.00%
0/73
|
|
General disorders
Facial flushing
|
0.00%
0/69
|
1.4%
1/73
|
|
General disorders
Halitosis
|
0.00%
0/69
|
1.4%
1/73
|
|
Musculoskeletal and connective tissue disorders
Worsened arthritic pain
|
0.00%
0/69
|
1.4%
1/73
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place