Conclusions

The aim of the Schoendorfer et al adult RDBPCT, published January 2018, was to assess the efficacy of Urox, containing concentrated extracts of Cratevox, (Crataeva nurvala), Equisetum arvense and Lindera aggregata, in reducing symptoms of overactive bladder, including urinary urgency, day frequency, nocturia and urge urinary incontinence, as well stress urinary incontinence.

Conclusions

This study demonstrated significant efficacy and tolerability of the phytomedicine formula, Urox, in the treatment of UI and symptoms of OAB. A strength of this study is the lack of side effects typically associated with anticholinergic/antimuscarinic medications over the same 8-week period and the significant improvement in quality of life.

This study demonstrated significant efficacy and tolerability of the phytomedicine formula, Urox, in the treatment of UI and symptoms of OAB. A strength of this study is the lack of side effects typically associated with anticholinergic/antimuscarinic medications over the same 8-week period and the significant improvement in quality of life.

Frequency – Day and Night (Nocturia)

Results show that 60% of participants in the Urox group reported normalization (i.e., 8 or less micturitions/day) of their excessive day frequency after week-8 of the trial, compared with 11% of the placebo group. Similarly, for nocturia, 24% of the Urox group became symptom free at the end of the trial (with improvements observed as early as 2 weeks), compared to less than 2% of the placebo group.

Urinary Urgency

For urinary urgency, 21% of Urox participants reported no urgency at the end of the trial period, compared to only 5% in the placebo group.

Urinary incontinence

23% percent of participants in the Urox group reported they were incontinence free at the end of 8 weeks compared to 7% in the placebo group.

Urox® produced more extensive benefits for symptoms of OAB than has been shown with earlier herbal research, and within a shorter timeframe. As well these improvements were observed in both men and women. Urox® is the only herbal randomised, controlled research that has shown statistically significant improvement in symptoms of urinary incontinence.

Halving nocturia within two months of treatment reduces the additional debility of interrupted sleep in these patients, and is considered highly clinically relevant. Reductions in day urinary frequency, urgency and incontinence are also very clinically relevant particularly to patients whose lives can be continuously interrupted on a daily basis by needing to use toilet facilities within a close proximity of their whereabouts. Also, reduction of adult diaper or pad usage to “precautionary” is considered a significant quality of life improvement.

The outcome of this randomised controlled trial demonstrates both statistical significance and clinical relevance in reducing urinary frequency, OAB and UI symptoms, over 8 weeks, without side effects commonly seen with anticholinergic and antimuscarinic medications, showing Urox is an effective herbal option for bladder control.

The study results help to confirm the results of previous published and unpublished animal and human studies and demonstrate the effectiveness of Urox in improving bladder control, reducing diaper usage and improving quality of life in humans.

Results include:

Statistically significant reduction in urinary frequency in the Urox group compared to the placebo group.
Statistically significant improvement in nocturia in the Urox group compared to the placebo group
Statistically significant reduction in urinary urgency, in the Urox group compared to the placebo group.
Statistically significant reduction in stress urinary incontinence, in the Urox group compared to the placebo group.
Statistically significant reduction in urge urinary incontinence, in the Urox group compared to the placebo group.
Statistically significant reduction in diaper usage, in the Urox group compared to the placebo group.
Statistically significant Quality of Life (QOL) improvements using validated questionnaires found with the Urox group but not in the placebo group include:
- Total QOL scores
- Bothersome
- Difficulty in coping
- Concern/worry
- Difficulty sleeping
- Social interaction
No significant side effects were observed resulting in withdrawal from the study

Urinary incontinence

23% percent of participants in the Urox group reported they were incontinence free at the end of 8 weeks compared to 7% in the placebo group.

Urox® produced more extensive benefits for symptoms of OAB than has been shown with earlier herbal research, and within a shorter timeframe. As well these improvements were observed in both men and women. Urox® is the only herbal randomised, controlled research that has shown statistically significant improvement in symptoms of urinary incontinence.

Halving nocturia within two months of treatment reduces the additional debility of interrupted sleep in these patients, and is considered highly clinically relevant. Reductions in day urinary frequency, urgency and incontinence are also very clinically relevant particularly to patients whose lives can be continuously interrupted on a daily basis by needing to use toilet facilities within a close proximity of their whereabouts. Also, reduction of adult diaper or pad usage to “precautionary” is considered a significant quality of life improvement.

The outcome of this randomised controlled trial demonstrates both statistical significance and clinical relevance in reducing urinary frequency, OAB and UI symptoms, over 8 weeks, without side effects commonly seen with anticholinergic and antimuscarinic medications, showing Urox is an effective herbal option for bladder control.

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Conclusions

Conclusions

Results include:

Bladder Control Background

Clinical Trials

Conclusions

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