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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; 18(1):42BC

Abstract

BACKGROUND

Storage lower urinary tract symptoms (LUTS) including overactive bladder (OAB) and urinary incontinence (UI) affect millions of people worldwide, significantly impacting quality of life. Plant based medicines have been documented both empirically and in emerging scientific research to have varying benefits in reducing bladder symptoms. We assessed the efficacy of Urox®, a proprietary combination of phytomedicine extracts including, Cratevox™ (Crataeva nurvala) stem bark, Equisetem arvense stem and Lindera aggregata root, in reducing symptoms of OAB and UI.

METHODS

Efficacy of the herbal combination on a variety of bladder symptoms compared to an identical placebo, were documented in a randomised, double-blind, placebo controlled trial conducted at two primary care centres. Data were collected at baseline, 2, 4 and 8 weeks, with the primary outcome being self-reported urinary frequency. Statistical analysis included mixed effects ordered logistic regression with post hoc Holm's test to account for repeated measures, and included an intention-to-treat analysis.

RESULTS

One hundred and fifty participants (59% female, aged; mean ± SD; 63.5 ± 13.1 years) took part in the study. At week 8, urinary day frequency was significantly lower (OR 0.01; 95%CI 0.01 to 0.02; p < 0.001) in response to treatment (mean ± SD; 7.69 ± 2.15/day) compared to placebo (10.95 ± 2.47/day). Similarly, episodes of nocturia were significantly fewer (OR 0.03; 95%CI 0.02 to 0.05) after 8 weeks of treatment (2.16 ± 1.49/night) versus placebo (3.14 ± 1.36/night). Symptoms of urgency (OR 0.02; 95%CI 0.01 to 0.03), and total incontinence (OR 0.03; 95% CI 0.01 to 0.06) were also lower (all p < 0.01) in the treatment group. Significant improvements in quality of life were reported after treatment in comparison to placebo. No significant side effects were observed resulting in withdrawal from treatment.

CONCLUSIONS

The outcome of this study demonstrated both statistical significance and clinical relevance in reducing symptoms of OAB, urinary frequency and/or urgency and incontinence. The demonstrated viability of the herbal combination to serve as an effective treatment, with minimal side-effects, warrants further longer term research and consideration by clinicians.

TRIAL REGISTRATION

NCT02396160 (registered on 17 March 2015 - before any statistical analyses commenced).

Authors+Show Affiliations

School of Medicine, University of Queensland, Herston, Australia.School of Medicine, University of Queensland, Herston, Australia.Occidental Medicine Department, Endeavour College of Natural Health, Brisbane, Queensland, Australia. Seipel Group, Brisbane, Australia.Bio5 Institute, Office of Research, Discovery and Innovation, and College of Science, University of Arizona; and, AIBMR Life Sciences, Seattle, Washington, USA.School of Health Sciences, University of Tasmania, Locked Bag 1322, Launceston, Tasmania, 7250, Australia. Kiran.Ahuja@utas.edu.au.

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

29385990

Citation

Schoendorfer, Niikee, et al. "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 Complementary and Alternative Medicine, vol. 18, no. 1, 2018, p. 42.
Schoendorfer N, Sharp N, Seipel T, et al. 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;18(1):42.
Schoendorfer, N., Sharp, N., Seipel, T., Schauss, A. G., & Ahuja, K. D. K. (2018). 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 Complementary and Alternative Medicine, 18(1), p. 42. doi:10.1186/s12906-018-2101-4.
Schoendorfer N, et al. 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. PubMed PMID: 29385990.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Schoendorfer,Niikee, AU - Sharp,Nita, AU - Seipel,Tracey, AU - Schauss,Alexander G, AU - Ahuja,Kiran D K, Y1 - 2018/01/31/ PY - 2016/12/06/received PY - 2018/01/17/accepted PY - 2018/2/2/entrez PY - 2018/2/2/pubmed PY - 2018/3/2/medline KW - Incontinence KW - Nocturia KW - Overactive bladder KW - Phytomedicine KW - Urgency SP - 42 EP - 42 JF - BMC complementary and alternative medicine JO - BMC Complement Altern Med VL - 18 IS - 1 N2 - BACKGROUND: Storage lower urinary tract symptoms (LUTS) including overactive bladder (OAB) and urinary incontinence (UI) affect millions of people worldwide, significantly impacting quality of life. Plant based medicines have been documented both empirically and in emerging scientific research to have varying benefits in reducing bladder symptoms. We assessed the efficacy of Urox®, a proprietary combination of phytomedicine extracts including, Cratevox™ (Crataeva nurvala) stem bark, Equisetem arvense stem and Lindera aggregata root, in reducing symptoms of OAB and UI. METHODS: Efficacy of the herbal combination on a variety of bladder symptoms compared to an identical placebo, were documented in a randomised, double-blind, placebo controlled trial conducted at two primary care centres. Data were collected at baseline, 2, 4 and 8 weeks, with the primary outcome being self-reported urinary frequency. Statistical analysis included mixed effects ordered logistic regression with post hoc Holm's test to account for repeated measures, and included an intention-to-treat analysis. RESULTS: One hundred and fifty participants (59% female, aged; mean ± SD; 63.5 ± 13.1 years) took part in the study. At week 8, urinary day frequency was significantly lower (OR 0.01; 95%CI 0.01 to 0.02; p < 0.001) in response to treatment (mean ± SD; 7.69 ± 2.15/day) compared to placebo (10.95 ± 2.47/day). Similarly, episodes of nocturia were significantly fewer (OR 0.03; 95%CI 0.02 to 0.05) after 8 weeks of treatment (2.16 ± 1.49/night) versus placebo (3.14 ± 1.36/night). Symptoms of urgency (OR 0.02; 95%CI 0.01 to 0.03), and total incontinence (OR 0.03; 95% CI 0.01 to 0.06) were also lower (all p < 0.01) in the treatment group. Significant improvements in quality of life were reported after treatment in comparison to placebo. No significant side effects were observed resulting in withdrawal from treatment. CONCLUSIONS: The outcome of this study demonstrated both statistical significance and clinical relevance in reducing symptoms of OAB, urinary frequency and/or urgency and incontinence. The demonstrated viability of the herbal combination to serve as an effective treatment, with minimal side-effects, warrants further longer term research and consideration by clinicians. TRIAL REGISTRATION: NCT02396160 (registered on 17 March 2015 - before any statistical analyses commenced). SN - 1472-6882 UR - https://www.unboundmedicine.com/medline/citation/29385990/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_ L2 - https://bmccomplementalternmed.biomedcentral.com/articles/10.1186/s12906-018-2101-4 DB - PRIME DP - Unbound Medicine ER -