Effectiveness of Oral Boldo in Women With Overactive Bladder

Summary

The objective of this clinical trial is to know if boldo oral powder capsules works well in the management of urinary symptoms in women with overactive bladder. The main questions it aims to answer are: * Is boldo supplementation safe? * Does boldo improve urinary parameters and body stability? 5 participants will be treated with an oral antimuscarinic (oxybutynin) and supplemented with oral spray bolus. The urinary chart will be applied to measure urinary frequency and voiding intervals. In addition, urinary symptoms and the level of discomfort they generate will be measured. Finally, the MiniBest test will be applied using a portable device which acts as an inertial sensor to record the movements made. For comparative purposes, 5 women who will only be treated with the oral antimuscarinic (oxybutynin) will be measured to see if there are significant differences between the medication alone versus the supplemented medication.

Timeline

Start

2023-11-01

Primary completion

2024-01-31

Completion

2024-03-30

Publications

• Background Gibson W, Jones A, Hunter K, Wagg A. Urinary urgency acts as a source of divided attention leading to changes in gait in older adults with overactive bladder. PLoS One. 2021 Oct 4;16(10):e0257506. doi: 10.1371/journal.pone.0257506. eCollection 2021.
• Background Lightner DJ, Gomelsky A, Souter L, Vasavada SP. Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults: AUA/SUFU Guideline Amendment 2019. J Urol. 2019 Sep;202(3):558-563. doi: 10.1097/JU.0000000000000309. Epub 2019 Aug 8.
• Background Neuhaus J, Pfeiffer F, Wolburg H, Horn LC, Dorschner W. Alterations in connexin expression in the bladder of patients with urge symptoms. BJU Int. 2005 Sep;96(4):670-6. doi: 10.1111/j.1464-410X.2005.05703.x.
• Background Subedi YP, Altenberg GA, Chang CT. Advances in the development of connexin hemichannel inhibitors selective toward Cx43. Future Med Chem. 2021 Feb;13(4):379-392. doi: 10.4155/fmc-2020-0291. Epub 2021 Jan 5.
• Background Cea LA, Vasquez W, Hernandez-Salinas R, Vielma AZ, Castillo-Ruiz M, Velarde V, Salgado M, Saez JC. Skeletal Muscle Atrophy Induced by Diabetes Is Mediated by Non-Selective Channels and Prevented by Boldine. Biomolecules. 2023 Apr 21;13(4):708. doi: 10.3390/biom13040708.
• Background Milsom I, Abrams P, Cardozo L, Roberts RG, Thuroff J, Wein AJ. How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study. BJU Int. 2001 Jun;87(9):760-6. doi: 10.1046/j.1464-410x.2001.02228.x.
• Background Nowakowski L, Kulik-Rechberger B, Wrobel A, Rechberger T. [Overactive bladder--a new insight into the pathogenesis of its idiopathic form]. Ginekol Pol. 2012 Nov;83(11):844-8. Polish.
• Background Christ GJ, Day NS, Day M, Zhao W, Persson K, Pandita RK, Andersson KE. Increased connexin43-mediated intercellular communication in a rat model of bladder overactivity in vivo. Am J Physiol Regul Integr Comp Physiol. 2003 May;284(5):R1241-8. doi: 10.1152/ajpregu.00030.2002.
• Background Ikeda Y, Fry C, Hayashi F, Stolz D, Griffiths D, Kanai A. Role of gap junctions in spontaneous activity of the rat bladder. Am J Physiol Renal Physiol. 2007 Oct;293(4):F1018-25. doi: 10.1152/ajprenal.00183.2007. Epub 2007 Jun 20.
• Background Backhouse N, Delporte C, Givernau M, Cassels BK, Valenzuela A, Speisky H. Anti-inflammatory and antipyretic effects of boldine. Agents Actions. 1994 Oct;42(3-4):114-7. doi: 10.1007/BF01983475.
• Background O'Brien P, Carrasco-Pozo C, Speisky H. Boldine and its antioxidant or health-promoting properties. Chem Biol Interact. 2006 Jan 5;159(1):1-17. doi: 10.1016/j.cbi.2005.09.002. Epub 2005 Oct 10.
• Background Gotteland M, Espinoza J, Cassels B, Speisky H. [Effect of a dry boldo extract on oro-cecal intestinal transit in healthy volunteers]. Rev Med Chil. 1995 Aug;123(8):955-60. Spanish.
• Background Peng B, Xu C, Wang S, Zhang Y, Li W. The Role of Connexin Hemichannels in Inflammatory Diseases. Biology (Basel). 2022 Feb 2;11(2):237. doi: 10.3390/biology11020237.
• Background Booth J, Paul L, Rafferty D, Macinnes C. The relationship between urinary bladder control and gait in women. Neurourol Urodyn. 2013 Jan;32(1):43-7. doi: 10.1002/nau.22272. Epub 2012 Jun 12.

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