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| Name | Class |
|---|---|
| Uro Medical Corporation | INDUSTRY |
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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:
10 women over 18 years of age who meet the selectivity criteria will be recruited under written informed consent, previously approved by the competent ethics committee. Patients will be diagnosed with overactive bladder through a clinical interview and a voiding record performed by a specialist urologist that may or may not be confirmed by a urodynamic study.
Prior to carrying out the tests, the informed consent will be read aloud to the patient by one of the responsible researchers, explaining the relevant aspects and any doubts that may arise in this regard. The document must be signed by each recruited patient if she wishes to participate voluntarily.
Additionally, your vital signs will be assessed to ensure your safety when taking measurements and baseline data will be generated. The self-application of the voiding chart will be explained to them, which should be done once a week throughout the treatment.
A postural evaluation through a stability test will be performed on all patients using a portable device placed through a harness. The cell phone has inertial sensors and will record position signals. This measurement will be carried out in two instances: pre-intervention and post-intervention to obtain postural parameters of anticipatory adjustments, reactive strategies, sensory orientation and dynamic gait.
Subsequently, the total sample will be randomly subdivided into two groups consisting of 5 patients. The first group will be treated through the use of oral antimuscarinics for 4 weeks under strict medical indication, with a treatment scheme consisting of 10 mg oxybutynin tablet once a day, while the other 5 remaining subjects will receive a combined oral treatment using the use of oral antimuscarinic under the same scheme (10 mg oxybutynin tablet once a day), but they will also be complemented with boldo powder for 4 weeks under strict medical indication. This last group will be complemented with 1 capsules of 380 mg every 8 hours of boldo (take suggested by the manufacturer), for 5 days in a row and 5 days off.
Patients will be monitored weekly by telephone and asked to report the results of the self-administered voiding record while the bladder control questionnaire for overactive bladder symptoms is administered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | women with overactive bladder will be treated using oral antimuscarinics for 4 weeks under strict medical indication, with a treatment scheme consisting of 10 mg tablet of oxybutynin once a day. |
|
| Group 2 | Experimental | 5 women will receive combined oral treatment. 1 tablet of 10 mg once a day of oral of oxybutynin and they will also be supplemented with powder boldo capsules for 4 weeks under strict medical indication. This group will be supplemented with 1 capsules of 340 mg every 8 hours of boldo (take suggested by the manufacturer), for 5 days in a row and 5 days off. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxybutynin Pill | Drug | pharmacological antimuscarinic treatment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary symptoms | Using a urinary chart, measure urinary frequency and intervals. | 1 month |
| Bladder Control Self-Assessment Questionnaire | measure the presence of urinary urgency and urine leakage along with the level of discomfort this produces | 1 month |
| MiniBESTest | Balance systems evaluation test (anticipatory, reactive postural control, sensory orientation, dynamic gait) | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ClÃnica Uromed | Santiago | Santiago Metropolitan | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34606514 | 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. | |
| 31039103 | 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. |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C005419 | oxybutynin |
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prospective experimental study
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| Boldo supplement |
| Dietary Supplement |
treatment supplemented with boldo |
|
| 16104929 | 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. |
| 33399487 | 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. |
| 37189454 | 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. |
| 11412210 | 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. |
| 23379193 | 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. |
| 12676745 | 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. |
| 17581924 | 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. |
| 7879695 | 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. |
| 16221469 | 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. |
| 8657963 | 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. |
| 35205103 | 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. |
| 22693146 | 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. |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |