Effectiveness of Oral Boldo in Women With Overactive Bladder

Urinary Bladder, Overactive Clinical Trial

Official title:

Effectiveness of Oral Boldo in Improving Urinary Symptoms and Body Stability in Women Diagnosed With Overactive Bladder

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06162065
• Other study ID #: 118/2023
• Status: Enrolling by invitation
• Phase: Phase 1
• Start date: November 1, 2023
• Est. completion date: March 30, 2024

Study information

• Verified date: November 2023
• Source: Universidad de Valparaiso
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10
• Est. completion date: March 30, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Adult patients with urinary urgency, frequency, nocturia, with or without urgency urinary incontinence.

Exclusion Criteria:

• Excessive fluid intake. Use of diuretics. Neurological diseases or cognitive impairment (e.g., stroke, multiple sclerosis, spinal cord injury), mobility deficits, medically complicated/uncontrolled diabetes, fecal motility disorders (fecal incontinence/constipation), chronic pelvic pain, history of recurrent urinary tract infections (UTI), gross hematuria, previous pelvic/vaginal surgeries (incontinence/prolapse surgeries), pelvic cancer (bladder, colon, cervix, uterus, prostate), pelvic radiation, female patient with significant prolapse (GIII and IV), pelvic floor disorders (e.g., spasticity of the pelvic floor muscles, pain or any pathology that could appear overactive bladder masking other diagnoses, glaucoma, drug or supplement allergy.

Related Conditions & MeSH terms

• Urinary Bladder, Overactive

Intervention

Drug:
• Oxybutynin Pill
pharmacological antimuscarinic treatment

Dietary Supplement:
• Boldo supplement
treatment supplemented with boldo

Locations

Country	Name	City	State
Chile	Clínica Uromed	Santiago	Región Metropolitana

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Valparaiso	Uro Medical Corporation

Country where clinical trial is conducted

Chile, 

References & Publications (14)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: BJU Int 2001 Nov;88(7):807. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary symptoms	Using a urinary chart, measure urinary frequency and intervals.	1 month
Primary	Bladder Control Self-Assessment Questionnaire	measure the presence of urinary urgency and urine leakage along with the level of discomfort this produces	1 month
Primary	MiniBESTest	Balance systems evaluation test (anticipatory, reactive postural control, sensory orientation, dynamic gait)	1 month