Effectiveness of Oral Boldo in Women With Overactive Bladder

NCT06162065 | Unknown Phase 1

• 1 other identifier: 118/2023
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Urinary Bladder, Overactive

Keywords

Urinary, Overactive Bladder, Boldine

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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.

Drug: Oxybutynin Pill

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.

Drug: Oxybutynin Pill; Dietary Supplement: Boldo supplement

Interventions

Oxybutynin Pill DRUG

pharmacological antimuscarinic treatment

Group 1; Group 2

Boldo supplement DIETARY_SUPPLEMENT

treatment supplemented with boldo

Group 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Valparaiso: lead
• Uro Medical Corporation: collaborator

Study Sites (1)

Clínica Uromed

Santiago, Santiago Metropolitan, Chile

Location

Related Publications (14)

• 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.

  PMID: 34606514 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.

  PMID: 31039103 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.

  PMID: 16104929 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.

  PMID: 33399487 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.

  PMID: 37189454 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.

  PMID: 11412210 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.

  PMID: 23379193 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.

  PMID: 12676745 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.

  PMID: 17581924 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.

  PMID: 7879695 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.

  PMID: 16221469 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.

  PMID: 8657963 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.

  PMID: 35205103 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.

  PMID: 22693146 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

oxybutynin

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective experimental study

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 8, 2023
• Study Start: November 1, 2023
• Primary Completion: January 31, 2024
• Study Completion: March 30, 2024
• Last Updated: December 8, 2023

Record last verified: 2023-11

Locations

CL (1)