Effectiveness of Oral Boldo in Women With Overactive Bladder

November 29, 2023 updated by: Universidad de Valparaiso

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • Región Metropolitana
      • Santiago, Región Metropolitana, Chile
        • Clínica Uromed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
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
pharmacological antimuscarinic treatment
Experimental: Group 2
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
pharmacological antimuscarinic treatment
Dietary supplement: Boldo supplement
treatment supplemented with boldo

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Valparaiso

Collaborators

Uro Medical Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

January 31, 2024

Study Completion (Estimated)

March 30, 2024

Study Registration Dates

First Submitted

November 29, 2023

First Submitted That Met QC Criteria

November 29, 2023

First Posted (Estimated)

December 8, 2023

Study Record Updates

Last Update Posted (Estimated)

December 8, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 118/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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