Clinical trial NCT06162065: Effectiveness of Oral Boldo in Women With Overactive Bladder
Official title: Effectiveness of Oral Boldo in Improving Urinary Symptoms and Body Stability in Women Diagnosed With Overactive Bladder
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
Conditions: Urinary Bladder, Overactive
Keywords: Urinary, Overactive Bladder, Boldine
Lead sponsor: Universidad de Valparaiso
Sponsor class: OTHER
Collaborators: name: Uro Medical Corporation
First posted: 2023-12-08
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective experimental study
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Urinary symptoms
timeFrame: 1 month
measure: Bladder Control Self-Assessment Questionnaire
timeFrame: 1 month
measure: MiniBESTest
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Clínica Uromed
state: Región Metropolitana
Study officials:
References:
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