Effectiveness of Oral Boldo in Women With Overactive Bladder

Universidad de Valparaiso

Status and phase: Invitation-only; Phase 1

Conditions: Urinary Bladder, Overactive

Treatments: Dietary Supplement: Boldo supplement; Drug: Oxybutynin Pill

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06162065

118/2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 2 patient groups

Group 1

Active Comparator group

Description:

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.

Treatment:

Drug: Oxybutynin Pill

Group 2

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Boldo supplement

Drug: Oxybutynin Pill