A Phase 1 interventional study of Oxybutynin Pill and Boldo supplement in Urinary Bladder, Overactive, sponsored by Universidad de Valparaiso. Enrolling by invitation at 1 site in Chile. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-12-08.
Sponsored by Universidad de Valparaiso · Phase 1, Interventional, and Treatment
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:
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.
858 studies on the registry are indexed under Urinary Bladder, Overactive; 127 are open to participants now.
This study's planned enrollment of 10 is below the median of 70 across 649 interventional studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →Universidad de Valparaiso is the lead sponsor of 29 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
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
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
pharmacological antimuscarinic treatment
treatment supplemented with boldo
Urinary symptoms
Using a urinary chart, measure urinary frequency and intervals.
Time frame: 1 month
Bladder Control Self-Assessment Questionnaire
measure the presence of urinary urgency and urine leakage along with the level of discomfort this produces
Time frame: 1 month
MiniBESTest
Balance systems evaluation test (anticipatory, reactive postural control, sensory orientation, dynamic gait)
Time frame: 1 month
Plan to share: Undecided
Started Nov 2023 (actual). Primary completion is estimated for Jan 2024, 2 months after the start.
Of 30 phase 1 interventional studies under Urinary Bladder, Overactive, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 22. This study's planned 2 months is below that.
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Universidad de Valparaiso