Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06162065
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-12-08
First Post:
2023-11-29
Brief Title:
Effectiveness of Oral Boldo in Women With Overactive Bladder
Sponsor:
Universidad de Valparaiso
Organization:
Universidad de Valparaiso
Study Overview
Official Title:
Effectiveness of Oral Boldo in Improving Urinary Symptoms and Body Stability in Women Diagnosed With Overactive Bladder
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None