Overactive bladder
Conditions
Interventions
The screening period for this study has a maximum duration of 42 days prior to 
the insertion of the MedRing. The treatment consists of three treatment 
periods, with a total duration of 28 days. The intravaginal delivery of 
oxybutynin via the MedRing system will be performed in three treatment periods. 
Treatment period 1 (Day 1 - 14): fixed dosing at fixed timepoints as defined 
and programmed by the physician. Subjects will receive 3 doses of 2 mg per day 
(total 6 mg / 24 hours) at preset times.
Treatment period 2 (Day 14 - 21): fixed dosing at flexible timepoints. Subjects 
will be instructed to administer 3 doses of 2 mg oxybutynin per 24 hours via 
the MedRing system at free to choose timepoints. The minimum interval between 
two doses must be 3 hours. 
Treatment period 3 (Day 21- Day 28): flexible dosing at flexible timepoints. 
Subjects will be instructed to administer oxybutynin via the MedRing system as 
needed. Oxybutynin can be administered in steps of 1 or 2 mg, with a maximum of 
6 mg in 24 hours and a minimum dose interval of 3 hours.
Subjects will visit the study site on day 1, 7, 14, 21, 28 and 35. On day 1, 
subjects will be trained on how to use the MedRing system, including insertion 
and removal, followed by self-insertion of the MedRing. The first dosing of 
oxybutynin via the MedRing will be performed at the study site. On day 1, 14 
and 28, PK samples will be taken. On day 28, the MedRing will be removed, 
followed by a vaginal inspection. Final follow-up visit will take place on day 
35 +/- 2 days for all subjects participating in the study
Sponsors
LiGalli B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Female subjects, 18 to 80 years of age, inclusive at screening 2. All women of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for at least 30 days (females) after their last dose of study treatment 3. Patient must have OAB, defined as *urinary urgency, usually with urinary frequency and nocturia, with or without urgency urinary incontinence* according to the guidelines of the ICS/IUGA, diagnosed by a general practitioner or medical specialist 4. Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions 5. Owns an iPhone or Android smartphone with iOS 15 or higher and/or Android 9 or higher and willing and able to use it during the study
Exclusion criteria
Exclusion criteria: 1. Botox injection into the bladder as treatment for OAB within 6 months prior to dosing or percutaneous tibial nerve stimulation (PTNS) within 6 months prior to dosing 2. Active urinary tract infection 3. A vaginal infection or clinically relevant mucosal lesion at vaginal speculum inspection 4. Vaginismus or hypertonia of pelvic floor muscles 5. Being a virgin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Questionnaire MedRing OAB system at day 28 - Physical and emotional burden of MedRing system (Q10 to Q24) - Practical use of MedRing system (Q25 to Q31) - As needed dosing feasibility (Q32 to Q37) - General opinion use MedRing (Q38 to Q48) • Signs and Symptoms: - Treatment emergent (Serious) Adverse Events ((S)AE) and Device related (S)AEs - AE reported via Questionnaire MedRing system Q1 to Q9 on day 2, 7, 14, 21, 28. • Visual inspection of vaginal mucosae • Other safety parameters (Vital signs and Lab) | — |
Secondary
| Measure | Time frame |
|---|---|
| • Read out of log data of MedRing on drug delivery and connectivity: - Dosing time - Dosing volume - Temperature • Synchronization timepoints between MedRing and smartphone App • Plasma concentrations of oxybutynin and DEOB at day 1, day 14 and day 28. • Post calibration programmed volume output test • Questionnaire MedRing OAB system at all timepoints • Overactive bladder quality of life short-form questionnaire (OAB-q SF) at all timepoints • Smartphone app usage: - Number of openings of the app, adjusting the treatment schedule, synchronizing between smartphone app and the MedRing. - Use of reporting, instructions and Frequently Asked Questions | — |
Countries
Netherlands
Outcome results
None listed