An open label study to explore the feasibility and tolerability of 28 days use of intravaginal oxybutynin via the MedRing OAB system in out-patients with overactive bladder

Recruiting

• Conditions: Overactive bladder; 10004994

• Registration Number: NL-OMON56571
• Lead Sponsor: iGalli B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 12

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• Questionnaire MedRing OAB system at day 28<br /><br>- Physical and emotional burden of MedRing system (Q10 to Q24)<br /><br>- Practical use of MedRing system (Q25 to Q31)<br /><br>- As needed dosing feasibility (Q32 to Q37)<br /><br>- General opinion use MedRing (Q38 to Q48)<br /><br>• Signs and Symptoms:<br /><br>- Treatment emergent (Serious) Adverse Events ((S)AE) and Device related<br /><br>(S)AEs<br /><br>- AE reported via Questionnaire MedRing system Q1 to Q9 on day 2, 7, 14,<br /><br>21, 28.<br /><br>• Visual inspection of vaginal mucosae<br /><br>• Other safety parameters (Vital signs and Lab)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Read out of log data of MedRing on drug delivery and connectivity:<br /><br>- Dosing time<br /><br>- Dosing volume<br /><br>- Temperature<br /><br>• Synchronization timepoints between MedRing and smartphone App<br /><br>• Plasma concentrations of oxybutynin and DEOB at day 1, day 14 and day 28.<br /><br>• Post calibration programmed volume output test<br /><br>• Questionnaire MedRing OAB system at all timepoints<br /><br>• Overactive bladder quality of life short-form questionnaire (OAB-q SF) at all<br /><br>timepoints<br /><br>• Smartphone app usage:<br /><br>- Number of openings of the app, adjusting the treatment schedule,<br /><br>synchronizing between smartphone app and the MedRing.<br /><br>- Use of reporting, instructions and Frequently Asked Questions</p><br>