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 - Feasibility and tolerability of 28 days oxybutynin via the MedRing

iGalli B.V.0 个研究点目标入组 12 人开始时间: 待定最近更新: 2024年7月15日

适应症

试验速览

暂无简介。

•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

•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
•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

发起方

iGalli B.V.