Introducing personalized patient care in overactive bladder management using the MedRing OAB system for intravaginal oxybutynin administration
Drug Delivery, vol. 33, pp. 2617683
Abstract
Although numerous drugs have been developed for intravaginal administration, the implementation of personalized intravaginal treatment options is limited. The MedRing overactive bladder (OAB) system is a medical device for intravaginal oxybutynin administration via patient-controlled schedules. The primary aim was to assess the feasibility, tolerability, and safety of intravaginal oxybutynin administration via the MedRing OAB system. Second, the functioning of the MedRing OAB system, user satisfaction and quality of life (QoL) were assessed. Female OAB patients were included to receive the MedRing OAB system. Treatment was divided into three periods with increasing dosing flexibility: 2 mg at three fixed timepoints daily, 2 mg at three patient-defined timepoints daily, and flexible dosing up to 6 mg/day of 1 or 2 mg doses. Feasibility, tolerability, satisfaction, and QoL were assessed via questionnaires, safety via treatment-emergent adverse events (TEAEs), device deficiencies (DDs) and physical examination and functioning via pharmacokinetics and MedRing logs. Thirteen patients were enrolled, of whom three patients discontinued the study prematurely. Most patients reported low user burden, found the system practical and expressed positive opinions. The TEAEs were consistent with known oxybutynin effects and local TEAEs were comparable to other intravaginal devices. Most DDs were synchronization difficulties, which improved after a software update. After 10 minutes, oxybutynin levels were detected in 12 of the 13 patients. This study showed that the MedRing OAB system appears to be a feasible, tolerable and safe alternative intravaginal oxybutynin administration for 28 days in OAB patients, offering a potential alternative to existing treatment options and introducing personalized patient care.
Authors 7
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Leiden University · Leiden University Medical Center · Centre for Human Drug Research
Affiliation as printed
Center for Human Drug Research
Leiden University Medical Centre
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Leiden University · Leiden University Medical Center · Centre for Human Drug Research
Affiliation as printed
Center for Human Drug Research
Leiden University Medical Centre
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Affiliation as printed
Product Usability Department, LiGalli BV
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Centre for Human Drug Research
Affiliation as printed
Center for Human Drug Research
-
Centre for Human Drug Research
Affiliation as printed
Center for Human Drug Research
-
Centre for Human Drug Research
Affiliation as printed
Center for Human Drug Research
-
Leiden University · Leiden University Medical Center · Centre for Human Drug Research
Affiliation as printed
Center for Human Drug Research
Leiden University Medical Centre
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