Ambulatory and Office UrologyEfficacy and Safety of Oxybutynin Transdermal System in Spinal Cord Injury Patients With Neurogenic Detrusor Overactivity and Incontinence: An Open-label, Dose-titration Study
Section snippets
Patients
This study was performed at 4 US centers. Institutional Review Board approval and informed consent were obtained before patients were enrolled. Participants included men and women with SCI, ≥ 18 years old, who had a history of urinary incontinence between CICs from NDO.24 In accordance with recommendations of the Standardization Subcommittee of the International Continence Society, NDO was confirmed through urodynamic assessments during screening. Patients completed a 3-day urinary diary during
Patient Disposition and Demographic Characteristics
A total of 24 patients entered the dose-titration period of the study and constituted the safety population. Of the 24 patients, 18 (75.0%) completed the study, 4 (16.7%) withdrew voluntarily, 1 (4.2%) was lost to follow-up, and 1 (4.2%) did not complete the study because it was closed by the sponsor. No patient discontinued the study because of an adverse event. Discontinuation rates showed no dependence on the final dose; patients who left the study included 1 of 4 (25.0%) who were taking 7.8
Comment
Results of this pilot study show that oxybutynin-TDS promotes significant increases in the daily number of catheterizations without leakage in patients with NDO resulting from SCI. Substantial, statistically significant improvements during the 8-week dose-titration period were observed for several urodynamic parameters, including maximal cystometric bladder capacity and residual urine volume. Urodynamic indicators of a motor effect, for example, amplitude of the largest or first detrusor
Conclusions
Oxybutynin-TDS significantly increased the daily number of CIC periods without leakage in SCI patients with NDO. Oxybutynin-TDS was well tolerated in these patients at up to 3 times the standard dose.
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Cited by (26)
Preliminary Experience with Transdermal Oxybutynin Patches for Hyperhidrosis
2016, Actas Dermo-SifiliograficasThe value of oxybutynin in transdermal patches for treating overactive bladder
2015, Actas Urologicas EspanolasDysfunction of lower urinary tract in patients with spinal cord injury
2015, Handbook of Clinical NeurologyCitation Excerpt :Increasing the dose or combination therapy can be offered to maximize efficacy but patient compliance with long-term utilization of multiple drugs can be a serious issue and caution is recommended in SCI patients with cardiac arrhythmias, especially with the combination of these medications. Transdermal administration of oxybutinin could have been an alternative to oral medication, with the same positive effect and less dry mouth (Kennelly et al., 2009), but one-third of patients in this study had to stop this medication due to cutaneous eruption. Other drugs that have been utilized to reduce detrusor overactivity in SCI patients are vanilloids, capsaicin, and resiniferatoxin (Chancellor and de Groat, 1999).
Anticholinergic drugs for adult neurogenic detrusor overactivity: A systematic review and meta-analysis
2012, European UrologyCitation Excerpt :Sixteen RCTs were included, with a total of 960 patients (485 men and 372 women; one study did not mention sex distribution) (Table 1), comparing anticholinergic drugs and placebo (eight RCTs; n = 390), one anticholinergic drug compared with another (five RCTs; n = 358), different doses and formulation of the same anticholinergic drug (five RCTs; n = 384), and different routes of administration of the same anticholinergic drug (three RCTs; n = 84). Ten studies were excluded [24–33]; reasons for exclusion are listed in Table 2. A total of 98 patients were lost to follow-up.
Pharmacologic therapy for the neurogenic bladder
2010, Urologic Clinics of North AmericaCitation Excerpt :In individuals with NGB, when the dosage of oxybutynin ER is titrated upwards based on symptoms, side effects, and urodynamics, even including individuals who void spontaneously, the dose most often chosen is 30 mg/d.17,38 The side effects do not increase linearly with dosage as is the case with immediate release oxybutinin.39 Recently, transdermal oxybutynin systems have been evaluated in individuals with SCI,40 with the expected improvements in the number of CICs per day, urinary leakage, maximum cystometric capacity (MCC), and detrusor pressures seen in other studies of the oral preparation. The incidence of dry mouth was low at 8.3%, but skin reactions to the patch were high at 12.5%.
A systematic review of the diagnosis and treatment of patients with neurogenic hyperactivity of the detrusor muscle
2018, Actas Urologicas Espanolas
This study was supported by Watson Laboratories, Inc, Morristown, New Jersey.
Editorial assistance was provided by Scientific Connexions, Newtown, Pennsylvania.
Relevant financial disclosures and conflicts of interest: Michael J. Kennelly. Watson Laboratories, Allergan, Pfizer–Study investigator and consultant and educator/speaker; GSK, Astellas, Novartis—Consultant and educator/speaker; Gary E. Lemack. Allergan–Research support/study site for clinical research; Astellas–Speaker; Novartis–Consultant and speaker; Pfizer–Consultant and speaker; Watson Laboratories–Study investigator (at the time of this study); Jenelle E. Foote. Pfizer–Detrol LA; Astellas/GSK–Vesicare advisory board, speakers bureau; Novartis–Enablex research support, speakers bureau; Allergan–Botox study research support; Pfizer–Fesoterodine research support, speakers bureau; Cynthia S. Trop. Watson Laboratories–Study investigator; Allergan–Botox study investigator.