Clinical trial NCT01796548: Extended-Release Oxybutynin for the Treatment of Neurogenic Detrusor Overactivity
Official title: Extended-Release Oxybutynin in the Treatment of Neurogenic Detrusor Overactivity (RONDO)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Detrusor Function, Overactive
Keywords: Detrusor function, overactive
Urinary incontinence
Oxybutynin
Lyrinel
Lead sponsor: Janssen-Cilag Ltd.,Thailand
Sponsor class: INDUSTRY
First posted: 2013-02-21
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects and tolerability (how well a participant can stand a particular medicine or treatment) of flexible dose Oxybutynin Extended-Release (OXY-ER, Lyrinel) including safety and quality of life assessment in participants with neurogenic detrusor overactivity (NDO - the nerves mediating the detrusor muscle do not work properly leading to frequent feeling of need to urinate during the day, night, or both).

Detailed description: This is an open-label (all people know the identity of the intervention), single arm, prospective (study following participants forward in time), multi-center study of participants with NDO. The initial dose of Oxybutynin ER will be 10 milligram (mg) and will be titrated to a maximum of 30 mg. Dosage will be adjusted in 5-mg increments at approximately 14-day intervals until continence is achieved or the participant cannot tolerate side effects. The duration of participation in the study will be 12 weeks. The study will consist of 6 visits: baseline, Weeks 2, 4, 6, 8 and 12. Week 4 and Week 8 will be telephone visits. Overall safety and efficacy of Oxybutinin ER will be assessed as well as safety and efficacy during the titration and maintenance phases. The efficacy of treatment will be assessed using urodynamic parameters (the force and flow of urine) and clinical parameters (voiding diary and catheterization \[use or insertion of a tubular device to drain the bladder\] schedules). The quality of life will also be monitored in the study.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of overactive bladder as a result of neurogenic condition, for example following spinal cord injury, multiple sclerosis (slowly worsening disorder of the central nervous system that causes symptoms such as weakness, incoordination, numbness, problems talking and problems seeing), Parkinson's disease (a progressive disorder of the central nervous system, seen usually in older persons, in which there is slow movement \[due to muscle weakness\], trembling and sweating), or cerebrovascular accidents (CVAs - stroke-sudden loss of blood supply to brain)
* Women must not be pregnant and be of either non-childbearing potential or is using adequate means of birth control
* Overactive bladder symptoms and/or has urge incontinence episodes
* Must have normal results on urine culture tests and on urinalysis
* ECOG (Eastern Cooperative Oncology Group) performance status score of less than or equal to 3

Exclusion Criteria:

* Participants with 1 or more treatable or conditions, other than neurogenic bladder dysfunction, that may cause urinary incontinence or urgency
* Any medical or unstable condition that precludes their participation in the study or may confound the outcome of the study (participants with or at risk for urinary retention, gastric retention or uncontrolled narrow angle; heart failure or kidney failure; diabetes mellitus; abnormal muscle weakness \[myasthenia gravis\]; paralysis or inactivity in the intestines that prevents material moving through the gut \[intestinal atony or paralytic ileus\]; severe inflammation of the bowel \[ulcerative colitis\] sudden expansion of the large intestine seen in advanced ulcerative colitis or Crohn's disease \[toxic megacolon\]; history of major lower urinary tract surgery \[transurethral resection will be excluded\])
* Hypersensitivity to the investigational drug or any of its ingredients (eg, lactose)
* Pregnant or breast feeding female
* Significant bacteriuria (presence of bacteria in the urine) or pyuria (presence of white blood cells) in the urine

Primary outcomes:
measure: Maximal Detrusor Pressure
timeFrame: Week 12
Secondary outcomes:
measure: Maximal Cystometric Capacity (MCC)
timeFrame: Baseline and Week 12
measure: Detrusor Leakpoint Pressure
timeFrame: Baseline and Week 12
measure: Post-Void Residual Urine Volume
timeFrame: Baseline and Week 12
measure: Reflex Volume
timeFrame: Baseline and Week 12
measure: Urge Incontinence Episodes
timeFrame: Baseline, Week 4 and Week 12
measure: Total Incontinence Episodes
timeFrame: Baseline, Week 4 and Week 12
measure: Percentage of Participants With no Episodes of Urge-Urinary Incontinence
timeFrame: Baseline, Week 4 and Week 12
measure: King Health Questionnaire Score
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
city: Bangkok
country: Thailand
city: Chiangmai
country: Thailand
city: Phathumwan
country: Thailand
Study officials:
affiliation: Janssen-Cilag Ltd.,Thailand
name: Janssen-Cilag Ltd.,Thailand Clinical trial
role: STUDY_DIRECTOR
References: