Back to resultsExtended-Release Oxybutynin for the Treatment of Neurogenic Detrusor Overactivity (RONDO)
Primary Purpose
Detrusor Function, Overactive
Status
Terminated
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Oxybutinin Extended-Release
Sponsored by
About this trial
This is an interventional treatment trial for Detrusor Function, Overactive focused on measuring Detrusor function, overactive, Urinary incontinence, Oxybutynin, Lyrinel
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Oxybutynin Extended-Release
Arm Description
Oxybutynin chloride 5, 10, 15 milligram (mg) per tablet 10-30 mg per day orally
Outcomes
Primary Outcome Measures
Maximal Detrusor Pressure
Maximal detrusor pressure represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. Detrusor pressure is the component of intravesical (in the bladder) pressure that is created by forces in the bladder wall (passive and active). It was estimated by subtracting abdominal pressure from intravesical pressure.
Secondary Outcome Measures
Maximal Cystometric Capacity (MCC)
MCC represents the maximum volume of urine the bladder holds.
Detrusor Leakpoint Pressure
Detrusor leakpoint pressure is the level of pressure at which leakage of urine through the urethra occurs as the bladder fills without an increase in abdominal pressure. This was a measure of both strength of the urethral sphincters and compliance of the detrusor muscle.
Post-Void Residual Urine Volume
Post-void residual urine volume is the amount of urine remaining in the bladder after void completion.
Reflex Volume
Reflex volume is the infused volume that induces the first detrusor contraction.
Urge Incontinence Episodes
Urge incontinence episodes were reported. Urge urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency with sudden feeling to go to toilet.
Total Incontinence Episodes
Episodes of total urinary incontinence were reported. Urinary incontinence is the complaint of any involuntary leakage of urine.
Percentage of Participants With no Episodes of Urge-Urinary Incontinence
Percentage of participants with no episodes of urge urinary incontinence was reported. Urge urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency.
King Health Questionnaire Score
King Health Questionnaire assesses the physical and psycho-social aspects of the disease state. It is a self-administered questionnaire containing 21 questions scored in 9 domains (general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep or energy, and severity of urinary symptoms). All domains were assessed in a range: 0-100, where 0=best outcome/response and 100=worst outcome or response. Lower scores indicates better outcome or response.
Full Information
NCT ID
NCT01796548
First Posted
January 30, 2013
Last Updated
October 31, 2013
Sponsor
Janssen-Cilag Ltd.,Thailand
1. Study Identification
Unique Protocol Identification Number
NCT01796548
Brief Title
Extended-Release Oxybutynin for the Treatment of Neurogenic Detrusor Overactivity
Acronym
RONDO
Official Title
Extended-Release Oxybutynin in the Treatment of Neurogenic Detrusor Overactivity (RONDO)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Terminated
Why Stopped
Slow rate of participant's enrollment
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen-Cilag Ltd.,Thailand
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Detrusor Function, Overactive
Keywords
Detrusor function, overactive, Urinary incontinence, Oxybutynin, Lyrinel
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxybutynin Extended-Release
Arm Type
Experimental
Arm Description
Oxybutynin chloride 5, 10, 15 milligram (mg) per tablet 10-30 mg per day orally
Intervention Type
Drug
Intervention Name(s)
Oxybutinin Extended-Release
Other Intervention Name(s)
Lyrinel
Intervention Description
Oxybutynin chloride 5, 10, 15 milligram (mg) per tablet 10-30 mg per day orally
Primary Outcome Measure Information:
Title
Maximal Detrusor Pressure
Description
Maximal detrusor pressure represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. Detrusor pressure is the component of intravesical (in the bladder) pressure that is created by forces in the bladder wall (passive and active). It was estimated by subtracting abdominal pressure from intravesical pressure.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Maximal Cystometric Capacity (MCC)
Description
MCC represents the maximum volume of urine the bladder holds.
Time Frame
Baseline and Week 12
Title
Detrusor Leakpoint Pressure
Description
Detrusor leakpoint pressure is the level of pressure at which leakage of urine through the urethra occurs as the bladder fills without an increase in abdominal pressure. This was a measure of both strength of the urethral sphincters and compliance of the detrusor muscle.
Time Frame
Baseline and Week 12
Title
Post-Void Residual Urine Volume
Description
Post-void residual urine volume is the amount of urine remaining in the bladder after void completion.
Time Frame
Baseline and Week 12
Title
Reflex Volume
Description
Reflex volume is the infused volume that induces the first detrusor contraction.
Time Frame
Baseline and Week 12
Title
Urge Incontinence Episodes
Description
Urge incontinence episodes were reported. Urge urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency with sudden feeling to go to toilet.
Time Frame
Baseline, Week 4 and Week 12
Title
Total Incontinence Episodes
Description
Episodes of total urinary incontinence were reported. Urinary incontinence is the complaint of any involuntary leakage of urine.
Time Frame
Baseline, Week 4 and Week 12
Title
Percentage of Participants With no Episodes of Urge-Urinary Incontinence
Description
Percentage of participants with no episodes of urge urinary incontinence was reported. Urge urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency.
Time Frame
Baseline, Week 4 and Week 12
Title
King Health Questionnaire Score
Description
King Health Questionnaire assesses the physical and psycho-social aspects of the disease state. It is a self-administered questionnaire containing 21 questions scored in 9 domains (general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep or energy, and severity of urinary symptoms). All domains were assessed in a range: 0-100, where 0=best outcome/response and 100=worst outcome or response. Lower scores indicates better outcome or response.
Time Frame
Baseline and Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen-Cilag Ltd.,Thailand Clinical trial
Organizational Affiliation
Janssen-Cilag Ltd.,Thailand
Official's Role
Study Director
Facility Information:
City
Bangkok
Country
Thailand
City
Chiangmai
Country
Thailand
City
Phathumwan
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
Extended-Release Oxybutynin for the Treatment of Neurogenic Detrusor Overactivity
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