Extended-Release Oxybutynin for the Treatment of Neurogenic Detrusor Overactivity (RONDO)

• ClinicalTrials.gov Identifier: NCT01796548
• Recruitment Status: Terminated
• First Posted: February 21, 2013
• Results First Posted: July 31, 2013
• Last Update Posted: November 26, 2013
• Sponsor: Janssen-Cilag Ltd.,Thailand
• Information provided by (Responsible Party): Janssen-Cilag Ltd.,Thailand

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).

Condition or disease	Intervention/treatment	Phase
Detrusor Function, Overactive	Drug: Oxybutinin Extended-Release	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 17 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Extended-Release Oxybutynin in the Treatment of Neurogenic Detrusor Overactivity (RONDO)
• Study Start Date: December 2008
• Actual Primary Completion Date: December 2010
• Actual Study Completion Date: December 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: Oxybutynin Extended-Release; Oxybutynin chloride 5, 10, 15 milligram (mg) per tablet 10-30 mg per day orally	Drug: Oxybutinin Extended-Release; Oxybutynin chloride 5, 10, 15 milligram (mg) per tablet 10-30 mg per day orally; Other Name: Lyrinel

Outcome Measures

Primary Outcome Measures :

1. Maximal Detrusor Pressure [ Time Frame: Week 12 ]
   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 :

1. Maximal Cystometric Capacity (MCC) [ Time Frame: Baseline and Week 12 ]
   MCC represents the maximum volume of urine the bladder holds.
2. Detrusor Leakpoint Pressure [ Time Frame: Baseline and Week 12 ]
   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.
3. Post-Void Residual Urine Volume [ Time Frame: Baseline and Week 12 ]
   Post-void residual urine volume is the amount of urine remaining in the bladder after void completion.
4. Reflex Volume [ Time Frame: Baseline and Week 12 ]
   Reflex volume is the infused volume that induces the first detrusor contraction.
5. Urge Incontinence Episodes [ Time Frame: Baseline, Week 4 and Week 12 ]
   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.
6. Total Incontinence Episodes [ Time Frame: Baseline, Week 4 and Week 12 ]
   Episodes of total urinary incontinence were reported. Urinary incontinence is the complaint of any involuntary leakage of urine.
7. Percentage of Participants With no Episodes of Urge-Urinary Incontinence [ Time Frame: Baseline, Week 4 and Week 12 ]
   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.
8. King Health Questionnaire Score [ Time Frame: Baseline and Week 12 ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Thailand

Bangkok, Thailand

Chiangmai, Thailand

Phathumwan, Thailand

Sponsors and Collaborators

Janssen-Cilag Ltd.,Thailand

Investigators

• Study Director: Janssen-Cilag Ltd.,Thailand Clinical trial; Janssen-Cilag Ltd.,Thailand

More Information

• Responsible Party: Janssen-Cilag Ltd.,Thailand
• ClinicalTrials.gov Identifier: NCT01796548
• Other Study ID Numbers: CR015205; R016446OAB4011
• First Posted: February 21, 2013
• Results First Posted: July 31, 2013
• Last Update Posted: November 26, 2013
• Last Verified: October 2013

Keywords provided by Janssen-Cilag Ltd.,Thailand:

Detrusor function, overactive; Urinary incontinence; Oxybutynin; Lyrinel

Additional relevant MeSH terms:

Urinary Bladder, Overactive; Urinary Bladder Diseases; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations