Neurogenic Bladder Disorder, Neurogenic Bladder, Spastic, Neurogenic Bladder, Uninhibited, Neurogenic Dysfunction of the Urinary Bladder, Neurogenic Urinary Bladder
Conditions
Keywords
Neurogenic detrusor overactivity, spinal cord lesions, spinal cord injury
Brief summary
This study will assess the safety, tolerability and efficacy of SAF312 in patients with overactive bladder disease due to spinal cord lesions. The overactive bladder of patients who qualify for this study is insufficiently managed by antimuscarinic therapy, or patients poorly tolerate the treatment with antimuscarinic drugs. The efficacy of SAF312 will be primarily determined via urodynamic measurements.
Interventions
DRUGSAF312
One week of treatment in a BID (two times a day) regimen (hard gelatin capsules for oral use)
DRUGPlacebo to SAF312
One week of treatment in a BID (two times a day) regimen (hard gelatin capsules for oral use)
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients with neurogenic detrusor overactivity due to spinal cord lesions * Patients are inadequately managed by antimuscarinic medication and present with a cystometric bladder capacity of max. 400 mL
Exclusion criteria
* Chronic inflammation such as interstitial cystitis, bladder stones, hematuria of unknown origin, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs * Pelvic or genitourinary tract anomalies including surgery or bladder disease other than detrusor overactivity impacting on bladder function
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum cystometric capacity (MCC) | 1 week | Examined during filling cystometry as measured by changes from baseline following treatment for one week. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety | 1 week | Safety (physical exam, vital signs, haematology, coagulation parameters, clinical chemistry and urinalysis, ECG, pregnancy test, hand immersion test and PK \[concentrations of SAF312 in blood\]). |
| Bladder threshold vol, threshold pressure, instilled vol at first leak, detrusor pressure at first leak, vol/detrusor pressure at first sensation and at first desire to void, maximum detrusor pressure during filling/storage, bladder wall compliance | 1 week | All parameters examined during filling cystometry as measured by changes from baseline following treatment for one week |
| Micturition or catheterization frequency | 1 week | Changes from baseline, as measured by daily diaries. |
| Incontinence episodes | 1 week | Changes from baseline as measured by daily diaries. |
Countries
Germany, Netherlands, Switzerland
Outcome results
None listed