neurogenic detrusor overactivity overactive bladder
Conditions
Interventions
Treatment with SAF312 and placebo.
Sponsors
Novartis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Males and females 18-65 years of age with an established diagnosis of Neurogenic Detrusor overactivity as result of a spinal cord lesions with complete or incomplete lesions that have occurred at least 6 months prior to screening. • Subjects must have not been adequately managed through antimuscarinic therapy prior to screening. Inadequate management: see protocol for details. • For subjects taking antimuscarinics with good tolerability, the dose is stable and subjects are willing to maintain the same dose during study participation. • For subjects with intolerable side-effects associated with antimuscarinic therapy, dosing of antimuscarinics must end at least 1 week prior to the onset of the baseline period. • Subjects use or are willing to use Intermittent Catheterization (IC) throughout the study. • Subjects are willing to take an antibiotic medication prophylactically at each of the three cystometries.
Exclusion criteria
Exclusion criteria: • Subjects with evidence of 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. • Subjects with a history or evidence of any pelvic or genitourinary tract anomalies that may impact on bladder function with the exception of bladder stones (>6 months ago) and stress incontinence, uterine prolapse, rectocele, or cystocele (>1 year ago) from screening. • Subjects with an acute urinary tract infection. • Use of other treatment intended to treat overactive bladder symptoms including electrostimulation therapy, botulinum toxin, capsaicin and/or resiniferatoxin therapy in the six (6) months prior to the commencement of the study. • Use of antidepressants or muscle relaxants which have not been administered at a constant dose for at least 1 month prior to the commencement of the study. • Subjects not able to perform the hand immersion test at Baseline 1. This only applies to subjects who present with a non-impaired skin thermal perception of at least one hand; subjects with sensitivity disturbances of their hands will not be tested. • Subjects who undergo the hand immersion test and keep one hand in the water bath at 49°C for >= 1 minute (no painful sensation during this time period) at first baseline.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximal Cystometric Capacity. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events, PK, PD, additional parameters examined during cystometry, micturition or catheterization frequency, incontinence episodes. | — |
Countries
Netherlands
Outcome results
None listed