Overactive bladder syndrome (OAB) Urological and Genital Diseases Bladder disorders
Conditions
Interventions
0.2 mg oral desmopressin tablets versus placebo.
Sponsors
Bristol Urological Institute (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female patients 18 years of age or older with overactive bladder syndrome if they have an average of four or more voids in the first eight hours of the day (excluding the first void in the morning) and/or more than one incontinence episode in the first eight hours of the day during the seven days screening period.
Exclusion criteria
Exclusion criteria: 1. Consistent residual volume >150 ml 2. Abnormal levels of serum/plasma sodium 3. Newly started Benign Prostatic Hypertrophy (BPH) medical/surgical treatment 4. Diabetes insipidus/primary polydipsia 5. Multiple sclerosis 6. Stress urinary incontinence 7. Pelvic organ prolapse
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of effectiveness of desmopressin by decreasing the average number of unwanted events (micturitions, incontinence episodes, urgency episode), during the first eight hours of the day, following treatment. | — |
Primary
| Measure | Time frame |
|---|---|
| 1. Evaluation of effectiveness of desmopressin in increasing the time to first unwanted event, in patients with overactive bladder, in the first eight hours of the day, following treatment. 2. Evaluation of the effect of desmopressin on quality of life in patients with overactive bladder syndrome using the International Confrontation on Incontinence (ICI) OAB short form questionnaire. | — |
Countries
United Kingdom
Outcome results
None listed