None listed
Conditions
Interventions
TOLTERODINE Type of group
The dosage sequence in a 4 mg tolterodine LP capsule once a day in the evening.
Group name:PLACEBO Type of group
The dosage sequence in a 4 mg placebo tolterodine capsule once a day in the evening.
Sponsors
PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients> 18 years of age. 2. Urinary frequency of> 8 voids / 24 hours and urgency with or without urge incontinence. 3. That an average of> 2.5 micturitions occur during the planned sleep cycle, defined as from the moment in which the patient intends to fall asleep until the moment in which the patient intends to wake up. 4. An average evacuated night volume less than 35% of the total volume eliminated in 24 hours. 5. Symptoms of overactive bladder including urge incontinence, urgency and / or urinary frequency for> 6 months. 6. Ability and willingness to correctly complete the micturition journals. 7. Ability to understand and sign the informed consent form after a full discussion of the research, nature of the treatment and its risks and benefits.
Exclusion criteria
Exclusion criteria: 1. Significant effort incontinence as determined by the investigator through a cough test according to Appendix 2. 2. An average evacuated volume of> 200 ml per urination as verified in the urination diary before the baseline visit. 3. Total daily urine production of> 3000 ml, as verified in the journal of urination before the baseline visit. 4. Any condition that, in the opinion of the investigator, makes the patient inadequate, or with contraindications, for inclusion (eg, uncontrolled narrow-angle glaucoma, urinary retention, or gastric retention). 5. Patients with conduction, fi ction or heart rate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Number of nocturnal urinations Measure:Percentage change in the average number of nighttime voids from baseline to week 12 of treatment Timepoints:12 week | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Adverse events will be evaluated using the MeDRA classification system. Measure:Summary of adverse events will present the number of patients in each group that at least presents an adverse event. Timepoints:12 weeks | — |
Countries
Canada, French Polynesia, Peru, Poland, United States
Outcome results
None listed