A DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED STUDY IN EUROPE / LATIN AMERICA, CANADA TO EVALUATE THE EFFECT OF TOLTERODINE FOR PROLONGED RELEASE ON NICTURIA IN PATIENTS WITH HYPERACTIVE BLADDER SYMPTOMS (VHA)

Not Applicable

• Conditions: -N318 Other neuromuscular dysfunction of bladder; Other neuromuscular dysfunction of bladder; N318

• Registration Number: PER-047-02
• Lead Sponsor: PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2002-07-11
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified