A Double-Blind, Single-Dose, 2-period Crossover Exploratory Study to Evaluate the Effects of Single Oral Dose of Duloxetine on Urethral Pressure in Japanese Female Patients with Stress Urinary Incontinence

Not Applicable

• Conditions: Stress urinary incontinence

• Registration Number: JPRN-UMIN000011611
• Lead Sponsor: Medical Co. LTA Nishikumamoto Hospital

Brief Summary

Single oral administration of duloxetine significantly increased the mean and maximal urethral pressures at rest over the proximal, middle and distal third of the urethra. During coughing, duloxetine significantly increased the mean distal urethral pressure. All adverse events were mild and were resolved without further treatments.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-17
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Subject who/with -received study drug within 16 weeks before the study. -is related to the study site or its employees, or may consent under duress. -a history of disease considered to be unsuitable for the study. -a history of convulsive disease and/or cardiac arrhythmias. -carries an implant type medical device. -an indwelling magnetic body in the cranial cavity. -a history of gastrointestinal surgery that may affect the drug absorption, or a history of surgery for intrapelvic organ that may injure nerve related to lower urethra or other nerve. -has chronic urinary tract infection or has had an episode within 4 weeks or evidence of current urinary tract infection. -is hypersensitive to drugs including duloxetine and levofloxacin. -has taken any medication that may affect the urinary tract function. -has a history of alcohol abuse within 52 weeks prior and is unable to abstain from alcohol during the study. -has a positive test result for HBsAg, HCV, HIV antibody/antigen or syphilis. -smokes excessively routinely (unable to refrain from smoking during the hospitalization). -has donated blood component within 2 weeks , or received blood collection in a volume exceeding 200 mL within 4 weeks or in a volume exceeding 400 mL within 12 weeks before hospitalization. -has a history of drug therapy for urinary incontinence within 3 months. -the pelvic floor muscles training has not stabilized or may not stabilize during the study period. -is a patient with urinary incontinence in whom symptoms of urge incontinence are prevailing. -has a supine blood pressure over 140 mm Hg for systolic, or 90 mm Hg for diastolic, or is taking medication for hypertention. -is considered unsuitable for this study by the principal investigator or the sub-investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified