Stress urinary incontinence
Conditions
Interventions
Measurement of urethral, and bladder pressure in response to transcranial, sacral root magnetic and cough stimulation using micro-tip transducer catheter, before and after single oral administration o
Sponsors
Medical Co. LTA Nishikumamoto Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: At the time of screening 1.In the opinion of the primary investigator or the sub-investigator, the subject is capable of understanding and complying with protocol requirements. 2.The subject is a Japanese female patient with urinary incontinence, who signed the written informed consent, is not pregnant or lactating, and has prevailing symptoms of SUI. 3.The subject is aged 20 or higher at the time of signing the informed consent form. 4.The subject weights at least 45 kg and has BMI between 18.0 and 30.0 kg/m2, inclusive, at Screening. 5.The subject has no clinically significant abnormalities in accordance with the study site's criteria and is judged eligible to participate in this study by the investigator. 6.The subject presents symptoms of SUI beginning 3 months or more before consent acquisition. 7.The subject experiences SUI once or more per week. 8.The subject is positive in one-hour pad test. 9.A subject of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study and 4 weeks (28 days) after the last dose of study medication. On the day of medication 1.The subject presents symptoms of SUI beginning 3 months or more before consent acquisition. 2.The subject experiences SUI once or more per week
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Intensity (threshold) of TMS causing urethral sphincter contraction (elevation in urethral pressure) -Urethral pressure measured under SMS -Urethral pressure measured under cough stimulation -Leak Point Pressure (LPP) -Volume of incontinence in the 20-minute pad test | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of magnetic stimulator, urodynamics equipment, and administration of Duloxetine. | — |
Countries
Japan
Contacts
Public ContactMakoto Yono
Medical Co. LTA Nishikumamoto Hospital Clinical Pharmacology Department
Outcome results
None listed