Urinary Stress Incontinence
Conditions
Brief summary
Biomechanical and electrophysiological effects of duloxetine in the treatment of women with urinary stress incontinence
Interventions
DRUGDuloxetine
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Have a diagnosis of only stress urinary incontinence * Have no pelvic organ prolapse protruding more than 1 cm beyond the hymen
Exclusion criteria
* At visit 1, have a positive urine culture or a history of four or more urinary tract infections in the preceding year. * Have had more than one continence surgery. * Have a current or past urogenital cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess the effects of duloxetine in women with urodynamically proved stress urinary incontinence on the within-group change in vesical Valsalva leak point pressure (VLPP) from baseline to endpoint. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the within-group endpoint/baseline ratios of Root Mean Square Voltage and Mean Rectified Voltage from the rhabdosphincter electromyogram (EMG) at rest and with coughing, and the ratio of cough/rest ratios from baseline to endpoint. | — |
| To evaluate the within-group changes in VLPP and ratios of EMG variables from baseline to 6 months and from 4 weeks to 6 months. | — |
| To describe the percent change in incontinence episode frequency (IEF) from baseline to post-baseline and define two groups, responders and non-responders, based on threshold value of < 50% IEF reduction values. | — |
| To compare the changes in VLPP and EMG ratios from baseline to 4 weeks and from baseline to 6 months in responder and non responders | — |
| To evaluate the safety and tolerability of duloxetine for up to 28 weeks in subjects diagnosed with urodynamic stress incontinence.Based on treatment-emergent adverse events, discontinuation rates, vital signs, and laboratory analyses | — |
Countries
Slovenia, United Kingdom, United States
Outcome results
None listed