Evaluation of Duloxetine and Innovative Pelvic Floor Muscle Training in Women With Stress Urinary Incontinence

A Randomized-Intervention, Parallel, Multicentric Study to Evaluate Duloxetine and Innovative Pelvic Floor Muscle Training in Women With Uncomplicated Stress Urinary Incontinence - The DULOXING Study

This study will evaluate the safety, tolerability and efficacy of duloxetine and pelvic floor muscle training in women who suffer from stress urinary incontinence

This is a randomized-intervention, parallel, multicentric study which will evaluate the safety, tolerability and efficacy of oral duloxetine and innovative pelvic floor muscle training to woman suffering from stress urinary incontinence

Inclusion Criteria:

• Woman's willing to provide written informed consent
• Women over 18 years that experience uncomplicated stress urinary incontinence
• Score of the International Consultation on Urinary Incontinence Questionnaire ≥ 14 points
• Symptoms of urinary incontinence for at least 3 consecutive months
• Have at least seven urinary incontinence episodes per week
• Degree of pelvic organ prolapse ≤ 2 stage
• Willingness to accept the randomization process and fully participate in tests

Exclusion Criteria:

• Recent use of any pharmacologic agent used to treat symptoms of urinary incontinence in the past six months
• History of anti-incontinence surgery in the past 12 months
• Use of onabotulinumtoxinA for the treatment of urinary incontinence in the past 12 months
• History of pelvic prolapse repair or urethral surgery in the past 12 months
• History of pelvic floor muscle training in the past 12 months
• History of interstitial cystitis or bladder-related pain
• Chronic severe constipation
• Clinically significant renal or hepatic impairment
• Clinically significant heart impairment
• Pregnant woman, lactating, or actively trying to become pregnant
• Non-compliance with limitation of duloxetine treatment for mixed urinary incontinence
• Positive urinary tract infection
• Use of rehabilitation aids (pessary, urethral plugs, vaginal beads, etc.)
• Use of antidepressant therapy
• Insufficient understanding of pelvic floor exercises and/or omitting exercises
• Participation in any clinical study in the past six months