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

Comenius University

Status: Completed

Conditions: Stress Urinary Incontinence in Women

Treatments: Behavioral: Pelvic floor muscle training (PFMT) with lumbopelvic stabilization

Study type: Interventional

Funder types: Other

Identifiers

NCT04140253

24012019

Details and patient eligibility

About

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

Full description

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

Enrollment: 158 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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158 participants in 2 patient groups

Standard Duloxetine treatment

Active Comparator group

Description:

Peroral treatment with duloxetine at a dose of 40 mg twice a day

Treatment:

Behavioral: Pelvic floor muscle training (PFMT) with lumbopelvic stabilization

Standard Duloxetine treatment with PFMT

Experimental group

Description:

Peroral treatment with duloxetine at a dose of 40 mg twice a day. Pelvic floor muscle training (PFMT) with lumbopelvic stabilization.

Treatment:

Behavioral: Pelvic floor muscle training (PFMT) with lumbopelvic stabilization