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

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

Detailed 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

Official Title
-----------------
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

Conditions
-----------------
Stress Urinary Incontinence in Women

Intervention / Treatment
-----------------
* Behavioral: Pelvic floor muscle training (PFMT) with lumbopelvic stabilization


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Duloxetine treatment<br>Peroral treatment with duloxetine at a dose of 40 mg twice a day | Behavioral: Pelvic floor muscle training (PFMT) with lumbopelvic stabilization<br>* Pelvic floor muscle training (PFMT) with lumbopelvic stabilization. Educating of probands about anatomy, physiology, and pelvic floor muscles functions Training of pelvic floor muscles in different position Training of pelvic floor muscles with lumbopelvic stabilization Exercise 5 times a week for 20-30 minutes a day, after initial training with a physiotherapist.<br>|
| Experimental: Standard Duloxetine treatment with PFMT<br>Peroral treatment with duloxetine at a dose of 40 mg twice a day. Pelvic floor muscle training (PFMT) with lumbopelvic stabilization. | Behavioral: Pelvic floor muscle training (PFMT) with lumbopelvic stabilization<br>* Pelvic floor muscle training (PFMT) with lumbopelvic stabilization. Educating of probands about anatomy, physiology, and pelvic floor muscles functions Training of pelvic floor muscles in different position Training of pelvic floor muscles with lumbopelvic stabilization Exercise 5 times a week for 20-30 minutes a day, after initial training with a physiotherapist.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in incontinence episode frequency | The investigators will compare change in incontinence episode frequency in the combined duloxetine and pelvic floor muscle training to duloxetine treatment alone | over 12 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in incontinence quality of life according to Incontinence Quality of Life scale (I-QoL) | The investigators will compare change in incontinence quality of life in the combined duloxetine and pelvic floor muscle training to duloxetine treatment alone. 0 = worst quality of life, 100 = best quality of life. | over 12 weeks of treatment | 
| Change in Patient Global Impression of Improvement (PGI-I score) | To examine change in Patient Global Impression of Improvement in the combined duloxetine and pelvic floor muscle training to duloxetine treatment alone . 1 = much better. 7 = definitely worse. | over 12 weeks of treatment | 
| Incidence of adverse events | To examine incidence of adverse events in the combined duloxetine and pelvic floor muscle training to duloxetine treatment alone | over 12 weeks of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stress urinary incontinence, Pelvic floor muscle training