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

Stress Urinary Incontinence in Women Clinical Trial

— DULOXING  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04140253
• Other study ID #: 24012019
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: March 10, 2020

Study information

• Verified date: July 2020
• Source: Comenius University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: March 10, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence in Women
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

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

Locations

Country	Name	City	State
Slovakia	Jessenius Faculty of Medicine in Martin, Comenius University in Bratislava	Martin

Sponsors (1)

Lead Sponsor	Collaborator
Comenius University

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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