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

Not Applicable

Completed

• Conditions: Stress Urinary Incontinence in Women
• Interventions: Behavioral: Pelvic floor muscle training (PFMT) with lumbopelvic stabilization

• Registration Number: NCT04140253
• Lead Sponsor: Comenius University

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

Study Timeline

• Study Start: 2019-02-01
• Study First Submitted: 2019-10-22
• Study First Submitted QC: 2019-10-24
• Study First Posted: 2019-10-25
• Primary Completion: 2020-02-01
• Study Completion: 2020-03-10
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-18
• Last Update Posted: 2020-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 158

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in incontinence episode frequency	over 12 weeks of treatment	The investigators will compare change in incontinence episode frequency in the combined duloxetine and pelvic floor muscle training to duloxetine treatment alone

Secondary Outcome Measures

Name	Time	Method
Change in Patient Global Impression of Improvement (PGI-I score)	over 12 weeks of treatment	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.
Incidence of adverse events	over 12 weeks of treatment	To examine incidence of adverse events in the combined duloxetine and pelvic floor muscle training to duloxetine treatment alone
Change in incontinence quality of life according to Incontinence Quality of Life scale (I-QoL)	over 12 weeks of treatment	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.

Trial Locations

Locations (1)

Jessenius Faculty of Medicine in Martin, Comenius University in Bratislava; 🇸🇰 Martin, Slovakia