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

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

Study Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence in Women
• Intervention / Treatment: Behavioral: Pelvic floor muscle training (PFMT) with lumbopelvic stabilization

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 Type: Interventional
• Enrollment (Actual): 158
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovakia
  • Martin, Slovakia, 03601
    • Jessenius Faculty of Medicine in Martin, Comenius University in Bratislava

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Duloxetine treatment; Peroral treatment with duloxetine at a dose of 40 mg twice a day	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.
Experimental: Standard Duloxetine treatment with PFMT; 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; 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.

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

Collaborators and Investigators

• Sponsor: Comenius University

Publications and helpful links

General Publications

• Hagovska M, Svihra J, Breza J Jr, Dubravicky J, Vargovcak M. A randomized, intervention parallel multicentre study to evaluate duloxetine and innovative pelvic floor muscle training in women with uncomplicated stress urinary incontinence-the DULOXING study. Int Urogynecol J. 2021 Jan;32(1):193-201. doi: 10.1007/s00192-020-04516-w. Epub 2020 Aug 27.
• Hagovska M, Svihra J. Evaluation of duloxetine and innovative pelvic floor muscle training in women with stress urinary incontinence (DULOXING): Study protocol clinical trial (SPIRIT Compliant). Medicine (Baltimore). 2020 Feb;99(6):e18834. doi: 10.1097/MD.0000000000018834.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): February 1, 2020
• Study Completion (Actual): March 10, 2020

Study Registration Dates

• First Submitted: October 22, 2019
• First Submitted That Met QC Criteria: October 24, 2019
• First Posted (Actual): October 25, 2019

Study Record Updates

• Last Update Posted (Actual): July 21, 2020
• Last Update Submitted That Met QC Criteria: July 18, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Pelvic floor muscle training; Stress urinary incontinence
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: 24012019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: After study completion

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No