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

• Sponsor: Comenius University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04140253
• Collaborator: (none)
• Enrollment: 158
• Location: 1
• Arms: 2
• Actual Duration (Months): 13.2
• Patients Per Site Per Month: 11.9

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence in Women	Behavioral: Pelvic floor muscle training (PFMT) with lumbopelvic stabilization	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 158 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Feb 1, 2019
• Actual Primary Completion Date: Feb 1, 2020
• Actual Study Completion Date: Mar 10, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jessenius Faculty of Medicine in Martin, Comenius University in Bratislava	Martin		Slovakia	03601

Sponsors and Collaborators

• Comenius University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Comenius University
• ClinicalTrials.gov Identifier: NCT04140253
• Other Study ID Numbers: 24012019
• First Posted: Oct 25, 2019
• Last Update Posted: Jul 21, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Comenius University: Stress urinary incontinence; Pelvic floor muscle training
• Additional relevant MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress

Study Results

No Results Posted as of Jul 21, 2020