Evaluation of Duloxetine and Innovative Pelvic Floor Muscle Training in Women With Stress Urinary Incontinence
NCT ID: NCT04140253
Last Updated: 2020-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
158 participants
INTERVENTIONAL
2019-02-01
2020-03-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard Duloxetine treatment
Peroral treatment with duloxetine at a dose of 40 mg twice a day
Pelvic floor muscle training (PFMT) with lumbopelvic stabilization
Pelvic floor muscle training (PFMT) with lumbopelvic stabilization.
1. Educating of probands about anatomy, physiology, and pelvic floor muscles functions
2. Training of pelvic floor muscles in different position
3. 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.
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.
Pelvic floor muscle training (PFMT) with lumbopelvic stabilization
Pelvic floor muscle training (PFMT) with lumbopelvic stabilization.
1. Educating of probands about anatomy, physiology, and pelvic floor muscles functions
2. Training of pelvic floor muscles in different position
3. 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.
Interventions
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Pelvic floor muscle training (PFMT) with lumbopelvic stabilization
Pelvic floor muscle training (PFMT) with lumbopelvic stabilization.
1. Educating of probands about anatomy, physiology, and pelvic floor muscles functions
2. Training of pelvic floor muscles in different position
3. 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
FEMALE
No
Sponsors
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Comenius University
OTHER
Responsible Party
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Locations
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Jessenius Faculty of Medicine in Martin, Comenius University in Bratislava
Martin, , Slovakia
Countries
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References
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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.
Other Identifiers
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24012019
Identifier Type: -
Identifier Source: org_study_id
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