Clinical trial NCT04140253: Evaluation of Duloxetine and Innovative Pelvic Floor Muscle Training in Women With Stress Urinary Incontinence
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence in Women
Keywords: Stress urinary incontinence
Pelvic floor muscle training
Lead sponsor: Comenius University
Sponsor class: OTHER
First posted: 2019-10-25
Enrollment: 158
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in incontinence episode frequency
timeFrame: over 12 weeks of treatment
Secondary outcomes:
measure: Change in incontinence quality of life according to Incontinence Quality of Life scale (I-QoL)
timeFrame: over 12 weeks of treatment
measure: Change in Patient Global Impression of Improvement (PGI-I score)
timeFrame: over 12 weeks of treatment
measure: Incidence of adverse events
timeFrame: over 12 weeks of treatment
Other outcomes:
Locations:
city: Martin
country: Slovakia
facility: Jessenius Faculty of Medicine in Martin, Comenius University in Bratislava
Study officials:
References:
citation: 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.
citation: 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.