Skip to main content
OpenTrials
Completed

NCT Number: NCT04140253

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

This study will evaluate the safety, tolerability and efficacy of duloxetine and pelvic floor muscle training in women who suffer from stress urinary incontinence

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stress Urinary Incontinence in Women Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Jessenius Faculty of Medicine in Martin, Comenius University in Bratislava

Martin, 03601, Slovakia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pelvic floor muscle training (PFMT) with lumbopelvic stabilization

Behavioral

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.

Primary outcomes

  1. Change in incontinence episode frequency

    Time frame: 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 outcomes

  1. Change in incontinence quality of life according to Incontinence Quality of Life scale (I-QoL)

    Time frame: 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)

    Time frame: 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

    Time frame: over 12 weeks of treatment

    To examine incidence of adverse events in the combined duloxetine and pelvic floor muscle training to duloxetine treatment alone

Sponsors and collaborators

Lead sponsor

Comenius University

Other

Registry information

Official study 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

Acronym: DULOXING

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 25, 2019
Registry last updated
Jul 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.