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

Primary Purpose

Stress Urinary Incontinence in Women

Status
Completed
Phase
Not Applicable
Locations
Slovakia
Study Type
Interventional
Intervention
Pelvic floor muscle training (PFMT) with lumbopelvic stabilization
Sponsored by
Comenius University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence in Women focused on measuring Stress urinary incontinence, Pelvic floor muscle training

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Duloxetine treatment

Standard Duloxetine treatment with PFMT

Arm Description

Peroral treatment with duloxetine at a dose of 40 mg twice a day

Peroral treatment with duloxetine at a dose of 40 mg twice a day. Pelvic floor muscle training (PFMT) with lumbopelvic stabilization.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 22, 2019
Last Updated
July 18, 2020
Sponsor
Comenius University
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1. Study Identification

Unique Protocol Identification Number
NCT04140253
Brief Title
Evaluation of Duloxetine and Innovative Pelvic Floor Muscle Training in Women With Stress Urinary Incontinence
Acronym
DULOXING
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

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
February 1, 2020 (Actual)
Study Completion Date
March 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Comenius University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence in Women
Keywords
Stress urinary incontinence, Pelvic floor muscle training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Duloxetine treatment
Arm Type
Active Comparator
Arm Description
Peroral treatment with duloxetine at a dose of 40 mg twice a day
Arm Title
Standard Duloxetine treatment with PFMT
Arm Type
Experimental
Arm Description
Peroral treatment with duloxetine at a dose of 40 mg twice a day. Pelvic floor muscle training (PFMT) with lumbopelvic stabilization.
Intervention Type
Behavioral
Intervention Name(s)
Pelvic floor muscle training (PFMT) with lumbopelvic stabilization
Intervention Description
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 Outcome Measure Information:
Title
Change in incontinence episode frequency
Description
The investigators will compare change in incontinence episode frequency in the combined duloxetine and pelvic floor muscle training to duloxetine treatment alone
Time Frame
over 12 weeks of treatment
Secondary Outcome Measure Information:
Title
Change in incontinence quality of life according to Incontinence Quality of Life scale (I-QoL)
Description
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.
Time Frame
over 12 weeks of treatment
Title
Change in Patient Global Impression of Improvement (PGI-I score)
Description
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.
Time Frame
over 12 weeks of treatment
Title
Incidence of adverse events
Description
To examine incidence of adverse events in the combined duloxetine and pelvic floor muscle training to duloxetine treatment alone
Time Frame
over 12 weeks of treatment

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
woman with stress urinary incontinence
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Jessenius Faculty of Medicine in Martin, Comenius University in Bratislava
City
Martin
ZIP/Postal Code
03601
Country
Slovakia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
After study completion
Citations:
PubMed Identifier
32852574
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.
Results Reference
derived
PubMed Identifier
32028393
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.
Results Reference
derived

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

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