Stress Urinary Incontinence in WomenDULOXINGNCT04140253
Evaluation of Duloxetine and Innovative Pelvic Floor Muscle Training in Women With Stress Urinary Incontinence
A study testing Pelvic floor muscle training (PFMT) with lumbopelvic stabilization in people with Stress Urinary Incontinence in Women, run by Comenius University at 1 site in Slovakia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Stress Urinary Incontinence in Women
- What is being tested?
- Pelvic floor muscle training (PFMT) with lumbopelvic stabilization
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteSlovakia
- Study dates
- 1 Feb 2019to 10 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Slovakia1 site
Jessenius Faculty of Medicine in Martin, Comenius University in Bratislava
Martin, 03601
About this study
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
This study will evaluate the safety, tolerability and efficacy of duloxetine and pelvic floor muscle training in women who suffer from stress urinary incontinence
Read the 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
- Conditions
- Stress Urinary Incontinence in Women
- Being tested
- Pelvic floor muscle training (PFMT) with lumbopelvic stabilization
- Keywords
- Stress urinary incontinence, Pelvic floor muscle training
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor muscle training (PFMT) with lumbopelvic stabilizationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Duloxetine treatment | Active comparator | Peroral treatment with duloxetine at a dose of 40 mg twice a day Receives: Behavioral: Pelvic floor muscle training (PFMT) with lumbopelvic stabilization |
| Standard Duloxetine treatment with PFMT | Experimental | Peroral treatment with duloxetine at a dose of 40 mg twice a day. Pelvic floor muscle training (PFMT) with lumbopelvic stabilization. Receives: Behavioral: Pelvic floor muscle training (PFMT) with lumbopelvic stabilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: over 12 weeks of treatment
Secondary outcomes (3)
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.
Measured: over 12 weeks of treatment
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.
Measured: over 12 weeks of treatment
Incidence of adverse events
To examine incidence of adverse events in the combined duloxetine and pelvic floor muscle training to duloxetine treatment alone
Measured: over 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start1 Feb 2019
- Primary completion1 Feb 2020
- Study completion10 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary Incontinence in WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Comenius University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04140253
- Sponsor's protocol ID
- 24012019
- Acronym
- DULOXING
- Status last verified
- Jul 2020
- First submitted
- 22 Oct 2019
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After study completion
Publications
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.
PubMed 32852574Hagovska 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.
PubMed 32028393
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04140253
- Acronym / sponsor ID
- DULOXING / 24012019
- Conditions
- Stress Urinary Incontinence in Women
- Keywords
- Stress urinary incontinence, Pelvic floor muscle training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Comenius UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 10 Mar 2020 (actual)
- First posted
- 25 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Duloxetine treatment | Active comparator | Behavioral: Pelvic floor muscle training (PFMT) with lumbopelvic stabilizationPeroral treatment with duloxetine at a dose of 40 mg twice a day |
| Standard Duloxetine treatment with PFMT | Experimental | Behavioral: Pelvic floor muscle training (PFMT) with lumbopelvic stabilizationPeroral treatment with duloxetine at a dose of 40 mg twice a day. Pelvic floor muscle training (PFMT) with lumbopelvic stabilization. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic floor muscle training (PFMT) with lumbopelvic stabilizationPelvic 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. | Behavioural | Standard Duloxetine treatment, Standard Duloxetine treatment with PFMT |
Primary outcome
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
3 secondary outcomes
Change in incontinence quality of life according to Incontinence Quality of Life scale (I-QoL)
Time frame: over 12 weeks of treatment
Change in Patient Global Impression of Improvement (PGI-I score)
Time frame: over 12 weeks of treatment
Incidence of adverse events
Time frame: over 12 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
- Derived from this study: PubMed 32852574Hagovska 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.
- Derived from this study: PubMed 32028393Hagovska 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.
- Individual participant dataSharing planned: No. After study completion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor muscle training (PFMT) with lumbopelvic stabilization in people with Stress Urinary Incontinence in Women, run by Comenius University at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in incontinence episode frequency (time frame: over 12 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04140253, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2020.