Women With Stress Urinary IncontinencePhase 3NCT05677295
Therapeutic Efficacy in Women With Stress Urinary Incontinence
A Phase 3 study testing duloxetine and Imipramine in people with Women With Stress Urinary Incontinence, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
We will get the impact of duloxetine versus imipramine on therapeutic efficacy in women with SUI. Read more about this study
- Who is it for?
- Ages 25 years and older, women only
- Conditions the study is for
- Women With Stress Urinary Incontinence
- What is being tested?
- duloxetine and Imipramine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 Apr 2023to 31 Dec 2024
- Phase
- Phase 3
- 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 25 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients over 25 years old with stress urinary incontinence.
- Patients who are currently not considered for surgical treatment.
- Patients who have undergone regular Kegel exercises but have poor results.
Who cannot join
- The result of urodynamic examination, if the main cause of urinary incontinence is detrusor overactivity.
- Those who are taking or plan to take monoamine oxidase inhibitor (MAOI) inhibitors.
- Patients with acute myocardial infarction.
- Those who are allergic to duloxetine, imipramine and dibenzazepine tricyclic antidepressants.
- Patients with uncontrolled narrow-angle glaucoma.
- Pregnant women.
- Those who are contraindicated to duloxetine or imipramine.
- Patients with suicidal ideation and behavior.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital
Banqiao District, New Taipei, 22050
Sheng-Mou Hsiao, M.D., +886-2-89667000 ext. 1818, smhsiao2@gmail.com
About this study
Official title: Comparisons of the Impact of Duloxetine Versus Imipramine on Therapeutic Efficacy in Women With Stress Urinary Incontinence: a Randomized Controlled Study.
We will get the impact of duloxetine versus imipramine on therapeutic efficacy in women with SUI.
Read the detailed description
Background/Purpose: Pharmacologic treatments for female stress urinary incontinence (SUI) include duloxetine and imipramine. Duloxetine and Imipramine has been reported to have clinical significant therapeutic efficacy on female SUI and overactive bladder syndrome. However, there was no randomized controlled study to compare duloxetine and imipramine for the treatment of female SUI.
Patients and Methods: We will perform a prospective randomized controlled study to recruit 90 female SUI patients at the Obstetrics \& Gynecology outpatient clinic of Far Eastern Memorial Hospital. All SUI female patients will be asked to complete ICIQ-UI, USS, OABSS, and bladder diary before and after 4 weeks' duloxetine versus imipramine treatment.
- Conditions
- Women With Stress Urinary Incontinence
- Being tested
- duloxetine, Imipramine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
duloxetineDrug
Duloxetine 30 mg per day
ImipramineDrug
Imipramine 25 mg per day
| Study group | Role | What they receive |
|---|---|---|
| Duloxetine | Experimental | Not described Receives: Drug: duloxetine |
| Imipramine | Active comparator | Not described Receives: Drug: Imipramine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of stress urinary incontinence
Urinary Incontinence Questionnaire (by ICIQ-UI short form)
Measured: 4 weeks
Secondary outcomes (2)
Improvement of urgency symptoms
Urgency severity scale
Measured: 4 weeks
Improvement of overactive bladder symptoms
Overactive bladder symptom score
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start18 Apr 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women With Stress Urinary IncontinenceStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng-Mou Hsiao, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05677295
- Sponsor's protocol ID
- 111220-F
- Status last verified
- Apr 2023
- First submitted
- 1 Jan 2023
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparisons of the Impact of Duloxetine Versus Imipramine on Therapeutic Efficacy in Women With Stress Urinary Incontinence: a Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT05677295
- Acronym / sponsor ID
- 111220-F
- Conditions
- Women With Stress Urinary Incontinence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 18 Apr 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 Jan 2023 (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.
We will get the impact of duloxetine versus imipramine on therapeutic efficacy in women with SUI.
Detailed description
Background/Purpose: Pharmacologic treatments for female stress urinary incontinence (SUI) include duloxetine and imipramine. Duloxetine and Imipramine has been reported to have clinical significant therapeutic efficacy on female SUI and overactive bladder syndrome. However, there was no randomized controlled study to compare duloxetine and imipramine for the treatment of female SUI.
Patients and Methods: We will perform a prospective randomized controlled study to recruit 90 female SUI patients at the Obstetrics \& Gynecology outpatient clinic of Far Eastern Memorial Hospital. All SUI female patients will be asked to complete ICIQ-UI, USS, OABSS, and bladder diary before and after 4 weeks' duloxetine versus imipramine treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Duloxetine | Experimental | Drug: duloxetine |
| Imipramine | Active comparator | Drug: Imipramine |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female patients over 25 years old with stress urinary incontinence.
- Patients who are currently not considered for surgical treatment.
- Patients who have undergone regular Kegel exercises but have poor results.
Key exclusion criteria (8 listed)
- The result of urodynamic examination, if the main cause of urinary incontinence is detrusor overactivity.
- Those who are taking or plan to take monoamine oxidase inhibitor (MAOI) inhibitors.
- Patients with acute myocardial infarction.
- Those who are allergic to duloxetine, imipramine and dibenzazepine tricyclic antidepressants.
- Patients with uncontrolled narrow-angle glaucoma.
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 |
|---|---|---|
| duloxetineDuloxetine 30 mg per day | Drug | Duloxetine |
| ImipramineImipramine 25 mg per day | Drug | Imipramine |
Primary outcome
Improvement of stress urinary incontinence
Time frame: 4 weeks
Urinary Incontinence Questionnaire (by ICIQ-UI short form)
2 secondary outcomes
Improvement of urgency symptoms
Time frame: 4 weeks
Improvement of overactive bladder symptoms
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing duloxetine and Imipramine in people with Women With Stress Urinary Incontinence, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 19 May 2023. 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 Taiwan. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sheng-Mou Hsiao, MD (+886289667000 ext. 1818, smhsiao2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of stress urinary incontinence (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2023.