Urinary Incontinence, StressPhase 4NCT00244296

To Determine How Effective Duloxetine is in Treating Women 65 Years and Older With Symptoms of Stress Urinary Incontinence, or With a Combination of Stress Urinary Incontinence and Urge Urinary Incontinence Symptoms

A Phase 4 study testing Duloxetine hydrochloride in people with Urinary Incontinence, Stress, run by Eli Lilly and Company at 31 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine how effective duloxetine is in treating women who are 65 years of age or older with symptoms of stress urinary incontinence, or with a combination of stress urinary incontinence and urge urinary incontinence symptoms. Read more about this study

Who is it for?: Ages 65 years and older, women only
Conditions the study is for: Urinary Incontinence, Stress
What is being tested?: Duloxetine hydrochloride
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 276 participants
Where: 31 sitesin 7 countries
Study dates: Oct 2005to Jan 2007
Phase: Phase 4
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 65 years and older
Women only
No healthy volunteers
Older adult

Who may be able to join

female outpatient greater than or equal to 65 years of age
have symptoms of SUI or stress-predominant MUI for at least 3 consecutive months
have at least 7 incontinence episodes per week. For patients with MUI, at least 50% of the IEF must be due to stress.
is ambulatory and able to use a toilet independently and without difficulty

Who cannot join

at Visit 1 have a positive urine culture or a history of four or more urinary tract infections (UTIs) in the preceding year
have had continence surgery or received bladder neck bulking agent therapy within 3 months prior to study entry
began pelvic floor muscle exercises (for example, Kegel or biofeedback) within 3 months prior to study entry or at any time during the study.
have neurologic lesions or conditions (e.g. multiple sclerosis, spinal cord lesions or Parkinson's disease) or local lesions (e.g. bladder stones present or tumors) that affect the lower urinary tract.
intake of monoamine oxidase inhibitors (MAOIs) within 14 days prior to randomisation or at any time during the study

Trial locations and contacts

31 sites in 7 countries.

Country

City, postcode or hospital

31 sites in 7 countries

Germany10 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Alzey
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Bad Ems
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Düsseldorf
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Karlsruhe
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Koblenz
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Leipzig
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Mühlacker
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Rheinstetten/Baden
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Vellmar
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Wiesloch

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France5 sites

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Champcueil
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Limoges
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Nice
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Nîmes
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Paris

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Netherlands5 sites

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Amsterdam
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Apeldoorn
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Nieuwegein
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Tilburg
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Zeist

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Spain4 sites

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Barcelona
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Castellon
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Santa Cruz de Tenerife
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Vigo

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Sweden3 sites

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Lund
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Stockholm
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Uppsala

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Switzerland3 sites

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Basel
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Riehen
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Zurich

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South Africa1 site

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Johannesburg

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About this study

Official title: A Double-Blind, Stratified, Randomised, Parallel, Placebo-Controlled, Multi-Centre Study to Assess the Efficacy and Safety of Duloxetine (20 mg Bid for 2 Weeks Escalating to 40 mg Bid) for up to 12 Weeks, Compared to Placebo, in Community-Dwelling Elderly Women > or = 65 Years of Age With Symptoms of Stress Urinary Incontinence or Stress-Predominant Mixed Urinary Incontinence.

Conditions: Urinary Incontinence, Stress
Being tested: Duloxetine hydrochloride, placebo
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.

Duloxetine hydrochlorideDrug
placeboDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

Assess the efficacy of duloxetine for up to 12 weeks, compared to placebo, in community dwelling women > or = 65 years of age with symptoms of pure stress urinary incontinence (SUI) or stress-predominant mixed urinary incontinence

Secondary outcomes (12)

Compare the efficacy of duloxetine 40 mg twice daily with that of placebo in the treatment of the symptoms of SUI and stress-predominant MUI as measured by:Absolute change in IEF
Change in mean time between voids
Percent change in the number of continence pads used per week
Change in the Incontinence Quality of Life total score and 3 sub-domain scores
Responder analysis based on the established within-treatment minimal clinically important difference established for the I-QOL
Responder analysis based on percent change in IEF
Patient's rating of improvement using the PGI-I
Compare efficacy of duloxetine 40 mg twice daily with that of placebo as measured by the percent change in IEF using in the SUI and MUI subgroups
To assess the impact of treatment with duloxetine 40 mg twice daily and placebo on the development of suicidal ideation.
Assess the impact of treatment with duloxetine 40 mg twice daily and placebo in cognition.
Assess the impact of treatment with duloxetine 40 mg twice daily and placebo as measured by changes in BDI-II.
To compare the safety of duloxetine with placebo based on changes in vital signs, clinical lab values, occurrence and duration of adverse events and premature discontinuation of study due to adverse events.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2005Jan 2007

First posted26 Oct 2005 (estimated)
Study startOct 2005
Study completionJan 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Urinary Incontinence, StressStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 276 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00244296
Sponsor's protocol ID: 8672
Other IDs: F1J-MC-SBCM
Status last verified: Jan 2007
First submitted: 24 Oct 2005
Last updated: 26 Jan 2007
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Urinary Incontinence,Stress
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
RecruitingPhase 1
Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
Urinary Incontinence Stress
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)
RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
Urinary Incontinence , Stress, Laser Therapy

All Urinary Incontinence, Stress trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind, Stratified, Randomised, Parallel, Placebo-Controlled, Multi-Centre Study to Assess the Efficacy and Safety of Duloxetine (20 mg Bid for 2 Weeks Escalating to 40 mg Bid) for up to 12 Weeks, Compared to Placebo, in Community-Dwelling Elderly Women > or = 65 Years of Age With Symptoms of Stress Urinary Incontinence or Stress-Predominant Mixed Urinary Incontinence.
ClinicalTrials.gov ID: NCT00244296
Acronym / sponsor ID: 8672
Conditions: Urinary Incontinence, Stress
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 276 participants
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Collaborators: Boehringer Ingelheim
Study start: Oct 2005
Study completion: Jan 2007
First posted: 26 Oct 2005 (estimated)
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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind

Who may qualify

Ages: 65 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (4 listed)

female outpatient greater than or equal to 65 years of age
have symptoms of SUI or stress-predominant MUI for at least 3 consecutive months
have at least 7 incontinence episodes per week. For patients with MUI, at least 50% of the IEF must be due to stress.
is ambulatory and able to use a toilet independently and without difficulty

Key exclusion criteria (5 listed)

at Visit 1 have a positive urine culture or a history of four or more urinary tract infections (UTIs) in the preceding year
have had continence surgery or received bladder neck bulking agent therapy within 3 months prior to study entry
began pelvic floor muscle exercises (for example, Kegel or biofeedback) within 3 months prior to study entry or at any time during the study.
have neurologic lesions or conditions (e.g. multiple sclerosis, spinal cord lesions or Parkinson's disease) or local lesions (e.g. bladder stones present or tumors) that affect the lower urinary tract.
intake of monoamine oxidase inhibitors (MAOIs) within 14 days prior to randomisation or at any time during the study

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
Duloxetine hydrochloride	Drug	–
placebo	Drug	–

Primary outcome

Assess the efficacy of duloxetine for up to 12 weeks, compared to placebo, in community dwelling women > or = 65 years of age with symptoms of pure stress urinary incontinence (SUI) or stress-predominant mixed urinary incontinence

12 secondary outcomes

Compare the efficacy of duloxetine 40 mg twice daily with that of placebo in the treatment of the symptoms of SUI and stress-predominant MUI as measured by:Absolute change in IEF
Change in mean time between voids
Percent change in the number of continence pads used per week
Change in the Incontinence Quality of Life total score and 3 sub-domain scores
Responder analysis based on the established within-treatment minimal clinically important difference established for the I-QOL
Responder analysis based on percent change in IEF
Patient's rating of improvement using the PGI-I
Compare efficacy of duloxetine 40 mg twice daily with that of placebo as measured by the percent change in IEF using in the SUI and MUI subgroups
To assess the impact of treatment with duloxetine 40 mg twice daily and placebo on the development of suicidal ideation.
Assess the impact of treatment with duloxetine 40 mg twice daily and placebo in cognition.
Assess the impact of treatment with duloxetine 40 mg twice daily and placebo as measured by changes in BDI-II.
To compare the safety of duloxetine with placebo based on changes in vital signs, clinical lab values, occurrence and duration of adverse events and premature discontinuation of study due to adverse events.

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 26 Jan 2007.

Related trials for Urinary Incontinence, Stress

RecruitingPhase 3
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Urinary Incontinence,Stress
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
RecruitingPhase 1
Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
Urinary Incontinence Stress
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)
RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
Urinary Incontinence , Stress, Laser Therapy

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.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

31 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Duloxetine hydrochloride in people with Urinary Incontinence, Stress, run by Eli Lilly and Company at 31 sites in 7 countries.

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 4 inclusion and 5 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 26 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in Germany, France, Netherlands, Spain, Sweden and 2 more countries. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Assess the efficacy of duloxetine for up to 12 weeks, compared to placebo, in community dwelling women > or = 65 years of age with symptoms of pure stress urinary incontinence (SUI) or stress-predominant mixed urinary incontinence. 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 NCT00244296.

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 26 Jan 2007.