Overactive BladderPhase 3NCT00425100

A Clinical Trial To Assess Fesoterodine On Treatment Satisfaction And Symptom Improvement In Overactive Bladder Patients

A Phase 3 study testing fesoterodine fumarate in people with Overactive Bladder, run by Pfizer at 60 sites in 9 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

To evaluate the effect of fesoterodine on patient satisfaction and overactive bladder (OAB) symptom relief in OAB patients who were dissatisfied with their prior therapy with tolterodine. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Overactive Bladder
What is being tested?: fesoterodine fumarate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 516 participants
Where: 60 sitesin 9 countries
Study dates: Jan 2007to Oct 2007
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

OAB patients who present with OAB symptoms(≥8 micturitions and ≥3 urgency episodes per 24 h documented in the baseline bladder diary)
OAB patients dissatisfied with their prior therapy with tolterodine

Who cannot join

Patients with any contraindication to fesoterodine usage, e.g., urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, or known hypersensitivity to the drug or its ingredients.
Patients with significant hepatic and renal disease or other significant unstable diseases.
OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.

Trial locations and contacts

60 sites in 9 countries.

Country

City, postcode or hospital

60 sites in 9 countries

United States24 sites

Pfizer Investigational Site
Aurora, Colorado, 80012
Pfizer Investigational Site
Aurora, Illinois, 60504
Pfizer Investigational Site
Bethany, Oklahoma, 73008
Pfizer Investigational Site
Cincinnati, Ohio, 45212
Pfizer Investigational Site
Eugene, Oregon, 97401
Pfizer Investigational Site
Homewood, Alabama, 35209
Pfizer Investigational Site
Houston, Texas, 77024
Pfizer Investigational Site
Huntsville, Alabama, 35801
Pfizer Investigational Site
Kingston, New York, 12401
Pfizer Investigational Site
La Mesa, California, 91942
Pfizer Investigational Site
Milford, Massachusetts, 01757
Pfizer Investigational Site
Milwaukee, Wisconsin, 53209
Pfizer Investigational Site
New York, New York, 10016
Pfizer Investigational Site
Omaha, Nebraska, 68114
Pfizer Investigational Site
Orangevale, California, 95662
Pfizer Investigational Site
Poughkeepsie, New York, 12601
Pfizer Investigational Site
Pratt, Kansas, 67124
Pfizer Investigational Site
Salt Lake City, Utah, 84107
Pfizer Investigational Site
Salt Lake City, Utah, 84124
Pfizer Investigational Site
Sellersville, Pennsylvania, 18960
Pfizer Investigational Site
Shreveport, Louisiana, 71106
Pfizer Investigational Site
West Palm Beach, Florida, 33407
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103
Pfizer Investigational Site
Woodlane, New Jersey, 08060

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Germany7 sites

Pfizer Investigational Site
Alzey, 55232
Pfizer Investigational Site
Berlin, 13347
Pfizer Investigational Site
Duisburg, 47179
Pfizer Investigational Site
Frankfurt, 65929
Pfizer Investigational Site
Marburg, 35039
Pfizer Investigational Site
Muelheim A.d. Ruhr, 45468
Pfizer Investigational Site
München, 81925

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South Korea6 sites

Pfizer Investigational Site
Bucheon-si, Gyunggi-do, 420-767
Pfizer Investigational Site
Busan, 602-739
Pfizer Investigational Site
Daejeon, 301-721
Pfizer Investigational Site
Jeonnam, 519-809
Pfizer Investigational Site
Seoul, 135-710
Pfizer Investigational Site
Seoul, 138-736

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Belgium5 sites

Pfizer Investigational Site
Brussels, B-1200
Pfizer Investigational Site
Edegem, B-2650
Pfizer Investigational Site
Ghent, B-9000
Pfizer Investigational Site
Jette, B-1090
Pfizer Investigational Site
Turnhout, B-2300

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Slovakia5 sites

Pfizer Investigational Site
Bratislava, 833 05
Pfizer Investigational Site
Malacky, 901 01
Pfizer Investigational Site
Piešťany, 921 01
Pfizer Investigational Site
Prešov, 080 01
Pfizer Investigational Site
Skalica, 909 82

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Ukraine5 sites

Pfizer Investigational Site
Chernivtsi, 58002
Pfizer Investigational Site
Dnipropetrovsk, 49005
Pfizer Investigational Site
Kharkiv, 61037
Pfizer Investigational Site
Odesa, 65000
Pfizer Investigational Site
Zaporizhzhya, 69000

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Czechia4 sites

Pfizer Investigational Site
Brno-Bohunice, 625 00
Pfizer Investigational Site
Hradec Králové, 500 05
Pfizer Investigational Site
Prague, 128 08
Pfizer Investigational Site
Prague, 152 00

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Costa Rica2 sites

Pfizer Investigational Site
Alajuela Centro, Alajuela Province
Pfizer Investigational Site
San José

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Poland2 sites

Pfizer Investigational Site
Lodz, 93-316
Pfizer Investigational Site
Mysłowice, 41-400

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About this study

Official title: A 12-Week, Multicenter, Open-Label, Single-Arm Study To Evaluate The Effects Of Fesoterodine On Treatment Satisfaction And Symptom Relief In Overactive Bladder Patients.

To evaluate the effect of fesoterodine on patient satisfaction and overactive bladder (OAB) symptom relief in OAB patients who were dissatisfied with their prior therapy with tolterodine.

Conditions: Overactive Bladder
Being tested: fesoterodine fumarate
Medical subject headings: Urinary Bladder, Overactive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

fesoterodine fumarateDrug
12 weeks of study treatment: Subjects received fesoterodine tablets 4 mg once daily for 4 weeks; thereafter, daily dosage was maintained at 4 mg or increased to 8 mg based on subject's and physician's subjective assessment of efficacy and tolerability.

Study groups in NCT00425100
Study group	Role	What they receive
Open Label-fesoterodine	Experimental	Single treatment study arm. Receives: Drug: fesoterodine fumarate

What is being measured

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

Mean Number of Micturition Episodes Per 24 Hours
The mean number of micturitions per 24 hours is calculated as the total number of micturitions divided by the total number of diary days collected at that visit.
Measured: Baseline and Week 12
Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours
The mean number of UUI episodes per 24 hours is calculated as the total number of micturitions with Bladder Sensation Scale (BSS) = 5 divided by the total number of diary days collected at that visit. BSS: 5 point scale measuring need to urinate from 1=no urgency to 5=unable to hold; leak urine.
Measured: Baseline and Week 12
Mean Number of Urgency Episodes Per 24 Hours
The mean number of urgency episodes per 24 hours is calculated as the total number of micturitions with Bladder Sensation Scale (BSS) >= 3 divided by the total number of diary days collected at that visit. BSS: 5 point scale measuring need to urinate from 1=no urgency to 5=unable to hold; leak urine.
Measured: Baseline and Week 12
Number of Participants Reporting Satisfaction With Current Overactive Bladder (OAB) Treatment
Number of Participants who responded satisfied = (very satisfied or somewhat satisfied) and dissatisfied = (somewhat dissatisfied or very dissatisfied) to the treatment satisfaction question.
Measured: Week 12

Secondary outcomes (16)

Nocturnal Micturitions Per 24 Hours
Nocturnal micturitions (synonymous with the term "nighttime micturitions") were those recorded in the bedtime section of the bladder diary.
Measured: Baseline and Week 12
Severe Urgency Episodes Per 24 Hours
Severe urgency episodes defined as Urinary Sensation Scale (USS) rating ≥4. Subjects rated the feeling of urgency associated with each micturition episode using USS provided in the bladder diary. Scale ranges from 1=no feeling of urgency to 5=unable to hold; leak urine; decrease indicates an improvement with respect to urgency symptoms.
Measured: Baseline and Week 12
Mean Rating on the Urinary Sensation Scale
The mean rating was calculated as the sum of rating scores on the Urinary Sensation Scale divided by the total number of micturitions with non-missing rating at that visit. The scale ranges from 1 "no feeling of urgency" to 5 "unable to hold; leak urine."
Measured: Baseline and Week 12
Patient Perception of Bladder Condition (PPBC) Score
The PPBC score ranges from 1 "no problems at all" to 6 "many severe problems."
Measured: Baseline and Week 12
Patient Perception of Bladder Condition (PPBC) Score at Week 12 Relative to Baseline (Categorical Change)
Improvement: negative score change; No change: score change=0; Deterioration: positive score change
Measured: Baseline and Week 12
Urgency Perception Scale (UPS)
UPS scores range from 0 ("I am usually not able to hold urine") to 2 ("I am usually able to finish what I am doing before going to the toilet [without leaking]").
Measured: Baseline and Week 12
Urgency Perception Scale (UPS) at Week 12 Relative to Baseline (Categorical Change)
Improvement: positive score change; No improvement: zero or negative score change
Measured: Baseline and Week 12
Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Concern Domain
Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.
Measured: Baseline and Week 12
Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Coping Domain
Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.
Measured: Baseline and Week 12
Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Sleep Domain
Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.
Measured: Baseline and Week 12
Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Social Interaction Domain
Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.
Measured: Baseline and Week 12
Overactive Bladder Questionnaire (OAB-q) - Total Health Related Quality of Life (HRQL) Scale
Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.
Measured: Baseline and Week 12
Overactive Bladder Questionnaire (OAB-q) - Symptom Bother Scale
Each item rated by subject on a Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent less favorable outcome.
Measured: Baseline and Week 12
"Satisfaction With OAB Control" Module of Overactive Bladder (OAB) Treatment Satisfaction Questionnaire (TSQ) (OAB-S)
Module coded on scale (1-very satisfied to 5-very dissatisfied). Coding reversed algorithmically \& results transformed: total score range 0-100. Higher final response value associated with better satisfaction. Satisfied on TSQ = very or somewhat satisfied; Not satisfied on TSQ =very or somewhat dissatisfied or neither dissatisfied nor satisfied.
Measured: Week 12
Sum Rating on the Urinary Sensation Scale
The sum rating per 24 hours was calculated as the mean rating score on the Urinary Sensation Scale multiplied by the mean number of micturitions per 24 hours at that visit. The scale ranges from 1 "no feeling of urgency" to 5 "unable to hold; leak urine."
Measured: Baseline and Week 12
Treated Subjects Reporting Satisfaction With Their Current OAB Treatment (Supportive Analysis)
Number of participants who responded satisfied = (very satisfied or somewhat satisfied) or dissatisfied = (somewhat dissatisfied or very dissatisfied) to the treatment satisfaction question at Week 12 in the safety set.
Measured: Week 12

Timeline

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

Jan 2007Oct 2007

First posted22 Jan 2007 (estimated)
Study startJan 2007
Primary completionOct 2007
Study completionOct 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Overactive BladderStudies of the same condition, open and under way.
More trials run by PfizerThe 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 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 516 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00425100
Sponsor's protocol ID: A0221007
Status last verified: Nov 2018
First submitted: 19 Jan 2007
Last updated: 5 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Wyndaele JJ, Goldfischer ER, Morrow JD, Gong J, Tseng LJ, Guan Z, Choo MS. Effects of flexible-dose fesoterodine on overactive bladder symptoms and treatment satisfaction: an open-label study. Int J Clin Pract. 2009 Apr;63(4):560-7. doi: 10.1111/j.1742-1241.2009.02035.x.
PubMed 19348029

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

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Study at a glance

From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 12-Week, Multicenter, Open-Label, Single-Arm Study To Evaluate The Effects Of Fesoterodine On Treatment Satisfaction And Symptom Relief In Overactive Bladder Patients.
ClinicalTrials.gov ID: NCT00425100
Acronym / sponsor ID: A0221007
Conditions: Overactive Bladder
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 516 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jan 2007
Primary completion: Oct 2007 (actual)
Study completion: Oct 2007 (actual)
First posted: 22 Jan 2007 (estimated)
Results: Posted 10 Feb 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To evaluate the effect of fesoterodine on patient satisfaction and overactive bladder (OAB) symptom relief in OAB patients who were dissatisfied with their prior therapy with tolterodine.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Open Label-fesoterodine	Experimental	Drug: fesoterodine fumarateSingle treatment study arm.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

OAB patients who present with OAB symptoms(≥8 micturitions and ≥3 urgency episodes per 24 h documented in the baseline bladder diary)
OAB patients dissatisfied with their prior therapy with tolterodine

Key exclusion criteria (3 listed)

Patients with any contraindication to fesoterodine usage, e.g., urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, or known hypersensitivity to the drug or its ingredients.
Patients with significant hepatic and renal disease or other significant unstable diseases.
OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.

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
fesoterodine fumarate12 weeks of study treatment: Subjects received fesoterodine tablets 4 mg once daily for 4 weeks; thereafter, daily dosage was maintained at 4 mg or increased to 8 mg based on subject's and physician's subjective assessment of efficacy and tolerability.	Drug	Open Label-fesoterodine

Primary outcome

Mean Number of Micturition Episodes Per 24 Hours
Time frame: Baseline and Week 12
The mean number of micturitions per 24 hours is calculated as the total number of micturitions divided by the total number of diary days collected at that visit.
Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours
Time frame: Baseline and Week 12
The mean number of UUI episodes per 24 hours is calculated as the total number of micturitions with Bladder Sensation Scale (BSS) = 5 divided by the total number of diary days collected at that visit. BSS: 5 point scale measuring need to urinate from 1=no urgency to 5=unable to hold; leak urine.
Mean Number of Urgency Episodes Per 24 Hours
Time frame: Baseline and Week 12
The mean number of urgency episodes per 24 hours is calculated as the total number of micturitions with Bladder Sensation Scale (BSS) >= 3 divided by the total number of diary days collected at that visit. BSS: 5 point scale measuring need to urinate from 1=no urgency to 5=unable to hold; leak urine.
Number of Participants Reporting Satisfaction With Current Overactive Bladder (OAB) Treatment
Time frame: Week 12
Number of Participants who responded satisfied = (very satisfied or somewhat satisfied) and dissatisfied = (somewhat dissatisfied or very dissatisfied) to the treatment satisfaction question.

16 secondary outcomes

Nocturnal Micturitions Per 24 Hours
Time frame: Baseline and Week 12
Severe Urgency Episodes Per 24 Hours
Time frame: Baseline and Week 12
Mean Rating on the Urinary Sensation Scale
Time frame: Baseline and Week 12
Patient Perception of Bladder Condition (PPBC) Score
Time frame: Baseline and Week 12
Patient Perception of Bladder Condition (PPBC) Score at Week 12 Relative to Baseline (Categorical Change)
Time frame: Baseline and Week 12
Urgency Perception Scale (UPS)
Time frame: Baseline and Week 12
Urgency Perception Scale (UPS) at Week 12 Relative to Baseline (Categorical Change)
Time frame: Baseline and Week 12
Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Concern Domain
Time frame: Baseline and Week 12
Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Coping Domain
Time frame: Baseline and Week 12
Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Sleep Domain
Time frame: Baseline and Week 12
Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Social Interaction Domain
Time frame: Baseline and Week 12
Overactive Bladder Questionnaire (OAB-q) - Total Health Related Quality of Life (HRQL) Scale
Time frame: Baseline and Week 12
Overactive Bladder Questionnaire (OAB-q) - Symptom Bother Scale
Time frame: Baseline and Week 12
"Satisfaction With OAB Control" Module of Overactive Bladder (OAB) Treatment Satisfaction Questionnaire (TSQ) (OAB-S)
Time frame: Week 12
Sum Rating on the Urinary Sensation Scale
Time frame: Baseline and Week 12
Treated Subjects Reporting Satisfaction With Their Current OAB Treatment (Supportive Analysis)
Time frame: Week 12

Results and safety

Results posted to the registry on 10 Feb 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Open Label-fesoterodine	516	463

Primary outcome: Mean Number of Micturition Episodes Per 24 Hours

Time frame: Baseline and Week 12. Mean (Standard Deviation). Unit: number of episodes

Measure	Open Label Baseline n = 514	Open Label Week 12 n = 514
Value	12.7 (3.9)	9.7 (3.4)

Open Label Baseline vs Open Label Week 12: Mean Difference (Net): -3.0 (95% CI -3.2 to -2.7), p <0.0001, 2-sided paired t-test

Population analysed: Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (last observation carried forward (LOCF)). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.

Primary outcome: Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours

Time frame: Baseline and Week 12. Mean (Standard Deviation). Unit: number of episodes

Measure	Open Label Baseline n = 256	Open Label Week 12 n = 256
Value	2.3 (2.8)	0.6 (1.3)

Open Label Baseline vs Open Label Week 12: Mean Difference (Net): -1.7 (95% CI -2.0 to -1.4), p <0.0001, 2-sided paired t-test

Primary outcome: Mean Number of Urgency Episodes Per 24 Hours

Time frame: Baseline and Week 12. Mean (Standard Deviation). Unit: number of episodes

Measure	Open Label Baseline n = 514	Open Label Week 12 n = 514
Value	10.0 (4.5)	5.0 (4.7)

Open Label Baseline vs Open Label Week 12: Mean Difference (Net): -5.0 (95% CI -5.4 to -4.5), p <0.0001, 2-sided paired t-test

Population analysed: Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (last observation carried forward (LOCF)).The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.

Primary outcome: Number of Participants Reporting Satisfaction With Current Overactive Bladder (OAB) Treatment

Time frame: Week 12. Number. Unit: participants

Measure	Open Label Week 12 n = 474
Satisfied (very satisfied or somewhat satisfied)	378
Neither dissatisfied nor satisfied	42
Dissatisfied (somewhat or very dissatisfied)	54

Population analysed: Subjects in the Full Analysis Set (FAS) with non-missing value at Week 12. The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.

16 secondary outcomes are reported in the full results.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 19348029Wyndaele JJ, Goldfischer ER, Morrow JD, Gong J, Tseng LJ, Guan Z, Choo MS. Effects of flexible-dose fesoterodine on overactive bladder symptoms and treatment satisfaction: an open-label study. Int J Clin Pract. 2009 Apr;63(4):560-7. doi: 10.1111/j.1742-1241.2009.02035.x.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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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.

Pfizer CT.gov Call Center study director

Pfizer

60 sites in 9 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing fesoterodine fumarate in people with Overactive Bladder, run by Pfizer at 60 sites in 9 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 2 inclusion and 3 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 5 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in United States, Germany, South Korea, Belgium, Slovakia and 4 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 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?

Yes. Results are posted in the registry (first posted 10 Feb 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Number of Micturition Episodes Per 24 Hours (time frame: Baseline and Week 12). The study lists 4 primary outcomes in all. 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 NCT00425100, which also lists 1 linked publication.

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 5 Dec 2018.