Overactive BladderNCT01367886

Comparative Urine Proteomic Studies of Overactive Bladder in Humans

A study testing fesoterodine in people with Overactive Bladder, run by Washington University School of Medicine at 1 site in United States.

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

This study is being done to evaluate the use of a new technology (urine proteomics) - the study of proteins in the urine to identify urine markers of overactive bladder (OAB) from a simple voided urine specimen. Read more about this study

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Overactive Bladder
What is being tested?: fesoterodine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteUnited States
Study dates: Aug 2010to Sep 2011
Phase: Interventional
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
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

For healthy volunteers the inclusion criteria are:
Females ≥ 18 years old
Not experiencing overactive bladder symptoms
Not experiencing frequency or urgency
For overactive bladder patients the inclusion criteria are
Females ≥ 18 years old
Overactive bladder symptoms for ≥ 3 months before screening ) Recurrent urinary tract infections (UTIS) > 3/year

Who cannot join

For healthy volunteers the exclusion criteria are:
Overactive bladder symptoms, such as frequency and urgency
Intermittent/unstable use of bladder medications
Pregnant women or women unwilling to use contraceptives
Neurological conditions: stroke, Multiple Sclerosis (MS), Parkinson's, spinal cord injury
Significant pelvic organ prolapsed (grade 3 or above based on physical exam)

Show all 22Show fewer

Lower urinary tract surgery within past 6 months
Known history of IC or pain associated with OAB
Urinary retention requiring catheterization, indwelling catheter of Self-cath
Recurrent UTIS > 3/year
For overactive bladder patients the exclusion criteria are:
Contraindications to Fesoterodine use such as hypersensitivity, GI and urinary retention, and Glaucoma
Intermittent/unstable use of bladder medications
Pregnant women or women unwilling to use contraceptives
Neurological conditions: stroke, MS, Parkinson's, spinal cord injury
Significant pelvic organ prolapsed (grade 3 or above based on physical exam)
Lower urinary tract surgery within past 6 months
Known history of Interstitial Cystitis (IC) or pain associated with OAB
Urinary retention requiring catheterization, indwelling catheter of Self-cath
Recurrent urinary tract infections (UTIS) > 3/year
Deferral Criteria:
Treatment with OAB medications within 2 weeks before baseline visit. If patient is currently on OAB medications the patient will be asked to stop OAB medication for 2 weeks and return for baseline visit.

Trial locations and contacts

1 site in 1 country.

United States1 site

Washington University School of Medicine
St Louis, Missouri, 63110

Other trials in United States

About this study

Read the detailed description

The objectives of the study are:

to improve the diagnosis of overactive bladder using a non-invasive technology (urine proteomics) and
to study how potential urine biomarkers changes with overactive bladder symptoms after patients have been treated with fesoterodine, an FDA approved drug for the treatment of overactive bladder.

Conditions: Overactive Bladder
Being tested: fesoterodine
Keywords: Urine proteomics, overactive bladder
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.

fesoterodineDrug
Also called Toviaz
Fesoterodine 4 mg. tablet by mouth daily for six weeks

Study groups in NCT01367886
Study group	Role	What they receive
Fesoterodine	Other	Females with overactive bladder symptoms will be given Fesoterodine 4 mg. daily for six weeks. Receives: Drug: fesoterodine

What is being measured

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

Bladder Diary to Assess Urinary Frequency at Baseline and at End of 6-week Treatment
Overactive bladder subjects filled out a 3-day bladder diary before starting Fesoterodine and another 3-day bladder diary at the end of taking 6 weeks of Fesoterodine. The bladder diary was used to assess urinary frequency. The average number of urinations (frequency) per day over a period of 3 days before the start of medication and at the end of 6 weeks of medication were compared for each subject and then as a group.
Measured: Outcome measure was assessed at baseline and at the end of the 6-week treatment
Bladder Diary (Using Urinary Sensation Scale Found in Bladder Diary) to Assess Urinary Urgency at Baseline and at 6-week Treatment
The Urinary Sensation Scale found in the bladder diary given to subjects was used to assess urinary urgency. The Urinary Sensation Scale was filled out by the subject for 3 days before starting Fesoterodine and filled out again for 3 days at the end of taking 6 weeks of Fesoterodine. The scale ranges from 1 (no feeling of urgency), 2 (mild), 3 (moderate), 4 (severe) to 5 (unable to hold; leak urine). The urgency scale with the most check marks per day over a period of 3 days before start of medication was averaged for each subject. The urgency scale with the most check marks per day over a period of 3 days at the end of taking 6 weeks of medication was averaged for each subject. Then, the average before start of medication for all subjects and the average at the end of taking 6 weeks of medication for all subjects were compared.
Measured: Outcome measure was assesses at baseline and at the end of the 6-week treatment period.

Secondary outcomes (2)

Overactive Bladder Questionnaire (OAB-q) to Assess Bother From Urinary Frequency at Baseline and at 6 Weeks.
Overactive Bladder subjects answered the Overactive Bladder Questionnaire (OAB-q) before starting Fesoterodine and at the end of taking 6 weeks of Fesoterodine. The OAB-q consists of 8 questions asking how bothered subject was in the past 4 weeks. Questions # 1 (Frequent urination during the daytime hours?); #5 (Nighttime urination?) and #6 (Waking up at night because you have to urinate?) are asking about frequency. Choices of answers are: 1 (Not at all); 2 (A little bit); 3 (Somewhat); 4 (Quite a bit); 5 (A great deal) 6 (A very great deal). Multiple responses to the questionnaire were averaged for each participant at baseline and at 6 weeks and then all participants' answers were totaled and averaged at baseline and at 6 weeks.
Measured: Outcome measure was assessed at baseline and after the 6 week visit.
Overactive Bladder Questionnaire (OAB-q) Will be Used to Assess Bother From Urinary Urgency at Baseline and at 6 Weeks..
Overactive bladder subjects answered the Overactive Bladder questionnaire (OAB-q) before starting Fesoterodine and at the end of taking 6 weeks of Fesoterodine. The OAB-q consists of 8 questions asking how bothered subject was in the past 4 weeks. Questions #2 (An uncomfortable urge to urinate?); #3 (A sudden urge to urinate with little or no warning?); #4 (Accidental loss of small amounts of urine?); #7 (An uncontrollable urge to urinate?); #8 (Urine loss associated with a strong desire to urinate?) are asking about urgency. Choices for answers are: 1 (Not at all); 2 (A little bit); 3 (Somewhat); 4 (Quite a bit); 5 (A great deal); 6 (A very great deal). Multiple responses to the questionnaire was averaged per participant at baseline and at 6 weeks and then all participants answers were totaled and then averaged at baseline and at 6 weeks.
Measured: Outcome measures were assessed at baseline and after the 6 week visit.

Timeline

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

Aug 2010Sep 2011

First posted7 Jun 2011 (estimated)
Study startAug 2010
Primary completionSep 2011
Study completionSep 2011

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.
Other trials for Overactive BladderStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe 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 N/A
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01367886
Sponsor's protocol ID: WS473527
Status last verified: Feb 2015
First submitted: 19 May 2011
Last updated: 27 Feb 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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

Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
RecruitingObservational study
Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
Overactive Bladder (OAB)
Recruiting
Ambulatory Long Length URodynamics Evaluation
Urology, Urinary Bladder, Overactive
Not yet recruitingPhase 4
Behavioral and/or Mirabegron to Treat Urinary Symptoms in Parkinson Disease
Overactive Bladder, Parkinson Disease
Active, not recruiting
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Overactive Bladder (OAB), Urinary Urgency

All Overactive Bladder trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Urine Proteomic Studies of Overactive Bladder in Humans
ClinicalTrials.gov ID: NCT01367886
Acronym / sponsor ID: WS473527
Conditions: Overactive Bladder
Keywords: Urine proteomics, overactive bladder
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Study start: Aug 2010
Primary completion: Sep 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 7 Jun 2011 (estimated)
Results: Posted 12 Jan 2015

Clinical summary

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

Detailed description

The objectives of the study are:

to improve the diagnosis of overactive bladder using a non-invasive technology (urine proteomics) and
to study how potential urine biomarkers changes with overactive bladder symptoms after patients have been treated with fesoterodine, an FDA approved drug for the treatment of overactive bladder.

Study design

Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Fesoterodine	Other	Drug: fesoterodineFemales with overactive bladder symptoms will be given Fesoterodine 4 mg. daily for six weeks.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Females ≥ 18 years old
Not experiencing overactive bladder symptoms
Not experiencing frequency or urgency
For overactive bladder patients the inclusion criteria are
Females ≥ 18 years old

Key exclusion criteria (22 listed)

Overactive bladder symptoms, such as frequency and urgency
Intermittent/unstable use of bladder medications
Pregnant women or women unwilling to use contraceptives
Neurological conditions: stroke, Multiple Sclerosis (MS), Parkinson's, spinal cord injury
Significant pelvic organ prolapsed (grade 3 or above based on physical exam)

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
fesoterodineAlso: ToviazFesoterodine 4 mg. tablet by mouth daily for six weeks	Drug	Fesoterodine

Primary outcome

Bladder Diary to Assess Urinary Frequency at Baseline and at End of 6-week Treatment
Time frame: Outcome measure was assessed at baseline and at the end of the 6-week treatment
Overactive bladder subjects filled out a 3-day bladder diary before starting Fesoterodine and another 3-day bladder diary at the end of taking 6 weeks of Fesoterodine. The bladder diary was used to assess urinary frequency. The average number of urinations (frequency) per day over a period of 3 days before the start of medication and at the end of 6 weeks of medication were compared for each subject and then as a group.
Bladder Diary (Using Urinary Sensation Scale Found in Bladder Diary) to Assess Urinary Urgency at Baseline and at 6-week Treatment
Time frame: Outcome measure was assesses at baseline and at the end of the 6-week treatment period.
The Urinary Sensation Scale found in the bladder diary given to subjects was used to assess urinary urgency. The Urinary Sensation Scale was filled out by the subject for 3 days before starting Fesoterodine and filled out again for 3 days at the end of taking 6 weeks of Fesoterodine. The scale ranges from 1 (no feeling of urgency), 2 (mild), 3 (moderate), 4 (severe) to 5 (unable to hold; leak urine). The urgency scale with the most check marks per day over a period of 3 days before start of medication was averaged for each subject. The urgency scale with the most check marks per day over a period of 3 days at the end of taking 6 weeks of medication was averaged for each subject. Then, the average before start of medication for all subjects and the average at the end of taking 6 weeks of medication for all subjects were compared.

2 secondary outcomes

Overactive Bladder Questionnaire (OAB-q) to Assess Bother From Urinary Frequency at Baseline and at 6 Weeks.
Time frame: Outcome measure was assessed at baseline and after the 6 week visit.
Overactive Bladder Questionnaire (OAB-q) Will be Used to Assess Bother From Urinary Urgency at Baseline and at 6 Weeks..
Time frame: Outcome measures were assessed at baseline and after the 6 week visit.

Results and safety

Results posted to the registry on 12 Jan 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fesoterodine	21	14

Primary outcome: Bladder Diary to Assess Urinary Frequency at Baseline and at End of 6-week Treatment

Time frame: Outcome measure was assessed at baseline and at the end of the 6-week treatment. Mean (Standard Deviation). Unit: urinations/day

Measure	Fesoterodine n = 14
Average number of urinations/day after 6 weeks	12.32 (4.88)
Average number of urinations/day at baseline	10.79 (3.64)

Fesoterodine: Mean Difference (Final Values): 1.53, p = 0.19, t-test, 2 sided

Primary outcome: Bladder Diary (Using Urinary Sensation Scale Found in Bladder Diary) to Assess Urinary Urgency at Baseline and at 6-week Treatment

Time frame: Outcome measure was assesses at baseline and at the end of the 6-week treatment period.. Mean (Standard Deviation). Unit: scores on Urinary Sensation Scale

Measure	Fesoterodine n = 21
USS to assess baseline urgency	2.84 (1.02)
USS to assess 6 week urgency	2.50 (1.16)

Fesoterodine: Mean Difference (Final Values): 0.34, p = 0.18, t-test, 2 sided

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected at the 6-week follow-up clinic visit. Subjects were also instructed to call if there are any adverse events after the 6-week follow-up visit if they continue on the medication.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fesoterodine	0 of 21 (0%)	0 of 21 (0%)	Not reported

Limitations and caveats (from the sponsor): No serious adverse events.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Overactive Bladder

Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
RecruitingObservational study
Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
Overactive Bladder (OAB)
Recruiting
Ambulatory Long Length URodynamics Evaluation
Urology, Urinary Bladder, Overactive
Not yet recruitingPhase 4
Behavioral and/or Mirabegron to Treat Urinary Symptoms in Parkinson Disease
Overactive Bladder, Parkinson Disease
Active, not recruiting
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Overactive Bladder (OAB), Urinary Urgency

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.

H. Henry Lai, M.D. principal investigator

Washington University School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing fesoterodine in people with Overactive Bladder, run by Washington University School of Medicine at 1 site in United States.

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 22 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 27 Feb 2015. 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 United States. 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?

Yes. Results are posted in the registry (first posted 12 Jan 2015). 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?

Bladder Diary to Assess Urinary Frequency at Baseline and at End of 6-week Treatment (time frame: Outcome measure was assessed at baseline and at the end of the 6-week treatment). The study lists 2 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 NCT01367886.

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 27 Feb 2015.