Comparative Urine Proteomic Studies of Overactive Bladder in Humans

• Sponsor: Washington University School of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT01367886
• Collaborator: (none)
• Enrollment: 21
• Location: 1
• Arm: 1
• Duration (Months): 13
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder	Drug: fesoterodine	N/A

Detailed Description

The objectives of the study are:

1. to improve the diagnosis of overactive bladder using a non-invasive technology (urine proteomics) and

2. 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

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Official Title: Comparative Urine Proteomic Studies of Overactive Bladder in Humans
• Study Start Date: Aug 1, 2010
• Actual Primary Completion Date: Sep 1, 2011
• Actual Study Completion Date: Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: Fesoterodine Females with overactive bladder symptoms will be given Fesoterodine 4 mg. daily for six weeks.	Drug: fesoterodine; Fesoterodine 4 mg. tablet by mouth daily for six weeks; Other Names: Toviaz

Outcome Measures

Primary Outcome Measures

1. Bladder Diary to Assess Urinary Frequency at Baseline and at End of 6-week Treatment [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.

2. Bladder Diary (Using Urinary Sensation Scale Found in Bladder Diary) to Assess Urinary Urgency at Baseline and at 6-week Treatment [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.

Secondary Outcome Measures

1. Overactive Bladder Questionnaire (OAB-q) to Assess Bother From Urinary Frequency at Baseline and at 6 Weeks. [Outcome measure was assessed at baseline and after the 6 week visit.]

   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.

2. Overactive Bladder Questionnaire (OAB-q) Will be Used to Assess Bother From Urinary Urgency at Baseline and at 6 Weeks.. [Outcome measures were assessed at baseline and after the 6 week visit.]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

For healthy volunteers the inclusion criteria are:

1. Females ≥ 18 years old

2. Not experiencing overactive bladder symptoms

3. Not experiencing frequency or urgency

For overactive bladder patients the inclusion criteria are

1. Females ≥ 18 years old

2. Overactive bladder symptoms for ≥ 3 months before screening ) Recurrent urinary tract infections (UTIS) > 3/year

Exclusion Criteria:

For healthy volunteers the exclusion criteria are:

1. Overactive bladder symptoms, such as frequency and urgency

2. Intermittent/unstable use of bladder medications

3. Pregnant women or women unwilling to use contraceptives

4. Neurological conditions: stroke, Multiple Sclerosis (MS), Parkinson's, spinal cord injury

5. Significant pelvic organ prolapsed (grade 3 or above based on physical exam)

6. Lower urinary tract surgery within past 6 months

7. Known history of IC or pain associated with OAB

8. Urinary retention requiring catheterization, indwelling catheter of Self-cath

9. Recurrent UTIS > 3/year

For overactive bladder patients the exclusion criteria are:

1. Contraindications to Fesoterodine use such as hypersensitivity, GI and urinary retention, and Glaucoma

2. Intermittent/unstable use of bladder medications

3. Pregnant women or women unwilling to use contraceptives

4. Neurological conditions: stroke, MS, Parkinson's, spinal cord injury

5. Significant pelvic organ prolapsed (grade 3 or above based on physical exam)

6. Lower urinary tract surgery within past 6 months

7. Known history of Interstitial Cystitis (IC) or pain associated with OAB

8. Urinary retention requiring catheterization, indwelling catheter of Self-cath

9. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University School of Medicine	St. Louis	Missouri	United States	63110

Sponsors and Collaborators

• Washington University School of Medicine

Investigators

• Principal Investigator: H. Henry Lai, M.D., Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT01367886
• Other Study ID Numbers: WS473527
• First Posted: Jun 7, 2011
• Last Update Posted: Feb 27, 2015
• Last Verified: Feb 1, 2015

• Keywords provided by Washington University School of Medicine: Urine proteomics; overactive bladder
• Additional relevant MeSH terms: Urinary Bladder, Overactive; Fesoterodine

Study Results

Participant Flow

Recruitment Details	Subjects with overactive bladder were recruited from principal investigator's clinic practice.
Pre-assignment Detail	Overactive bladder subjects completed a 3-day bladder diary and the Overactive Bladder questionnaire (OAB-q) prior to starting Toviaz (Fesoterodine) 4 mg daily. Another 3-day bladder diary and Overactive Bladder questionnaire (OAB-q) was completed by each subject at the end of a 6-week treatment with Toviaz. No washout period.

Arm/Group Title	Fesoterodine
Arm/Group Description	Females with overactive bladder symptoms were given Fesoterodine 4 mg. daily for six weeks. Fesoterodine : Fesoterodine 4 mg. tablet by mouth daily for six weeks
Period Title: Overall Study
STARTED	21
COMPLETED	14
NOT COMPLETED	7

Baseline Characteristics

Arm/Group Title	Fesoterodine
Arm/Group Description	Overactive bladder subjects took Fesoterodine 4 mg daily for 6 weeks.
Overall Participants	21
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	19 90.5%
>=65 years	2 9.5%
Sex: Female, Male (Count of Participants)
Female	21 100%
Male	0 0%
Region of Enrollment (participants) [Number]
United States	21 100%

Outcome Measures

1. Primary Outcome

Title	Bladder Diary to Assess Urinary Frequency at Baseline and at End of 6-week Treatment
Description	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.
Time Frame	Outcome measure was assessed at baseline and at the end of the 6-week treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fesoterodine
Arm/Group Description	Females with overactive bladder symptoms will be given fesoterodine 4 mg. daily for six weeks. fesoterodine : Fesoterodine 4 mg. tablet by mouth daily for six weeks
Measure Participants	14
Average number of urinations/day after 6 weeks	12.32 (4.88)
Average number of urinations/day at baseline	10.79 (3.64)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.19
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.53
	Confidence Interval	() %; to
	Parameter Dispersion	Type: Standard Deviation; Value: 4.88
	Estimation Comments

2. Secondary Outcome

Title	Overactive Bladder Questionnaire (OAB-q) to Assess Bother From Urinary Frequency at Baseline and at 6 Weeks.
Description	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.
Time Frame	Outcome measure was assessed at baseline and after the 6 week visit.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fesoterodine
Arm/Group Description	Females with overactive bladder symptoms will be given fesoterodine 4 mg. daily for six weeks. fesoterodine : Fesoterodine 4 mg. tablet by mouth daily for six weeks
Measure Participants	21
OAB-q to assess bother from frequency at baseline	4.89 (0.87)
OAB-q to assess bother from frequency at 6 weeks	3.50 (1.45)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0021
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.39
	Confidence Interval	() %; to
	Parameter Dispersion	Type: Standard Deviation; Value: 0.87
	Estimation Comments

3. Primary Outcome

Title	Bladder Diary (Using Urinary Sensation Scale Found in Bladder Diary) to Assess Urinary Urgency at Baseline and at 6-week Treatment
Description	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.
Time Frame	Outcome measure was assesses at baseline and at the end of the 6-week treatment period.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fesoterodine
Arm/Group Description	Females with overactive bladder symptoms will be given fesoterodine 4 mg. daily for six weeks. fesoterodine: Fesoterodine 4 mg. tablet by mouth daily for six weeks
Measure Participants	21
USS to assess baseline urgency	2.84 (1.02)
USS to assess 6 week urgency	2.50 (1.16)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.18
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.34
	Confidence Interval	() %; to
	Parameter Dispersion	Type: Standard Deviation; Value: 1.02
	Estimation Comments

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fesoterodine
Arm/Group Description	Females with overactive bladder symptoms will be given fesoterodine 4 mg. daily for six weeks. fesoterodine: Fesoterodine 4 mg. tablet by mouth daily for six weeks
Measure Participants	21
OAB-q to measure bother from urgency at baseline	4.52 (1.34)
OAB-q to measure bther from urgency at 6 weeks	3.14 (1.46)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0025
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.38
	Confidence Interval	() %; to
	Parameter Dispersion	Type: Standard Deviation; Value: 1.34
	Estimation Comments

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.
Arm/Group Title	Fesoterodine
Arm/Group Description	Females with overactive bladder symptoms will be given Fesoterodine 4 mg. daily for six weeks. Fesoterodine : Fesoterodine 4 mg. tablet by mouth daily for six weeks
All Cause Mortality
	Fesoterodine
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Fesoterodine
	Affected / at Risk (%)	# Events
Total	0/21 (0%)
Other (Not Including Serious) Adverse Events
	Fesoterodine
	Affected / at Risk (%)	# Events
Total	0/21 (0%)

Limitations/Caveats

No serious adverse events.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.