Overactive Bladder
Conditions
Keywords
Urine proteomics, overactive bladder
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.
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.
Interventions
DRUGfesoterodine
Fesoterodine 4 mg. tablet by mouth daily for six weeks
Sponsors
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Recruitment details
Subjects with overactive bladder were recruited from principal investigator's clinic practice.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Fesoterodine Overactive bladder subjects took Fesoterodine 4 mg daily for 6 weeks. | 21 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Lack of Efficacy | 2 |
| Overall Study | Lost to Follow-up | 4 |
Baseline characteristics
| Characteristic | Fesoterodine |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
Primary
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.
Time frame: Outcome measure was assessed at baseline and at the end of the 6-week treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fesoterodine | Bladder Diary to Assess Urinary Frequency at Baseline and at End of 6-week Treatment | Average number of urinations/day after 6 weeks | 12.32 urinations/day | Standard Deviation 4.88 |
| Fesoterodine | Bladder Diary to Assess Urinary Frequency at Baseline and at End of 6-week Treatment | Average number of urinations/day at baseline | 10.79 urinations/day | Standard Deviation 3.64 |
p-value: 0.19t-test, 2 sided
Primary
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.
Time frame: Outcome measure was assesses at baseline and at the end of the 6-week treatment period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fesoterodine | Bladder Diary (Using Urinary Sensation Scale Found in Bladder Diary) to Assess Urinary Urgency at Baseline and at 6-week Treatment | USS to assess baseline urgency | 2.84 scores on Urinary Sensation Scale | Standard Deviation 1.02 |
| Fesoterodine | Bladder Diary (Using Urinary Sensation Scale Found in Bladder Diary) to Assess Urinary Urgency at Baseline and at 6-week Treatment | USS to assess 6 week urgency | 2.50 scores on Urinary Sensation Scale | Standard Deviation 1.16 |
p-value: 0.18t-test, 2 sided
Secondary
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.
Time frame: Outcome measure was assessed at baseline and after the 6 week visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fesoterodine | Overactive Bladder Questionnaire (OAB-q) to Assess Bother From Urinary Frequency at Baseline and at 6 Weeks. | OAB-q to assess bother from frequency at baseline | 4.89 scores on a scale | Standard Deviation 0.87 |
| Fesoterodine | Overactive Bladder Questionnaire (OAB-q) to Assess Bother From Urinary Frequency at Baseline and at 6 Weeks. | OAB-q to assess bother from frequency at 6 weeks | 3.50 scores on a scale | Standard Deviation 1.45 |
p-value: 0.0021t-test, 2 sided
Secondary
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.
Time frame: Outcome measures were assessed at baseline and after the 6 week visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fesoterodine | Overactive Bladder Questionnaire (OAB-q) Will be Used to Assess Bother From Urinary Urgency at Baseline and at 6 Weeks.. | OAB-q to measure bother from urgency at baseline | 4.52 scores on a scale | Standard Deviation 1.34 |
| Fesoterodine | Overactive Bladder Questionnaire (OAB-q) Will be Used to Assess Bother From Urinary Urgency at Baseline and at 6 Weeks.. | OAB-q to measure bther from urgency at 6 weeks | 3.14 scores on a scale | Standard Deviation 1.46 |
p-value: 0.0025t-test, 2 sided