Trial Outcomes & Findings for Comparative Urine Proteomic Studies of Overactive Bladder in Humans (NCT NCT01367886)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

21 participants

Primary outcome timeframe

Outcome measure was assessed at baseline and at the end of the 6-week treatment

Results posted on

2015-02-27

Participant Flow

Subjects with overactive bladder were recruited from principal investigator's clinic practice.

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.

Participant milestones

Participant milestones
Measure	Fesoterodine 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
Overall Study STARTED	21
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Fesoterodine 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
Overall Study Lost to Follow-up	4
Overall Study Lack of Efficacy	2
Overall Study Death	1

Baseline Characteristics

Comparative Urine Proteomic Studies of Overactive Bladder in Humans

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fesoterodine n=21 Participants Overactive bladder subjects took Fesoterodine 4 mg daily for 6 weeks.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Fesoterodine n=14 Participants 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
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
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

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Fesoterodine n=21 Participants 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
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
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

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Fesoterodine n=21 Participants 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
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
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

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Fesoterodine n=21 Participants 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
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
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

Adverse Events

Fesoterodine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

H. Henry Lai, MD

Washington University School of Medicine

Phone: 314-362-8295

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place