Overactive Bladder
Conditions
Keywords
Double-blind, Placebo-controlled, frequency, urgency, web-based, incontinence, methodology, ediary, safety, efficacy, tolerability ER, overactive bladder
Brief summary
To compare the effect of tolterodine ER 4 mg to placebo on patient reported outcomes in subjects with overactive bladder after 1, 4, and 12 weeks of treatment using an innovative web-based trial design
Interventions
DRUGTolterodine ER
One 4 mg capsule will be taken with water every day with or without food. It should be swallowed whole without chewing.
DRUGPlacebo
A placebo of Tolterodine ER 4 mg will be taken with water every day with or without food. It should be swallowed whole without chewing.
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female and 21 years or older * Overactive bladder symptoms (subject-reported) for at least 3 months * Be resident in the United States of America and have access and be able to use a computer with internet access throughout the duration of the study
Exclusion criteria
* Clinically significant hepatic, renal or neurological condition such as stroke (with residual deficit), multiple sclerosis, spinal cord injury, or Parkinson's disease. * History of cystitis, continence, urogenitalcancer or radiation * Subjects who are pregnant, nursing, or with a positive urine pregnancy test or who are intending to become pregnant within 28 days after the completion of the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12 | Baseline, Week 12 | Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI). UUI episodes were defined as those micturitions with Urinary Sensation Scale (USS) rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine. The mean number of micturitions per 24 hours was calculated as the total number of micturitions divided by the total number of diary days collected at that visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12 | Baseline (Bl), Week 1, 4, 12 | PPUS: a self-administered, single-item, validated questionnaire that measures the participant's perception of urinary urgency. It is sensitive to changes in perceptions of urinary urgency over time. Scale of 0 (usually not able to hold urine), 1 (usually able to hold urine \[without leaking\] until reaching toilet if go to toilet immediately), or 2 (usually able to finish what he/she is doing before going to toilet \[without leaking\]). Results categorized as SC from baseline on 3-point scale: improvement (positive SC), no change (SC 0), deterioration (negative SC). |
| Participant Perception Regarding Satisfaction Related to Study | Week 12 | PEQ:self-administered, to assess perception of trial method. Question3, How satisfied were you with items? on scale 1(very satisfied) to 5(very dissatisfied)- recruitment; questionnaires,surveys(Ques,Sur); identification verification(IV); informed consent(IC) process; website experience; phone call; laboratory(lab) kit delivery; lab location; lab staff service(Ser); physical exam(PE) scheduling,location (sch,loc); PE visit; medication(med) first batch delivery; med second batch delivery; cell phone(CP) received; CP use; call center(CC) ser; medical support(supp); technical supp; overall. |
| Participant Perception Regarding Cell Phone Diary | Week 12 | PEQ:self-administered, assesses participants perception of trial method. Question4, How satisfied were you with items? on scale 1(very easy) to 5(very difficult)- a: teaching video explaining CP use; recording urinations using CP; size of text on CP; sending your urinary information(inf) using your CP, e: overall, suitability for capturing urinations as they happened. |
| Participant Perception Regarding Received Treatment in the Study | Week 12 | PEQ is a web-based self-administered, exploratory questionnaire that assesses the participant's perception of trial method. Number of participants who responded to question 5, What treatment did you think you were on? are reported. |
| Participant Perception Regarding Recommending a Friend to Enter Similar Study | Week 12 | PEQ is a web-based self-administered, exploratory questionnaire that assesses the participant's perception of trial method. Number of participants who responded to question 6, How likely would you be to recommend a friend to enter a similar study? are reported. |
| Change From Baseline in Mean Voided Volume Per Micturition at Week 1, 4 and 12 | Baseline, Week 1, 4, 12 | Mean voided volume per micturition was calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume greater than 0 at that visit. Baseline values for each time point were calculated separately considering only those participants who were evaluable at the given time point. |
| Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 1, 4 and 12 | Baseline, Week 1, 4, 12 | UUI episodes were defined as those with the Urinary Sensation Scale (USS) rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. Baseline values for each time point were calculated separately considering only those participants who were evaluable at the given time point. |
| Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 1 and 4 | Baseline, Week 1, 4 | Micturitions include episodes of voluntary micturition and episodes of UUI. UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine. The mean number of micturitions per 24 hours was calculated as the total number of micturitions divided by the total number of diary days collected at that visit. Baseline values for each time point were calculated separately considering only those participants who were evaluable at the given time point. |
| Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours at Week 1, 4 and 12 | Baseline, Week 1, 4, 12 | Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the participant went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit. |
| Change From Baseline in Mean Number of Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 1, 4 and 12 | Baseline, Week 1, 4, 12 | The mean number of micturition-related nocturnal urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (\>=) 3 that occurred between time participant went to bed and time participant arose to start next day divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. |
| Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 1, 4 and 12 | Baseline, Week 1, 4, 12 | The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of \>= 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. Baseline values for each time point were calculated separately considering only those participants who were evaluable at the given time point. |
| Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Baseline, Week 1, 4, 12 | PPBC: self-administered,single-item questionnaire to describe participant's perception of bladder-related problems. PPBC assessed on 6-point scale:1=no problems at all,2=some very minor problems,3=some minor problems,4=some moderate problems,5=severe problems,6=many severe problems. Results categorized as score change (SC) from baseline on 2-point scale:improvement (negative SC),no improvement (SC 0 or more) and on 4-point scale:major improvement (SC is negative in magnitude of 2 or more), minor improvement (SC is negative in magnitude of 1), no change (SC= 0),deterioration (positive SC). |
| Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12 | Baseline, Week 12 | OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (not at all) to 6 (a very great deal). Symptom bother score derived as sum of scores for items 1 to 8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale \[(Actual total raw score - lowest possible value of raw score)/range\]\*100. Higher scores values indicative of greater symptom bother. |
| Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12 | Baseline, Week 12 | OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains (range): concern(7-42), coping(8-48), sleep(5-30), and social function(5-30). Total HRQL score (25-125) derived as sum of HRQL domains. Transformed score range 0 to 100 (HRQL domain or total) = \[(Highest possible raw score-Actual total raw score)/Raw score range\]\*100. Higher transformed scores indicate better HRQL. |
| Change From Baseline in Health Related Quality of Life (HRQL) Social Domain Score at Week 12 | Baseline, Week 12 | OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains (range): concern(7-42), coping(8-48), sleep(5-30), and social function(5-30). Total HRQL score (25-125) derived as sum of HRQL domains. Transformed score range 0 to 100 (HRQL domain or total) = \[(Highest possible raw score-Actual total raw score)/Raw score range\]\*100. Higher transformed scores indicate better HRQL. |
| Number of Participants With Response Regarding Source of First Information About Study | Week 12 | Participant experience questionnaire (PEQ) is a web-based self-administered, exploratory questionnaire that assesses the participant's perception of trial method. Number of participants who responded to question 1, Where did you hear first about the study? are reported. |
| Number of Participants With Reason for Participation in the Study | Week 12 | PEQ is a web-based self-administered, exploratory questionnaire that assesses the participant's perception of trial method. Number of participants who responded to question 2, What led you to participate given the study drug is already available? are reported. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Discontinued the Study Due to Adverse Events | Baseline up to 28 days after last dose | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. |
| Number of Participants With Laboratory Abnormalities | Week 12 | Criteria for potentially clinically significant (PCS) laboratory values: Hemoglobin, hematocrit, red blood cell less than (\<) 0.8 lower limit of normal(LLN); platelet \<0.5 LLN, \>1.75 upper LN (ULN);white blood cell \<0.6 LLN, \>1.5 ULN; lymphocyte, total neutrophil(absolute\[AL\]),Total protein, albumin, phosphate \<0.8 LLN, \>1.2 ULN; basophil, eosinophil, monocyte \>1.2ULN; Total bilirubin \>1.5ULN; aspartate, alanine aminotransferase, alkaline phosphatase \>3ULN; Blood urea nitrogen, creatinine \>1.3ULN; sodium \<0.95LLN, \>1.05ULN; potassium, chloride, bicarbonate, calcium \<0.9LLN, \>1.1ULN. |
| Number of Participants With Adverse Events (AEs) by Relatedness and Severity | Baseline up to 28 days after last dose | AE:any untoward medical occurrence attributed to study medication in participant who received study drug. Relatedness to study medication was assessed by the investigator. Severity of AEs assessed as: mild (does not interfere with participant's usual function), moderate (interferes to some extent with participant's usual function) and severe (interferes significantly with participant's usual function). Mild, moderate and severe are not mutually exclusive; hence same participant may be included in more than 1 type of severity of AEs. |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Baseline up to 28 days after last dose | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. |
Countries
United States
Participant flow
Pre-assignment details
Out of 237 participants screened, 118 participants received single-blind placebo matched to tolterodine 4 milligram (mg) capsule once daily during run-in period for 2 weeks. Only 18 participants were randomized to receive double-blind treatment due to early termination of the study.
Participants by arm
| Arm | Count |
|---|---|
| Tolterodine Tolterodine 4 mg extended release capsule once daily for 12 weeks. | 12 |
| Placebo Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks. | 6 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Tolterodine | Placebo | Total |
|---|---|---|---|
| Age, Customized 18 to 44 years | 4 participants | 3 participants | 7 participants |
| Age, Customized 45 to 64 years | 7 participants | 3 participants | 10 participants |
| Age, Customized Greater than or equal to (>=) 65 years | 1 participants | 0 participants | 1 participants |
| Sex: Female, Male Female | 12 Participants | 6 Participants | 18 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 12 | 1 / 6 |
| serious Total, serious adverse events | 0 / 12 | 0 / 6 |
Outcome results
Primary
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12
Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI). UUI episodes were defined as those micturitions with Urinary Sensation Scale (USS) rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine. The mean number of micturitions per 24 hours was calculated as the total number of micturitions divided by the total number of diary days collected at that visit.
Time frame: Baseline, Week 12
Population: Full analysis set (FAS) included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. Missing values imputed using Last observation carried forward (LOCF) method. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tolterodine | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12 | Baseline | 11.5 micturitions per 24 hours | Standard Deviation 3.5 |
| Tolterodine | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12 | Change at Week 12 | -2.6 micturitions per 24 hours | Standard Deviation 2.3 |
| Placebo | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12 | Baseline | 9.9 micturitions per 24 hours | Standard Deviation 1.7 |
| Placebo | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12 | Change at Week 12 | -0.3 micturitions per 24 hours | Standard Deviation 2.3 |
Comparison: Change at Week 12: Analysis was performed using an analysis of covariance (ANCOVA) with term for treatment with baseline value as a covariate.95% CI: [-3.9, 0.6]
Secondary
Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12
OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains (range): concern(7-42), coping(8-48), sleep(5-30), and social function(5-30). Total HRQL score (25-125) derived as sum of HRQL domains. Transformed score range 0 to 100 (HRQL domain or total) = \[(Highest possible raw score-Actual total raw score)/Raw score range\]\*100. Higher transformed scores indicate better HRQL.
Time frame: Baseline, Week 12
Population: FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tolterodine | Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12 | Baseline: Total HRQL Score | 54.1 units on a scale | Standard Deviation 21.1 |
| Tolterodine | Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12 | Change at Week 12: Coping Subscale | 26.3 units on a scale | Standard Deviation 19 |
| Tolterodine | Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12 | Change at Week 12: Concern Subscale | 29.4 units on a scale | Standard Deviation 25.8 |
| Tolterodine | Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12 | Baseline: Coping Subscale | 50.0 units on a scale | Standard Deviation 25.9 |
| Tolterodine | Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12 | Change at Week 12: Total HRQL Score | 22.5 units on a scale | Standard Deviation 21.6 |
| Tolterodine | Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12 | Baseline: Concern Subscale | 41.7 units on a scale | Standard Deviation 25.8 |
| Tolterodine | Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12 | Baseline: Sleep Subscale | 49.2 units on a scale | Standard Deviation 32.2 |
| Tolterodine | Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12 | Change at Week 12: Sleep Subscale | 21.6 units on a scale | Standard Deviation 31.2 |
| Placebo | Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12 | Baseline: Concern Subscale | 53.8 units on a scale | Standard Deviation 37.2 |
| Placebo | Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12 | Change at Week 12: Sleep Subscale | 8.0 units on a scale | Standard Deviation 19.4 |
| Placebo | Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12 | Baseline: Total HRQL Score | 58.5 units on a scale | Standard Deviation 35.1 |
| Placebo | Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12 | Change at Week 12: Total HRQL Score | 12.0 units on a scale | Standard Deviation 14.4 |
| Placebo | Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12 | Change at Week 12: Coping Subscale | 13.8 units on a scale | Standard Deviation 10.1 |
| Placebo | Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12 | Baseline: Coping Subscale | 56.3 units on a scale | Standard Deviation 33.3 |
| Placebo | Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12 | Change at Week 12: Concern Subscale | 16.7 units on a scale | Standard Deviation 20.8 |
| Placebo | Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12 | Baseline: Sleep Subscale | 55.3 units on a scale | Standard Deviation 38 |
Comparison: Change at Week 12; Coping Subscale: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.95% CI: [-6.9, 30.3]
Comparison: Change at Week 12; Concern Subscale: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.95% CI: [-16.7, 32.7]
Comparison: Change at Week 12; Sleep Subscale: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.95% CI: [-13.3, 33.8]
Comparison: Change at Week 12; Total HRQL Score: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.95% CI: [-11, 29]
Secondary
Change From Baseline in Health Related Quality of Life (HRQL) Social Domain Score at Week 12
OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains (range): concern(7-42), coping(8-48), sleep(5-30), and social function(5-30). Total HRQL score (25-125) derived as sum of HRQL domains. Transformed score range 0 to 100 (HRQL domain or total) = \[(Highest possible raw score-Actual total raw score)/Raw score range\]\*100. Higher transformed scores indicate better HRQL.
Time frame: Baseline, Week 12
Population: FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Tolterodine | Change From Baseline in Health Related Quality of Life (HRQL) Social Domain Score at Week 12 | Baseline | 84.0 units on a scale |
| Tolterodine | Change From Baseline in Health Related Quality of Life (HRQL) Social Domain Score at Week 12 | Change at Week 12 | 10.0 units on a scale |
| Placebo | Change From Baseline in Health Related Quality of Life (HRQL) Social Domain Score at Week 12 | Baseline | 92.0 units on a scale |
| Placebo | Change From Baseline in Health Related Quality of Life (HRQL) Social Domain Score at Week 12 | Change at Week 12 | 2.0 units on a scale |
Comparison: Change at Week 12; Social Subscale: Non-parametric Hodges-Lehmann's method was used to obtain median difference and 95% CI.95% CI: [-20, 20]
Secondary
Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 1, 4 and 12
The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of \>= 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. Baseline values for each time point were calculated separately considering only those participants who were evaluable at the given time point.
Time frame: Baseline, Week 1, 4, 12
Population: FAS population. Missing values imputed using LOCF method. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tolterodine | Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 1, 4 and 12 | Baseline for Week 1 (n=10,5) | 9.1 episodes per 24 hours | Standard Deviation 2.2 |
| Tolterodine | Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 1, 4 and 12 | Baseline for Week 4 (n=11,6) | 9.0 episodes per 24 hours | Standard Deviation 2.1 |
| Tolterodine | Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 1, 4 and 12 | Baseline for Week 12 (n=11,6) | 9.0 episodes per 24 hours | Standard Deviation 2.1 |
| Tolterodine | Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 1, 4 and 12 | Change at Week 1 (n=10,5) | -1.1 episodes per 24 hours | Standard Deviation 1.2 |
| Tolterodine | Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 1, 4 and 12 | Change at Week 4 (n=11,6) | -3.2 episodes per 24 hours | Standard Deviation 2.1 |
| Tolterodine | Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 1, 4 and 12 | Change at Week 12 (n=11,6) | -3.9 episodes per 24 hours | Standard Deviation 2.8 |
| Placebo | Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 1, 4 and 12 | Change at Week 4 (n=11,6) | -1.6 episodes per 24 hours | Standard Deviation 1.9 |
| Placebo | Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 1, 4 and 12 | Baseline for Week 1 (n=10,5) | 8.5 episodes per 24 hours | Standard Deviation 3.1 |
| Placebo | Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 1, 4 and 12 | Change at Week 1 (n=10,5) | -1.6 episodes per 24 hours | Standard Deviation 0.8 |
| Placebo | Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 1, 4 and 12 | Baseline for Week 4 (n=11,6) | 8.1 episodes per 24 hours | Standard Deviation 3 |
| Placebo | Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 1, 4 and 12 | Change at Week 12 (n=11,6) | -1.0 episodes per 24 hours | Standard Deviation 3.1 |
| Placebo | Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 1, 4 and 12 | Baseline for Week 12 (n=11,6) | 8.1 episodes per 24 hours | Standard Deviation 3 |
Comparison: Change at Week 1: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.95% CI: [-0.8, 1.9]
Comparison: Change at Week 4: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.95% CI: [-3.7, 0.8]
Comparison: Change at Week 12: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.95% CI: [-6.3, 0.4]
Secondary
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 1 and 4
Micturitions include episodes of voluntary micturition and episodes of UUI. UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine. The mean number of micturitions per 24 hours was calculated as the total number of micturitions divided by the total number of diary days collected at that visit. Baseline values for each time point were calculated separately considering only those participants who were evaluable at the given time point.
Time frame: Baseline, Week 1, 4
Population: FAS population. Missing values imputed using LOCF method. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tolterodine | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 1 and 4 | Baseline for Week 1 (n=10,5) | 11.7 micturitions per 24 hours | Standard Deviation 3.6 |
| Tolterodine | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 1 and 4 | Change at Week 1 (n=10,5) | -0.6 micturitions per 24 hours | Standard Deviation 1.2 |
| Tolterodine | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 1 and 4 | Baseline for Week 4 (n=11,6) | 11.5 micturitions per 24 hours | Standard Deviation 3.5 |
| Tolterodine | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 1 and 4 | Change at Week 4 (n=11,6) | -2.4 micturitions per 24 hours | Standard Deviation 2.2 |
| Placebo | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 1 and 4 | Change at Week 4 (n=11,6) | -1.0 micturitions per 24 hours | Standard Deviation 0.9 |
| Placebo | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 1 and 4 | Baseline for Week 1 (n=10,5) | 9.9 micturitions per 24 hours | Standard Deviation 1.8 |
| Placebo | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 1 and 4 | Baseline for Week 4 (n=11,6) | 9.9 micturitions per 24 hours | Standard Deviation 1.7 |
| Placebo | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 1 and 4 | Change at Week 1 (n=10,5) | -0.7 micturitions per 24 hours | Standard Deviation 1.4 |
Comparison: Change at Week 1: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.95% CI: [-1.3, 1.8]
Comparison: Change at Week 4: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.95% CI: [-2.2, 0.9]
Secondary
Change From Baseline in Mean Number of Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 1, 4 and 12
The mean number of micturition-related nocturnal urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (\>=) 3 that occurred between time participant went to bed and time participant arose to start next day divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Time frame: Baseline, Week 1, 4, 12
Population: Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis, as per change in planned analysis.
Secondary
Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours at Week 1, 4 and 12
Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the participant went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit.
Time frame: Baseline, Week 1, 4, 12
Population: Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis, as per change in planned analysis.
Secondary
Change From Baseline in Mean Voided Volume Per Micturition at Week 1, 4 and 12
Mean voided volume per micturition was calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume greater than 0 at that visit. Baseline values for each time point were calculated separately considering only those participants who were evaluable at the given time point.
Time frame: Baseline, Week 1, 4, 12
Population: FAS population. Missing values imputed using LOCF method. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tolterodine | Change From Baseline in Mean Voided Volume Per Micturition at Week 1, 4 and 12 | Baseline for Week 1 (n=10,5) | 163.7 milliliter (mL) | Standard Deviation 59.8 |
| Tolterodine | Change From Baseline in Mean Voided Volume Per Micturition at Week 1, 4 and 12 | Baseline for Week 4 (n=11,6) | 161.2 milliliter (mL) | Standard Deviation 57.4 |
| Tolterodine | Change From Baseline in Mean Voided Volume Per Micturition at Week 1, 4 and 12 | Baseline for Week 12 (n=11,6) | 161.2 milliliter (mL) | Standard Deviation 57.4 |
| Tolterodine | Change From Baseline in Mean Voided Volume Per Micturition at Week 1, 4 and 12 | Change at Week 1 (n=10,5) | 49.8 milliliter (mL) | Standard Deviation 66.3 |
| Tolterodine | Change From Baseline in Mean Voided Volume Per Micturition at Week 1, 4 and 12 | Change at Week 4 (n=11,6) | 45.2 milliliter (mL) | Standard Deviation 84 |
| Tolterodine | Change From Baseline in Mean Voided Volume Per Micturition at Week 1, 4 and 12 | Change at Week 12 (n=11,6) | 31.9 milliliter (mL) | Standard Deviation 68.3 |
| Placebo | Change From Baseline in Mean Voided Volume Per Micturition at Week 1, 4 and 12 | Change at Week 4 (n=11,6) | 19.2 milliliter (mL) | Standard Deviation 41.2 |
| Placebo | Change From Baseline in Mean Voided Volume Per Micturition at Week 1, 4 and 12 | Baseline for Week 1 (n=10,5) | 194.2 milliliter (mL) | Standard Deviation 60.3 |
| Placebo | Change From Baseline in Mean Voided Volume Per Micturition at Week 1, 4 and 12 | Change at Week 1 (n=10,5) | 27.9 milliliter (mL) | Standard Deviation 51.1 |
| Placebo | Change From Baseline in Mean Voided Volume Per Micturition at Week 1, 4 and 12 | Baseline for Week 4 (n=11,6) | 185.2 milliliter (mL) | Standard Deviation 58.3 |
| Placebo | Change From Baseline in Mean Voided Volume Per Micturition at Week 1, 4 and 12 | Change at Week 12 (n=11,6) | -10.1 milliliter (mL) | Standard Deviation 30.4 |
| Placebo | Change From Baseline in Mean Voided Volume Per Micturition at Week 1, 4 and 12 | Baseline for Week 12 (n=11,6) | 185.2 milliliter (mL) | Standard Deviation 58.3 |
Comparison: Change at Week 1: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.95% CI: [-47.8, 106.6]
Comparison: Change at Week 4: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.95% CI: [-55.4, 111.4]
Comparison: Change at Week 12: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.95% CI: [-24.2, 110.3]
Secondary
Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 1, 4 and 12
UUI episodes were defined as those with the Urinary Sensation Scale (USS) rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. Baseline values for each time point were calculated separately considering only those participants who were evaluable at the given time point.
Time frame: Baseline, Week 1, 4, 12
Population: FAS population. Missing values imputed using LOCF method. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Tolterodine | Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 1, 4 and 12 | Baseline for Week 1 (n=10,5) | 3.2 episodes per 24 hours |
| Tolterodine | Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 1, 4 and 12 | Baseline for Week 12 (n=11,6) | 2.7 episodes per 24 hours |
| Tolterodine | Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 1, 4 and 12 | Change at Week 4 (n=11,6) | -1.3 episodes per 24 hours |
| Tolterodine | Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 1, 4 and 12 | Baseline for Week 4 (n=11,6) | 2.7 episodes per 24 hours |
| Tolterodine | Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 1, 4 and 12 | Change at Week 12 (n=11,6) | -1.7 episodes per 24 hours |
| Tolterodine | Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 1, 4 and 12 | Change at Week 1 (n=10,5) | -1.0 episodes per 24 hours |
| Placebo | Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 1, 4 and 12 | Change at Week 12 (n=11,6) | -1.2 episodes per 24 hours |
| Placebo | Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 1, 4 and 12 | Change at Week 1 (n=10,5) | -0.7 episodes per 24 hours |
| Placebo | Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 1, 4 and 12 | Baseline for Week 1 (n=10,5) | 2.3 episodes per 24 hours |
| Placebo | Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 1, 4 and 12 | Baseline for Week 4 (n=11,6) | 2.3 episodes per 24 hours |
| Placebo | Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 1, 4 and 12 | Baseline for Week 12 (n=11,6) | 2.3 episodes per 24 hours |
| Placebo | Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 1, 4 and 12 | Change at Week 4 (n=11,6) | -1.9 episodes per 24 hours |
Comparison: Change at Week 1: Non-parametric Hodges-Lehmann's method was used to obtain median difference and 95 percent (%) confidence intervals (CI).95% CI: [-0.67, 1.67]
Comparison: Change at Week 4: Non-parametric Hodges-Lehmann's method was used to obtain median difference and 95% CI.95% CI: [-1, 1.83]
Comparison: Change at Week 12: Non-parametric Hodges-Lehmann's method was used to obtain median difference and 95% CI.95% CI: [-3, 1]
Secondary
Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12
OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (not at all) to 6 (a very great deal). Symptom bother score derived as sum of scores for items 1 to 8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale \[(Actual total raw score - lowest possible value of raw score)/range\]\*100. Higher scores values indicative of greater symptom bother.
Time frame: Baseline, Week 12
Population: FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tolterodine | Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12 | Baseline | 66.5 units on a scale | Standard Deviation 25.8 |
| Tolterodine | Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12 | Change at Week 12 | -27.8 units on a scale | Standard Deviation 21.8 |
| Placebo | Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12 | Baseline | 54.6 units on a scale | Standard Deviation 32.7 |
| Placebo | Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12 | Change at Week 12 | -12.5 units on a scale | Standard Deviation 25.8 |
Comparison: Change at Week 12: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.95% CI: [-33.2, 13.2]
Secondary
Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12
PPBC: self-administered,single-item questionnaire to describe participant's perception of bladder-related problems. PPBC assessed on 6-point scale:1=no problems at all,2=some very minor problems,3=some minor problems,4=some moderate problems,5=severe problems,6=many severe problems. Results categorized as score change (SC) from baseline on 2-point scale:improvement (negative SC),no improvement (SC 0 or more) and on 4-point scale:major improvement (SC is negative in magnitude of 2 or more), minor improvement (SC is negative in magnitude of 1), no change (SC= 0),deterioration (positive SC).
Time frame: Baseline, Week 1, 4, 12
Population: FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. Missing values imputed using LOCF method. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Baseline, Week 1: Many Severe Problems (n=11,5) | 0 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Week 4:Improvement (2-point scale) (n=12,6) | 7 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Baseline, Week 1: No Problems at all (n=11,5) | 0 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Baseline, Week 1:Some Very Minor Problems(n=11,5) | 0 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Baseline, Week 1: Some Minor Problems (n=11,5) | 1 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Baseline, Week 1:Some Moderate Problems(n=11,5) | 2 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Baseline, Week 1: Severe Problems (n=11,5) | 8 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Baseline, Week 4: No Problems at all (n=12,6) | 0 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Baseline, Week 4: Some Very Minor Problems(n=12,6) | 0 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Baseline, Week 4: Some Minor Problems (n=12,6) | 1 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Baseline, Week 4: Some Moderate Problems (n=12,6) | 3 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Baseline, Week 4: Severe Problems (n=12,6) | 8 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Baseline, Week 4: Many Severe Problems (n=12,6) | 0 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Baseline, Week 12: No Problems at all (n=12,6) | 0 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Baseline, Week12: Some Very Minor Problems(n=12,6) | 0 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Baseline, Week 12: Some Minor Problems (n=12,6) | 1 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Baseline, Week 12: Some Moderate Problems (n=12,6) | 3 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Baseline, Week 12: Severe Problems (n=12,6) | 8 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Baseline, Week 12: Many Severe Problems (n=12,6) | 0 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Week 1:Improvement (2-point scale) (n=11,5) | 7 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Week 1:No improvement (2-point scale) (n=11,5) | 4 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Week 1:Major improvement (4-point scale) (n=11,5) | 2 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Week 1:Minor improvement (4-point scale) (n=11,5) | 5 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Week 1:No Change (4-point scale) (n=11,5) | 3 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Week 1:Deterioration (4-point scale) (n=11,5) | 1 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Week 4:No improvement (2-point scale) (n=12,6) | 5 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Week 4:Major improvement (4-point scale) (n=12,6) | 4 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Week 4:Minor improvement (4-point scale) (n=12,6) | 3 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Week 4:No Change (4-point scale) (n=12,6) | 5 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Week 4:Deterioration (4-point scale) (n=12,6) | 0 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Week 12:Improvement (2-point scale) (n=12,6) | 9 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Week 12:No improvement (2-point scale) (n=12,6) | 3 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Week 12:Major improvement (4-point scale) (n=12,6) | 7 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Week 12:Minor improvement (4-point scale) (n=12,6) | 2 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Week 12:No Change (4-point scale) (n=12,6) | 3 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Week 12:Deterioration (4-point scale) (n=12,6) | 0 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Baseline, Week 12: Severe Problems (n=12,6) | 1 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Baseline, Week 1: Many Severe Problems (n=11,5) | 1 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Week 1:Deterioration (4-point scale) (n=11,5) | 2 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Week 12:No improvement (2-point scale) (n=12,6) | 2 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Week 4:Improvement (2-point scale) (n=12,6) | 3 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Baseline, Week 12: Many Severe Problems (n=12,6) | 1 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Baseline, Week 1: No Problems at all (n=11,5) | 0 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Week 4:Minor improvement (4-point scale) (n=12,6) | 2 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Baseline, Week 1:Some Very Minor Problems(n=11,5) | 0 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Week 1:Improvement (2-point scale) (n=11,5) | 2 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Baseline, Week 1: Some Minor Problems (n=11,5) | 1 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Week 12:Deterioration (4-point scale) (n=12,6) | 0 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Baseline, Week 1:Some Moderate Problems(n=11,5) | 2 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Week 1:No improvement (2-point scale) (n=11,5) | 3 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Baseline, Week 1: Severe Problems (n=11,5) | 1 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Week 4:No Change (4-point scale) (n=12,6) | 2 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Baseline, Week 4: No Problems at all (n=12,6) | 0 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Week 1:Major improvement (4-point scale) (n=11,5) | 1 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Baseline, Week 4: Some Very Minor Problems(n=12,6) | 0 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Week 12:Major improvement (4-point scale) (n=12,6) | 1 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Baseline, Week 4: Some Minor Problems (n=12,6) | 2 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Week 1:Minor improvement (4-point scale) (n=11,5) | 1 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Baseline, Week 4: Some Moderate Problems (n=12,6) | 2 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Week 4:Deterioration (4-point scale) (n=12,6) | 1 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Baseline, Week 4: Severe Problems (n=12,6) | 1 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Week 1:No Change (4-point scale) (n=11,5) | 1 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Baseline, Week 4: Many Severe Problems (n=12,6) | 1 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Week 12:No Change (4-point scale) (n=12,6) | 2 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Baseline, Week 12: No Problems at all (n=12,6) | 0 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Week 12:Improvement (2-point scale) (n=12,6) | 4 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Baseline, Week12: Some Very Minor Problems(n=12,6) | 0 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Week 4:No improvement (2-point scale) (n=12,6) | 3 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Baseline, Week 12: Some Minor Problems (n=12,6) | 2 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Week 12:Minor improvement (4-point scale) (n=12,6) | 3 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Baseline, Week 12: Some Moderate Problems (n=12,6) | 2 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12 | Week 4:Major improvement (4-point scale) (n=12,6) | 1 participants |
Secondary
Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12
PPUS: a self-administered, single-item, validated questionnaire that measures the participant's perception of urinary urgency. It is sensitive to changes in perceptions of urinary urgency over time. Scale of 0 (usually not able to hold urine), 1 (usually able to hold urine \[without leaking\] until reaching toilet if go to toilet immediately), or 2 (usually able to finish what he/she is doing before going to toilet \[without leaking\]). Results categorized as SC from baseline on 3-point scale: improvement (positive SC), no change (SC 0), deterioration (negative SC).
Time frame: Baseline (Bl), Week 1, 4, 12
Population: FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. Missing values imputed using LOCF method. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12 | Week 4:No change (n=12,6) | 7 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12 | Week 4:Deterioration (n=12,6) | 1 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12 | Week 12:No change (n=12,6) | 6 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12 | Bl,Week 1:Not able to hold urine (n=11,5) | 6 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12 | Bl,Week 1:Able to hold until reach toilet (n=11,5) | 4 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12 | Bl,Week 1:Able to finish what I am doing (n=11,5) | 1 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12 | Bl,Week 4:Not able to hold urine (n=12,6) | 6 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12 | Bl,Week 4:Able to hold until reach toilet (n=12,6) | 5 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12 | Bl,Week 4:Able to finish what I am doing (n=12,6) | 1 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12 | Bl,Week 12:Not able to hold urine (n=12,6) | 6 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12 | Bl,Week 12:Able to hold until reach toilet(n=12,6) | 5 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12 | Bl,Week 12:Able to finish what I am doing (n=12,6) | 1 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12 | Week 1:Improvement (n=11,5) | 4 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12 | Week 1:No change (n=11,5) | 6 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12 | Week 1:Deterioration (n=11,5) | 1 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12 | Week 4:Improvement (n=12,6) | 4 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12 | Week 12:Improvement (n=12,6) | 6 participants |
| Tolterodine | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12 | Week 12:Deterioration (n=12,6) | 0 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12 | Week 1:No change (n=11,5) | 3 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12 | Week 4:No change (n=12,6) | 5 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12 | Bl,Week 12:Not able to hold urine (n=12,6) | 1 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12 | Week 12:Improvement (n=12,6) | 1 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12 | Week 12:Deterioration (n=12,6) | 1 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12 | Week 4:Improvement (n=12,6) | 0 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12 | Bl,Week 12:Able to hold until reach toilet(n=12,6) | 4 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12 | Bl,Week 1:Not able to hold urine (n=11,5) | 1 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12 | Week 1:Deterioration (n=11,5) | 1 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12 | Bl,Week 1:Able to hold until reach toilet (n=11,5) | 3 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12 | Bl,Week 12:Able to finish what I am doing (n=12,6) | 1 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12 | Bl,Week 1:Able to finish what I am doing (n=11,5) | 1 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12 | Week 12:No change (n=12,6) | 4 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12 | Bl,Week 4:Not able to hold urine (n=12,6) | 1 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12 | Week 1:Improvement (n=11,5) | 1 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12 | Bl,Week 4:Able to hold until reach toilet (n=12,6) | 4 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12 | Week 4:Deterioration (n=12,6) | 1 participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12 | Bl,Week 4:Able to finish what I am doing (n=12,6) | 1 participants |
Secondary
Number of Participants With Reason for Participation in the Study
PEQ is a web-based self-administered, exploratory questionnaire that assesses the participant's perception of trial method. Number of participants who responded to question 2, What led you to participate given the study drug is already available? are reported.
Time frame: Week 12
Population: FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tolterodine | Number of Participants With Reason for Participation in the Study | Contribute to research | 8 participants |
| Tolterodine | Number of Participants With Reason for Participation in the Study | Experience internet research study and try it out | 2 participants |
| Tolterodine | Number of Participants With Reason for Participation in the Study | Ease of participation | 3 participants |
| Tolterodine | Number of Participants With Reason for Participation in the Study | Free medication | 3 participants |
| Tolterodine | Number of Participants With Reason for Participation in the Study | Payment for participation | 1 participants |
Secondary
Number of Participants With Response Regarding Source of First Information About Study
Participant experience questionnaire (PEQ) is a web-based self-administered, exploratory questionnaire that assesses the participant's perception of trial method. Number of participants who responded to question 1, Where did you hear first about the study? are reported.
Time frame: Week 12
Population: FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tolterodine | Number of Participants With Response Regarding Source of First Information About Study | On-line Community | 1 participants |
| Tolterodine | Number of Participants With Response Regarding Source of First Information About Study | Friend | 2 participants |
| Tolterodine | Number of Participants With Response Regarding Source of First Information About Study | Google or related internet search engine | 3 participants |
| Tolterodine | Number of Participants With Response Regarding Source of First Information About Study | Web-site advertisement | 3 participants |
| Tolterodine | Number of Participants With Response Regarding Source of First Information About Study | Blogger, on-line health group leader or activist | 1 participants |
| Tolterodine | Number of Participants With Response Regarding Source of First Information About Study | 3 participants | |
| Tolterodine | Number of Participants With Response Regarding Source of First Information About Study | Other | 4 participants |
Secondary
Participant Perception Regarding Cell Phone Diary
PEQ:self-administered, assesses participants perception of trial method. Question4, How satisfied were you with items? on scale 1(very easy) to 5(very difficult)- a: teaching video explaining CP use; recording urinations using CP; size of text on CP; sending your urinary information(inf) using your CP, e: overall, suitability for capturing urinations as they happened.
Time frame: Week 12
Population: FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tolterodine | Participant Perception Regarding Cell Phone Diary | CP use video: somewhat easy | 4 participants |
| Tolterodine | Participant Perception Regarding Cell Phone Diary | CP use video: neither difficult nor easy | 1 participants |
| Tolterodine | Participant Perception Regarding Cell Phone Diary | CP use video: very easy | 12 participants |
| Tolterodine | Participant Perception Regarding Cell Phone Diary | Recording urinations using CP: somewhat easy | 3 participants |
| Tolterodine | Participant Perception Regarding Cell Phone Diary | Recording urinations using CP: very easy | 14 participants |
| Tolterodine | Participant Perception Regarding Cell Phone Diary | CP text size: neither difficult nor easy | 1 participants |
| Tolterodine | Participant Perception Regarding Cell Phone Diary | CP text size: somewhat easy | 4 participants |
| Tolterodine | Participant Perception Regarding Cell Phone Diary | CP text size: very easy | 12 participants |
| Tolterodine | Participant Perception Regarding Cell Phone Diary | Sending urinary inf using CP: somewhat easy | 4 participants |
| Tolterodine | Participant Perception Regarding Cell Phone Diary | Sending urinary inf using CP: very easy | 13 participants |
| Tolterodine | Participant Perception Regarding Cell Phone Diary | Overall: neither difficult nor easy | 1 participants |
| Tolterodine | Participant Perception Regarding Cell Phone Diary | Overall: somewhat easy | 3 participants |
| Tolterodine | Participant Perception Regarding Cell Phone Diary | Overall: very easy | 13 participants |
Secondary
Participant Perception Regarding Received Treatment in the Study
PEQ is a web-based self-administered, exploratory questionnaire that assesses the participant's perception of trial method. Number of participants who responded to question 5, What treatment did you think you were on? are reported.
Time frame: Week 12
Population: FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tolterodine | Participant Perception Regarding Received Treatment in the Study | Placebo | 3 participants |
| Tolterodine | Participant Perception Regarding Received Treatment in the Study | Tolterodine | 8 participants |
| Placebo | Participant Perception Regarding Received Treatment in the Study | Placebo | 4 participants |
| Placebo | Participant Perception Regarding Received Treatment in the Study | Tolterodine | 2 participants |
Secondary
Participant Perception Regarding Recommending a Friend to Enter Similar Study
PEQ is a web-based self-administered, exploratory questionnaire that assesses the participant's perception of trial method. Number of participants who responded to question 6, How likely would you be to recommend a friend to enter a similar study? are reported.
Time frame: Week 12
Population: FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tolterodine | Participant Perception Regarding Recommending a Friend to Enter Similar Study | Very likely | 11 participants |
| Tolterodine | Participant Perception Regarding Recommending a Friend to Enter Similar Study | Somewhat likely | 5 participants |
| Tolterodine | Participant Perception Regarding Recommending a Friend to Enter Similar Study | Neither | 1 participants |
Secondary
Participant Perception Regarding Satisfaction Related to Study
PEQ:self-administered, to assess perception of trial method. Question3, How satisfied were you with items? on scale 1(very satisfied) to 5(very dissatisfied)- recruitment; questionnaires,surveys(Ques,Sur); identification verification(IV); informed consent(IC) process; website experience; phone call; laboratory(lab) kit delivery; lab location; lab staff service(Ser); physical exam(PE) scheduling,location (sch,loc); PE visit; medication(med) first batch delivery; med second batch delivery; cell phone(CP) received; CP use; call center(CC) ser; medical support(supp); technical supp; overall.
Time frame: Week 12
Population: FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | Recruitment: very satisfied | 12 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | Medical supp: somewhat dis-satisfied | 1 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | IC: neither dis-satisfied nor satisfied | 1 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | IC: somewhat dis-satisfied | 1 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | Recruitment: neither dis-satisfied nor satisfied | 1 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | Recruitment: somewhat satisfied | 4 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | Ques,Sur: somewhat dis-satisfied | 1 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | Ques,Sur: somewhat satisfied | 4 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | Ques,Sur: very satisfied | 12 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | IV: somewhat dis-satisfied | 1 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | IV: neither dis-satisfied nor satisfied | 2 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | IV: somewhat satisfied | 3 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | IV: very satisfied | 11 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | IC: somewhat satisfied | 2 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | IC: very satisfied | 13 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | Website experience: very dis-satisfied | 2 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | Website experience: somewhat satisfied | 4 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | Website experience: very satisfied | 11 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | Phone call: very dis-satisfied | 1 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | Phone call: somewhat dis-satisfied | 1 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | Phone call: somewhat satisfied | 1 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | Phone call: very satisfied | 14 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | Lab kit delivery: very dis-satisfied | 1 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | Lab kit delivery: very satisfied | 16 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | Lab location: neither dis-satisfied nor satisfied | 3 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | Lab location: somewhat satisfied | 1 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | Lab location: very satisfied | 13 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | Lab staff Ser: neither dis-satisfied nor satisfied | 1 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | Lab staff Ser: somewhat satisfied | 3 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | Lab staff Ser: very satisfied | 13 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | PE sch,loc: somewhat dis-satisfied | 2 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | PE sch,loc: neither dis-satisfied nor satisfied | 3 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | PE sch,loc: very satisfied | 12 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | PE visit: very dis-satisfied | 1 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | PE visit: somewhat dis-satisfied | 2 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | PE visit: neither dis-satisfied nor satisfied | 2 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | PE visit: somewhat satisfied | 1 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | PE visit: very satisfied | 11 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | Med first batch delivery: very dis-satisfied | 1 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | Med first batch delivery: very satisfied | 16 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | Med second batch delivery: very dis-satisfied | 1 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | Med second batch delivery: somewhat satisfied | 1 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | Med second batch delivery: very satisfied | 15 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | CP received: very satisfied | 17 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | CP use: very dis-satisfied | 1 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | CP use: neither dis-satisfied nor satisfied | 1 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | CP use: somewhat satisfied | 1 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | CP use: very satisfied | 14 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | CC ser: neither dis-satisfied nor satisfied | 4 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | CC ser: somewhat satisfied | 1 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | CC ser: very satisfied | 12 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | Medical supp: somewhat satisfied | 1 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | Medical supp: very satisfied | 15 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | Technical supp:neither dis-satisfied nor satisfied | 2 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | Technical supp: somewhat satisfied | 1 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | Technical supp: very satisfied | 14 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | Overall: somewhat dis-satisfied | 2 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | Overall: somewhat satisfied | 4 participants |
| Tolterodine | Participant Perception Regarding Satisfaction Related to Study | Overall: very satisfied | 11 participants |
Other Pre-specified
Number of Participants Who Discontinued the Study Due to Adverse Events
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Time frame: Baseline up to 28 days after last dose
Population: Safety set included all participants who received at least 1 dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tolterodine | Number of Participants Who Discontinued the Study Due to Adverse Events | 1 participants |
| Placebo | Number of Participants Who Discontinued the Study Due to Adverse Events | 0 participants |
Other Pre-specified
Number of Participants With Adverse Events (AEs) by Relatedness and Severity
AE:any untoward medical occurrence attributed to study medication in participant who received study drug. Relatedness to study medication was assessed by the investigator. Severity of AEs assessed as: mild (does not interfere with participant's usual function), moderate (interferes to some extent with participant's usual function) and severe (interferes significantly with participant's usual function). Mild, moderate and severe are not mutually exclusive; hence same participant may be included in more than 1 type of severity of AEs.
Time frame: Baseline up to 28 days after last dose
Population: Safety set included all participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tolterodine | Number of Participants With Adverse Events (AEs) by Relatedness and Severity | Treatment-related AEs | 2 participants |
| Tolterodine | Number of Participants With Adverse Events (AEs) by Relatedness and Severity | Mild AEs | 4 participants |
| Tolterodine | Number of Participants With Adverse Events (AEs) by Relatedness and Severity | Moderate AEs | 3 participants |
| Tolterodine | Number of Participants With Adverse Events (AEs) by Relatedness and Severity | Severe AEs | 1 participants |
| Placebo | Number of Participants With Adverse Events (AEs) by Relatedness and Severity | Severe AEs | 0 participants |
| Placebo | Number of Participants With Adverse Events (AEs) by Relatedness and Severity | Treatment-related AEs | 0 participants |
| Placebo | Number of Participants With Adverse Events (AEs) by Relatedness and Severity | Moderate AEs | 0 participants |
| Placebo | Number of Participants With Adverse Events (AEs) by Relatedness and Severity | Mild AEs | 3 participants |
Other Pre-specified
Number of Participants With Laboratory Abnormalities
Criteria for potentially clinically significant (PCS) laboratory values: Hemoglobin, hematocrit, red blood cell less than (\<) 0.8 lower limit of normal(LLN); platelet \<0.5 LLN, \>1.75 upper LN (ULN);white blood cell \<0.6 LLN, \>1.5 ULN; lymphocyte, total neutrophil(absolute\[AL\]),Total protein, albumin, phosphate \<0.8 LLN, \>1.2 ULN; basophil, eosinophil, monocyte \>1.2ULN; Total bilirubin \>1.5ULN; aspartate, alanine aminotransferase, alkaline phosphatase \>3ULN; Blood urea nitrogen, creatinine \>1.3ULN; sodium \<0.95LLN, \>1.05ULN; potassium, chloride, bicarbonate, calcium \<0.9LLN, \>1.1ULN.
Time frame: Week 12
Population: Safety set included all participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tolterodine | Number of Participants With Laboratory Abnormalities | 1 participants |
| Placebo | Number of Participants With Laboratory Abnormalities | 1 participants |
Other Pre-specified
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Time frame: Baseline up to 28 days after last dose
Population: Safety set included all participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tolterodine | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AEs | 6 participants |
| Tolterodine | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAEs | 0 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AEs | 3 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAEs | 0 participants |