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Web-based Methodology Trial to Evaluate the Efficacy and Safety of Tolterodine ER in Subjects With Overactive Bladder (REMOTE)

Primary Purpose

Overactive Bladder

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tolterodine ER
Placebo
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring Double-blind, Placebo-controlled, frequency, urgency, web-based, incontinence, methodology, ediary, safety, efficacy, tolerability ER, overactive bladder

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Mytrus, Inc.
  • University of California San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tolterodine ER

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
February 22, 2011
Last Updated
January 26, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01302938
Brief Title
Web-based Methodology Trial to Evaluate the Efficacy and Safety of Tolterodine ER in Subjects With Overactive Bladder
Acronym
REMOTE
Official Title
Exploratory, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Single Center, Web-Based Phase IV Pilot Methodology Trial To Evaluate The Efficacy And Safety Of Tolterodine ER In Subjects With Overactive Bladder
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why Stopped
Stop date for randomization: 31/5/2012. Recruitment terminated due to lack of recruitment. No new safety issues were identified.
Study Start Date
March 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
Double-blind, Placebo-controlled, frequency, urgency, web-based, incontinence, methodology, ediary, safety, efficacy, tolerability ER, overactive bladder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tolterodine ER
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Tolterodine ER
Intervention Description
One 4 mg capsule will be taken with water every day with or without food. It should be swallowed whole without chewing.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12
Description
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
Secondary Outcome Measure Information:
Title
Change From Baseline in Mean Voided Volume Per Micturition at Week 1, 4 and 12
Description
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
Title
Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 1, 4 and 12
Description
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
Title
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 1 and 4
Description
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
Title
Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours at Week 1, 4 and 12
Description
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
Title
Change From Baseline in Mean Number of Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 1, 4 and 12
Description
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
Title
Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 1, 4 and 12
Description
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
Title
Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12
Description
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
Title
Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12
Description
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
Title
Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12
Description
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
Title
Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12
Description
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
Title
Change From Baseline in Health Related Quality of Life (HRQL) Social Domain Score at Week 12
Description
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
Title
Number of Participants With Response Regarding Source of First Information About Study
Description
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
Title
Number of Participants With Reason for Participation in the Study
Description
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
Title
Participant Perception Regarding Satisfaction Related to Study
Description
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
Title
Participant Perception Regarding Cell Phone Diary
Description
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
Title
Participant Perception Regarding Received Treatment in the Study
Description
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
Title
Participant Perception Regarding Recommending a Friend to Enter Similar Study
Description
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
Other Pre-specified Outcome Measures:
Title
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Description
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
Title
Number of Participants With Adverse Events (AEs) by Relatedness and Severity
Description
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
Title
Number of Participants Who Discontinued the Study Due to Adverse Events
Description
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
Title
Number of Participants With Laboratory Abnormalities
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Mytrus, Inc.
City
San Francisco
State/Province
California
ZIP/Postal Code
94104
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24792229
Citation
Orri M, Lipset CH, Jacobs BP, Costello AJ, Cummings SR. Web-based trial to evaluate the efficacy and safety of tolterodine ER 4 mg in participants with overactive bladder: REMOTE trial. Contemp Clin Trials. 2014 Jul;38(2):190-7. doi: 10.1016/j.cct.2014.04.009. Epub 2014 May 2.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6121195&StudyName=Web-based%20Methodology%20Trial%20to%20Evaluate%20the%20Efficacy%20and%20Safety%20of%20Tolterodine%20ER%20in%20Subjects%20with%20Overactive%20Bladder%20
Description
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Web-based Methodology Trial to Evaluate the Efficacy and Safety of Tolterodine ER in Subjects With Overactive Bladder

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