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

This study has been terminated.
(Stop date for randomization: 31/5/2012. Recruitment terminated due to lack of recruitment. No new safety issues were identified.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01302938
First received: February 22, 2011
Last updated: July 22, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention Phase
Overactive Bladder
Drug: Tolterodine ER
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 1, 4, 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 1, 4, 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 1, 4 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 1, 4, 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 1, 4, 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 1, 4, 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 1, 4, 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline (Bl), Week 1, 4, 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Baseline up to 28 days after last dose ] [ Designated as safety issue: Yes ]
    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.

  • Number of Participants With Adverse Events (AEs) by Relatedness and Severity [ Time Frame: Baseline up to 28 days after last dose ] [ Designated as safety issue: Yes ]
    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 Who Discontinued the Study Due to Adverse Events [ Time Frame: Baseline up to 28 days after last dose ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 18
Study Start Date: March 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tolterodine ER Drug: Tolterodine ER
One 4 mg capsule will be taken with water every day with or without food. It should be swallowed whole without chewing.
Placebo Comparator: Placebo Drug: Placebo
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01302938

Locations
United States, California
Mytrus, Inc.
San Francisco, California, United States, 94104
University of California San Francisco
San Francisco, California, United States, 94121
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01302938     History of Changes
Other Study ID Numbers: A6121195
Study First Received: February 22, 2011
Results First Received: July 22, 2013
Last Updated: July 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Double-blind
Placebo-controlled
frequency
urgency
web-based
incontinence
methodology
ediary
safety
efficacy
tolerability ER
overactive bladder

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Lower Urinary Tract Symptoms
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Phenylpropanolamine
Tolterodine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-Agonists
Anti-Obesity Agents
Appetite Depressants
Autonomic Agents
Cardiovascular Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Nasal Decongestants
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sympathomimetics
Therapeutic Uses
Urological Agents
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on October 20, 2014