A Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency

November 7, 2018 updated by: Pfizer

A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicenter Trial To Evaluate The Efficacy And Safety Of A Fesoterodine Flexible Dose Regimen In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency.

This study is designed to assess the efficacy of a flexible dose regimen of fesoterodine on micturition related nocturnal urgency episodes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

963

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alabama
      • Mobile, Alabama, United States, 36608
        • Pfizer Investigational Site
    • Arizona
      • Goodyear, Arizona, United States, 85395
        • Pfizer Investigational Site
      • Litchfield Park, Arizona, United States, 85340
        • Pfizer Investigational Site
      • Phoenix, Arizona, United States, 85020
        • Pfizer Investigational Site
      • Tucson, Arizona, United States, 85741
        • Pfizer Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Pfizer Investigational Site
    • California
      • Fresno, California, United States, 93720
        • Pfizer Investigational Site
      • La Mesa, California, United States, 91942
        • Pfizer Investigational Site
      • Newport Beach, California, United States, 92660
        • Pfizer Investigational Site
      • Roseville, California, United States, 95661
        • Pfizer Investigational Site
      • Sacramento, California, United States, 95825
        • Pfizer Investigational Site
      • San Diego, California, United States, 92108
        • Pfizer Investigational Site
      • San Diego, California, United States, 92103
        • Pfizer Investigational Site
      • San Diego, California, United States, 92103-6204
        • Pfizer Investigational Site
      • Tarzana, California, United States, 91356
        • Pfizer Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80220
        • Pfizer Investigational Site
      • Denver, Colorado, United States, 80218
        • Pfizer Investigational Site
    • Connecticut
      • Farmington, Connecticut, United States, 06032
        • Pfizer Investigational Site
      • New Britain, Connecticut, United States, 06052
        • Pfizer Investigational Site
      • Norwalk, Connecticut, United States, 06850
        • Pfizer Investigational Site
    • Delaware
      • Dover, Delaware, United States, 19904
        • Pfizer Investigational Site
    • Florida
      • Bonita Springs, Florida, United States, 34134
        • Pfizer Investigational Site
      • Brooksville, Florida, United States, 34601
        • Pfizer Investigational Site
      • DeFuniak Springs, Florida, United States, 32435
        • Pfizer Investigational Site
      • Destin, Florida, United States, 32541
        • Pfizer Investigational Site
      • Leesburg, Florida, United States, 34748
        • Pfizer Investigational Site
      • Naples, Florida, United States, 34102
        • Pfizer Investigational Site
      • Ocala, Florida, United States, 34471
        • Pfizer Investigational Site
      • Ocala, Florida, United States, 34474
        • Pfizer Investigational Site
      • Pembroke Pines, Florida, United States, 33024
        • Pfizer Investigational Site
      • Saint Petersburg, Florida, United States, 33709
        • Pfizer Investigational Site
      • South Miami, Florida, United States, 33143
        • Pfizer Investigational Site
      • Tallahassee, Florida, United States, 32308
        • Pfizer Investigational Site
      • Tampa, Florida, United States, 33606
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30329-5102
        • Pfizer Investigational Site
    • Idaho
      • Coeur d'Alene, Idaho, United States, 83814
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60654
        • Pfizer Investigational Site
      • Chicago, Illinois, United States, 60634
        • Pfizer Investigational Site
    • Indiana
      • Fort Wayne, Indiana, United States, 46825
        • Pfizer Investigational Site
      • Jeffersonville, Indiana, United States, 47130
        • Pfizer Investigational Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Pfizer Investigational Site
      • West Des Moines, Iowa, United States, 50266
        • Pfizer Investigational Site
    • Kansas
      • Newton, Kansas, United States, 67114
        • Pfizer Investigational Site
      • Overland Park, Kansas, United States, 66211
        • Pfizer Investigational Site
      • Overland Park, Kansas, United States, 66210
        • Pfizer Investigational Site
      • Overland Park, Kansas, United States, 66202
        • Pfizer Investigational Site
      • Pratt, Kansas, United States, 67124
        • Pfizer Investigational Site
    • Kentucky
      • Madisonville, Kentucky, United States, 42431
        • Pfizer Investigational Site
      • Mount Sterling, Kentucky, United States, 40353
        • Pfizer Investigational Site
    • Louisiana
      • Shreveport, Louisiana, United States, 71106
        • Pfizer Investigational Site
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Pfizer Investigational Site
    • Massachusetts
      • Fall River, Massachusetts, United States, 02720
        • Pfizer Investigational Site
      • Hyannis, Massachusetts, United States, 02601
        • Pfizer Investigational Site
      • Milford, Massachusetts, United States, 01757
        • Pfizer Investigational Site
      • New Bedford, Massachusetts, United States, 02740
        • Pfizer Investigational Site
      • Watertown, Massachusetts, United States, 02472
        • Pfizer Investigational Site
    • Michigan
      • Troy, Michigan, United States, 48098
        • Pfizer Investigational Site
    • Minnesota
      • Chaska, Minnesota, United States, 55318
        • Pfizer Investigational Site
    • Mississippi
      • Olive Branch, Mississippi, United States, 38654
        • Pfizer Investigational Site
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Pfizer Investigational Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Pfizer Investigational Site
      • Omaha, Nebraska, United States, 68114
        • Pfizer Investigational Site
    • New Jersey
      • Hamilton, New Jersey, United States, 08690
        • Pfizer Investigational Site
    • New York
      • Brooklyn, New York, United States, 11215
        • Pfizer Investigational Site
      • Garden City, New York, United States, 11530
        • Pfizer Investigational Site
      • Kingston, New York, United States, 12401
        • Pfizer Investigational Site
      • Manlius, New York, United States, 13104
        • Pfizer Investigational Site
      • New York, New York, United States, 10016
        • Pfizer Investigational Site
      • Poughkeepsie, New York, United States, 12601
        • Pfizer Investigational Site
    • North Carolina
      • Burlington, North Carolina, United States, 27215
        • Pfizer Investigational Site
      • Cary, North Carolina, United States, 27518
        • Pfizer Investigational Site
      • Charlotte, North Carolina, United States, 28207
        • Pfizer Investigational Site
      • Concord, North Carolina, United States, 28025
        • Pfizer Investigational Site
      • Huntersville, North Carolina, United States, 28078
        • Pfizer Investigational Site
      • Salisbury, North Carolina, United States, 28144
        • Pfizer Investigational Site
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Pfizer Investigational Site
    • Ohio
      • Akron, Ohio, United States, 44311
        • Pfizer Investigational Site
      • Cincinnati, Ohio, United States, 45249
        • Pfizer Investigational Site
      • Columbus, Ohio, United States, 43221
        • Pfizer Investigational Site
      • Columbus, Ohio, United States, 43214
        • Pfizer Investigational Site
      • Dayton, Ohio, United States, 45439
        • Pfizer Investigational Site
      • Westerville, Ohio, United States, 43081
        • Pfizer Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97225
        • Pfizer Investigational Site
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, United States, 19004
        • Pfizer Investigational Site
      • Bridgeville, Pennsylvania, United States, 15017
        • Pfizer Investigational Site
      • Lansdale, Pennsylvania, United States, 19446
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, United States, 19114
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15236
        • Pfizer Investigational Site
      • Sellersville, Pennsylvania, United States, 18960
        • Pfizer Investigational Site
    • Rhode Island
      • East Greenwich, Rhode Island, United States, 02818
        • Pfizer Investigational Site
      • Pawtucket, Rhode Island, United States, 02860
        • Pfizer Investigational Site
      • Warwick, Rhode Island, United States, 02886
        • Pfizer Investigational Site
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Pfizer Investigational Site
      • Mount Pleasant, South Carolina, United States, 29464
        • Pfizer Investigational Site
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Pfizer Investigational Site
      • Kingsport, Tennessee, United States, 37660
        • Pfizer Investigational Site
      • Knoxville, Tennessee, United States, 37920
        • Pfizer Investigational Site
      • Milan, Tennessee, United States, 38358
        • Pfizer Investigational Site
      • Nashville, Tennessee, United States, 37203
        • Pfizer Investigational Site
      • New Tazewell, Tennessee, United States, 37825
        • Pfizer Investigational Site
    • Texas
      • Bryan, Texas, United States, 77802
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75231
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77030
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77024
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77079
        • Pfizer Investigational Site
      • Plano, Texas, United States, 75024
        • Pfizer Investigational Site
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Pfizer Investigational Site
      • Richmond, Virginia, United States, 23294
        • Pfizer Investigational Site
    • Washington
      • Mountlake Terrace, Washington, United States, 98043
        • Pfizer Investigational Site
      • Seattle, Washington, United States, 98104
        • Pfizer Investigational Site
      • Spokane, Washington, United States, 99207
        • Pfizer Investigational Site
    • Wisconsin
      • Menomonee Falls, Wisconsin, United States, 53051
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Mean urinary frequency of >=8 micturitions per 24 hours as verified by the screening bladder diary prior to Start of Placebo run in visit (Visit 2)
  • Mean number of micturition related urgency episodes >=3 per 24 hours as verified by the screening bladder diary prior to Start of Placebo run in /Visit 2 (Urgency episodes are defined as those with Urinary Sensation Scale rating >=3)
  • Mean number of micturition related nocturnal urgency episodes >=2 but no more than 8 episodes per 24 hours as verified by the bladder diary at Visit 2 (nocturnal urgency episodes are defined as those with Urinary Sensation Scale rating of >3 recorded in the bed time section of the bladder diary)

Exclusion Criteria:

  • A known recent history or previous diagnosis of any sleep disorder such as obstructive sleep apnea, primary insomnia, periodic limb movement, parasomnia
  • Nocturia due to other underlying uncontrolled conditions, such as congestive heart failure, diabetes mellitus, diabetes insipidus, polyuria of any cause, etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo sham 4mg and 8 mg tables taken daily.
Experimental: Fesoterodine
Fesoterodine 4mg and 8 mg tablets taken daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours
Time Frame: Baseline
Micturition-related nocturnal urgency episodes had urinary sensation scale (USS) rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of nocturnal micturition-related urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.
Baseline
Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 12
Time Frame: Baseline and Week 12
Micturition-related nocturnal urgency episodes had USS rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of nocturnal micturition-related urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.
Baseline and Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 4
Time Frame: Baseline and Week 4
Micturition-related nocturnal urgency episodes had USS rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of micturition-related nocturnal urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.
Baseline and Week 4
Percent Change From Baseline in Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 4 and 12
Time Frame: Baseline, Week 4 and 12
Percent change of micturition-related nocturnal urgency episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline).
Baseline, Week 4 and 12
Number of Nocturnal Micturitions Per 24 Hours
Time Frame: Baseline
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.
Baseline
Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Week 4 and 12
Time Frame: Baseline, Week 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.
Baseline, Week 4 and 12
Percent Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12
Time Frame: Baseline, Week 4 and 12
Percent change of nocturnal micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline).
Baseline, Week 4 and 12
Mean Number of Micturitions Per 24 Hours
Time Frame: Baseline
Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence [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.
Baseline
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4 and 12
Time Frame: Baseline, Week 4 and 12
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.
Baseline, Week 4 and 12
Percent Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12
Time Frame: Baseline, Week 4 and 12
Percent change of micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline).
Baseline, Week 4 and 12
Number of Micturition-related Urgency Episodes Per 24 Hours
Time Frame: Baseline
The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to 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
Change From Baseline in Number of Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12
Time Frame: Baseline, Week 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 greater than or equal to 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, Week 4 and 12
Percent Change From Baseline in Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12
Time Frame: Baseline, Week 4 and 12
Percent change of micturition-related urgency episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline).
Baseline, Week 4 and 12
Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours
Time Frame: Baseline
UUI episodes were defined as those with the 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
Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12
Time Frame: Baseline, Week 4 and 12
UUI episodes were defined as those with the 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, Week 4 and 12
Percent Change From Baseline in of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12
Time Frame: Baseline, Week 4 and 12
Percent change of UUI episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline).
Baseline, Week 4 and 12
Nocturnal Frequency-urgency Sum Rating Per 24 Hours
Time Frame: Baseline
Frequency-urgency sum is total USS ratings recorded for all nocturnal micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine. Numerical decrease indicates improvement.
Baseline
Change From Baseline in Nocturnal Frequency-urgency Sum Rating Per 24 Hours at Week 4 and 12
Time Frame: Baseline, Week 4 and 12
Frequency-urgency sum is total USS ratings recorded for all nocturnal micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine. Numerical decrease indicates improvement.
Baseline, Week 4 and 12
Frequency-urgency Sum Rating Per 24 Hours
Time Frame: Baseline
Frequency-urgency sum is total USS ratings recorded for all micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine.
Baseline
Change From Baseline in Frequency-urgency Sum Rating Per 24 Hours at Week 4 and 12
Time Frame: Baseline, Week 4 and 12
Frequency-urgency sum is total USS ratings recorded for all micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine. Numerical decrease indicates improvement.
Baseline, Week 4 and 12
Mean Voided Volume Per Nocturnal Micturition
Time Frame: Baseline
Mean voided volume per nocturnal micturition was calculated as sum of voided volume during bedtime divided by the total number of bedtime micturition episodes with a recorded voided volume greater than 0 at that visit.
Baseline
Change From Baseline in Mean Voided Volume Per Nocturnal Micturition at Week 12
Time Frame: Baseline and Week 12
Mean voided volume per nocturnal micturition was calculated as sum of voided volume during bedtime divided by the total number of bedtime micturition episodes with a recorded voided volume greater than 0 at that visit.
Baseline and Week 12
Mean Voided Volume Per Micturition
Time Frame: Baseline
Mean voided volume per micturition was calculated as sum of voided volume divided by the total number of total micturition episodes with a recorded voided volume greater than 0 at that visit.
Baseline
Change From Baseline in Mean Voided Volume Per Micturition at Week 12
Time Frame: Baseline and Week 12
Mean voided volume per micturition was calculated as sum of voided volume divided by the total number of total micturition episodes with a recorded voided volume greater than 0 at that visit.
Baseline and Week 12
Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score
Time Frame: Baseline
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 (least symptom bother) to 6 (most symptom bother). Symptom bother score derived as sum of scores for questions 1-8; 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.
Baseline
Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 4 and 12
Time Frame: Baseline, Week 4 and 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 (least symptom bother) to 6 (most symptom bother). Symptom bother score derived as sum of scores for questions 1-8; 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.
Baseline, Week 4 and 12
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
Time Frame: Baseline
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 (least symptom bother) to 6 (most symptom bother). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.
Baseline
Change From Baseline in Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 4 and 12
Time Frame: Baseline, Week 4 and 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 (least symptom bother) to 6 (most symptom bother). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.
Baseline, Week 4 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

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Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

June 1, 2009

First Submitted That Met QC Criteria

June 2, 2009

First Posted (Estimate)

June 3, 2009

Study Record Updates

Last Update Posted (Actual)

December 4, 2018

Last Update Submitted That Met QC Criteria

November 7, 2018

Last Verified

November 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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