Exploring Predictors of Symptoms Relapse After Discontinuation of Treatment in Overactive Bladder (OAB) Patients

NCT00730535 | Completed Phase 4 DMC

• 1 other identifier: 2005-08-069
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 4

Brief Summary

This is a Phase IV, prospective, randomized, multi-center study to find risk factors of OAB symptoms relapse in patients who showed therapeutic benefits after 1, 3, or 6 months of treatment with Tolterodine SR and who then discontinued these antimuscarinics for 3 month. Patients who have OAB symptoms for 6 or more than 6 months and who show successful treatment response to 1 month of treatment with Tolterodine SR 4mg will be enrolled and randomized to 1, 3 or 6 months of treatment group. After completion of the treatment, subjects will be evaluated for changes in OAB symptoms and retreatment rate will be assessed.

Conditions

Overactive Bladder

Keywords

Overactive bladder, Tolterodine,Symptoms Relapse, Predictor

Outcome Measures

Primary Outcomes (1)

• Risk factors and relapse rate of the OAB symptoms after drug discontinuation

  from baseline (treatment completion) to 1, 3 month after drug discontinuation

Secondary Outcomes (3)

• Micturition diary efficacy parameters

  from baseline (treatment completion) to 1, 3 month after drug discontinuation

• Quality of life parameters: change in total score and subscale scores of OAB-questionnaire

  from baseline (treatment completion) to 1, 3 month after drug discontinuation

• Patient perceptions: change in patient perception of urgency, change in patient perception of bladder condition and percentage of patients who wants retreatment

  from baseline (treatment completion) to 1, 3 month after drug discontinuation

Study Arms (3)

Tolterodine 1

EXPERIMENTAL

Drug: Tolterodine

Toterodine 3

EXPERIMENTAL

Drug: Tolterodine

Tolterodine 6

EXPERIMENTAL

Drug: Tolterodine 6

Interventions

Tolterodine DRUG

Extended release tolterodine tartrate 4 mg, once daily, for 1 months

Also known as: Detrusitol ER 4mg

Tolterodine 1

Tolterodine 6 DRUG

Extended release tolterodine tartrate 4 mg, once daily, for 6 months

Also known as: Detrusitol ER 4mg

Tolterodine 6

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female aged 18≤and ≤80 years
• Symptoms of urinary urgency (defined as a level of 3 to 5 in a 5 point Urinary Sensation Scale) over 2 times per day
• Symptoms of urinary frequency (≥ 8 micturitions per 24 hours) as verified by baseline micturition diary.
• Symptoms of overactive bladder, including urinary urge incontinence, urgency and/or frequency for ≥6 months.
• Ability and willingness to correctly complete the micturition diary and questionnaire
• Capable of understanding and having signed the informed consent form after full discussion of the research nature of the treatment and its risks and benefits

You may not qualify if:

• Clinical significant stress incontinence as determined by the investigator and confirmed for female patients by a cough provocation test
• An average volume voided of \> 200 ml per micturition as verified on the baseline micturition diary
• Total daily urine volume of \> 3000 ml as verified on the baseline micturition diary
• Significant hepatic or renal disease, defined as having twice the upper limit of the reference ranges for serum concentrations of aspartate aminotransferase (AST \[SGOT\]), alanine aminotransferase (ALT \[SGPT\]), alkaline phosphatase or creatinine
• Any condition that is a contraindication for anticholinergic treatment, including uncontrolled narrow-angled glaucoma, urinary retention or gastric retention
• Symptomatic acute urinary tract infection (UTI) during the run-in period
• Recurrent UTIs defined as having been treated for symptomatic UTIs \> 4 times in the last year
• Diagnosed or suspected interstitial cystitis
• Uninvestigated hematuria or hematuria secondary to malignant disease.
• Clinically significant bladder outlet obstruction defined by clinical symptoms and investigator's opinion according to local standard of care
• Patients with marked cystocele or other clinically significant pelvic prolapse.
• On an unstable dosage of any drug with anticholinergic side effects, or expected to start such treatment during the study
• Receipt of any electrostimulation or bladder training within the 14 days before the start of tolterodine SR, or expected to start such treatment during the study
• Use of any other drugs for the treatment of overactive bladder (e.g. anticholinergics except tolterodine) within the 14 days before the start of tolterodine SR, or expected to start such treatment during the study
• An indwelling catheter or practicing intermittent self-catheterization

Sponsors & Collaborators

• KYU-SUNG LEE: lead
• Pfizer: collaborator

Study Sites (4)

Samsung Medical Center

Irwon-dong, Seoul, 135-710, South Korea

Location

Holy Family Hospital, The Catholic University of Korea

Gyeonggi-do, South Korea

Location

Asan Medical Center, Ulsan College of Medicine

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Tolterodine Tartrate

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropanolamine; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cresols; Phenols

Study Officials

• Kyu-Sung Lee, Ph.D

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 7, 2008
• First Posted: August 8, 2008
• Study Start: August 1, 2006
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: December 2, 2019

Record last verified: 2011-04

Locations

KR (4)