Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Detrol Long Acting (LA) vs Estrace Vaginal Cream for the Treatment of Overactive Bladder Symptoms (DRIVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00465894
Recruitment Status : Completed
First Posted : April 25, 2007
Results First Posted : October 23, 2012
Last Update Posted : November 1, 2018
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
David Rich Ellington, University of Alabama at Birmingham

Tracking Information
First Submitted Date  ICMJE April 23, 2007
First Posted Date  ICMJE April 25, 2007
Results First Submitted Date  ICMJE June 1, 2012
Results First Posted Date  ICMJE October 23, 2012
Last Update Posted Date November 1, 2018
Study Start Date  ICMJE April 2007
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2018)
Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score [ Time Frame: From baseline through 12 Weeks of Intervention ]
The first part of the OAB-q consists of eight questions assessing symptom bother with a possible score from 0 to 100 with a higher score indicating greater symptom bother.
Original Primary Outcome Measures  ICMJE
 (submitted: April 24, 2007)
Subjective Patient Improvement in Irritative Urinary Symptoms as Measured by the Overactive Bladder Questionnaire (OAB-q) After 12 Weeks Intervention
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2018)
  • Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Health Related Quality of Life (HRQL) [ Time Frame: From baseline through 12 Weeks of Intervention ]
    Assessment made using the Health Related Quality of Life (HRQL) portion of the OAB-q. The second part of the OAB-q, the HRQL consists of 25 questions that assesses HRQL which addresses coping, concern, sleep and social interaction where the scoring scale is from 0 to 100 with a higher score indicating a better quality of life.
  • Evaluate Subjective Patient Change in Irritative Urinary Symptoms [ Time Frame: From baseline through 12 Weeks of Intervention ]
    Assessment measured using the Patient Global Impression of Improvement (PGI-I), patient perception of improvement. The PGI-I is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 being very much better to 7 being very much worse. Frequencies of each response was reported. Each level achieved (movement towards 1), is considered an improvement.
  • Subjective Patient Change in Irritative Urinary Symptoms [ Time Frame: From baseline through 12 Weeks of Intervention ]
    This was measured using the Patient Satisfaction Questionnaire (PSQ). The PSQ consists of a single question, "How satisfied are you with your progress since your treatment" in which the 3 possible responses are "completely satisfied," "somewhat satisfied," and "not satisfied." The goal of treatment was to move all participants to "completely satisfied.
  • Subjective Patient Change in Irritative Urinary Symptoms As Measured By the 3-Day Voiding Diary [ Time Frame: From baseline through 12 weeks of Intervention ]
    Number of voids and accidents/leakage per 3 day diary. A void is a voluntary and intentional event. An accident is involuntary and unintentional.
  • Subjective Patient Change in Irritative Urinary Symptoms [ Time Frame: Baseline to 24 weeks ]
    The first part of the OAB-q consists of eight questions assessing symptom bother with a possible score from 0 to 100 with a higher score indicating greater symptom bother.
  • Subjective Patient Change in Irritative Urinary Symptoms [ Time Frame: Baseline to 24 weeks ]
    Assessment made using the Health Related Quality of Life (HRQL) portion of the OAB-q. The second part of the OAB-q, the HRQL consists of 25 questions that assesses HRQL which addresses coping, concern, sleep and social interaction where the scoring scale is from 0 to 100 with a higher score indicating a better quality of life.
  • Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Global Impression of Improvement (PGI-I) [ Time Frame: Baseline through 24 weeks ]
    Assessment measured using the Patient Global Impression of Improvement (PGI-I), patient perception of improvement. The PGI-I is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 being very much better to 7 being very much worse. Each level achieved(movement towards 1), is considered an improvement.
  • Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Satisfaction Questionnaire (PSQ) [ Time Frame: Baseline through 24 weeks ]
    As measured by the Patient Satisfaction Questionnaire (PSQ). The PSQ consists of a single question, "How satisfied are you with your progress since your treatment" in which the 3 possible responses are "completely satisfied," "somewhat satisfied," and "not satisfied." The goal of treatment was to move all participants to "completely satisfied.
  • Subjective Patient Change in Irritative Urinary Symptoms [ Time Frame: Baseline through 52 weeks ]
    The first part of the OAB-q consists of eight questions assessing symptom bother with a possible score from 0 to 100 with a higher score indicating greater symptom bother.
  • Subjective Patient Change in Irritative Urinary Symptoms [ Time Frame: Baseline through 52 weeks ]
    Assessment made using the Health Related Quality of Life (HRQL) portion of the OAB-q. The second part of the OAB-q, the HRQL consists of 25 questions that assesses HRQL which addresses coping, concern, sleep and social interaction where the scoring scale is from 0 to 100 with a higher score indicating a better quality of life.
  • Subjective Patient Change in Irritative Symptoms as Indicated by the Patient Global Impression of Improvement (PGI-I) [ Time Frame: Baseline through 52 weeks ]
    Assessment measured using the Patient Global Impression of Improvement (PGI-I), patient perception of improvement. The PGI-I is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 being very much better to 7 being very much worse. Each level achieved(movement towards 1), is considered an improvement.
  • Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Satisfaction Questionnaire (PSQ) [ Time Frame: Baseline through 52 Weeks ]
    As measured by the Patient Satisfaction Questionnaire (PSQ).The PSQ consists of a single question, "How satisfied are you with your progress since your treatment" in which the 3 possible responses are "completely satisfied," "somewhat satisfied," and "not satisfied." The goal of treatment was to move all participants to "completely satisfied.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Detrol Long Acting (LA) vs Estrace Vaginal Cream for the Treatment of Overactive Bladder Symptoms
Official Title  ICMJE Randomized Controlled Trial of Tolterodine in Combination With or Without Low-Dose Intravaginal Estradiol Cream for the Treatment of Overactive Bladder in Post-Menopausal Women
Brief Summary The purpose of this study is to determine if long acting tolterodine confers more benefit than intravaginal low dose estrogen in the treatment of Overactive Bladder Syndrome at 12 weeks post-treatment initiation. The hypothesis is that low dose intra-vaginal estrogen confers greater benefit than tolterodine in the treatment of Overactive Bladder symptoms. Secondary outcomes were to assess if the addition of the other therapy to the treatment regimen conferred benefit at 24 weeks and 52 weeks.
Detailed Description

Lower urinary tract bladder storage symptoms include urinary frequency, urinary urgency, nocturia and urge incontinence. Overactive Bladder (OAB)Syndrome is a condition in which urgency is the predominant symptom with or without urge incontinence and is usually accompanied by frequency and nocturia. The mainstay of treatment of women with OAB syndrome is treatment with anticholinergic medication as well as behavioral therapy. This method of treatment has demonstrated a 60% response rate as reported in the Cochrane Database of Systemic Reviews.

In addition to anticholinergic therapy, vaginal atrophy is often corrected as part of a pharmacologic treatment plan. Vaginal atrophy is a condition this is vastly prevalent in post-menopausal women. It is thought to affect up to 48% of post-menopausal women. Many women with this condition experience vaginal dryness, irritation, painful intercourse, as well as urinary symptoms including dysuria, urgency, frequency, nocturia, incontinence and recurrent urinary tract infections.

Comparison: Tolterodine LA compared to low dose intra-vaginal estrogen cream for the treatment of OAB symptoms

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Overactive Bladder
Intervention  ICMJE
  • Drug: Extended Release Tolterodine LA
    Tolterodine LA 4 mg once daily for 52 weeks. At 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks
    Other Name: Detrol
  • Drug: Intra Vaginal Estradiol Cream
    17-B estradiol cream 0.5 grams nightly for 6 weeks then two times weekly for 46 weeks. At 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks.
    Other Names:
    • Estrace
    • Premarin vaginal cream
Study Arms  ICMJE
  • Active Comparator: Extended Release Tolterodine LA
    An anti-muscarinic drug that is used for symptomatic treatment of urinary incontinence.
    Intervention: Drug: Extended Release Tolterodine LA
  • Active Comparator: Intra Vaginal Estradiol Cream
    For topical application to the vaginal area to treat symptoms of urgency or irritation with urination.
    Intervention: Drug: Intra Vaginal Estradiol Cream
Publications * Ellington DR, Szychowski JM, Malek JM, Gerten KA, Burgio KL, Richter HE. Combined Tolterodine and Vaginal Estradiol Cream for Overactive Bladder Symptoms After Randomized Single-Therapy Treatment. Female Pelvic Med Reconstr Surg. 2016 Jul-Aug;22(4):254-60. doi: 10.1097/SPV.0000000000000256.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 14, 2011)
58
Original Enrollment  ICMJE
 (submitted: April 24, 2007)
60
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Irritative voiding symptoms to include sensory urgency, frequency, urge incontinence, nocturia
  • Postmenopausal women with a prior oophorectomy or 1 year from last menstrual period
  • Women age 40-90
  • Women with hysterectomy with preserved ovaries must be age 55 or greater or have a documented follicle-stimulating hormone (FSH)>40 to ensure post-menopausal status
  • Community dwelling
  • Ambulatory
  • Ability to participate in a 12 month study

Exclusion Criteria:

  • Post-void residual volume>150ml
  • Glaucoma without ophthalmologist clearance
  • Hormone replacement therapy in the past 6 months
  • Current anticholinergic treatment
  • Breast cancer
  • Impaired mental status
  • Undiagnosed vaginal bleeding in the past 12 months
  • Endometrial thickness on pelvic ultrasound >5mm
  • History of thromboembolic event
  • Gynecologic cancer
  • Untreated urinary tract infection (would be eligible after treatment)
  • Stage III pelvic organ prolapse or greater
  • Recent diuretic medication changes (one month from change)
  • Neurologic condition affecting bladder function (Multiple Sclerosis, Parkinsons, spinal cord injury, spina bifida)
  • Congestive heart failure
  • Prior pelvic irradiation
  • Interstitial cystitis
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 40 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00465894
Other Study ID Numbers  ICMJE F061208008
IIR - DRIVE
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Rich Ellington, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Kimberly Gerten, M.D. Park Nicollette, St. Louis, Minnesota
Principal Investigator: Holly E. Richter, Ph.D., M.D. University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP