N/A
N=58
Detrol Long Acting (LA) vs Estrace Vaginal Cream for the Treatment of Overactive Bladder Symptoms
Overactive Bladder
Bottom Line
View on ClinicalTrials.gov: NCT00465894 ↗Enrolled (actual)
58
Serious AEs
0.0%
Results posted
Oct 2012
Primary outcome: Primary: Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score — 65.4; 61.6; 46.7; 45.4 units on a scale — p=.45
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Extended Release Tolterodine LA (Drug); Intra Vaginal Estradiol Cream (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score |
65.4; 61.6; 46.7; 45.4 | .45 |
| SECONDARY Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Health Related Quality of Life (HRQL) |
53.1; 60.9; 66.0; 69.8 | — |
| SECONDARY Evaluate Subjective Patient Change in Irritative Urinary Symptoms |
3; 0; 8; 7; 8; 12 | — |
| SECONDARY Subjective Patient Change in Irritative Urinary Symptoms |
26.8; 19.7 | — |
| SECONDARY Subjective Patient Change in Irritative Urinary Symptoms As Measured By the 3-Day Voiding Diary |
30.4; 26.4; 26.3; 24.6; 10.8; 11.9 | — |
| SECONDARY Subjective Patient Change in Irritative Urinary Symptoms |
26.8; 19.7 | — |
| SECONDARY Subjective Patient Change in Irritative Urinary Symptoms |
26.8; 19.7 | — |
| SECONDARY Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Global Impression of Improvement (PGI-I) |
77; 77 | — |
| SECONDARY Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Satisfaction Questionnaire (PSQ) |
84; 84 | — |
| SECONDARY Subjective Patient Change in Irritative Urinary Symptoms |
26.8; 19.7 | — |
| SECONDARY Subjective Patient Change in Irritative Urinary Symptoms |
26.8; 19.7 | — |
| SECONDARY Subjective Patient Change in Irritative Symptoms as Indicated by the Patient Global Impression of Improvement (PGI-I) |
85; 85 | — |
| SECONDARY Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Satisfaction Questionnaire (PSQ) |
84; 84 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00465894). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.