Clinical trial NCT00465894: Detrol Long Acting (LA) vs Estrace Vaginal Cream for the Treatment of Overactive Bladder Symptoms
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder
Keywords: overactive bladder
urge leakage
nightime urination
incontinence
urinary frequency
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2007-04-25
Enrollment: 58
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score
timeFrame: From baseline through 12 Weeks of Intervention
Secondary outcomes:
measure: Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Health Related Quality of Life (HRQL)
timeFrame: From baseline through 12 Weeks of Intervention
measure: Evaluate Subjective Patient Change in Irritative Urinary Symptoms
timeFrame: From baseline through 12 Weeks of Intervention
measure: Subjective Patient Change in Irritative Urinary Symptoms
timeFrame: From baseline through 12 Weeks of Intervention
measure: Subjective Patient Change in Irritative Urinary Symptoms As Measured By the 3-Day Voiding Diary
timeFrame: From baseline through 12 weeks of Intervention
measure: Subjective Patient Change in Irritative Urinary Symptoms
timeFrame: Baseline to 24 weeks
measure: Subjective Patient Change in Irritative Urinary Symptoms
timeFrame: Baseline to 24 weeks
measure: Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Global Impression of Improvement (PGI-I)
timeFrame: Baseline through 24 weeks
measure: Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Satisfaction Questionnaire (PSQ)
timeFrame: Baseline through 24 weeks
measure: Subjective Patient Change in Irritative Urinary Symptoms
timeFrame: Baseline through 52 weeks
measure: Subjective Patient Change in Irritative Urinary Symptoms
timeFrame: Baseline through 52 weeks
measure: Subjective Patient Change in Irritative Symptoms as Indicated by the Patient Global Impression of Improvement (PGI-I)
timeFrame: Baseline through 52 weeks
measure: Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Satisfaction Questionnaire (PSQ)
timeFrame: Baseline through 52 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: Park Nicollette, St. Louis, Minnesota
name: Kimberly Gerten, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Holly E. Richter, Ph.D., M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.