Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00465894
Status:
COMPLETED
Last Update Posted:
2018-11-01
First Post:
2007-04-23
Brief Title:
Detrol Long Acting LA vs Estrace Vaginal Cream for the Treatment of Overactive Bladder Symptoms
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DRIVE
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 OABSyndrome 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IIR - DRIVE | None | None | None |