Ignite Creation Date:
2025-12-18 @ 9:37 AM
Ignite Modification Date:
2025-12-23 @ 10:37 PM
Study NCT ID:
NCT02297178
Status:
None
Last Update Posted:
2016-10-17 00:00:00
First Post:
2014-11-11 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Follow-net Investigation of a Randomised Study of Cystoscopy and Urethral Dilatation Versus Cystoscopy Alone in Women With Overactive Bladder Syndrome and Impaired Voiding
Sponsor:
None
Organization:
Study Overview
Official Title:
A Follow-net Investigation of a Randomised Study of Cystoscopy and Urethral Dilatation Versus Cystoscopy Alone in Women With Overactive Bladder Syndrome and Impaired Voiding
Status:
None
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to recruit resaerch staff for study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Urinary incontinences is a highly prevalent and distressing condition which has a significant impact on health related quality of life in millions of women worldwide. Of all women with incontinence, 90% will have overactive bladder symptoms (OAB), and 50% will have detrusor overactivity (DO) on cystometry. The overactive bladder syndrome is defined by the International Continence society as "Urinary urgency, with or without urge incontinence, usually with frequency and nocturia if there is a no infection or proven pathology" (Abrams et al 2002)
Initial management of OAB and DO consists of conservative measures such as altering fluid intake, bladder retraining and drug therapy. The next step consists of interventions such as cystoscopy and urethral dilatation, on the basis that it will allow intrinsic bladder problems such as interstitial cystitis to excluded, excluded, and may confer a symptomatic benefit.
Cystoscopy and urethral dilatation have long been advocated as empirical treatments for women with lower urinary tract symptoms (LUTS). A review of the literature reveals a marked lack of evidence regarding the survey of practice amongst UK urologists found that 61% had performed urethral dilatation 7 or more times during the year in which the survey was conducted, although 55% believed that less than half of the patients experience long term improvement (Masarani and Willis, 2006)
The original study showed no benefit of urethral dilatation versus no dilatation at 6 months follow up (Duckett 2007). The investigators do not know the natural history of patients with voiding dysfunction. Therefore reviewing their symptoms will give a better idea of what happens to these patients symptoms over time. The aim of the study is to identify any long term benefit from urethral dilatation over cystoscopy alone.
Initial management of OAB and DO consists of conservative measures such as altering fluid intake, bladder retraining and drug therapy. The next step consists of interventions such as cystoscopy and urethral dilatation, on the basis that it will allow intrinsic bladder problems such as interstitial cystitis to excluded, excluded, and may confer a symptomatic benefit.
Cystoscopy and urethral dilatation have long been advocated as empirical treatments for women with lower urinary tract symptoms (LUTS). A review of the literature reveals a marked lack of evidence regarding the survey of practice amongst UK urologists found that 61% had performed urethral dilatation 7 or more times during the year in which the survey was conducted, although 55% believed that less than half of the patients experience long term improvement (Masarani and Willis, 2006)
The original study showed no benefit of urethral dilatation versus no dilatation at 6 months follow up (Duckett 2007). The investigators do not know the natural history of patients with voiding dysfunction. Therefore reviewing their symptoms will give a better idea of what happens to these patients symptoms over time. The aim of the study is to identify any long term benefit from urethral dilatation over cystoscopy alone.
Detailed Description:
None
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?: