Ignite Creation Date:
2024-05-06 @ 2:06 AM
Last Modification Date:
2024-10-26 @ 11:14 AM
Study NCT ID:
NCT01971437
Status:
COMPLETED
Last Update Posted:
2016-03-22
First Post:
2013-10-21
Brief Title:
Cystoscopy and Cystodistension Therapeutic and Aetiological Aspect in Overactive Bladder
Sponsor:
Medway NHS Foundation Trust
Organization:
Medway NHS Foundation Trust
Study Overview
Official Title:
A Randomised Study of Cystoscopy and Cystodistension Versus Cystoscopy Alone in Women With Overactive Bladder Syndrome
Status:
COMPLETED
Status Verified Date:
2016-03
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:
None
Brief Summary:
This is an ethically approved randomised controlled study looking at whether Cystodistensionfilling the bladder with fluid under pressure provides any benefit over cystoscopy alone looking in the bladder in women with refractory overactive bladder Urine samples will also be assessed for underlying infected cause of OAB using urinalysis microscopy and culture and cytokine assays In collaboration with the University of Kent We hypothesize that Cystodistension has a therapeutic benefit to women with refractory OAB and the there is an increase prevalence in chronic urinary infections with raised cytokines in women with refractory OAB
Detailed Description:
We aim to measure outcomes initially 6 weels and 6months follow-up
1 Resolution measured by Urgency Perception Scale UPS Resolution of urgency will be assessed with the UPS The numbers of women with a Level 3 UPS score hold and finish task will be compared using Chi square test in patients treated with cystodistension vs non cystodistension arms
2 Change in quality of life status determined by quality of life questionnaires will ismilarly be comapred between the 2 arms of the study
3 Change in urinary symptoms defined by Patients Perception of Intensity Scale Change in uregncy scores will be compared between the 2 arms of the study
Secondary Outcome Measure1 Prevalence of chronic urinary infection and organisms in patients with refractory OAB 2 To identify whether urinary cytokines are present in a higher proportion of patients with OAB
Inclusion Criteria
1 Women with only OAB symptoms
2 Women who have failed bladder drill and anticholinergic agents
3 Women who stopped medication due to side-effects or lack of efficacy
4 Currently receiving no treatment
Exclusion Criteria
1 Patient with co-existing urodynamic stress incontinence
2 Patients with neurological diseases
3 Patients with pre-existing voiding dysfunction
1 Resolution measured by Urgency Perception Scale UPS Resolution of urgency will be assessed with the UPS The numbers of women with a Level 3 UPS score hold and finish task will be compared using Chi square test in patients treated with cystodistension vs non cystodistension arms
2 Change in quality of life status determined by quality of life questionnaires will ismilarly be comapred between the 2 arms of the study
3 Change in urinary symptoms defined by Patients Perception of Intensity Scale Change in uregncy scores will be compared between the 2 arms of the study
Secondary Outcome Measure1 Prevalence of chronic urinary infection and organisms in patients with refractory OAB 2 To identify whether urinary cytokines are present in a higher proportion of patients with OAB
Inclusion Criteria
1 Women with only OAB symptoms
2 Women who have failed bladder drill and anticholinergic agents
3 Women who stopped medication due to side-effects or lack of efficacy
4 Currently receiving no treatment
Exclusion Criteria
1 Patient with co-existing urodynamic stress incontinence
2 Patients with neurological diseases
3 Patients with pre-existing voiding dysfunction
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