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Cystoscopy and Cystodistension; Therapeutic and Aetiological Aspect in Overactive Bladder

Primary Purpose

Urinary Incontinence, Urge

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Cystodistension & Cystoscopy
Sponsored by
Medway NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence, Urge focused on measuring Overactive Bladder, OAB, Cystoscopy, Cystodistension, UTI, Cytokines

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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. Patients with co-existing urodynamic stress incontinence
  2. Patients with neurological diseases
  3. Patients with pre-existing voiding dysfunction

    • Free flow rate <5th centile or equivalent reduced pressure flow rate OR
    • Post-void residual volume greater than 100ml

Sites / Locations

  • Medway Maritime Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cystodistension & Cystoscopy Arm

Cystoscopy Arm

Arm Description

This is the Arm receiving cystodistension and cystoscopy due to refractory OAB.

This is the arm that receives cystoscopy only in women with refractory OAB.

Outcomes

Primary Outcome Measures

To assess the presence of urgency and urge incontinence initially, 6 weeks and 6 months
Resolution measured by Urgency Perception Scale. Change in quality of life status. Change in urinary symptoms defined by the Patient's Perception of Intensity Scale

Secondary Outcome Measures

Improved quality of life.
Change in quality of life status, Urgency Perception Scale and Patient's Perception of Intensity Scale scoring initially, 6 weeks and 6 months.

Full Information

First Posted
October 21, 2013
Last Updated
March 20, 2016
Sponsor
Medway NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01971437
Brief Title
Cystoscopy and Cystodistension; Therapeutic and Aetiological Aspect in Overactive Bladder
Official Title
A Randomised Study of Cystoscopy and Cystodistension Versus Cystoscopy Alone in Women With Overactive Bladder Syndrome.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medway NHS Foundation Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is an ethically approved randomised controlled study looking at whether Cystodistension(filling 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. 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. Change in quality of life status determined by quality of life questionnaires will ismilarly be comapred between the 2 arms of the study. Change in urinary symptoms defined by Patient's Perception of Intensity Scale. Change in uregncy scores will be compared between the 2 arms of the study. Secondary Outcome Measure:1. 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 Women with only OAB symptoms Women who have failed bladder drill and anticholinergic agents Women who stopped medication due to side-effects or lack of efficacy Currently receiving no treatment Exclusion Criteria Patient with co-existing urodynamic stress incontinence Patients with neurological diseases Patients with pre-existing voiding dysfunction

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Urge
Keywords
Overactive Bladder, OAB, Cystoscopy, Cystodistension, UTI, Cytokines

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cystodistension & Cystoscopy Arm
Arm Type
Experimental
Arm Description
This is the Arm receiving cystodistension and cystoscopy due to refractory OAB.
Arm Title
Cystoscopy Arm
Arm Type
Placebo Comparator
Arm Description
This is the arm that receives cystoscopy only in women with refractory OAB.
Intervention Type
Procedure
Intervention Name(s)
Cystodistension & Cystoscopy
Other Intervention Name(s)
Cystodistension, Cystoscopy, OAB, Treatments
Intervention Description
Women with refractory OAB receiving Cystoscopy and cystodistension
Primary Outcome Measure Information:
Title
To assess the presence of urgency and urge incontinence initially, 6 weeks and 6 months
Description
Resolution measured by Urgency Perception Scale. Change in quality of life status. Change in urinary symptoms defined by the Patient's Perception of Intensity Scale
Time Frame
12-18months
Secondary Outcome Measure Information:
Title
Improved quality of life.
Description
Change in quality of life status, Urgency Perception Scale and Patient's Perception of Intensity Scale scoring initially, 6 weeks and 6 months.
Time Frame
12-18 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Women with only OAB symptoms Women who have failed bladder drill and anticholinergic agents Women who stopped medication due to side-effects or lack of efficacy Currently receiving no treatment Exclusion Criteria Patients with co-existing urodynamic stress incontinence Patients with neurological diseases Patients with pre-existing voiding dysfunction Free flow rate <5th centile or equivalent reduced pressure flow rate OR Post-void residual volume greater than 100ml
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan RA Duckett, FRCOG
Organizational Affiliation
Medway NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medway Maritime Hospital
City
Gillingham
State/Province
Kent
ZIP/Postal Code
Me7 5NY
Country
United Kingdom

12. IPD Sharing Statement

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Cystoscopy and Cystodistension; Therapeutic and Aetiological Aspect in Overactive Bladder

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