Cystoscopy and Cystodistension; Therapeutic and Aetiological Aspect in Overactive Bladder

Urinary Incontinence, Urge Clinical Trial

Official title:

A Randomised Study of Cystoscopy and Cystodistension Versus Cystoscopy Alone in Women With Overactive Bladder Syndrome.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01971437
• Other study ID #: TBC
• Status: Completed
• Phase: N/A
• First received: October 21, 2013
• Last updated: March 20, 2016
• Start date: October 2013
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: Medway NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Bladder, Overactive
• Urinary Incontinence
• Urinary Incontinence, Urge

Intervention

Procedure:
• Cystodistension & Cystoscopy
Women with refractory OAB receiving Cystoscopy and cystodistension

Locations

Country	Name	City	State
United Kingdom	Medway Maritime Hospital	Gillingham	Kent

Sponsors (1)

Lead Sponsor	Collaborator
Medway NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12-18months	No
Secondary	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.	12-18 months	No