Cystoscopy and Cystodistension; Therapeutic and Aetiological Aspect in Overactive Bladder

Not Applicable

Completed

• Conditions: Urinary Incontinence, Urge
• Interventions: Procedure: Cystodistension & Cystoscopy

• Registration Number: NCT01971437
• Lead Sponsor: Medway NHS Foundation Trust

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.

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

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-21
• Study First Submitted QC: 2013-10-23
• Study First Posted: 2013-10-29
• Status Verified: 2016-03
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Last Update Submitted: 2016-03-20
• Last Update Posted: 2016-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cystodistension & Cystoscopy Arm	Cystodistension & Cystoscopy	This is the Arm receiving cystodistension and cystoscopy due to refractory OAB.
Cystoscopy Arm	Cystodistension & Cystoscopy	This is the arm that receives cystoscopy only in women with refractory OAB.

Primary Outcome Measures

Name	Time	Method
To assess the presence of urgency and urge incontinence initially, 6 weeks and 6 months	12-18months	1. Resolution measured by Urgency Perception Scale.; 2. Change in quality of life status.; 3. Change in urinary symptoms defined by the Patient's Perception of Intensity Scale

Secondary Outcome Measures

Name	Time	Method
Improved quality of life.	12-18 months	Change in quality of life status, Urgency Perception Scale and Patient's Perception of Intensity Scale scoring initially, 6 weeks and 6 months.

Trial Locations

Locations (1)

Medway Maritime Hospital; 🇬🇧 Gillingham, Kent, United Kingdom