Cystoscopy and Cystodistension; Therapeutic and Aetiological Aspect in Overactive Bladder

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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence, Urge
• Intervention / Treatment: Procedure: Cystodistension & Cystoscopy

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Kent
    • Gillingham, Kent, United Kingdom, ME7 5NY
      • Medway Maritime Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cystodistension & Cystoscopy Arm; This is the Arm receiving cystodistension and cystoscopy due to refractory OAB.	Procedure: Cystodistension & Cystoscopy; Women with refractory OAB receiving Cystoscopy and cystodistension; Other Names: Cystoscopy; Cystodistension; OAB; Treatments
Placebo Comparator: Cystoscopy Arm; This is the arm that receives cystoscopy only in women with refractory OAB.	Procedure: Cystodistension & Cystoscopy; Women with refractory OAB receiving Cystoscopy and cystodistension; Other Names: Cystoscopy; Cystodistension; OAB; Treatments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Medway NHS Foundation Trust
• Investigators: Principal Investigator: Jonathan RA Duckett, FRCOG, Medway Nhs Foundation Trust

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: October 21, 2013
• First Submitted That Met QC Criteria: October 23, 2013
• First Posted (Estimate): October 29, 2013

Study Record Updates

• Last Update Posted (Estimate): March 22, 2016
• Last Update Submitted That Met QC Criteria: March 20, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Overactive Bladder; Cystoscopy; Cytokines; UTI; OAB; Cystodistension
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Bladder, Overactive; Urinary Incontinence; Urinary Incontinence, Urge
• Other Study ID Numbers: TBC