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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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01971437
Enrollment
70
Registered
2013-10-29
Start date
2013-10-31
Completion date
2016-03-31
Last updated
2016-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Incontinence, Urge

Keywords

Overactive Bladder, OAB, Cystoscopy, Cystodistension, UTI, Cytokines

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

Interventions

PROCEDURECystodistension & Cystoscopy

Women with refractory OAB receiving Cystoscopy and cystodistension

Sponsors

Medway NHS Foundation Trust
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
To assess the presence of urgency and urge incontinence initially, 6 weeks and 6 months12-18months1. 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

MeasureTime frameDescription
Improved quality of life.12-18 monthsChange in quality of life status, Urgency Perception Scale and Patient's Perception of Intensity Scale scoring initially, 6 weeks and 6 months.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026