A Randomised Study of Cystoscopy and Cystodistension Versus Cystoscopy Alone in Women With Overactive Bladder Syndrome.
| Registry | NCT01971437 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 70 (Actual) |
| Sponsor | Medway NHS Foundation Trust (Other) |
| Conditions | Urinary Incontinence, Urge |
| Interventions | Cystodistension & Cystoscopy (Procedure) |
| Dates | start 2013-10-01, primary completion 2016-03-01, completion 2016-03-01, first posted 2013-10-29, last updated 2016-03-22 |
| Locations | 1 site in United Kingdom |
Related Papers Related Patents Related Grants Related Experts
All trials for Urinary Incontinence, Urge All trials of Cystodistension & Cystoscopy
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.
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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Cystodistension & Cystoscopy Arm | Experimental | Procedure: Cystodistension & Cystoscopy | This is the Arm receiving cystodistension and cystoscopy due to refractory OAB. |
| Cystoscopy Arm | Placebo comparator | Procedure: Cystodistension & Cystoscopy | This is the arm that receives cystoscopy only in women with refractory OAB. |
Sex: Female, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Medway Maritime Hospital | Gillingham, Kent | United Kingdom |