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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.
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
Exclusion Criteria
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cystodistension & Cystoscopy Arm | Experimental | This is the Arm receiving cystodistension and cystoscopy due to refractory OAB. |
|
| Cystoscopy Arm | Placebo Comparator | This is the arm that receives cystoscopy only in women with refractory OAB. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cystodistension & Cystoscopy | Procedure | Women with refractory OAB receiving Cystoscopy and cystodistension |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the presence of urgency and urge incontinence initially, 6 weeks and 6 months |
| 12-18months |
| 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 |
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Inclusion Criteria
Exclusion Criteria
Patients with co-existing urodynamic stress incontinence
Patients with neurological diseases
Patients with pre-existing voiding dysfunction
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan RA Duckett, FRCOG | Medway NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medway Maritime Hospital | Gillingham | Kent | Me7 5NY | United Kingdom |
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| ID | Term |
|---|---|
| D053202 | Urinary Incontinence, Urge |
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D003558 | Cystoscopy |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001745 | Urinary Bladder Diseases |
| D003950 | Diagnostic Techniques, Urological |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |