Cystoscopy Plus Urethral Dilatation Versus Cystoscopy Alone in Women With Overactive Bladder Syndrome and Impaired Voiding
Cystoscopy Plus Urethral Dilatation Versus Cystoscopy Alone in Women With Overactive Bladder Syndrome and Impaired Voiding
Urethral dilatation is a commonly undertaken intervention for a variety of urinary complaints
 including overactive bladder symptoms. There is however very little evidence for its
 efficacy, and no randomized trial evidence. The aim of this study is to ascertain the effect
 of urethral dilatation on overactive bladder symptoms and on voiding parameters. The null
 hypothesis is that there will be no difference in symptoms or voiding parameters between the
 urethral dilatation and sham groups.

 Eligible women will be assessed initially with a history and examination, a King's Health
 Questionnaire and Bristol Female Urinary Tract Symptoms (BFLUTS) questionnaire and pressure
 flow studies. They will be randomized to undergo either cystoscopy alone or cystoscopy and
 urethral dilatation. Patients will be blinded to the procedure undertaken and randomized
 using a series of opaque envelopes. Follow up will be at 6 weeks with repeat questionnaires
 and pressure flow studies. Subjective and objective outcomes will be compared between the two
 groups.
This study is a randomised controlled trial. Objective outcomes will be evaluated at 6 weeks'
 post-operatively. Subjective outcomes will be evaluated at 6 weeks' and 6 months'
 post-operatively.

 Study Population Entry to the study will be offered to all women with OAB symptoms with
 impaired voiding on cystometry (flow rate less than 15mls/sec with volume of 200mls voided
 and a normal or high detrusor pressure at maximum flow), who have failed to improve with 2
 different anticholinergic medications. Subjects will be recruited from the Urogynaecology
 clinic at Medway Maritime Hospital. A power calculation was carried out which showed a
 minimum sample size of 30 (i.e. 15 in each arm) to be necessary to ensure an 80% power with a
 significance level of 0.05.

 Pre-operative Assessment All patients will undergo an initial assessment consisting of a full
 urogynaecogical history and examination, BFLUTS questionnaire and Urgency Perception Scale,
 and pressure flow studies. As mentioned before, each patient will have been treated with
 anticholinergic medications prior to being offered this intervention.

 Surgical Technique All procedures will be carried out under general anaesthesia. A dose of
 intravenous gentamicin will be given to each patient at induction. After emptying the
 bladder, saline cystoscopy will be carried out with a 30 degree cystoscope. The bladder
 mucosa will be systematically inspected for any abnormalities and the bladder filled either
 until the sphincter mechanism is overcome or to 1000mls. The bladder is emptied again and a
 second fill undertaken. The bladder mucosa is inspected for petechial haemorrhages, erythema
 and other signs of chronic cystitis on the second fill.

 In subjects randomised to undergo urethral dilatation, this will be undertaken using Hagar
 dilators. There is no evidence in the literature regarding normal urethral calibre in women.
 Therefore, the urethra will be dilated to a maximum of 10 Hagar as per our unit's protocol.
 Women will be discharged on the same day, if they pass urine adequately.

 Post-operative Assessment Subjects will be seen in the Urogynaecology clinic at 6 weeks'
 post-operatively and assessed with a BFLUTS questionnaire, UPS and repeat pressure flow
 studies. Each patient will be assessed subjectively at 6 months' post-operatively using the
 symptom questionnaires.

 Significance testing will be used to compare symptom scores and pressure flow parameters
 between each group pre- and post-operatively.
Inclusion Criteria:

 1. OAB symptoms (based on relevant domains of BFLUTS questionnaire and Urgency Perception
 Scale) which have not improved with 2 anticholinergic treatments.

 2. Maximum flow rate of less than 15 ml/s on a volume voided of 200mls or more, with a
 normal or high detrusor pressure at maximum flow on pressure flow studies

 3. Patients must be able to give informed consent for the study

 Exclusion Criteria:

 1. Presence of concurrent urodynamic stress incontinence

 2. Patient unfit or unwilling to undergo a general anaesthetic

 3. Patients with bladder pathology or haematuria of unknown origin

 4. Patients with neurological disorders (as these may affect voiding)