Cystoscopy Plus Urethral Dilatation Versus Cystoscopy Alone in Women With Overactive Bladder Syndrome and Impaired Voiding
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| ClinicalTrials.gov Identifier: NCT00839969 |
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Recruitment Status : Unknown
Verified February 2009 by Medway NHS Foundation Trust.
Recruitment status was: Recruiting
First Posted : February 10, 2009
Last Update Posted : February 10, 2009
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Overactive Bladder Syndrome Voiding Dysfunction | Procedure: Cystoscopy Procedure: Cystoscopy and urethral dilatation | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 30 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized Study of Cystoscopy and Urethral Dilatation Versus Cystoscopy Alone in Women With Overactive Bladder Syndrome and Impaired Voiding. |
| Study Start Date : | January 2009 |
| Estimated Primary Completion Date : | October 2009 |
| Estimated Study Completion Date : | October 2009 |
| Arm | Intervention/treatment |
|---|---|
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Sham Comparator: Cystoscopy alone
Women in this arm will undergo saline cystoscopy under general anaesthesia only.
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Procedure: Cystoscopy
Saline cystoscopy under general anaesthesia |
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Active Comparator: Cystoscopy and urethral dilatation
Women in this group will undergo cystoscopy and urethral dilatation under general anaesthesia
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Procedure: Cystoscopy and urethral dilatation
Saline cystoscopy and urethral dilatation (using Hegar dilators) under general anaesthesia |
- Change in pressure flow parameters (voided volume, maximum flow rate, acceleration of flow rate and detrusor pressure at maximum flow) at 6 weeks' post-operatively. [ Time Frame: 6 weeks ]
- Change in symptoms as measured by the BFLUTS questionnaire and Urgency Perception Scale at 6 weeks' and 6 months' post-operatively. [ Time Frame: 6 weeks and 6 months ]
- Change in quality of life status as determined by change in King's Health Questionnaire scoring at 6 weeks and 6 months' post-operatively. [ Time Frame: 6 weeks and 6 months ]
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- OAB symptoms (based on relevant domains of BFLUTS questionnaire and Urgency Perception Scale) which have not improved with 2 anticholinergic treatments.
- 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
- Patients must be able to give informed consent for the study
Exclusion Criteria:
- Presence of concurrent urodynamic stress incontinence
- Patient unfit or unwilling to undergo a general anaesthetic
- Patients with bladder pathology or haematuria of unknown origin
- Patients with neurological disorders (as these may affect voiding)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00839969
| Contact: Jonathan Duckett, FRCOG | +1634 830000 ext 5154 | jonathan.duckett@medway.nhs.uk |
| United Kingdom | |
| Medway Maritime Hospital | Recruiting |
| Gillingham, Kent, United Kingdom, ME7 5NY | |
| Principal Investigator: Jonathan Duckett, FRCOG | |
| Sub-Investigator: Maya Basu, MBBS, BSc(Hons) | |
| Principal Investigator: | Jonathan Duckett, FRCOG | Medway NHS Trust |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Mr Jonathan Duckett, Medway NHS Trust |
| ClinicalTrials.gov Identifier: | NCT00839969 History of Changes |
| Other Study ID Numbers: |
08/H1101/97 |
| First Posted: | February 10, 2009 Key Record Dates |
| Last Update Posted: | February 10, 2009 |
| Last Verified: | February 2009 |
Keywords provided by Medway NHS Foundation Trust:
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overactive bladder syndrome voiding pressure flow studies urethral dilatation |
Additional relevant MeSH terms:
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Syndrome Urinary Bladder, Overactive Aneurysm Dilatation, Pathologic Disease Pathologic Processes Urinary Bladder Diseases Urologic Diseases Lower Urinary Tract Symptoms |
Urological Manifestations Signs and Symptoms Vascular Diseases Cardiovascular Diseases Pathological Conditions, Anatomical Anesthetics Central Nervous System Depressants Physiological Effects of Drugs |