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Cystoscopy Plus Urethral Dilatation Versus Cystoscopy Alone in Women With Overactive Bladder Syndrome and Impaired Voiding

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ClinicalTrials.gov Identifier: NCT00839969
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
Sponsor:
Information provided by:
Medway NHS Foundation Trust

Tracking Information
First Submitted Date  ICMJE February 9, 2009
First Posted Date  ICMJE February 10, 2009
Last Update Posted Date February 10, 2009
Study Start Date  ICMJE January 2009
Estimated Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2009)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2009)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cystoscopy Plus Urethral Dilatation Versus Cystoscopy Alone in Women With Overactive Bladder Syndrome and Impaired Voiding
Official Title  ICMJE A Randomized Study of Cystoscopy and Urethral Dilatation Versus Cystoscopy Alone in Women With Overactive Bladder Syndrome and Impaired Voiding.
Brief Summary

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.

Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Overactive Bladder Syndrome
  • Voiding Dysfunction
Intervention  ICMJE
  • Procedure: Cystoscopy
    Saline cystoscopy under general anaesthesia
  • Procedure: Cystoscopy and urethral dilatation
    Saline cystoscopy and urethral dilatation (using Hegar dilators) under general anaesthesia
Study Arms  ICMJE
  • Sham Comparator: Cystoscopy alone
    Women in this arm will undergo saline cystoscopy under general anaesthesia only.
    Intervention: Procedure: Cystoscopy
  • Active Comparator: Cystoscopy and urethral dilatation
    Women in this group will undergo cystoscopy and urethral dilatation under general anaesthesia
    Intervention: Procedure: Cystoscopy and urethral dilatation
Publications * Basu M, Khullar V, Duckett J. Urethral dilatation: Is there any benefit over cystoscopy and distension? A randomized trial in women with overactive bladder symptoms. Neurourol Urodyn. 2014 Mar;33(3):283-8. doi: 10.1002/nau.22411. Epub 2013 May 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 9, 2009)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2009
Estimated Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00839969
Other Study ID Numbers  ICMJE 08/H1101/97
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mr Jonathan Duckett, Medway NHS Trust
Study Sponsor  ICMJE Medway NHS Foundation Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jonathan Duckett, FRCOG Medway NHS Trust
PRS Account Medway NHS Foundation Trust
Verification Date February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP