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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Medway NHS Foundation Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medway NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00839969
First received: February 9, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

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 Intervention
Overactive Bladder Syndrome
Voiding Dysfunction
Procedure: Cystoscopy
Procedure: Cystoscopy and urethral dilatation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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.

Resource links provided by NLM:


Further study details as provided by Medway NHS Foundation Trust:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2009
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Cystoscopy alone
Women in this arm will undergo saline cystoscopy under general anaesthesia only.
Procedure: Cystoscopy
Saline cystoscopy under general anaesthesia
Active Comparator: Cystoscopy and urethral dilatation
Women in this group will undergo cystoscopy and urethral dilatation under general anaesthesia
Procedure: Cystoscopy and urethral dilatation
Saline cystoscopy and urethral dilatation (using Hegar dilators) under general anaesthesia

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00839969

Contacts
Contact: Jonathan Duckett, FRCOG +1634 830000 ext 5154 jonathan.duckett@medway.nhs.uk

Locations
United Kingdom
Medway Maritime Hospital Recruiting
Gillingham, Kent, United Kingdom, ME7 5NY
Principal Investigator: Jonathan Duckett, FRCOG         
Sub-Investigator: Maya Basu, MBBS, BSc(Hons)         
Sponsors and Collaborators
Medway NHS Foundation Trust
Investigators
Principal Investigator: Jonathan Duckett, FRCOG Medway NHS Trust
  More Information

No publications provided by Medway NHS Foundation Trust

Additional 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
Study First Received: February 9, 2009
Last Updated: February 9, 2009
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Medway NHS Foundation Trust:
overactive bladder syndrome
voiding
pressure flow studies
urethral dilatation

Additional relevant MeSH terms:
Dilatation, Pathologic
Urinary Bladder, Overactive
Pathological Conditions, Anatomical
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 27, 2014