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

A Randomized Study of Cystoscopy and 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.

Study Overview

• Status: Unknown
• Conditions: Overactive Bladder Syndrome; Voiding Dysfunction
• Intervention / Treatment: Procedure: Cystoscopy; Procedure: Cystoscopy and urethral dilatation

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: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Kent
    • Gillingham, Kent, United Kingdom, ME7 5NY
      • Recruiting
      • Medway Maritime Hospital
      • Principal Investigator: Jonathan Duckett, FRCOG
      • Sub-Investigator: Maya Basu, MBBS, BSc(Hons)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	6 weeks
Change in symptoms as measured by the BFLUTS questionnaire and Urgency Perception Scale at 6 weeks' and 6 months' post-operatively.	6 weeks and 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in quality of life status as determined by change in King's Health Questionnaire scoring at 6 weeks and 6 months' post-operatively.	6 weeks and 6 months

Collaborators and Investigators

• Sponsor: Medway NHS Foundation Trust
• Investigators: Principal Investigator: Jonathan Duckett, FRCOG, Medway NHS Trust

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (ANTICIPATED): October 1, 2009
• Study Completion (ANTICIPATED): October 1, 2009

Study Registration Dates

• First Submitted: February 9, 2009
• First Submitted That Met QC Criteria: February 9, 2009
• First Posted (ESTIMATE): February 10, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): February 10, 2009
• Last Update Submitted That Met QC Criteria: February 9, 2009
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Keywords: overactive bladder syndrome; voiding; pressure flow studies; urethral dilatation
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Disease; Pathological Conditions, Anatomical; Urinary Bladder, Overactive; Syndrome; Dilatation, Pathologic
• Other Study ID Numbers: 08/H1101/97