A Follow-net Investigation of a Randomised Study of Cystoscopy and Urethral Dilatation Versus Cystoscopy Alone in Women With Overactive Bladder Syndrome and Impaired Voiding

Urinary Incontinence Clinical Trial

Official title:

A Follow-net Investigation of a Randomised Study of Cystoscopy and Urethral Dilatation Versus Cystoscopy Alone in Women With Overactive Bladder Syndrome and Impaired Voiding

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02297178
• Other study ID #: MedwayUD
• Status: Withdrawn
• Phase: N/A
• First received: November 11, 2014
• Last updated: October 13, 2016
• Start date: August 2016
• Est. completion date: December 2016

Study information

• Verified date: October 2016
• Source: Medway NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Observational

Clinical Trial Summary

Urinary incontinences is a highly prevalent and distressing condition which has a significant impact on health related quality of life in millions of women worldwide. Of all women with incontinence, 90% will have overactive bladder symptoms (OAB), and 50% will have detrusor overactivity (DO) on cystometry. The overactive bladder syndrome is defined by the International Continence society as "Urinary urgency, with or without urge incontinence, usually with frequency and nocturia if there is a no infection or proven pathology" (Abrams et al 2002)

Initial management of OAB and DO consists of conservative measures such as altering fluid intake, bladder retraining and drug therapy. The next step consists of interventions such as cystoscopy and urethral dilatation, on the basis that it will allow intrinsic bladder problems such as interstitial cystitis to excluded, excluded, and may confer a symptomatic benefit.

The original study showed no benefit of urethral dilatation versus no dilatation at 6 months follow up (Duckett 2007). The investigators do not know the natural history of patients with voiding dysfunction. Therefore reviewing their symptoms will give a better idea of what happens to these patients symptoms over time.

Description:

Urinary incontinences is a highly prevalent and distressing condition which has a significant impact on health related quality of life in millions of women worldwide. Of all women with incontinence, 90% will have overactive bladder symptoms (OAB), and 50% will have detrusor overactivity (DO) on cystometry. The overactive bladder syndrome is defined by the International Continence society as "Urinary urgency, with or without urge incontinence, usually with frequency and nocturia if there is a no infection or proven pathology" (Abrams et al 2002)

Initial management of OAB and DO consists of conservative measures such as altering fluid intake, bladder retraining and drug therapy. The next step consists of interventions such as cystoscopy and urethral dilatation, on the basis that it will allow intrinsic bladder problems such as interstitial cystitis to excluded, excluded, and may confer a symptomatic benefit.

Cystoscopy and urethral dilatation have long been advocated as empirical treatments for women with lower urinary tract symptoms (LUTS). A review of the literature reveals a marked lack of evidence regarding the survey of practice amongst UK urologists found that 61% had performed urethral dilatation 7 or more times during the year in which the survey was conducted, although 55% believed that less than half of the patients experience long term improvement (Masarani and Willis, 2006)

The original study showed no benefit of urethral dilatation versus no dilatation at 6 months follow up (Duckett 2007). The investigators do not know the natural history of patients with voiding dysfunction. Therefore reviewing their symptoms will give a better idea of what happens to these patients symptoms over time. The aim of the study is to identify any long term benefit from urethral dilatation over cystoscopy alone.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Significant Overactive Bladder Symptoms

• Based on scoring 1 or 2 on the Urgency Perception Scale

• On the symptoms domain of the KHQ

• More than 8 voids per day on frequency volume chart +/- 2 or more episodes of nocturia

2. Pressure flow studies demonstrate a maximum flow rate of less than 15ml on a minimum voided volume of 200ml with a high or normal detrusor pressure at maximum flow or post-void residual of 200ml or over

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

Exclusion Criteria:

1. Presence of concurrent urodynamic stress incontinence.

2. Patients with bladder pathology or haematuria of unknown origin.

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

4. Symptomatic pelvic organ prolapse requiring intervention

5. Patients with bladder pathology (including urinary tract infection) or haematuria of unknown origin

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Enuresis
• Overactive Bladder
• Urinary Bladder, Overactive
• Urinary Incontinence
• Voiding Dysfunction

Intervention

Procedure:
• Cystoscopy only
Cystoscopy performed for investigation and treatment of OAB and voiding dysfunction
• Cystoscopy and Urethral dilatation
Cystoscopy and urethral dilatation performed for investigation and treatment of OAB and voiding dysfunction

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medway NHS Foundation Trust

References & Publications (3)

Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the — View Citation

Duckett JR, Basu M. The predictive value of preoperative pressure-flow studies in the resolution of detrusor overactivity and overactive bladder after tension-free vaginal tape insertion. BJU Int. 2007 Jun;99(6):1439-42. Epub 2007 Apr 5. — View Citation

Masarani M, Willis RG. Urethral dilatation in women: urologists' practice patterns in the UK. Ann R Coll Surg Engl. 2006 Sep;88(5):496-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ICIQ-Fluts questionnaire	To identify if there is any long term benefit from urethral dilatation over cystoscopy alone. Their baseline symptoms will be assessed and compared to those identified at baseline in the previous study.	3 years	No
Secondary	King's Health Questionnaire	To identify if there is any long term benefit from urethral dilatation over cystoscopy alone. Their baseline symptoms will be assessed and compared to those identified at baseline in the previous study.	3 years	No
Secondary	Urgency Perception Scale Questionnaire	To identify if there is any long term benefit from urethral dilatation over cystoscopy alone. Their baseline symptoms will be assessed and compared to those identified at baseline in the previous study.	3 years	No
Secondary	Uroflowmetry	Flow rates will be repeated in all patients allowing for an objective comparison post-operatively and 3 years later.	3 years	No