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

NCT02297178 | Withdrawn

• 1 other identifier: MedwayUD
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Overactive Bladder; Voiding Dysfunction; Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• King's Health Questionnaire

  3 years

• Urgency Perception Scale Questionnaire

  3 years

• Uroflowmetry

  3 years

Study Arms (2)

Cystoscopy Alone

Patients who received cystoscopy only for treatment of OAB and voiding dysfunction.

Procedure: Cystoscopy only

Cystoscopy & Urethral Dilatation

Patients who received urethral dilatation and cystoscopy for treatment of OAB and voiding dysfunction.

Procedure: Cystoscopy and Urethral dilatation

Interventions

Cystoscopy only PROCEDURE

Cystoscopy performed for investigation and treatment of OAB and voiding dysfunction

Cystoscopy Alone

Cystoscopy and Urethral dilatation PROCEDURE

Cystoscopy and urethral dilatation performed for investigation and treatment of OAB and voiding dysfunction

Cystoscopy & Urethral Dilatation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Entry to the study will be offered to all women previously recruited into the original randomised controlled trial. This study is a 3 year follow up of a randomised controlled trial. Patients will be sent a letter offering a review appointment.

You may qualify if:

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

You may not qualify if:

• Presence of concurrent urodynamic stress incontinence.
• Patients with bladder pathology or haematuria of unknown origin.
• Patients with neurological disorders (as these may affect voiding).
• Symptomatic pelvic organ prolapse requiring intervention
• Patients with bladder pathology (including urinary tract infection) or haematuria of unknown origin

Sponsors & Collaborators

• Medway NHS Foundation Trust: lead

Related 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 Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78. doi: 10.1002/nau.10052. No abstract available.

  PMID: 11857671 RESULT

• 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. doi: 10.1111/j.1464-410X.2007.06842.x. Epub 2007 Apr 5.

  PMID: 17419703 RESULT

• 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. doi: 10.1308/003588406X114884.

  PMID: 17002859 RESULT

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence

Interventions

Cystoscopy

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urination Disorders

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Jonathan RA Duckett, FRCOG, MBChB

  Medway Maritime Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Gynaecologist and Obstetrician

Study Record Dates

• First Submitted: November 11, 2014
• First Posted: November 21, 2014
• Study Start: August 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 17, 2016

Record last verified: 2016-10