Clinical trial NCT00909428: Validation of a Real-time Urodynamic Measure of Urinary Urgency
Official title: Validation of a Real-time Urodynamic Measure of Urinary Urgency as a Measure of the Success of Drug Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Overactive Bladder Syndrome
Keywords: Bladder
Urinary Urgency
Solifenacin
Vesicare(R)
Lead sponsor: Loyola University
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Inc
First posted: 2009-05-28
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Urinary urgency is a key symptom of overactive bladder syndrome (OAB) and may be more bothersome to a patient than the symptom of urinary frequency. Unfortunately, controversy continues to surround the term 'urgency' and there is no good tool to evaluate the severity of urgency. This fact has constrained the performance of clinical research in this field. The cause of urinary urgency is not fully understood and may vary from patient to patient.

Although clinicians regularly obtain measures of bladder sensation during cystometry, little attention has been paid to the patient experience of urinary urgency. In this study, the researchers will use a non-significant risk device (i.e., an Urgeometer) to measure urinary urgency in women with overactive bladder.

Detailed description: At baseline, a small catheter is placed inside the participant's bladder. The bladder is filled with sterile water through the catheter. As the bladder is filled, the participant is asked to rate their urinary urgency using the Urgeometer. The Urgeometer lever marks a continuous scale from 0 'no urge at all' to 100 'maximum urge which you can tolerate'. The testing is stopped once the bladder is filled. To minimize the chance of infection, participants receive one dose of oral antibiotics prior to the bladder testing.

Following completion of the bladder test, participants will take 10mg solifenacin succinate (VesicareR) daily for 30 days. Afterward, participants repeat the bladder test. The change in participants' maximal tolerated cystometric capacity (MCC) will be measured in milliliters and used to evaluate the effectiveness of the drug.

Eligibility criteria: Inclusion Criteria:

* Have symptoms of urge or mixed incontinence (urge predominant) and desire treatment with anticholinergic medication.
* Demonstrated detrusor overactivity with or without incontinence during urodynamic testing.
* Are able to consent and fill out study documents, complete repeated urodynamic testing, and follow-up in 4 weeks.

Exclusion Criteria:

* Have been treated with any anticholinergic medication in the previous month.
* Have an elevated post -void residual volume as determined during their routine clinical care.
* Have had a urinary tract infection in the last month, as determined by history.
* Have untreated narrow angle glaucoma, by patient history.
* Have a known allergy or intolerance to solifenacin, as determined by patient history.

Primary outcomes:
measure: Change in Maximal Cystometric Capacity (mL)
timeFrame: 30 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
Study officials:
affiliation: Loyola University
name: Mary P FitzGerald, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Craggs MD. Objective measurement of bladder sensation: use of a new patient-activated device and response to neuromodulation. BJU Int. 2005 Sep;96 Suppl 1:29-36. doi: 10.1111/j.1464-410X.2005.05649.x.
citation: Oliver S, Fowler C, Mundy A, Craggs M. Measuring the sensations of urge and bladder filling during cystometry in urge incontinence and the effects of neuromodulation. Neurourol Urodyn. 2003;22(1):7-16. doi: 10.1002/nau.10082.
citation: 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 in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Urology. 2003 Jan;61(1):37-49. doi: 10.1016/s0090-4295(02)02243-4. No abstract available.
citation: Barber MD, Kuchibhatla MN, Pieper CF, Bump RC. Psychometric evaluation of 2 comprehensive condition-specific quality of life instruments for women with pelvic floor disorders. Am J Obstet Gynecol. 2001 Dec;185(6):1388-95. doi: 10.1067/mob.2001.118659.
citation: Herzog AR, Diokno AC, Fultz NH. Urinary incontinence: medical and psychosocial aspects. Annu Rev Gerontol Geriatr. 1989;9:74-119. doi: 10.1007/978-3-662-40455-3_3.