Validation of a Real-time Urodynamic Measure of Urinary Urgency

NCT ID: NCT00909428

Last Updated: 2017-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2009-02-28

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.

Conditions

Overactive Bladder Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Solifenacin Succinate

The intervention for this study is 10mg daily solifenacin. Patients with overactive bladder syndrome will take this study drug for 30 days.

Group Type: EXPERIMENTAL

Solifenacin Succinate

Intervention Type: DRUG

Participants take 10mg daily solifenacin succinate for 30 days

Interventions

Solifenacin Succinate

Participants take 10mg daily solifenacin succinate for 30 days

Intervention Type: DRUG

Other Intervention Names

Vesicare(R)

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: collaborator

Loyola University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mary P FitzGerald, MD

Role: PRINCIPAL_INVESTIGATOR

Loyola University

Locations

Loyola University Medical Center

Maywood, Illinois, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 16086677 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12478595 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12559262 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11744914 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 2514773 (View on PubMed)

Other Identifiers

109248

Identifier Type: -

Identifier Source: org_study_id