Validation of a Real-time Urodynamic Measure of Urinary Urgency

NCT00909428 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 109248
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder Syndrome

Keywords

Bladder; Urinary Urgency; Solifenacin; Vesicare(R)

Outcome Measures

Primary Outcomes (1)

• Change in Maximal Cystometric Capacity (mL)

  At baseline, a small catheter is placed inside the participant's bladder. The bladder is filled with sterile water through the catheter and participants' maximal tolerated cystometric capacity (MCC) is measured in milliliters. Following completion of the bladder test, participants take 10mg solifenacin succinate (VesicareR) daily for 30 days. After 30 days of treatment, participants repeat the bladder test. Change in the MCC is used to evaluate the effectiveness of the drug.

  30 Days

Study Arms (1)

Solifenacin Succinate

EXPERIMENTAL

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

Drug: Solifenacin Succinate

Interventions

Solifenacin Succinate DRUG

Participants take 10mg daily solifenacin succinate for 30 days

Also known as: Vesicare(R)

Solifenacin Succinate

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Loyola University: lead
• Astellas Pharma Inc: collaborator

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Related Publications (5)

• 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.

  PMID: 16086677 BACKGROUND

• 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.

  PMID: 12478595 BACKGROUND

• 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.

  PMID: 12559262 BACKGROUND

• 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.

  PMID: 11744914 BACKGROUND

• 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.

  PMID: 2514773 BACKGROUND

MeSH Terms

Interventions

Solifenacin Succinate

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

The trial experienced significant attrition. Otherwise, there are no limitations or caveats to report.

Results Point of Contact

• Title: Mary P FitzGerald
• Organization: Loyola University Chicago

mfitzg8@lumc.edu

708-216-2170

Study Officials

• Mary P FitzGerald, MD

  Loyola University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2009
• First Posted: May 28, 2009
• Study Start: January 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: February 1, 2009
• Last Updated: May 24, 2017
• Results First Posted: May 24, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)