Urinary Biomarkers For Objective Measurement Of InterStim® Response In Over Active Bladder (OAB) Patients.

Overactive Bladder Clinical Trial

Official title:

Urinary Biomarkers For Objective Measurement Of InterStim® Response In Over Active Bladder (OAB) Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01739946
• Other study ID #: 2012-143
• Status: Completed
• Phase: N/A
• First received: November 28, 2012
• Last updated: July 27, 2017
• Start date: October 2012
• Est. completion date: December 2016

Study information

• Verified date: July 2017
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this study is to compare protein markers in the urine of patients with and without overactive bladder (OAB) and InterStim®.

Description:

This study will look for changes in protein markers that might reflect bladder symptoms before and after InterStim® implant.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

OAB subjects (n=10 Phase I and n=10 Phase II)

Inclusion Criteria:

• Female

• Age 18-75 years

• Clinical symptoms of OAB (urgency and frequency with or without urge incontinence) for at least 3 or the 6 months immediately before the first visit.

• At least 8 voids/day and an average of 1 nocturnal void over 3 consecutive days on baseline bladder diary.

• InterStim® treatment naïve or being revised with a new lead

Exclusion Criteria:

• Pelvic mass, pelvic prolapse, urinary retention, and pelvic malignancies as revealed by physical examination/medical record review

• Implanted Programmable Generator (IPG) is not implanted/connected to the tined lead (failed Stage I)

• Revision of only the IPG (without replacement of the tined lead)

• More than one InterStim® device being placed (undergoing bilateral stimulation)

Controls (n=10)

Inclusion:

• Female

• Age 18-75 years

• Deny history of OAB diagnosis or symptoms (urgency and frequency with or without urge incontinence)

• American Urological Association (AUA) symptom score of =4

Exclusion:

-History of pelvic mass, prolapse, urinary retention, or pelvic malignancy within the last year

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Locations

Country	Name	City	State
United States	William Beaumont Hospital	Royal Oak	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Michael Chancellor, MD	William Beaumont Hospitals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nerve Growth Factor (NGF) levels	pg/ml	4 weeks