Status:
COMPLETED
Trial of Continuous Versus Cyclic Stimulation in Interstim Therapy
Lead Sponsor:
University of California, Irvine
Conditions:
Urge Incontinence
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Sacral Nerve Stimulation (SNS) delivers non-painful, mild electrical pulses to the sacral nerves to modulate the reflexes that influence the bladder, sphincter, and pelvic floor to improve or restore ...
Detailed Description
The components of SNS include a quadripolar lead wire that is placed adjacent to a sacral nerve root (typically S3), and an implantable pulse generator (IPG) that the lead wire is attached to. The IPG...
Eligibility Criteria
Inclusion
- You are eligible to participate in this study if you have the diagnosis of urge/frequency or urge incontinence and have undergone a successful Interstim trial and are planning on proceeding with IPG placement.
- All subjects must have had a minimum of a 50% improvement of one or more of the parameters being measured on the voiding diary to be considered a candidate for implant.
- Eligibility criteria also include non-pregnant women over the age of 18 who are able to provide informed consent and are willing to accept randomization.
Exclusion
- You are not eligible to participate in this study if:
- you are under 18 years of age;
- pregnant or planning to become pregnant;
- have underlying neurological disease;
- stress incontinence;
- unable to read English;
- inability to complete the voiding diary; and
- inability to complete the follow-up visits.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00928499
Start Date
April 1 2009
End Date
April 1 2012
Last Update
October 6 2021
Active Locations (1)
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1
UCI Women's Healthcare
Orange, California, United States, 92868