N/A
N=31
Comparison of Motor and Sensory Response With Interstim Stimulation
Overactive Bladder · Urgency-Frequency
Bottom Line
View on ClinicalTrials.gov: NCT00943904 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcome: Primary: Percent of Symptoms With Improvement of Leaks Reported — 14.4; 19.8; 18.2 Percent change in leaks
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Interstim implant for SNS (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of California, Irvine
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Symptoms With Improvement of Leaks Reported |
14.4; 19.8; 18.2 | — |
Summary
Sacral nerve stimulation (SNS) implantation is a minimally invasive procedure which has current FDA approval for urinary urge incontinence, urgency-frequency syndrome and non-obstructive urinary retention, and has been available in the United States since 1997. The 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 normal voiding function. While SNS has been shown to have efficacy for the aforementioned conditions, the exact mechanism of action is unknown, but it is believed to work primarily through the somatic afferent system in promoting inhibitory reflex pathways to facilitate urine storage. The degree of stimulation is thought to be at a level that only evokes a sensory and not a motor response; however this has not been tested.
Eligibility Criteria
Inclusion Criteria
- You are eligible to participate in this study if:
- you are at least 18 years of age or older
- you have the capacity to give informed consent
- you are currently implanted with a functioning Interstim device for the treatment of urge urinary leakage or overactive bladder
Exclusion Criteria
- You are not eligible to participate in this study if:
- you do not meet the inclusion criteria and/or are not able to fully empty your bladder
- you have a history of an underlying neurologic disorder
- you are currently pregnant, or have an active urinary tract or vaginal infection
Data sourced from ClinicalTrials.gov (NCT00943904). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.