N/A
N=32
Trial of Continuous Versus Cyclic Stimulation in Interstim Therapy
Urge Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT00928499 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcome: Primary: Number of Micturitions in 24 Hours
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Interstim (SNS) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of California, Irvine
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Micturitions in 24 Hours |
— | — |
| PRIMARY Number of Urge Incontinence Episodes in 24 Hours |
— | — |
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 normal voiding function. Sacral nerve stimulation is indicated for refractory voiding dysfunction including urinary urgency/frequency, urinary urge incontinence, and nonobstructive urinary retention. Since its introduction, SNS has undergone significant improvements in design and application so that implantation is now a minimally invasive procedure under local and intravenous (IV) sedation. However, despite the progress made in advancing this therapy to a minimally invasive procedure, there are neither data nor guidelines on ideal program settings. The purpose of this study is to evaluate the programming parameter of cyclic versus continuous stimulation on efficacy of the therapy. If the therapy is equally efficacious at both settings, the cyclic setting has the advantage of resulting in a longer battery life.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00928499). 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.