Monitoring Performance of Sacral Neuromodulation Systems in a Real-World Population: The Product Surveillance Registry

Kreder K1, Benson K2, Miller A3, Siddiqui N4, Cameron A5, Katz D6, Woo H7, Kaufman M R8, Lai H9, Castaño J C10, Sandberg K11, Weaver T11

Research Type

Clinical

Abstract Category

Continence Care Products / Devices / Technologies

Abstract 578
Open Discussion ePosters
Scientific Open Discussion Session 28
Friday 31st August 2018
13:20 - 13:25 (ePoster Station 9)
Exhibition Hall
Urgency Urinary Incontinence Urgency/Frequency Urgency, Fecal Neuromodulation Prospective Study
1. University of Iowa, 2. Sanford Health, 3. Manatee Medical Research Institute, 4. Duke University, 5. University of Michigan, 6. Premier Medical Group Hudson Valley, 7. Ochsner Medical Center, 8. Vanderbilt University, 9. Washington University, 10. UroGine, 11. Medtronic
Presenter
H

Henry Lai

Links

Poster

Abstract

Hypothesis / aims of study
Sacral neuromodulation (SNM) through InterStim® therapy has been shown to be a safe and effective treatment for urgency urinary incontinence, urinary urgency-frequency, non-obstructive urinary retention, and chronic fecal incontinence. To continually monitor safety and performance of this therapy, a registry was developed to prospectively track performance and outcomes data in real-world patients. This registry creates a standardized, uniform way to follow a large cohort of SNM patients over time for variables of interest.
Study design, materials and methods
The Product Surveillance Registry (PSR) is a prospective, long-term, multi-center global registry originated for SNM in 2010. The PSR enrolls both newly-implanted patients and patients receiving a replacement neurostimulator device, and each group is followed prospectively for events related to the device, procedure, or therapy. In 2013, the PSR was expanded to include the collection of patient reported outcome measures. To monitor safety, adverse and device events are classified as a product performance related (PPR) or non-product performance related event. A PPR event is defined as possibly due to a device-related issue, and non-PPR events are undesirable experiences occurring to the patient, that possibly resulted from or was related to the implant procedure, therapy, or delivery of therapy, and cannot be classified as a product performance related event. To monitor performance, device survival is calculated (freedom from a product performance event).
Results
As of October 31, 2017, 20 centers in North and South America have enrolled 969 SNM patients in the registry. As shown in Table 1, 80.3% of patients were receiving their first implant and 83.3% were female. The most common treatment indications were urgency urinary incontinence (41.5%) and urinary urge-frequency (31.8%) (Table 2). As an ongoing registry, not all patients may have demographic information included in the database at the time of the data cut-off or did not collect that variable in earlier versions of the protocol.

InterStim device survival (freedom from a product performance event) is 98.9% at two-years for the InterStim device and 98.5% at two years for the InterStim II device. Lead survival during the same time period is 90.4% for model 3889 and 94.0% for model 3093. 

Of the non-product performance events, common categories were therapeutic non-responders (15.5% of reported events), medical device site pain or discomfort (10.0%), with the majority being urinary tract infections (UTI) (45.7%).
Interpretation of results
Cumulatively, the PPR event rate is 6.3 events/100 patient years of follow-up.
Concluding message
The PSR was created to monitor the performance of commercially available SNM systems. The PSR prospectively captures valuable real-world information from a heterogeneous group of centers. This information is used to guide future product development efforts aimed at improving product reliability and quality. In addition, data from the registry provide information about the treatment practices of physicians using these therapies. With higher demands for post-market surveillance from multiple stakeholders, this registry can serve those evolving needs as well as inform clinicians and patients on safety and effectiveness of this important therapy.
Figure 1
Figure 2
Disclosures
Funding This trial was sponsored by Medtronic, Inc Clinical Trial Yes Registration Number ClinicalTrials.gov, NCT01524276 RCT No Subjects Human Ethics Committee Western Institutional Review Board, Quorum Review IRB, DUHS IRB, Medical School Institutional Review Board (IRBMED), Ochsner Clinic Foundation IRB, Vanderbilt University IRB, Washington University in St. Louis IRB, Universidad CES Helsinki Yes Informed Consent Yes
28/03/2024 10:26:08