Trial of Continuous Versus Cyclic Stimulation in Interstim Therapy

September 7, 2021 updated by: Karen Noblett, University of California, Irvine

Randomized Controlled Trial of Continuous vs. Cyclic Stimulation in Interstim Therapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 provides the electrical impulse and has several parameters that are amenable to adjustment including rate, strength and length of stimulation. Additionally, the stimulation can be programmed to be continuous or cyclic. If the therapy is equally efficacious at both settings, the cyclic setting has the advantage of resulting in a longer battery life. This would prolong the time interval between IPG replacements which would reduce the number of times a patient is exposed to a surgical procedure and may have a substantial impact on reducing cost to the healthcare system.

Participants will be randomized into one of two groups: either cyclic stimulation or continuous stimulation after IPG placement and will continue with this setting for four weeks. Subjects will return to the office 4 weeks post-op. They will complete a 3-day consecutive voiding diary just prior to their study visit. The subject will then undergo reprogramming to change the stimulation to the alternate pattern (from cyclic to continuous or vice versa as appropriate) keeping all other parameters the same. Subjects will be asked to return to the office 4 weeks after being switched to the alternate setting. She will complete a 3-day consecutive voiding diary just prior to the visit. The subject will also be asked their preference of mode of stimulation and the reason for their choice. After this visit, the participant will be switched to the mode of stimulation that is most efficacious for her.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • UCI Women's Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Interstim - continuous
Continuous stimulation
Device: Interstim (SNS)
Randomized Controlled Trial of Continuous vs. Cyclic Stimulation in Interstim Therapy
Other Names:
  • Sacral nerve stimulation
Other: Interstim - cyclic
Cyclic stimulation
Device: Interstim (SNS)
Randomized Controlled Trial of Continuous vs. Cyclic Stimulation in Interstim Therapy
Other Names:
  • Sacral nerve stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Micturitions in 24 Hours
Time Frame: After 4 weeks of stimulation a 3-day consecutive voiding diary was completed
Collected in the 3 day voiding diary depending on their primary diagnosis
After 4 weeks of stimulation a 3-day consecutive voiding diary was completed
Number of Urge Incontinence Episodes in 24 Hours
Time Frame: After 4 weeks of stimulation a 3-day consecutive voiding diary was completed
Collected in the 3 day voiding diary depending on their primary diagnosis
After 4 weeks of stimulation a 3-day consecutive voiding diary was completed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Investigators

  • Principal Investigator: Karen Noblett, MD, University of California, Irvine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

June 24, 2009

First Submitted That Met QC Criteria

June 25, 2009

First Posted (Estimate)

June 26, 2009

Study Record Updates

Last Update Posted (Actual)

October 6, 2021

Last Update Submitted That Met QC Criteria

September 7, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-6736

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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