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Trial of Continuous Versus Cyclic Stimulation in Interstim Therapy

Primary Purpose

Urge Incontinence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interstim (SNS)
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urge Incontinence focused on measuring urge/frequency, urge incontinence, Interstim, after success Interstim planning IPG placement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • UCI Women's Healthcare

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Interstim - continuous

Interstim - cyclic

Arm Description

Continuous stimulation

Cyclic stimulation

Outcomes

Primary Outcome Measures

Number of Micturitions in 24 Hours
Collected in the 3 day voiding diary depending on their primary diagnosis
Number of Urge Incontinence Episodes in 24 Hours
Collected in the 3 day voiding diary depending on their primary diagnosis

Secondary Outcome Measures

Full Information

First Posted
June 24, 2009
Last Updated
September 7, 2021
Sponsor
University of California, Irvine
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1. Study Identification

Unique Protocol Identification Number
NCT00928499
Brief Title
Trial of Continuous Versus Cyclic Stimulation in Interstim Therapy
Official Title
Randomized Controlled Trial of Continuous vs. Cyclic Stimulation in Interstim Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urge Incontinence
Keywords
urge/frequency, urge incontinence, Interstim, after success Interstim planning IPG placement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interstim - continuous
Arm Type
Other
Arm Description
Continuous stimulation
Arm Title
Interstim - cyclic
Arm Type
Other
Arm Description
Cyclic stimulation
Intervention Type
Device
Intervention Name(s)
Interstim (SNS)
Other Intervention Name(s)
Sacral nerve stimulation
Intervention Description
Randomized Controlled Trial of Continuous vs. Cyclic Stimulation in Interstim Therapy
Primary Outcome Measure Information:
Title
Number of Micturitions in 24 Hours
Description
Collected in the 3 day voiding diary depending on their primary diagnosis
Time Frame
After 4 weeks of stimulation a 3-day consecutive voiding diary was completed
Title
Number of Urge Incontinence Episodes in 24 Hours
Description
Collected in the 3 day voiding diary depending on their primary diagnosis
Time Frame
After 4 weeks of stimulation a 3-day consecutive voiding diary was completed

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Noblett, MD
Organizational Affiliation
University of California, Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCI Women's Healthcare
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States

12. IPD Sharing Statement

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Trial of Continuous Versus Cyclic Stimulation in Interstim Therapy

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