Trial of Continuous Versus Cyclic Stimulation in Interstim Therapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by University of California, Irvine.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00928499
First received: June 24, 2009
Last updated: November 16, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention
Urge Incontinence
Device: Interstim (SNS)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Continuous vs. Cyclic Stimulation in Interstim Therapy

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • voiding parameters (number of micturitions in 24 hours, number of nighttime voids, number of urge incontinence episodes in 24 hours, number of pads/diapers used per 24 hours and degree of urgency) as measured on the voiding diary. [ Time Frame: 3-day consecutive voiding ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: April 2009
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Interstim - continuous
Continuous stimulation
Device: Interstim (SNS)
Randomized Controlled Trial of Continuous vs. Cyclic Stimulation in Interstim Therapy
Other Name: Sacral nerve stimulation
Interstim - cyclic
Cyclic stimulation
Device: Interstim (SNS)
Randomized Controlled Trial of Continuous vs. Cyclic Stimulation in Interstim Therapy
Other Name: Sacral nerve stimulation

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00928499

Contacts
Contact: Karen Noblett, MD 714.456.8564 knoblett@uci.edu

Locations
United States, California
UCI Women's Healthcare Recruiting
Orange, California, United States, 92868
Contact: Jennifer Nakano    714-456-6846    jnakano@uci.edu   
Principal Investigator: Karen Noblett, MD         
Sub-Investigator: Felicia Lane, MD         
Sub-Investigator: Danielle Markle, MD         
Sub-Investigator: Ene George, MD         
Sub-Investigator: Jennifer Rhee, MD         
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Karen Noblett, MD University of California, Irvine
  More Information

No publications provided

Responsible Party: Karen Noblett, MD, University of California, Irvine Medical Center
ClinicalTrials.gov Identifier: NCT00928499     History of Changes
Other Study ID Numbers: 2009-6736
Study First Received: June 24, 2009
Last Updated: November 16, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
urge/frequency
urge incontinence
Interstim
after success Interstim planning IPG placement

Additional relevant MeSH terms:
Urinary Incontinence, Urge
Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 26, 2014