Trial of Continuous Versus Cyclic Stimulation in Interstim Therapy

NCT00928499 | Completed Results DMC

• 1 other identifier: 2009-6736
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Urge Incontinence

Keywords

urge/frequency; urge incontinence; Interstim; after success Interstim planning IPG placement

Outcome Measures

Primary Outcomes (2)

• Number of Micturitions in 24 Hours

  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

  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

Study Arms (2)

Interstim - continuous

OTHER

Continuous stimulation

Device: Interstim (SNS)

Interstim - cyclic

OTHER

Cyclic stimulation

Device: Interstim (SNS)

Interventions

Interstim (SNS) DEVICE

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

Also known as: Sacral nerve stimulation

Interstim - continuous; Interstim - cyclic

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

UCI Women's Healthcare

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Karen Noblett, MD
• Organization: University of California, Irvine

knoblett@uci.edu

714-456-8564

Study Officials

• Karen Noblett, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Director

Study Record Dates

• First Submitted: June 24, 2009
• First Posted: June 26, 2009
• Study Start: April 1, 2009
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: October 6, 2021
• Results First Posted: October 6, 2021

Record last verified: 2021-08

Locations

US (1)