InterStim® Sacral Nerve Modulation Cycling Study

NCT01957137 | Completed Results

• 1 other identifier: 1670
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

The study will assess the effects of different InterStim cycling settings on urinary urge incontinence.

Conditions

Urinary Urge Incontinence

Keywords

Urinary; Urge; Incontinence

Outcome Measures

Primary Outcomes (1)

• Number of Urinary Urge Incontinent (UUI) Episodes Per Day - Randomized Portion

  Urinary urge incontinent episodes were collected through a diary on daily basis for approximately 4 weeks when subjects were under each cycling setting. Only the last 7-day diaries were used for the analysis. The first 3 weeks were used as an adjustment period.

  4 weeks

Secondary Outcomes (8)

• Degree of Urgency - Randomized Portion

  4 week

• Number of Pads Used Per Day - Randomized Portion

  4 weeks

• Global Response Assessment (GRA) - Randomized Portion

  4 weeks

• Number of UUI Episodes Per Day - no Stimulation

  4 Weeks

• Degree of Urgency - no Stimulation

  4 weeks

Study Arms (5)

Continuous

OTHER

The device parameter will be continuous.

Device: InterStim® (Device Programming)

Cycling Parameter #1

OTHER

The device parameter will be cyclic program #1.

Device: InterStim® (Device Programming)

Cycling Parameter #2

OTHER

The device parameter will be cyclic program #2.

Device: InterStim® (Device Programming)

Cycling Parameter #3

OTHER

The device parameter will be cyclic program #3.

Device: InterStim® (Device Programming)

No Stimulation

OTHER

Following the randomized portion of the study, an assessment was conducted to estimate the effect of a month of no stimulation on incontinence.

Device: InterStim® (Device Programming)

Interventions

InterStim® (Device Programming) DEVICE

Continuous; Cycling Parameter #1; Cycling Parameter #2; Cycling Parameter #3; No Stimulation

Eligibility Criteria

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

You may qualify if:

• Implanted with either Neurostimulator Model 3023 (InterStim) or Neurostimulator Model 3058 (InterStim II) for at least 3 months
• Implanted with tined lead models 3889 or 3093
• Tined lead is located at S3 as determined by sensory or motor responses or x-ray or fluoroscopy
• Currently showing some efficacy with an InterStim device but has the potential to be optimized per the opinion of the Investigator
• Primary diagnosis before InterStim implant is urinary urge incontinence.
• Must be willing to maintain her current regimen (dosage and frequency) of any overactive bladder (OAB) medication (anticholinergic, antimuscarinic or Myrbetriq (Mirabegron)) or tricyclic antidepression medication over the study duration, if applicable.
• Female subject 18 years of age or older
• Willing and able to accurately complete voiding diaries and questionnaires, attend visits (within the visit windows +7 days), and comply with the study protocol that includes maintenance of InterStim programming settings over the course of the study
• Have had no more than one (InterStim) reprogramming at or within 28 days at or prior to randomization
• Able to consent to participate by signing the Informed Consent Form

You may not qualify if:

• History of Multiple sclerosis
• History of Reiter's syndrome
• History of spinal cord injury or a cerebral vascular accident (CVA)
• History of diabetes unless the diabetes is well-controlled through diet and/or medications
• Active symptomatic urinary tract infection (UTI)
• Stress incontinence as the primary diagnosis
• Urgency frequency as a primary diagnosis
• Pelvic pain of uncertain etiology that is not associated with a voiding dysfunction or where pelvic pain is the primary diagnosis
• Interstitial cystitis as the primary diagnosis
• Urinary retention as the primary diagnosis
• Treatment of urinary symptoms with botulinum toxin in the past 12 months or any plan to have botulinum toxin treatment during the study
• Bilateral lead placement
• Have other implantable neurostimulator, pacemaker, or defibrillator
• Have knowledge of planned diathermy, microwave exposure, high output ultrasonic exposure, RF energy exposure, or MRI scans not included within the scanning conditions provided within the MRI Guidelines for InterStim Therapy neurostimulation systems.
• Have an anticipated system modification within the next 5 months

Sponsors & Collaborators

• MedtronicNeuro: lead

Study Sites (3)

Pinellas Urology, Inc.

St. Petersburg, Florida, 33710, United States

Location

University of Iowa Healthcare

Iowa City, Iowa, 52242, United States

Location

Metro Urology

Woodbury, Minnesota, 55125, United States

Location

Related Publications (1)

• Siegel S, Kreder K, Takacs E, McNamara R, Kan F. Prospective Randomized Feasibility Study Assessing the Effect of Cyclic Sacral Neuromodulation on Urinary Urge Incontinence in Women. Female Pelvic Med Reconstr Surg. 2018 Jul/Aug;24(4):267-271. doi: 10.1097/SPV.0000000000000457.

  PMID: 28914707 RESULT

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: Rachael McNamara / Clinical Research Specialist
• Organization: Pelvic Health and Gastric Therapies

rachael.m.mcnamara@medtronic.com

763.526.8107

Study Officials

• Steven W Siegel, MD

  Metro Urology

  PRINCIPAL INVESTIGATOR

• Shaw Zhou, MD

  Pinellas Urology, Inc.

  PRINCIPAL INVESTIGATOR

• Karl Kreder, Jr., MD, MBA

  University of Iowa Healthcare

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2013
• First Posted: October 8, 2013
• Study Start: September 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: December 12, 2017
• Results First Posted: May 5, 2017

Record last verified: 2017-11

Locations

US (3)