InterStim® Sacral Nerve Modulation Cycling Study

NCT ID: NCT01957137

Last Updated: 2017-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2015-11-30

Brief Summary

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

Detailed Description

This feasibility study will assess the following outcomes:

• Voiding diaries
• Patient reported assessments of response or satisfaction
• Adverse events

Conditions

Urinary Urge Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Continuous

The device parameter will be continuous.

Group Type: OTHER

InterStim® (Device Programming)

Intervention Type: DEVICE

Cycling Parameter #1

The device parameter will be cyclic program #1.

Group Type: OTHER

InterStim® (Device Programming)

Intervention Type: DEVICE

Cycling Parameter #2

The device parameter will be cyclic program #2.

Group Type: OTHER

InterStim® (Device Programming)

Intervention Type: DEVICE

Cycling Parameter #3

The device parameter will be cyclic program #3.

Group Type: OTHER

InterStim® (Device Programming)

Intervention Type: DEVICE

No Stimulation

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

Group Type: OTHER

InterStim® (Device Programming)

Intervention Type: DEVICE

Interventions

InterStim® (Device Programming)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Implanted with either Neurostimulator Model 3023 (InterStim) or Neurostimulator Model 3058 (InterStim II) for at least 3 months

2. Implanted with tined lead models 3889 or 3093

3. Tined lead is located at S3 as determined by sensory or motor responses or x-ray or fluoroscopy

4. Currently showing some efficacy with an InterStim device but has the potential to be optimized per the opinion of the Investigator

5. Primary diagnosis before InterStim implant is urinary urge incontinence.

6. 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.

7. Female subject 18 years of age or older

8. 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

9. Have had no more than one (InterStim) reprogramming at or within 28 days at or prior to randomization

10. Able to consent to participate by signing the Informed Consent Form

Exclusion Criteria

11. History of Multiple sclerosis

12. History of Reiter's syndrome

13. History of spinal cord injury or a cerebral vascular accident (CVA)

14. History of diabetes unless the diabetes is well-controlled through diet and/or medications

15. Active symptomatic urinary tract infection (UTI)

16. Stress incontinence as the primary diagnosis

17. Urgency frequency as a primary diagnosis

18. Pelvic pain of uncertain etiology that is not associated with a voiding dysfunction or where pelvic pain is the primary diagnosis

19. Interstitial cystitis as the primary diagnosis

20. Urinary retention as the primary diagnosis

21. Treatment of urinary symptoms with botulinum toxin in the past 12 months or any plan to have botulinum toxin treatment during the study

22. Bilateral lead placement

23. Have other implantable neurostimulator, pacemaker, or defibrillator

24. 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.

25. Have an anticipated system modification within the next 5 months

26. Women who are pregnant or planning to become pregnant (women of child-bearing potential must undergo a pregnancy test, with a clear negative result, no more than 7 days prior to randomization visit)

27. Subjects who frequently use the patient programmer to change device program settings ("frequently" is defined as at least once a day and does not include shutting off the device for safety purposes)

28. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol.

29. Study site personnel will contact the Medtronic Study Manager (or designee) to determine if a potential subject who plans to enroll in an investigational device or drug trial, or is currently enrolled in an investigational device or drug trial is eligible for this study

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

MedtronicNeuro

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven W Siegel, MD

Role: PRINCIPAL_INVESTIGATOR

Metro Urology

Shaw Zhou, MD

Role: PRINCIPAL_INVESTIGATOR

Pinellas Urology, Inc.

Karl Kreder, Jr., MD, MBA

Role: PRINCIPAL_INVESTIGATOR

University of Iowa Healthcare

Locations

Pinellas Urology, Inc.

St. Petersburg, Florida, United States

University of Iowa Healthcare

Iowa City, Iowa, United States

Metro Urology

Woodbury, Minnesota, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 28914707 (View on PubMed)

Other Identifiers

1670

Identifier Type: -

Identifier Source: org_study_id