Clinical trial NCT01957137: InterStim® Sacral Nerve Modulation Cycling Study
Official title: InterStim® Sacral Nerve Modulation Cycling Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Urge Incontinence
Keywords: Urinary
Urge
Incontinence
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2013-10-08
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Number of Urinary Urge Incontinent (UUI) Episodes Per Day - Randomized Portion
timeFrame: 4 weeks
Secondary outcomes:
measure: Degree of Urgency - Randomized Portion
timeFrame: 4 week
measure: Number of Pads Used Per Day - Randomized Portion
timeFrame: 4 weeks
measure: Global Response Assessment (GRA) - Randomized Portion
timeFrame: 4 weeks
measure: Number of UUI Episodes Per Day - no Stimulation
timeFrame: 4 Weeks
measure: Degree of Urgency - no Stimulation
timeFrame: 4 weeks
measure: Number of Pads Used Per Day - no Stimulation
timeFrame: 4 Weeks
measure: Global Response Assessment - no Stimulation
timeFrame: 4 Weeks
measure: Adverse Events - no Stimulation
timeFrame: 4 Weeks
Other outcomes:
Locations:
city: Saint Petersburg
country: United States
facility: Pinellas Urology, Inc.
state: Florida
city: Iowa City
country: United States
facility: University of Iowa Healthcare
state: Iowa
city: Woodbury
country: United States
facility: Metro Urology
state: Minnesota
Study officials:
affiliation: Metro Urology
name: Steven W Siegel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pinellas Urology, Inc.
name: Shaw Zhou, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Iowa Healthcare
name: Karl Kreder, Jr., MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.