InterStim® Sacral Nerve Modulation Cycling Study

Urinary Urge Incontinence Clinical Trial

Official title:

InterStim® Sacral Nerve Modulation Cycling Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01957137
• Other study ID #: 1670
• Status: Completed
• Phase: N/A
• First received: June 25, 2013
• Last updated: November 14, 2017
• Start date: September 2013
• Est. completion date: November 2015

Study information

• Verified date: November 2017
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

This feasibility study will assess the following outcomes:

• Voiding diaries

• Patient reported assessments of response or satisfaction

• Adverse events

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Urinary Incontinence, Urge
• Urinary Urge Incontinence

Intervention

Device:
• InterStim® (Device Programming)

Locations

Country	Name	City	State
United States	University of Iowa Healthcare	Iowa City	Iowa
United States	Pinellas Urology, Inc.	Saint Petersburg	Florida
United States	Metro Urology	Woodbury	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Country where clinical trial is conducted

United States, 

References & 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. 2017 Sep 13. doi: 10.1097/SPV.000000000 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Degree of Urgency - Randomized Portion	Each UUI episode was rated on following scales: 0=None, 1=Mild, 2=Moderate, 3=Severe, which were collected through a diary on daily basis for approximately 4 weeks when subjects were under each cycling setting. The average degree of urgency per UUI episode was calculated from the last 7-day diaries were used for the analysis. The first 3 weeks were used as an adjustment period.	4 week
Secondary	Number of Pads Used Per Day - Randomized Portion	Number of pad use 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	Global Response Assessment (GRA) - Randomized Portion	Summary statistics of GRA at different cycling settings are provided. The GRA assessed incontinence symptoms as compared to symptoms prior to subject's entry into the study. Subjects were asked how much their incontinence changed since starting the study: markedly worse, moderately worse, mildly worse, same, slightly improved, moderately improved, or markedly improved. The responses to the symptom change were categorized into three levels for the analysis: worse (markedly worse, moderately worse, mildly worse), same (same), better (slightly improved, moderately improved, or markedly improved).; Percentages of subjects reported worse, same or better under each cycling setting since starting the study are presented.	4 weeks
Secondary	Number of UUI Episodes Per Day - no Stimulation	UUI episodes were collected through a diary on daily basis for approximately 4 weeks when subjects were under no stimulation. Only the last 7-day diaries were used for the analysis. The first 3 weeks were used as an adjustment period.	4 Weeks
Secondary	Degree of Urgency - no Stimulation	Each UUI episode was rated on following scales: 0=None, 1=Mild, 2=Moderate, 3=Severe, which were collected through a diary on daily basis for approximately 4 weeks when subjects were under no stimulation. The average degree of urgency per UUI episode was calculated from the last 7-day diaries were used for the analysis. The first 3 weeks were used as an adjustment period.	4 weeks
Secondary	Number of Pads Used Per Day - no Stimulation	Number of pad use were collected through a diary on daily basis for approximately 4 weeks when subjects were under no stimulation. Only the last 7-day diaries were used for the analysis. The first 3 weeks were used as an adjustment period.	4 Weeks
Secondary	Global Response Assessment - no Stimulation	Summary of GRA under no stimulation setting is provided. The GRA assessed incontinence symptoms as compared to symptoms prior to subject's entry into the study. Subjects were asked how much their incontinence changed since starting the study: markedly worse, moderately worse, mildly worse, same, slightly improved, moderately improved, or markedly improved. The responses to the symptom change were categorized into three levels for the analysis: worse (markedly worse, moderately worse, mildly worse), same (same), better (slightly improved, moderately improved, or markedly improved).	4 Weeks
Secondary	Adverse Events - no Stimulation	Summary of adverse device effects when subjects were under no stimulation is provided. Percentage of subjects experiencing any type of Adverse Device Effect under no stimulation is presented.	4 Weeks