InterStim Therapy Programming Study

• Sponsor: MedtronicNeuro (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01009333
• Collaborator: (none)
• Enrollment: 13
• Location: 1
• Arms: 3
• Duration (Months): 12
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

This study assessed the effect of different InterStim rate settings on voiding diary outcomes. Specifically, the study evaluated how 3 different rate settings affected the number of urinary incontinent episodes per day collected through a voiding diary. The study also evaluated how the 3 different rate settings affected other voiding diary measures including number of voids per day, degree of urgency before each void, number of pads used per day, and number of fecal incontinent episodes, questionnaires, and adverse events.

Condition or Disease	Intervention/Treatment	Phase
Urgency Frequency; Urinary Urge Incontinence	Device: InterStim Therapy at rate 5.2 Hz; Device: InterStim Therapy at rate 14 Hz; Device: InterStim Therapy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Official Title: InterStim Therapy Programming Study
• Study Start Date: Nov 1, 2009
• Actual Primary Completion Date: Nov 1, 2010
• Actual Study Completion Date: Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low InterStim rate setting at 5.2 Hz	Device: InterStim Therapy at rate 5.2 Hz; All subjects enrolled in this study were programmed to this rate setting for a 1-week period.
Experimental: Medium InterStim rate setting at 14 Hz	Device: InterStim Therapy at rate 14 Hz; All subjects enrolled in this study were programmed to this rate setting for a 1-week period.
Experimental: High InterStim rate setting at 25 Hz	Device: InterStim Therapy; All subjects enrolled in this study were programmed to each rate setting (low, medium, high) for a 1-week period.

Outcome Measures

Primary Outcome Measures

1. Number of Urinary Incontinent Episodes Per Day [three weeks]

   In a diary, subjects are asked to rate each urine leaking episode at 'None', 'Slight', 'Moderate' or 'Heavy'. The urinary incontinence was counted if there is any degree of leaking, from 'Slight' to 'Heavy'. The total number of urinary incontinence was calculated per day.

Secondary Outcome Measures

1. Number of Voids Per Day [three weeks]

   In a diary, subjects are asked clarify each void as 'urine', 'fecal' or 'both'. Either 'urine' or 'both' are counted as void for this analysis. The total number of voids was calculated per day.

2. Number of Pads Per Day [three weeks]

   In a diary, subjects are asked to provide number of pads they used per day.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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 in S2, S3, or S4

• Diagnosis before InterStim implant included urgency frequency (an average of 8 or more voids per day) and any amount of urinary urge incontinence over the voiding diary reporting period. The diary reporting period must be at least 2 days.

• Able to tolerate (ie, no complaint of pain or discomfort) acute high InterStim rate setting

• Able to tolerate (ie, no complaint of pain or discomfort) acute medium InterStim rate setting

• Able to tolerate (ie, no complaint of pain or discomfort) acute low InterStim rate setting

• Must be willing to maintain their current regimen (dosage and frequency) of any overactive bladder medication (anticholinergic or antimuscarinic) or tricyclic antidepression medication over the study duration

• Female subject 18 years of age or older

• Willing and able to accurately complete voiding diaries and questionnaires, attend visits, and comply with the study protocol that includes maintenance of InterStim programming settings over the course of the study.

• Able to consent to participate by signing the Informed Consent Form

Exclusion Criteria:

• Multiple sclerosis

• Reiter's syndrome

• Exclude diabetics unless the subject's diabetes is well-controlled with diet or medication

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

• Active symptomatic urinary tract infection (UTI)

• Stress incontinence as the primary diagnosis

• Pelvic pain of uncertain etiology that is not associated with a voiding dysfunction or where pelvic pain is the primary complaint/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 MRIs, diathermy, microwave exposure, high output ultrasonic exposure, or RF energy exposure

• Have an anticipated system modification within the next 1 month

• Women who are pregnant or planning to become pregnant or women of child-bearing potential who are not using a medically-acceptable method of birth control. Women of child-bearing age potential must undergo a pregnancy test, with a clear negative result, no more than 7 days prior to randomization visit.

• 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.

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kenneth Peters, MD	Royal Oak	Michigan	United States	48073

Sponsors and Collaborators

• MedtronicNeuro

Investigators

• Study Director: Maureen McGuire, Ph.D., MedtronicNeuro

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: MedtronicNeuro
• ClinicalTrials.gov Identifier: NCT01009333
• Other Study ID Numbers: 1650
• First Posted: Nov 6, 2009
• Last Update Posted: May 27, 2013
• Last Verified: May 1, 2013

• Keywords provided by MedtronicNeuro: urgency frequency; urinary urge incontinence; InterStim Therapy
• Additional relevant MeSH terms: Urinary Incontinence, Urge

Study Results

Participant Flow

Arm/Group Title	Start at 5.2 Hz, Then 14 Hz, Then 25 Hz	Start at 5.2 Hz, Then 25 Hz, Then 14 Hz	Start at 14 Hz, Then 5.2 Hz, Then 25 Hz	Start at 14 Hz, Then 25 Hz, Then 5.2 Hz	Start at 25 Hz, Then 5.2 Hz, Then 14 Hz	Start at 25 Hz, Then 14 Hz, Then 5.2 Hz
Arm/Group Description	Participants started with Low InterStim Rate Setting at 5.2 Hz, then progressed to Medium InterStim Rate Setting at 14 Hz, then High InterStim Rate Settings at 25 Hz until they completed all three settings.	Participants started with Low InterStim Rate Setting at 5.2 Hz, then progressed to High InterStim Rate Setting at 25 Hz, then Medium InterStim Rate Settings at 14 Hz until they completed all three settings.	Participants started with Medium InterStim Rate Setting at 14 Hz, then progressed to Low InterStim Rate setting at 5.2 Hz, then High InterStim Rate Settings at 25 Hz until they completed all three settings.	Participants started with Medium InterStim Rate Setting at 14 Hz, then progressed to High InterStim Rate setting at 25 Hz, then Low InterStim Rate Settings at 5.2 Hz until they completed all three settings.	Participants started with High InterStim Rate Setting at 25 Hz, then progressed to Low InterStim Rate setting at 5.2 Hz, then Medium InterStim Rate Settings at 14 Hz until they completed all three settings.	Participants started with High InterStim Rate Setting at 25 Hz, then progressed to Medium InterStim Rate setting at 14 Hz, then Low InterStim Rate Settings at 5.2 Hz until they completed all three settings.
Period Title: Week 1
STARTED	2	3	2	2	2	2
COMPLETED	2	3	2	2	2	2
NOT COMPLETED	0	0	0	0	0	0
Period Title: Week 1
STARTED	2	2	2	2	2	2
COMPLETED	2	2	2	2	2	2
NOT COMPLETED	0	0	0	0	0	0
Period Title: Week 1
STARTED	2	2	2	2	2	2
COMPLETED	2	2	2	2	2	2
NOT COMPLETED	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	All Study Participants
Arm/Group Description
Overall Participants	12
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	10 83.3%
>=65 years	2 16.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.9 (6.9)
Sex: Female, Male (Count of Participants)
Female	12 100%
Male	0 0%
Region of Enrollment (participants) [Number]
United States	12 100%

Outcome Measures

1. Primary Outcome

Title	Number of Urinary Incontinent Episodes Per Day
Description	In a diary, subjects are asked to rate each urine leaking episode at 'None', 'Slight', 'Moderate' or 'Heavy'. The urinary incontinence was counted if there is any degree of leaking, from 'Slight' to 'Heavy'. The total number of urinary incontinence was calculated per day.
Time Frame	three weeks

Outcome Measure Data

Analysis Population Description

Data from 12 subjects who completed the study were included in the efficacy analysis; data from 1 subject was excluded because the subject was not compliant with the study protocol and was subsequently withdrawn from the study. Data from all 13 subjects were used for safety reporting.

Arm/Group Title	Low InterStim Rate Setting at 5.2 Hz	Medium InterStim Rate Setting at 14 Hz	High InterStim Rate Setting at 25 Hz
Arm/Group Description
Measure Participants	12	12	12
Mean (Standard Deviation) [Episodes Per Day]	3.83 (2.27)	2.37 (1.83)	2.82 (2.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Low InterStim Rate Setting at 5.2 Hz, High InterStim Rate Setting at 25 Hz
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.008
	Comments
	Method	Mixed Models Analysis
	Comments

2. Secondary Outcome

Title	Number of Voids Per Day
Description	In a diary, subjects are asked clarify each void as 'urine', 'fecal' or 'both'. Either 'urine' or 'both' are counted as void for this analysis. The total number of voids was calculated per day.
Time Frame	three weeks

Outcome Measure Data

Analysis Population Description

Data from 12 subjects who completed the study were included in the efficacy analysis; data from 1 subject was excluded because the subject was not compliant with the study protocol and was subsequently withdrawn from the study. Data from all 13 subjects were used for safety reporting.

Arm/Group Title	Low InterStim Rate Setting at 5.2 Hz	Medium InterStim Rate Setting at 14 Hz	High InterStim Rate Setting at 25 Hz
Arm/Group Description
Measure Participants	12	12	12
Mean (Standard Deviation) [Voids Per Day]	9.33 (2.08)	9.36 (2.34)	9.57 (2.28)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Low InterStim Rate Setting at 5.2 Hz, High InterStim Rate Setting at 25 Hz
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.589
	Comments
	Method	Mixed Models Analysis
	Comments

3. Secondary Outcome

Title	Number of Pads Per Day
Description	In a diary, subjects are asked to provide number of pads they used per day.
Time Frame	three weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Low InterStim Rate Setting at 5.2 Hz	Medium InterStim Rate Setting at 14 Hz	High InterStim Rate Setting at 25 Hz
Arm/Group Description
Measure Participants	12	12	12
Mean (Standard Deviation) [Pads Per Day]	2.61 (1.64)	1.84 (1.43)	1.94 (1.61)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Low InterStim Rate Setting at 5.2 Hz, High InterStim Rate Setting at 25 Hz
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.04
	Comments
	Method	Mixed Models Analysis
	Comments

Adverse Events

Arm/Group Title	Low InterStim Rate Setting at 5.2 Hz		Medium InterStim Rate Setting at 14 Hz		High InterStim Rate Setting at 25 Hz
Arm/Group Description
All Cause Mortality
	Low InterStim Rate Setting at 5.2 Hz		Medium InterStim Rate Setting at 14 Hz		High InterStim Rate Setting at 25 Hz
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Low InterStim Rate Setting at 5.2 Hz		Medium InterStim Rate Setting at 14 Hz		High InterStim Rate Setting at 25 Hz
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/12 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	Low InterStim Rate Setting at 5.2 Hz		Medium InterStim Rate Setting at 14 Hz		High InterStim Rate Setting at 25 Hz
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/13 (46.2%)		5/12 (41.7%)		7/12 (58.3%)
Gastrointestinal disorders
Abdominal discomfort	1/13 (7.7%)	1	0/12 (0%)	0	0/12 (0%)	0
Constipation	0/13 (0%)	0	0/12 (0%)	0	1/12 (8.3%)	1
Diarrhoea	1/13 (7.7%)	1	0/12 (0%)	0	0/12 (0%)	0
Faecal incontinence	0/13 (0%)	0	1/12 (8.3%)	1	0/12 (0%)	0
Painful defaecation	0/13 (0%)	0	0/12 (0%)	0	1/12 (8.3%)	1
General disorders
Pain	0/13 (0%)	0	1/12 (8.3%)	1	1/12 (8.3%)	1
Infections and infestations
Bronchitis	0/13 (0%)	0	1/12 (8.3%)	1	0/12 (0%)	0
Musculoskeletal and connective tissue disorders
Muscle spasms	0/13 (0%)	0	0/12 (0%)	0	1/12 (8.3%)	1
Nervous system disorders
Muscle contractions involuntary	0/13 (0%)	0	0/12 (0%)	0	1/12 (8.3%)	1
Paraesthesia	0/13 (0%)	0	0/12 (0%)	0	1/12 (8.3%)	1
Renal and urinary disorders
Bladder discomfort	1/13 (7.7%)	1	0/12 (0%)	0	1/12 (8.3%)	1
Change in sensation of stimulation	0/13 (0%)	0	1/12 (8.3%)	1	0/12 (0%)	0
Hypertonic bladder	2/13 (15.4%)	2	0/12 (0%)	0	0/12 (0%)	0
Micturition urgency	1/13 (7.7%)	1	0/12 (0%)	0	0/12 (0%)	0
Urinary incontinence	0/13 (0%)	0	2/12 (16.7%)	2	0/12 (0%)	0
Reproductive system and breast disorders
Pelvic pain	0/13 (0%)	0	0/12 (0%)	0	1/12 (8.3%)	1
Vascular disorders
Hypertension	0/13 (0%)	0	1/12 (8.3%)	1	0/12 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.