InterStim® Amplitude Study

• Sponsor: MedtronicNeuro (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03335761
• Collaborator: (none)
• Enrollment: 97
• Locations: 18
• Arms: 3
• Actual Duration (Months): 20.3
• Patients Per Site: 5.4
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This feasibility study will explore the effects of three different InterStim amplitude settings on overactive bladder symptoms (OAB).

Condition or Disease	Intervention/Treatment	Phase
Urinary Urge Incontinence	Device: InterStim Therapy	N/A

Detailed Description

This is a prospective, randomized, multicenter, single-blinded study to explore the efficacy and quality of life (QoL) of 3 different amplitude settings.

Study Design

• Study Type: Interventional
• Actual Enrollment: 97 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: InterStim® Amplitude Study
• Actual Study Start Date: Feb 27, 2018
• Actual Primary Completion Date: Nov 6, 2019
• Actual Study Completion Date: Nov 6, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Amplitude Setting #1 InterStim Therapy will be set to amplitude parameter #1.	Device: InterStim Therapy; Device Programming
Experimental: Amplitude Setting #2 InterStim Therapy will be set to amplitude parameter #2.	Device: InterStim Therapy; Device Programming
Experimental: Amplitude Setting #3 InterStim Therapy will be set to amplitude parameter #3.	Device: InterStim Therapy; Device Programming

Outcome Measures

Primary Outcome Measures

1. Change in Urinary Urge Incontinence (UUI) Episodes Per Day From Baseline to 12 Weeks. [12 weeks]

   Symptoms related to OAB were evaluated using paper voiding diaries. Subjects were trained to complete the urinary voiding diaries for 3-days.

Secondary Outcome Measures

1. Change in QoL Using ICIQ-OAB QOL From Baseline to 12 Weeks. [12 weeks]

   International Consultation on Incontinence Modular Questionnaire - Overactive Bladder Symptoms Quality of Life Questionnaire The questionnaire consists of 4 subscales and a single item on urinary symptom interference. The four subscales of Concern (7 items), Coping (8 items), Sleep (5 items), and Social (5 items) are measured on a scale from 0-100 using a range percentile transformation on the summed value from individual listed items. The Health-Related Quality of Life (HRQL) score is a calculated score with a range from 0 to 100 using a range percentile transformation on the summed value from the subscales. Subjects were asked a urinary symptom interference question. "Interference" was measured on a scale from 0-10. A positive change in Concern, Coping, Sleep, Social, and HRQL indicates improvement in Quality of Life; a negative change in Interference indicates improvement in Quality of Life.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

1. Primary diagnosis of urinary urge incontinence (UUI) as demonstrated on a 3-day baseline voiding diary demonstrating at least 3 UUI episodes

2. Female subjects 18 years of age or older

3. Candidate for InterStim Lead Placement

4. Willing and able to accurately complete voiding diaries, questionnaires, attend visits, and comply with the study protocol (which includes maintenance of InterStim II programming settings over the course of the study)

5. Willing and able to provide signed and dated informed consent

6. Willing to maintain current regimen (dosage and frequency) of any overactive bladder (OAB) medication

Exclusion Criteria:

1. Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury

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

3. Symptomatic urinary tract infection (UTI)

4. Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component

5. Treatment of urinary symptoms with botulinum toxin in the past 9 months or any plan to have botulinum toxin treatment during the study

6. Implanted with a neurostimulator, pacemaker, or defibrillator

7. Have knowledge of planned MRIs, diathermy, microwave exposure, high output ultrasonic exposure, or radio frequency (RF) energy exposure not included within the scanning conditions provided with the MRI Guidelines for InterStim Therapy

8. Women who are pregnant or planning to become pregnant

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

10. Currently enrolled or planning to enroll in a potentially confounding clinical study during the course of the study (co-enrollment in concurrent studies is only allowed when documented pre-approval is obtained from the Medtronic study manager (or designee).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Academic Urology & Urogynecology of Arizona	Phoenix	Arizona	United States	85027
2	East Coast Institute for Research	Jacksonville	Florida	United States	32216
3	Pinellas Urology	Saint Petersburg	Florida	United States	33710
4	Florida Urology Partners	Tampa	Florida	United States	33606
5	Minnesota Urology Fridley	Fridley	Minnesota	United States	55432
6	Minnesota Urology Woodbury	Woodbury	Minnesota	United States	55125
7	Adult Pediatric Urology and Urogynecology	Omaha	Nebraska	United States	68114
8	Urologic Research & Consulting	Englewood	New Jersey	United States	07631
9	Carolina Urology Partners	Concord	North Carolina	United States	28025
10	Chattanooga Hamilton County Hospital Authority d/b/a Erlanger Health System	Chattanooga	Tennessee	United States	37421
11	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232-2765
12	Aurora Research Institute - Aurora West Allis Women's Pavilion	West Allis	Wisconsin	United States	53227
13	UZ Leuven - Campus Gasthuisberg - Department Urology	Leuven		Belgium	3000
14	University Urology Associates, Toronto Western Hospital	Toronto	Ontario	Canada	M5T 2S8
15	CHU Hôpitaux de Rouen - Hôpital Charles Nicolle	Rouen		France
16	Azienda Ospedaliera Universitaria Integrata Verona	Verona		Italy	37126
17	Erasmus MC	Rotterdam		Netherlands	3015 GD
18	University College London Hospitals NHS Foundation Trust - University College Hospital	London		United Kingdom	W1G 8PH

Sponsors and Collaborators

• MedtronicNeuro

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Aug 23, 2018
• Statistical Analysis Plan - Mar 5, 2019

More Information

Publications

None provided.

• Responsible Party: MedtronicNeuro
• ClinicalTrials.gov Identifier: NCT03335761
• Other Study ID Numbers: MDT17030
• First Posted: Nov 8, 2017
• Last Update Posted: Jan 8, 2021
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by MedtronicNeuro: Urinary; Incontinence
• Additional relevant MeSH terms: Urinary Incontinence, Urge

Study Results

Participant Flow

Recruitment Details	Out of 97 subjects enrolled in the study, 48 were randomized, 46 were implanted with a neurostimulator device, and 43 completed their 12 week follow-up visit before exiting the study. Nineteen were randomized to 50% of sensory threshold, 14 were randomized to 80% of sensory threshold, and 15 were randomized to sensory threshold.

Arm/Group Title	Amplitude Setting #1 = 50% Sensory Threshold	Amplitude Setting #2 = 80% Sensory Threshold	Amplitude Setting #3 = Sensory Threshold
Arm/Group Description	InterStim Therapy will be set to amplitude parameter #1 (50% Sensory Threshold) InterStim Therapy: Device Programming	InterStim Therapy will be set to amplitude parameter #2 (80% Sensory Threshold) InterStim Therapy: Device Programming	InterStim Therapy will be set to amplitude parameter #3 (Sensory Threshold) InterStim Therapy: Device Programming
Period Title: Overall Study
STARTED	19	14	15
Implanted With a Neurostimulator Device	18	14	14
COMPLETED	17	13	13
NOT COMPLETED	2	1	2

Baseline Characteristics

Arm/Group Title	Amplitude Setting #1 = 50% Sensory Threshold	Amplitude Setting #2 = 80% Sensory Threshold	Amplitude Setting #3 = Sensory Threshold	Total
Arm/Group Description	InterStim Therapy will be set to amplitude parameter #1 (50% Sensory Threshold) InterStim Therapy: Device Programming	InterStim Therapy will be set to amplitude parameter #2 (80% Sensory Threshold) InterStim Therapy: Device Programming	InterStim Therapy will be set to amplitude parameter #3 (Sensory Threshold) InterStim Therapy: Device Programming	Total of all reporting groups
Overall Participants	19	14	15	48
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.1 (16)	57.9 (16.1)	56.7 (14.9)	60 (15.7)
Sex: Female, Male (Count of Participants)
Female	19 100%	14 100%	15 100%	48 100%
Male	0 0%	0 0%	0 0%	0 0%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	30.0 (5.7)	36.3 (11.2)	33.1 (6.4)	32.8 (8.1)

Outcome Measures

1. Primary Outcome

Title	Change in Urinary Urge Incontinence (UUI) Episodes Per Day From Baseline to 12 Weeks.
Description	Symptoms related to OAB were evaluated using paper voiding diaries. Subjects were trained to complete the urinary voiding diaries for 3-days.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Complete Case Subject Set

Arm/Group Title	Amplitude Setting #1 = 50% Sensory Threshold	Amplitude Setting #2 = 80% Sensory Threshold	Amplitude Setting #3 = Sensory Threshold
Arm/Group Description	InterStim Therapy will be set to amplitude parameter #1 (50% Sensory Threshold) InterStim Therapy: Device Programming	InterStim Therapy will be set to amplitude parameter #2 (80% Sensory Threshold) InterStim Therapy: Device Programming	InterStim Therapy will be set to amplitude parameter #3 (Sensory Threshold) InterStim Therapy: Device Programming
Measure Participants	17	13	13
UUI episodes per day at Baseline	4.4 (2.9)	5.3 (3.1)	5.1 (4.7)
UUI episodes per day at 12 weeks	1.4 (2.6)	2.4 (3.0)	1.5 (2.3)
Change in UUI episodes per day from baseline to 12 weeks	-3 (2.6)	-2.9 (2.9)	-3.6 (2.8)

2. Secondary Outcome

Title	Change in QoL Using ICIQ-OAB QOL From Baseline to 12 Weeks.
Description	International Consultation on Incontinence Modular Questionnaire - Overactive Bladder Symptoms Quality of Life Questionnaire The questionnaire consists of 4 subscales and a single item on urinary symptom interference. The four subscales of Concern (7 items), Coping (8 items), Sleep (5 items), and Social (5 items) are measured on a scale from 0-100 using a range percentile transformation on the summed value from individual listed items. The Health-Related Quality of Life (HRQL) score is a calculated score with a range from 0 to 100 using a range percentile transformation on the summed value from the subscales. Subjects were asked a urinary symptom interference question. "Interference" was measured on a scale from 0-10. A positive change in Concern, Coping, Sleep, Social, and HRQL indicates improvement in Quality of Life; a negative change in Interference indicates improvement in Quality of Life.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Complete Case Subject Set

Arm/Group Title	Amplitude Setting #1 = 50% Sensory Threshold	Amplitude Setting #2 = 80% Sensory Threshold	Amplitude Setting #3 = Sensory Threshold
Arm/Group Description	InterStim Therapy will be set to amplitude parameter #1 (50% Sensory Threshold) InterStim Therapy: Device Programming	InterStim Therapy will be set to amplitude parameter #2 (80% Sensory Threshold) InterStim Therapy: Device Programming	InterStim Therapy will be set to amplitude parameter #3 (Sensory Threshold) InterStim Therapy: Device Programming
Measure Participants	17	13	13
Change in Coping from baseline to 12 weeks	44.4 (30.4)	41.0 (26.3)	39.4 (27.9)
Change in Concern from baseline to 12 weeks	48.2 (28.9)	50.3 (17)	49.9 (30.2)
Change in Sleep from baseline to 12 weeks	31.4 (26.6)	37.8 (22.7)	32.0 (31.6)
Change in Social from baseline to 12 weeks	20.9 (25.0)	28.6 (17)	20.6 (19.9)
Change in HRQL from baseline to 12 weeks	38.1 (24.4)	40.5 (16.7)	37.1 (23.4)
Change in Interference from baseline to 12 weeks	-5.2 (3.3)	-4.7 (3.0)	-4.7 (3.5)

Adverse Events

Time Frame	From Post-Neurostimulator device implant to 12 weeks follow-up visit
Adverse Event Reporting Description	Serious, device related, procedure related, and/or therapy related adverse events are considered reportable for this study
Arm/Group Title	Amplitude Setting #1 = 50% Sensory Threshold		Amplitude Setting #2 = 80% Sensory Threshold		Amplitude Setting #3 = Sensory Threshold
Arm/Group Description	InterStim Therapy will be set to amplitude parameter #1 (50% Sensory Threshold) InterStim Therapy: Device Programming		InterStim Therapy will be set to amplitude parameter #2 (80% Sensory Threshold) InterStim Therapy: Device Programming		InterStim Therapy will be set to amplitude parameter #3 (Sensory Threshold) InterStim Therapy: Device Programming
All Cause Mortality
	Amplitude Setting #1 = 50% Sensory Threshold		Amplitude Setting #2 = 80% Sensory Threshold		Amplitude Setting #3 = Sensory Threshold
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/14 (0%)		0/15 (0%)
Serious Adverse Events
	Amplitude Setting #1 = 50% Sensory Threshold		Amplitude Setting #2 = 80% Sensory Threshold		Amplitude Setting #3 = Sensory Threshold
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/19 (15.8%)		1/14 (7.1%)		3/15 (20%)
Gastrointestinal disorders
Gastric ulcer haemorrhage	0/19 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1
Umbilical hernia	1/19 (5.3%)	1	0/14 (0%)	0	0/15 (0%)	0
Infections and infestations
Sepsis	1/19 (5.3%)	1	0/14 (0%)	0	0/15 (0%)	0
Musculoskeletal and connective tissue disorders
Pain in extremity	0/19 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1
Nervous system disorders
Cerebrovascular accident	0/19 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0
Migraine	0/19 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1
Psychiatric disorders
Suicide attempt	1/19 (5.3%)	1	0/14 (0%)	0	0/15 (0%)	0
Respiratory, thoracic and mediastinal disorders
Dyspnoea	0/19 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1
Other (Not Including Serious) Adverse Events
	Amplitude Setting #1 = 50% Sensory Threshold		Amplitude Setting #2 = 80% Sensory Threshold		Amplitude Setting #3 = Sensory Threshold
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/19 (15.8%)		1/14 (7.1%)		3/15 (20%)
General disorders
Medical device site pain	0/19 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0
Pain	0/19 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1
Nervous system disorders
Paraesthesia	1/19 (5.3%)	1	0/14 (0%)	0	2/15 (13.3%)	2
Skin and subcutaneous tissue disorders
Pruritus	1/19 (5.3%)	1	0/14 (0%)	0	0/15 (0%)	0
Dermatitis contact	1/19 (5.3%)	1	0/14 (0%)	0	1/15 (6.7%)	1

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.