Urinary Urge IncontinenceNCT03335761
InterStim® Amplitude Study
A study testing InterStim Therapy in people with Urinary Urge Incontinence, run by MedtronicNeuro at 18 sites in 7 countries.
Trial summary
This feasibility study will explore the effects of three different InterStim amplitude settings on overactive bladder symptoms (OAB). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Urge Incontinence
- What is being tested?
- InterStim Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 18 sitesin 7 countries
- Study dates
- 27 Feb 2018to 6 Nov 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary diagnosis of urinary urge incontinence (UUI) as demonstrated on a 3-day baseline voiding diary demonstrating at least 3 UUI episodes
- Female subjects 18 years of age or older
- Candidate for InterStim Lead Placement
- 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)
- Willing and able to provide signed and dated informed consent
- Willing to maintain current regimen (dosage and frequency) of any overactive bladder (OAB) medication
Who cannot join
- Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury
- History of diabetes unless the diabetes is well-controlled through diet and/or medications
- Symptomatic urinary tract infection (UTI)
- Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component
- Treatment of urinary symptoms with botulinum toxin in the past 9 months or any plan to have botulinum toxin treatment during the study
- Implanted with a neurostimulator, pacemaker, or defibrillator
Show all 10Show fewer
- 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
- Women who are pregnant or planning to become pregnant
- Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.
- 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).
Trial locations and contacts
18 sites in 7 countries.
18 sites in 7 countries
United States12 sites
Chattanooga Hamilton County Hospital Authority d/b/a Erlanger Health System
Chattanooga, Tennessee, 37421
Carolina Urology Partners
Concord, North Carolina, 28025
Urologic Research & Consulting
Englewood, New Jersey, 07631
Minnesota Urology Fridley
Fridley, Minnesota, 55432
East Coast Institute for Research
Jacksonville, Florida, 32216
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-2765
Adult Pediatric Urology and Urogynecology
Omaha, Nebraska, 68114
Academic Urology & Urogynecology of Arizona
Phoenix, Arizona, 85027
Pinellas Urology
St. Petersburg, Florida, 33710
Florida Urology Partners
Tampa, Florida, 33606
Aurora Research Institute - Aurora West Allis Women's Pavilion
West Allis, Wisconsin, 53227
Minnesota Urology Woodbury
Woodbury, Minnesota, 55125
Belgium1 site
UZ Leuven - Campus Gasthuisberg - Department Urology
Leuven, 3000
Canada1 site
University Urology Associates, Toronto Western Hospital
Toronto, Ontario, M5T 2S8
United Kingdom1 site
University College London Hospitals NHS Foundation Trust - University College Hospital
London, W1G 8PH
About this study
This feasibility study will explore the effects of three different InterStim amplitude settings on overactive bladder symptoms (OAB).
Read the 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.
- Conditions
- Urinary Urge Incontinence
- Being tested
- InterStim Therapy
- Keywords
- Urinary, Incontinence
- Medical subject headings
- Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterStim TherapyDevice
Device Programming
| Study group | Role | What they receive |
|---|---|---|
| Amplitude Setting #1 | Experimental | InterStim Therapy will be set to amplitude parameter #1. Receives: Device: InterStim Therapy |
| Amplitude Setting #2 | Experimental | InterStim Therapy will be set to amplitude parameter #2. Receives: Device: InterStim Therapy |
| Amplitude Setting #3 | Experimental | InterStim Therapy will be set to amplitude parameter #3. Receives: Device: InterStim Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Urinary Urge Incontinence (UUI) Episodes Per Day From Baseline to 12 Weeks.
Symptoms related to OAB were evaluated using paper voiding diaries. Subjects were trained to complete the urinary voiding diaries for 3-days.
Measured: 12 weeks
Secondary outcomes (1)
Change in QoL Using ICIQ-OAB QOL From Baseline to 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start27 Feb 2018
- Primary completion6 Nov 2019
- Study completion6 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Urinary Urge IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedtronicNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03335761
- Sponsor's protocol ID
- MDT17030
- Status last verified
- Dec 2020
- First submitted
- 23 Oct 2017
- Last updated
- 8 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- InterStim® Amplitude Study
- ClinicalTrials.gov ID
- NCT03335761
- Acronym / sponsor ID
- MDT17030
- Conditions
- Urinary Urge Incontinence
- Keywords
- Urinary, Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- MedtronicNeuroIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2018 (actual)
- Primary completion
- 6 Nov 2019 (actual)
- Study completion
- 6 Nov 2019 (actual)
- First posted
- 8 Nov 2017 (actual)
- Results
- Posted 8 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This feasibility study will explore the effects of three different InterStim amplitude settings on overactive bladder symptoms (OAB).
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Amplitude Setting #1 | Experimental | Device: InterStim TherapyInterStim Therapy will be set to amplitude parameter #1. |
| Amplitude Setting #2 | Experimental | Device: InterStim TherapyInterStim Therapy will be set to amplitude parameter #2. |
| Amplitude Setting #3 | Experimental | Device: InterStim TherapyInterStim Therapy will be set to amplitude parameter #3. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Primary diagnosis of urinary urge incontinence (UUI) as demonstrated on a 3-day baseline voiding diary demonstrating at least 3 UUI episodes
- Female subjects 18 years of age or older
- Candidate for InterStim Lead Placement
- 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)
- Willing and able to provide signed and dated informed consent
Key exclusion criteria (10 listed)
- Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury
- History of diabetes unless the diabetes is well-controlled through diet and/or medications
- Symptomatic urinary tract infection (UTI)
- Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component
- Treatment of urinary symptoms with botulinum toxin in the past 9 months or any plan to have botulinum toxin treatment during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterStim TherapyDevice Programming | Device | Amplitude Setting #1, Amplitude Setting #2, Amplitude Setting #3 |
Primary outcome
Change in Urinary Urge Incontinence (UUI) Episodes Per Day From Baseline to 12 Weeks.
Time frame: 12 weeks
Symptoms related to OAB were evaluated using paper voiding diaries. Subjects were trained to complete the urinary voiding diaries for 3-days.
1 secondary outcome
Change in QoL Using ICIQ-OAB QOL From Baseline to 12 Weeks.
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing InterStim Therapy in people with Urinary Urge Incontinence, run by MedtronicNeuro at 18 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Belgium, Canada, France, Italy and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Urinary Urge Incontinence (UUI) Episodes Per Day From Baseline to 12 Weeks. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2021.