An interventional study of InterStim Therapy in Urinary Urge Incontinence, sponsored by MedtronicNeuro. Completed at 18 sites in 7 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-08.
Sponsored by MedtronicNeuro (part of Medtronic) · Not applicable, Interventional, and Basic science
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Among 135 studies in Urinary Incontinence, Urge with a site in United States — 19 open to participants now, 27 under way, none of them phase 3. Urinary Incontinence, Urge · United States.
Among the 135 studies in Urinary Incontinence, Urge with a site in United States, this one is the 51st largest by enrollment of the 119 interventional ones that give a count, is one of 15 that started in 2018, is one of 72 with no phase, and was the 60th registered.
242 studies on the registry are indexed under Urinary Incontinence, Urge; 38 are open to participants now.
Browse Urinary Incontinence, Urge studies →19 of the 135 studies in Urinary Incontinence, Urge with a site in United States are open now. Recruiting first, the newest first:
Loma Linda University · Sites in United States
Ages 18–89
Axonics, Inc. · Sites in United States, Australia
Ages 18+
Neuspera Medical, Inc. · Sites in United States
Ages 22+
MedtronicNeuro · Sites in United States
Ages 18+
InMode MD Ltd. · Sites in United States
Ages 22–80 · Women only
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 25 Urinary Incontinence, Urge studies recruiting now, 18 (72%) set no upper age limit and 2 (8%) stop at 75 or younger; 1 takes children under 18; 2 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
135 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 10 · Phase 3 14 · Phase 4 19
First in 2003; this study’s year is marked. 15 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 97 is above the median of 86 across 190 interventional studies indexed under Urinary Incontinence, Urge.
Median enrollment 75 across the 119 interventional studies, 47 across the 15 observational. Of the 96 that completed or were terminated, 51 (53%) have results posted.
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53 of 135 have an industry lead sponsor. The 10 most frequent:
This study is registered under MedtronicNeuro, one of the names counted as Medtronic. Under that name alone:
MedtronicNeuro is the lead sponsor of 74 studies on the registry; 2 are open to participants now.
Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.
Medtronic has 7 studies filed under Urinary Incontinence, Urge — fewer than ten, so there is no comparison to draw.
11 of the studies in Urinary Incontinence, Urge with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06797245Medstar Health Research InstituteAPPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women | 2026-11 |
| NCT07387315TriHealth Inc.A Randomized, Placebo-controlled Trial of Nitrous Oxide During In-office Bladder Botox Injections | 2026-11 |
| NCT07335484Axonics, Inc.Aquarius Pilot Study to Evaluate the New Axonics Trial System | 2026-11 |
| NCT07247136Neuspera Medical, Inc.Study of 30-Minute Stimulation With the Neuspera Sacral Neuromodulation (SNM) System | 2026-11 |
| NCT06186765Axonics, Inc.F15 Recharge Free Axonics SNM System Clinical Study | 2026-12 |
Add all 11 to your calendar (.ics) → With an account.
Among the 135 studies in Urinary Incontinence, Urge with a site in United States, from their registry updates:
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This feasibility study will explore the effects of three different InterStim amplitude settings on overactive bladder symptoms (OAB).
This is a prospective, randomized, multicenter, single-blinded study to explore the efficacy and quality of life (QoL) of 3 different amplitude settings.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
InterStim Therapy will be set to amplitude parameter #1.
Device: InterStim Therapy
InterStim Therapy will be set to amplitude parameter #2.
Device: InterStim Therapy
InterStim Therapy will be set to amplitude parameter #3.
Device: InterStim Therapy
Device Programming
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
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.
| Milestone | Amplitude Setting #1 = 50% Sensory Threshold | Amplitude Setting #2 = 80% Sensory Threshold | Amplitude Setting #3 = Sensory Threshold |
|---|---|---|---|
| Started | 19 | 14 | 15 |
| Implanted with a neurostimulator device | 18 | 14 | 14 |
| Completed | 17 | 13 | 13 |
| Not completed | 2 | 1 | 2 |
Symptoms related to OAB were evaluated using paper voiding diaries. Subjects were trained to complete the urinary voiding diaries for 3-days.
| UUI episodes/day | Amplitude Setting #1 = 50% Sensory Threshold | Amplitude Setting #2 = 80% Sensory Threshold | Amplitude Setting #3 = Sensory Threshold |
|---|---|---|---|
| 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 |
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.
| units on a scale | Amplitude Setting #1 = 50% Sensory Threshold | Amplitude Setting #2 = 80% Sensory Threshold | Amplitude Setting #3 = Sensory Threshold |
|---|---|---|---|
| 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 |
Collected over From Post-Neurostimulator device implant to 12 weeks follow-up visit. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Amplitude Setting #1 = 50% Sensory Threshold | 0/19 (0%) | 3/19 (15.8%) | 3/19 (15.8%) |
| Amplitude Setting #2 = 80% Sensory Threshold | 0/14 (0%) | 1/14 (7.1%) | 1/14 (7.1%) |
| Amplitude Setting #3 = Sensory Threshold | 0/15 (0%) | 3/15 (20%) | 3/15 (20%) |
| Event | Amplitude Setting #1 = 50% Sensory Threshold | Amplitude Setting #2 = 80% Sensory Threshold | Amplitude Setting #3 = Sensory Threshold |
|---|---|---|---|
| Cerebrovascular accidentNervous system disorders | 0/19 | 1/14 | 0/15 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 0/19 | 0/14 | 1/15 |
| MigraineNervous system disorders | 0/19 | 0/14 | 1/15 |
| Gastric ulcer haemorrhageGastrointestinal disorders | 0/19 | 0/14 | 1/15 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 0/19 | 0/14 | 1/15 |
| SepsisInfections and infestations | 1/19 | 0/14 | 0/15 |
| Suicide attemptPsychiatric disorders | 1/19 | 0/14 | 0/15 |
| Umbilical herniaGastrointestinal disorders | 1/19 | 0/14 | 0/15 |
| Event | Amplitude Setting #1 = 50% Sensory Threshold | Amplitude Setting #2 = 80% Sensory Threshold | Amplitude Setting #3 = Sensory Threshold |
|---|---|---|---|
| ParaesthesiaNervous system disorders | 1/19 | 0/14 | 2/15 |
| Medical device site painGeneral disorders | 0/19 | 1/14 | 0/15 |
| Dermatitis contactSkin and subcutaneous tissue disorders | 1/19 | 0/14 | 1/15 |
| PainGeneral disorders | 0/19 | 0/14 | 1/15 |
| PruritusSkin and subcutaneous tissue disorders | 1/19 | 0/14 | 0/15 |
This summarizes demographics for subjects in the Randomized Subject Set.
| Age, Continuous(years) | Amplitude Setting #1 = 50% Sensory Threshold | Amplitude Setting #2 = 80% Sensory Threshold | Amplitude Setting #3 = Sensory Threshold | Total |
|---|---|---|---|---|
| Mean | 64.1 ± 16 | 57.9 ± 16.1 | 56.7 ± 14.9 | 60 ± 15.7 |
| Sex: Female, Male(Participants) | Amplitude Setting #1 = 50% Sensory Threshold | Amplitude Setting #2 = 80% Sensory Threshold | Amplitude Setting #3 = Sensory Threshold | Total |
|---|---|---|---|---|
| Female | 19 | 14 | 15 | 48 |
| Male | 0 | 0 | 0 | 0 |
| Race and Ethnicity Not Collected(Participants) | Amplitude Setting #1 = 50% Sensory Threshold | Amplitude Setting #2 = 80% Sensory Threshold | Amplitude Setting #3 = Sensory Threshold | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
| BMI(kg/m^2) | Amplitude Setting #1 = 50% Sensory Threshold | Amplitude Setting #2 = 80% Sensory Threshold | Amplitude Setting #3 = Sensory Threshold | Total |
|---|---|---|---|---|
| Mean | 30.0 ± 5.7 | 36.3 ± 11.2 | 33.1 ± 6.4 | 32.8 ± 8.1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Feb 2018 to primary completion in Nov 2019, 20 months.
Results were first posted in Jan 2021, 1 year 2 months after primary completion.
Of 77 interventional studies with no phase under Urinary Incontinence, Urge, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 20 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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