Home Stress-Incontinence Stimulator (pivot P2, two-channel trigger) — desirability

The chair: the user. She is a cognitively intact adult woman with stress urinary incontinence whose documented four-week pelvic muscle exercise trial has failed. Under P2 the discriminating trigger she would insert a stimulating probe and place an abdominal skin electrode on herself before every session, for a twelve-week course, on a device she rents month by month. This chair also covers the people she cannot get around: the prescriber who chooses between this device and a cleared single-channel triggered one, the DME (durable medical equipment) supplier who dispenses it, and the plan that pays.

How to read this: every slide is a condition, not a conclusion. A bracketed claim reference points into knowledge-base/candidates/idea-001.md. The number is the claim's position in that file's ## Claims list. The tag beside it is copied from that line exactly as it stands today, never softened and never upgraded. A bracketed "no claim" marker means nothing in the file speaks to the condition; after today's write-back, no condition on this deck needs one. See docs/deck-spec.md.

Rebuilt 2026-10-01 from the candidate file after pivot P2 the discriminating trigger. The earlier 2026-10-01 build, written for P1 commercially-insured first's mechanism, is retired, not amended. What changed underneath it:

• The candidate's mechanism: now reads: stimulation "triggered by a two-channel detector - pelvic floor surface EMG (electromyography) from the probe plus an abdominal-muscle surface-EMG reference from a skin electrode the woman places herself each session - so that each stimulation burst fires on a voluntary pelvic floor contraction and is withheld when the detector sees a Valsalva manoeuvre or abdominal brace before the burst". This deck describes the trigger at that level and no further.
• The premise the old shape stood on is refuted: a prescription EMG-triggered intravaginal stimulator for incontinence is listed and offered for US sale claim 167refuted. From this chair the question is no longer whether a prescriber wants a triggered device. It is whether a prescriber and a patient want this trigger, with its extra electrode, over the one already sold.
• Claims 168 to 172, which the retired build carried as unverified, have all been through a Verifier and now read unconfirmed. This deck put three new conditions on record today as claims 210, 211 and 212.

Slide 1 — The user, and the moment

Would have to be true: Each year a material number of US women would have to reach the moment this label describes: a cognitively intact adult with stress-predominant incontinence, a documented four-week exercise trial behind her that failed, and still in care. Among those women, enough would still have to strain or brace when asked to contract that a trigger which withholds on a strain behaves differently, for them, from a single-channel trigger.

Where it stands: The moment is real as a coverage construct. The population inside it, and P2 the discriminating trigger's segment within that population, are not measured.

• The label's precondition mirrors Medicare's coverage criterion word for word claim 9verified.
• Medicare fee-for-service furnished E0740 (a HCPCS code for durable medical equipment) to 689 beneficiaries in 2024 claim 70verified. That is a floor on one payer's population, not a count of women at this moment.
• Weighted urinary incontinence prevalence among US women is 22.3%, with stress-predominant incontinence 16.2% of cases claim 44unconfirmed.
• Whether women who fail the four-week trial stay in care or drop out is not known claim 26unconfirmed. The four-week trial is also shorter than the first-line supervised training trial a UK guideline recommends claim 93unconfirmed.
• P2 the discriminating trigger's segment. On first or brief instruction, 25% of 47 women performed a Kegel effort that could promote incontinence, and 30% of incontinent women depressed the bladder neck against 17% of continent women claim 175unconfirmed. No study reports that proportion after a failed four-week exercise trial, which is this label's population claim 176unconfirmed.

What would settle it: A clinical measurement of how many women still strain or depress the bladder neck on an attempted contraction at the point a four-week exercise trial is documented as failed. Perineal ultrasound or two-channel surface EMG would both do. No connector reaches it. A pelvic floor PT (physical therapist) practice could produce it by chart review or a short prospective series.

If it's false: If most women at this moment contract correctly, the reference channel rarely withholds anything. P2 the discriminating trigger's difference shrinks to an extra electrode with no benefit the user can feel, and Slides 2 to 5 describe a cost with nothing on the other side of it. On viability, the differentiation slide (Slide 6 there) loses its population.

Slide 2 — What she'd have to do differently

Would have to be true: Before every session for at least twelve weeks, she would have to place an abdominal skin electrode on herself, insert the probe, start the app and run the session. She would have to finish the course at a rate no lower than a woman given a cleared single-channel triggered device that needs no skin electrode.

Where it stands: Unmeasured for this device, and the analog record is not encouraging.

• Whether women use a home intravaginal stimulator at the prescribed frequency for twelve weeks claim 27unconfirmed, and whether they find the intravaginal route acceptable at all when an external alternative exists claim 28unconfirmed.
• Analogs, none of them this device: 5 of 33 withdrew from a twelve-week InTone pilot claim 42unconfirmed; 29.8% of the treatment arm and 40.0% of the sham arm did not complete the ELITONE stress trial claim 41unconfirmed; long-term adherence to exercise training ranges from 10% to 70% claim 39unconfirmed.
• The P2 the discriminating trigger increment: whether the per-session skin electrode lowers completion relative to a single-channel triggered device claim 210unverified.
• Whether she can place the electrode without a critical use error is the feasibility deck's condition (Slide 6 there) claim 172unconfirmed.

What would settle it: A formative human-factors study with a works-like prototype, in which a handful of women set up the probe and the electrode unaided, then say whether they would keep doing it daily. The completion comparison itself needs a pilot with a single-channel comparator, which is a Tier 3 decision. No connector reaches either.

If it's false: Low completion is an executional risk under Factor 6. It also shortens the rental months each woman generates, which the viability deck's revenue unit depends on (Slide 3 there), and it makes the 16-of-30-days data capture an adherence problem rather than an engineering one claim 108unconfirmed.

Slide 3 — Who else has to say yes

Would have to be true: A urogynecologist or pelvic floor PT who has already decided on a home EMG-triggered stimulator would have to choose this one, with its self-placed abdominal electrode, over a cleared single-channel triggered device. The same prescriber would have to teach her to place the electrode before she goes home, and would have to document the failed four-week trial. A DME supplier would then have to stock it, and a plan would have to pay.

Where it stands: Every link in the chain is a stakeholder choice nobody has asked about.

• The alternative is real and sold. The NeuroTrac MyoPlus Pro is cleared with an EMG-triggered mode for stress, urge or mixed incontinence through a vaginal probe, for prescription and home use claim 153verified. The premise that no such device is sold in the US is refuted claim 167refuted.
• Whether a prescriber chooses the two-channel trigger over it, despite the extra electrode claim 174unconfirmed. Whether a prescriber prefers a triggered device to a stimulation-only one at all claim 168unconfirmed.
• Whether she will teach electrode placement rather than decline a device that needs it claim 212unverified.
• Whether she will produce the documented failed trial claim 29unconfirmed, and send the woman home with a device rather than keep her in clinic claim 24unconfirmed, without losing revenue per episode claim 68unconfirmed.
• The supplier's stocking decision against the incumbent sits on the viability deck (Slide 6 there). Payer coverage sits on its Slides 1 and 2.

What would settle it: Twenty structured calls with urogynecologists and pelvic floor PTs. The calls would ask what they prescribe at week five for a woman who still strains, whether they would choose a device that withholds on a strain over the MyoPlus Pro, and whether they would teach electrode placement. This is a human act; no agent here can make the calls.

If it's false: If prescribers default to the cleared single-channel device, P2 the discriminating trigger's one difference has no buyer at the point of prescription. This is the load-bearing condition (Slide 8), and it takes the viability deck's differentiation slide with it.

Slide 4 — What it costs her

Would have to be true: She would have to tolerate four costs well enough to take delivery and finish the course. The first is a monthly cost share on a rental. The second is an adhesive electrode on her abdomen every session, with the skin reaction that can bring. The third is a device that sometimes declines to fire when she believes she contracted correctly. The fourth is a controller that another patient may have rented before her.

Where it stands:

• Money. Payment is a monthly rental, not a sale claim 82verified. Whether her out-of-pocket cost is low enough that she takes delivery claim 59unconfirmed, whether she keeps paying a monthly share for the whole course claim 80unconfirmed, and whether she waits out a case-by-case coverage decision claim 79unconfirmed are all unmeasured. In one US study, 33% of privately insured women referred to pelvic floor PT did not participate, and insurance noncoverage was a risk factor claim 143unconfirmed.
• Skin. The most frequent injury narrative in recent MAUDE (Manufacturer and User Facility Device Experience) reports for cutaneous electrodes applied at home is irritation, rash, blistering or burn under the adhesive. MAUDE has no denominator, so this is a category, not a rate claim 186unconfirmed. Whether burning at the stimulating electrode ends courses is also open claim 169unconfirmed.
• A withheld burst. Abdominal EMG rises during a correct pelvic floor contraction too claim 177unconfirmed, so the device could withhold on an effort she made correctly. Women who co-activate the abdomen would receive fewer stimulated contractions per session than under a single-channel trigger claim 179unconfirmed. Whether she reads a withheld burst as feedback on her technique or as a fault is untested claim 211unverified.
• A used controller. Whether she accepts a reprocessed controller with a new probe claim 138unconfirmed.

What would settle it: Exit questions in the same formative study as Slide 2, with the withhold behaviour shown to her. For the cost share, a human pull of plan benefit designs for DME rental coinsurance. No connector reaches plan benefit design.

If it's false: She abandons at the supplier or returns the device early. Each outcome removes rental months (viability Slide 3) and the treatment effect (Factor 6). If the withheld bursts read as a fault, the very feature P2 the discriminating trigger adds becomes the reason she stops.

Slide 5 — What would make them believe it

Would have to be true: A prescriber would need evidence that withholding stimulation on a strain matters. At a minimum, that the detector tells the two manoeuvres apart in women like hers. At best, that it changes a continence outcome compared with a single-channel trigger. The woman would need to see fewer leaks early enough to keep going.

Where it stands: Neither kind of evidence exists, and the evidence that does exist is about something else.

• No study compares a two-channel trigger with a single-channel trigger on any continence outcome claim 178unconfirmed. No study compares triggered with open-loop intravaginal stimulation either claim 91unconfirmed.
• The one randomised trial of sEMG-triggered intravaginal stimulation found fewer leakage episodes at twelve months than sham, with both arms also doing supervised training claim 142unconfirmed. It enrolled postpartum women aged 18 to 50 with very weak muscles claim 144unconfirmed, its comparator was a sub-therapeutic sham claim 145unconfirmed, and its registry record and publication disagree claim 146unconfirmed.
• A Cochrane review finds low-quality evidence of no difference between electrical stimulation and exercise training claim 43unconfirmed. The AUA (American Urological Association)/SUFU guideline's non-surgical statement names no electrical stimulation option, and that reading is recorded as overstated claim 94unconfirmed.
• Telling a prescriber that the device withholds on the wrong manoeuvre would be a performance claim, and against a named device a comparative one, needing test data in women claim 189unconfirmed.
• For her: whether she trusts her own leak count over the transmitted EMG trend claim 125unconfirmed, whether she sees a reduction within four weeks claim 61unconfirmed, and no trial of a home stimulator reports its primary endpoint that early claim 98unconfirmed. The between-day reliability of vaginal EMG is reported as poor claim 92unconfirmed.

What would settle it: Discrimination data first. A sensing-only study on a cleared device with detectors applied offline is on file as the cheapest route claim 166unconfirmed. An outcome comparison against a single-channel trigger is a clinical study, and committing to one is a human decision.

If it's false: Without discrimination data the prescriber has no reason to pay the extra electrode's cost in her patient's time, and Slide 3 fails. Without an early visible result the woman has no reason to keep going, and Slide 2 fails.

Slide 6 — The cheapest way to find out

Would have to be true: In twenty structured prescriber calls, a material share would have to say they would choose a trigger that withholds on a strain over the MyoPlus Pro and would teach electrode placement. In a formative session, a handful of women would have to place the electrode unaided, understand a withheld burst, and say they would continue. The falsifying observation would be prescribers saying the single-channel device is good enough, or that a PT already corrects technique in clinic, or women setting the electrode aside after the first session.

Where it stands: Nothing here has been observed. The prescriber choice claim 174unconfirmed and the teaching step claim 212unverified are unasked. Self-placement is unbuilt claim 172unconfirmed. Completion claim 210unverified and the reading of a withheld burst claim 211unverified are untested. Whether a practice would let a manufacturer observe its patients' uptake at all is open claim 126unconfirmed.

What would settle it: The calls, which are a human act and need no prototype. The formative session needs a works-like prototype with women as participants. Running it is a human decision and is not taken here.

If it's false: Each falsifier lands on a different slide. Prescribers content with the incumbent fail Slide 3. Women who will not place the electrode fail Slide 2. Women who read withholding as failure fail Slide 4.

Slide 7 — Where this deck outruns the file

Every condition above has nothing verified behind it. Four verified claims appear on this deck (9, 70, 82, 153), and each describes the setting: the coverage construct, a Medicare floor, the payment shape, and the incumbent. None of them says a woman or a prescriber wants this device. That is expected for this lens: the rubric scores no factor for whether a user wants the thing.

• The P2 the discriminating trigger segment exists at the label's moment. Women who still strain after a failed four-week trial. Rests on claim 175unconfirmed (measured before any training) and claim 176unconfirmed (never measured after it). Settled by a clinical measurement or chart review at a pelvic floor PT practice.
• She completes twelve weeks with a per-session skin electrode. Rests on claim 210unverified, put on record by this deck today, with claim 27unconfirmed behind it. Settled by a formative study, then a pilot.
• She can place the electrode herself. Rests on claim 172unconfirmed. Feasibility owns it.
• A prescriber chooses this trigger over the cleared single-channel one. Rests on claim 174unconfirmed. Settled by twenty structured calls.
• The prescriber teaches electrode placement. Rests on claim 212unverified, put on record by this deck today. Settled by the same calls.
• She reads a withheld burst as feedback, not a fault. Rests on claim 211unverified, put on record by this deck today. Settled in the formative study.
• The cost share, the skin and the used controller are tolerable. Rests on claim 59unconfirmed, claim 80unconfirmed, claim 186unconfirmed and claim 138unconfirmed. Settled by exit interviews and a plan benefit-design pull.
• Someone believes it works. Rests on claim 178unconfirmed and claim 189unconfirmed for the prescriber, claim 61unconfirmed for her. Settled by a discrimination study first, then an outcome comparison.

The honest measure here is not the length of a "no claim" list, which is empty. It is that every condition on this deck rests on unconfirmed or unverified lines, and most of the unconfirmed ones are stakeholder behaviour that no connector can ever check.

Slide 8 — The load-bearing condition

If only one thing from this chair could be checked: whether a urogynecologist or pelvic floor PT who has already decided on a home EMG-triggered stimulator would choose one whose trigger uses an abdominal electrode the woman places herself each session, to withhold stimulation on a Valsalva or brace, over a cleared single-channel triggered device such as the NeuroTrac MyoPlus Pro, despite the extra electrode claim 174unconfirmed.

Why this one: the closed loop is already sold claim 167refuted, so P2 the discriminating trigger exists only because of one difference. The prescriber is the first person who has to value it, and the only one whose choice decides whether the woman ever meets it. If the answer is no, the woman's burden (Slides 2 and 4) never arises and the money question on the viability deck has no product reason behind it. The check is also cheap: it is a set of calls, and needs no prototype.

Naming it is not a recommendation, a gate, or a kill. It is the answer to "check what first."