Research report
A research report is the sourced material a domain
dossier is synthesized from — generated on a plan and a cadence, one topic per file.
A report carries no confidence tags. Its bracketed markers say who might have
an incentive to shade a line; none of them says anyone checked it. To reach a score, a line has
to be drafted onto a candidate as unverified and pass the Verifier or the
Corroborator, like everything else.
Section care-pathway · Version 2026-09-01 · Cadence annual · Evidence class mixed · Sources 7 · Supersedes none
Domain: stress-urinary-incontinence · Scope: public primary sources reachable by this repo's connectors, WebSearch and WebFetch. Excludes CPT descriptors (AMA-licensed, so PT/biofeedback visit billing codes are named but not reproduced), fda.gov guidance documents, and CMS billing/coverage material, which belongs to this domain's reimbursement section rather than care pathway.
Sourcing: one AUA/SUFU guideline document, four US and one UK peer-reviewed observational/trial-design study, and one federal regulation section; the finding that US primary care under-refers pelvic-floor conditions rests on two independent, non-affiliated sources, and the one visit-cadence figure located is from a UK trial, not generalized to US practice.
This domain's dossier flags care pathway as its least-populated section — "not searched," in full. This report is the first pass at it. Two independent, non-affiliated US sources agree that primary care under-refers women with pelvic-floor conditions, including SUI, to specialists or pelvic floor physical therapy, even though the guideline's own first-visit workup is deliberately low-tech — a focused history and pelvic exam, an objective demonstration of leakage, a post-void residual, and a urinalysis, with cystoscopy and urodynamics reserved for non-routine cases [1]. A single-city US study finds that where pelvic floor physical therapy does exist, it clusters in higher-income areas [4]. The one primary source located that states a concrete supervised-PFMT visit cadence is a UK trial, not a US one, and is carried here flagged as such rather than folded into a US figure [5]. Long-term PFMT outcome data show a wide range of eventual surgical escalation, which is the pathway's other end [6]. None of this establishes where a home NMES device's prescription actually originates in practice — that remains unanswered below.
_Baseline (v1). No prior version; this establishes the starting point for future diffs._
The AUA/SUFU Stress Urinary Incontinence Guideline defines the "index patient" evaluation as an office-level workup: a "focused history, including assessment of bother," a "focused physical examination, including a pelvic examination," "objective demonstration of SUI with a comfortably full bladder (any method)," "assessment of post-void residual urine (any method)," and "urinalysis" (Statement 1). The same guideline states cystoscopy should not be performed routinely in index patients absent suspected urinary tract abnormality (Statement 4), and that urodynamic testing "may be omitted" when SUI is "clearly demonstrated" (Statement 5, Grade B), with further urodynamic testing reserved for clinician discretion in non-index patients (Statement 6). Bother, rather than a test result, is named as the variable that should drive whether a patient proceeds to conservative treatment at all (Statement 7) [1] [single-source]. Read together, the equipment this pathway's first visit actually requires is an exam room and a bladder-full demonstration — not imaging, endoscopy, or urodynamic hardware, for the majority of patients.
In a cohort of 4,382 women newly diagnosed with urinary incontinence during outpatient primary care visits at a large Midwestern US academic health system, 2016–2020, only 37.2% received guideline-concordant medication or referral within one year; 20.6% were referred for further management, split 17.7% to urology/urogynecology and 3.2% to pelvic floor physical therapy [2] [single-source]. Women with stress or mixed UI were more likely to be referred than those with urgency-only UI (adjusted OR 3.10 and 6.17 respectively), and referral likelihood fell during the COVID-19 pandemic period studied (adjusted OR 0.39) [2] [single-source]. A separate US survey of 153 primary care providers found more of them comfortable managing SUI and overactive bladder in-office than pelvic organ prolapse or fecal incontinence, and reported that discomfort with management and difficulty with referral each varied by condition and by provider experience and practice setting, rather than by a single common cause [3] [single-source]. Taken together, these two independent, non-affiliated US sources agree on the same shape of finding — primary care refers only a minority of women with pelvic-floor conditions, including SUI, onward for specialist or physical-therapy care — even though the specific referral percentages are each single-source.
A geographic-access study identified 19 pelvic floor physical therapy sites in Philadelphia, Pennsylvania, contacted each by telephone, and modeled census-tract distance to the nearest site against median income. Distance to the nearest site fell as income rose: the lowest income quartile's census tracts sat a median 2.1 miles from the nearest site versus 1.0 miles for the highest quartile (p < 0.001), and most sites reported treating urogynecologic or postpartum conditions rather than anorectal disease [4] [single-source]. This is a single-city finding, stated by its own authors to have limited generalizability, and no comparable US multi-city figure was found.
No US-based primary source located this pass states a session count or duration for a supervised PFMT program; several literature queries for that specific figure returned no PubMed records (see §5). The one primary source that states a concrete cadence is the OPAL RCT, a UK multicentre trial of 600 women (300 randomized per arm) with new stress or mixed UI, run in "UK community and outpatient care settings": "Both groups were offered six appointments over 16 weeks to receive biofeedback pelvic floor muscle training or basic pelvic floor muscle training. Home biofeedback units were provided to the biofeedback pelvic floor muscle training group" [5] [single-source]. This is carried here as a description of one trial's protocol design, not as a US care-pathway figure — the population, health system, and funder are all UK (NIHR Health Technology Assessment programme), and nothing in this pass extends it to US practice.
The same long-term PFMT systematic review already cited in this domain's dossier for adherence figures also reports the eventual surgical-escalation rate across its 19 included studies (1,141 women, 1–15 years' follow-up): "Surgery rates at long term varied between 4.9% and 58%" [6] [single-source]. The review does not attribute that range to a single cause, and no source located this pass breaks it down by referral source, prior device use, or care setting.
The product code this domain's device candidates compete in is defined by its own classification regulation as a plug-or-pessary device connected to a battery-powered pulse source, inserted vaginally or rectally, where "the plug or pessary may be removed by the user" when necessary [7] [single-source]. The regulation itself does not state a site of service, but its device description is written around self-insertion and self-removal rather than clinician administration, which is the one piece of primary-source text located this pass that speaks directly to where, physically, this device category is used.
[1] Stress Urinary Incontinence (SUI) Guideline — American Urological Association / Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (published 2017-10, day not given in the PubMed record; accessed 2026-09-01). PMID 28625508 — https://www.auanet.org/guidelines-and-quality/guidelines/stress-urinary-incontinence-(sui)-guideline [guideline] [2] Referral and Prescription Patterns for Female Patients With Urinary Incontinence — Urogynecology (Philadelphia, Pa.) (published 2024-05-01; accessed 2026-09-01). PMID 37881958 — https://pubmed.ncbi.nlm.nih.gov/37881958/ [peer-reviewed] [3] Primary care providers practice patterns regarding female pelvic floor disorders — Family Medicine and Community Health (published 2024-03-14; accessed 2026-09-01). PMID 38485284 — https://pubmed.ncbi.nlm.nih.gov/38485284/ [peer-reviewed] [4] Geographic Disparities by Income in Pelvic Floor Physical Therapy Locations in Philadelphia, Pennsylvania — Diseases of the Colon & Rectum (published 2025-11-01; accessed 2026-09-01). PMID 40767352 — https://pubmed.ncbi.nlm.nih.gov/40767352/ [peer-reviewed] [5] Basic versus biofeedback-mediated intensive pelvic floor muscle training for women with urinary incontinence: the OPAL RCT — Health Technology Assessment, Winchester, England (published 2020-12, day not given in the PubMed record; accessed 2026-09-01). PMID 33289476 — https://pubmed.ncbi.nlm.nih.gov/33289476/ [peer-reviewed] [6] Does it work in the long term?--A systematic review on pelvic floor muscle training for female stress urinary incontinence — Neurourology and Urodynamics (published 2013-03, day not given in the PubMed record; accessed 2026-09-01). PMID 22847318 — https://pubmed.ncbi.nlm.nih.gov/22847318/ [peer-reviewed] [7] Nonimplanted electrical continence device — eCFR, Title 21 (issue 2026-08-31; accessed 2026-09-01). 21 CFR 876.5320 — https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-876/subpart-F/section-876.5320 [federal-registry]
Well established: that US primary care refers only a minority of women with pelvic-floor conditions, including SUI, on to a specialist or to pelvic floor physical therapy rests on two independent, non-affiliated sources — a Midwestern academic health system referral cohort [2] and a national PCP practice-patterns survey [3] — and is stated plainly in the Summary and in Details for that reason.
Thin: every specific percentage or count attached to that finding is single-source — the 37.2%/20.6%/17.7%/3.2% referral figures [2], the 153-respondent survey's qualitative findings [3], the Philadelphia distance figures [4], the guideline's evaluation statements [1], the OPAL RCT's visit cadence [5], the PFMT systematic review's surgery-rate range [6], and the device classification text [7].
Rescoped from class 3: none in this report. The care-pathway questions addressed here — what a first visit is defined to require, where referral actually goes, where physical therapy sites are located, what visit cadence one trial used, and how the device category is classified — are each registry or published-finding questions in shape, not questions about what a person would do.
Out of scope: CPT descriptors for PT, biofeedback, and E/M visit codes (AMA-licensed, named in prose above only by reference to "office visit," never reproduced); CMS billing and coverage material, which belongs to this domain's reimbursement section, already partially addressed there; fda.gov guidance documents, which gate automated requests intermittently.
Not searched vs. not found:
[inference] That the guideline's own first-visit workup requires no equipment beyond a standard exam room, while the specialist and physical-therapy referral this pathway is supposed to lead to is both under-used [2][3] and geographically uneven where it does exist [4], is this writer's own reading of what the four sources together suggest about where a home-administered device would sit relative to the existing pathway. No single source states this connection directly.
| Proposition | Evidence class | Resolvable identifier | Dossier section |
|---|---|---|---|
| In a cohort of 4,382 women newly diagnosed with urinary incontinence in US primary care (2016-2020), 37.2% received guideline-concordant medication or referral within one year, including 17.7% referred to urology/urogynecology and 3.2% to pelvic floor physical therapy | 2 published | PMID 37881958 | 2 |
| The AUA/SUFU Stress Urinary Incontinence Guideline defines the index-patient evaluation as a focused history, focused physical/pelvic examination, objective demonstration of SUI, post-void residual assessment, and urinalysis, and states cystoscopy should not be performed routinely absent suspected urinary tract abnormality | 2 published | PMID 28625508 | 2 |
| A census-tract analysis of 19 pelvic floor physical therapy sites in Philadelphia found the lowest-income quartile's tracts sat a median 2.1 miles from the nearest site versus 1.0 miles for the highest-income quartile (p<0.001) | 2 published | PMID 40767352 | 2 |
| In the UK OPAL RCT (300 women randomized per arm), both basic and biofeedback-mediated pelvic floor muscle training groups were offered six clinic appointments over 16 weeks | 2 published | PMID 33289476 | 2 |
| A systematic review of 19 long-term PFMT studies (1,141 women, 1-15 years follow-up) found surgery rates at long-term varied between 4.9% and 58% | 2 published | PMID 22847318 | 2 |
| 21 CFR 876.5320 classifies the nonimplanted electrical continence device as Class II and describes it as a vaginal or rectal plug/pessary connected to a battery-powered pulse source that the user may remove | 1 registry | 21 CFR 876.5320 | 2 |