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 reference-products · Version 2026-09-01 · Cadence quarterly · Evidence class mixed · Sources 7 · Supersedes none
Domain: stress-urinary-incontinence · Scope: Public primary sources reachable by this repo's connectors, WebSearch and WebFetch.
Sourcing: Rests on one comparative RCT and one placebo-controlled RCT (each
The domain dossier's reference-products section already establishes a detailed abandonment record for prescription home electrical-stimulation devices and for PFMT itself. This report adds a category the dossier had not examined: non-electrical mechanical support devices — vaginal pessary and disposable intravaginal inserts — which the AUA/SUFU guideline lists alongside PFMT as a non-surgical option. A comparative RCT randomizing 50 women with SUI to a continence pessary or a disposable intravaginal continence device (Poise Impressa) found cohort-wide attrition of similar magnitude to the electrical-stimulation category already on record: only 17 of 50 enrolled women (34%) completed 6-month follow-up. The Uresta bladder support device is FDA-cleared (K233548, 2024) and has one small placebo-controlled trial behind it, but no post-market discontinuation study was found for it. A related device lineage — Rinovum's "Improve"/"Revive" bladder-support family — carries a recall for a functional failure (splitting or cracking within its own stated 31-use life), distinct from the labeling-only recalls that make up most of this product code's recall history. Pricing was retrievable for exactly one named device in this domain (ELITONE, direct from the manufacturer); InControl Medical's and Uresta's own pricing pages returned HTTP 403 and 429 respectively and are not cited here.
_Baseline (v1). No prior version; this establishes the starting point for future diffs._
FDA classifies the vaginal pessary as a Class II device under 21 CFR 884.3575, whose own identification text names its purpose as "to treat conditions such as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia" — prolapse, not incontinence [2]. Despite that, models marketed specifically for incontinence are cleared and sold under this same product code (HHW): FDA's recall database lists, among others, a "PESSARY, RING MILEX INCONT FLEXIBLE" and an "Incontinence Dish w/ Support Pessary," both from CooperSurgical [3]. Of the 17 device recalls logged under product code HHW between 2010-01-01 and 2026-09-02, the great majority are labeling problems — an incorrect size or expiration date printed on outer packaging, or a mislabeled latex disclosure — rather than a device-performance issue [3].
A multicenter randomized trial (PMID 34505171) directly compared a continence pessary (CP) to a disposable intravaginal continence device (DICD, Poise Impressa) in women with SUI, 1:1 allocation, evaluating success on the Patient Global Impression of Improvement after 4 weeks. Enrollment stopped early at 50 of a planned 138 participants "due to slow enrollment." Cohort retention fell steadily: "Thirty-five of 50 (70%) completed a fitting, and 22/50 (44%) completed 4-week and 17/50 (34%) completed 6-month follow-up." Of those retained to 4 weeks, treatment success was high in both arms — "80% (8/10) CP vs. 75% (9/12) DICD; p = 1.0" — and "DICD patients showed improvement on all questionnaires but had higher use of other therapies over 6 months," while "no serious adverse events occurred" [single-source] [1]. Read narrowly: the abstract does not report per-arm completion counts beyond the 4-week and 6-month totals cited above, so this cohort-wide attrition (66% not retained to 6 months) cannot be attributed to one device over the other from this source alone; it is, however, a second quantified abandonment signal — independent of the electrical-stimulation category the dossier already documents — that a non-electrical, non-hardware-dependent mechanical support device for SUI is also lost to follow-up or discontinued by roughly two-thirds of an enrolled trial cohort within 6 months [single-source] [1].
Uresta (Resilia, Inc.) was cleared under K233548 (decided 2024-04-03); its Indications for Use read, verbatim: "The Uresta bladder support is indicated for use in adult women over 18 years of age who experience stress urinary incontinence (involuntary urine loss, such as a pee leak that occurs when you cough, laugh, sneeze or with some physical tasks)" [4]. A single-blind, placebo-controlled trial (the "SURE" study, PMID 27438055) randomized 18 women per arm to the Uresta device or a placebo vaginal ring for the duration of a single pad test: "The percentage of patients who achieved the primary outcome was 66.7% in the Uresta group and 22.2% in the placebo group (p = 0.01)," with "no adverse events during the test period" [single-source] [5]. This trial measured short-term objective pad-weight reduction only, in a single urogynecology unit, with both study arms fully completing the protocol — it establishes nothing about longer-term use or discontinuation, and the paper's own conclusion calls for "further study to assess subjective outcomes and long-term patient satisfaction." No post-market adherence, discontinuation, or complaint record for Uresta specifically was located this pass.
K183468 (decided 2019-01-25, Rinovum Subsidiary 2, LLC) covers a reusable device in the same family as the earlier, single-use "Improve" and "Tampax/Always" bladder-support devices; its own 510(k) summary states the "Revive™ system consists of a reusable silicone bladder support ... with a removal string, and a reusable, tampon-like applicator," reusable "for 31 days," versus the single-use predicates [6]. This device was the subject of a 2019 recall (product code HHW, event Z-1952-2019) whose stated reason is a functional failure rather than a labeling defect: "The product is unable to meet the use life of 31 cycles and may split or crack at the base of the 'petals' after repeated use but within the use life of the product (31 uses)," with FDA's own root-cause code listed as "Process change control" [3]. This is the one recall in this domain's device set, across both this report and the domain dossier's own KPI/QAJ scan, that names a physical product failure occurring inside the device's own claimed use life, rather than a packaging or labeling error.
Manufacturer pricing was directly retrievable for exactly one device. ELITONE's own product page, fetched 2026-09-01, lists an "Essential Kit" (1 device plus 10 GelPads) at "$429 $389," a "Bundle" (1 device plus 30 GelPads) at "$539 $499," and a device-only option "Starting at $399 $359," with financing "$36/month" through a third-party lender; the page frames these as time-limited promotional prices against a stated list price, so the discounted figures should not be read as a stable price point [manufacturer] [7]. InControl Medical's site (InTone) and Uresta's own site each returned an HTTP error to direct fetch (403 and 429 respectively) and neither is cited here — see section 5.
[1] A randomized trial comparing continence pessary to continence device (Poise Impressa®) for stress incontinence — International Urogynecology Journal (published 2022-04, day not given in the PubMed record; accessed 2026-09-01). PMID 34505171 — https://pubmed.ncbi.nlm.nih.gov/34505171/ [peer-reviewed] [2] § 884.3575 Vaginal pessary — Code of Federal Regulations, Title 21 (eCFR, current issue 2026-08-31; accessed 2026-09-01). 21 CFR 884.3575 — https://www.ecfr.gov/current/title-21/section-884.3575 [federal-registry] [3] openFDA device/recall, product_code=HHW, event_date_initiated window 2010-01-01 to 2026-09-02 — 17 records, via this repo's recalls connector (accessed 2026-09-01), including Z-1952-2019 (Rinovum Subsidiary 2, LLC, Revive Reusable Bladder Support). 21 CFR 884.3575 — https://api.fda.gov/device/recall.json?search=product_code:HHW [federal-registry] [4] FDA 510(k) summary K233548 — Uresta®, Resilia, Inc. (decision 2024-04-03; accessed 2026-09-01). K233548 — https://www.accessdata.fda.gov/cdrh_docs/pdf23/K233548.pdf [federal-registry] [5] Short-term Uresta efficacy (SURE) study: a randomized controlled trial of the Uresta continence device — International Urogynecology Journal (published 2017-01, day not given in the PubMed record; accessed 2026-09-01). PMID 27438055 — https://pubmed.ncbi.nlm.nih.gov/27438055/ [peer-reviewed] [6] FDA 510(k) summary K183468 — Revive Reusable Bladder Support, Rinovum Subsidiary 2, LLC (decision 2019-01-25; accessed 2026-09-01). K183468 — https://www.accessdata.fda.gov/cdrh_docs/pdf18/K183468.pdf [federal-registry] [7] ELITONE product page — Elidah, Inc. (page undated; accessed 2026-09-01). Priced device cleared as K183585 — https://elitone.com/product/elitone/ [manufacturer]
Well established: No line in this report rests on ≥2 independent, non-affiliated primary sources — every quantitative finding here is new to the domain and each rests on exactly one source, marked accordingly below.
Thin: The pessary-vs-DICD attrition finding [1], the Uresta SURE trial's efficacy result [5], and the ELITONE pricing figures [7] each carry [single-source] or [manufacturer]. The recall record [3] and the two 510(k) summaries [4][6] are FDA registry records rather than directional sources and carry no marker; the CFR text [2] is likewise a plain registry fact.
Rescoped from class 3: None new in this report. The domain dossier already records this domain's class-3 rescoping (device acceptability versus PFMT's own discontinuation record) under its own reference-products section; this report's mechanical-support-device findings extend the same revealed-behaviour approach to a second device category rather than posing a new class-3 question.
Out of scope: Urethral bulking agents (an office injectable procedure, treated here as outside "conservative or home device" scope, not re-litigated); surgical sling and other surgical SUI treatment; MAUDE complaint narratives (no connector reaches MAUDE anywhere in this repo); CPT-coded billing for pessary fitting or management (AMA-licensed); any non-US/non-EU jurisdiction.
Not searched vs. not found: A literature search for SUI-specific (not pelvic-organ-prolapse-specific) pessary discontinuation returned four records; three were pelvic-organ-prolapse discontinuation studies (out of scope for this SUI-scoped domain) and are not used here — that is "found but out of scope," not "not searched." A dedicated post-market or real-world discontinuation study for Uresta specifically was searched for and not found — the SURE trial [5] is the only controlled evidence located for this device. InControl Medical's own pricing page (incontrolmedical.com) returned HTTP 403 to direct fetch and Uresta's own site (uresta.com) returned HTTP 429 on three attempts; both are recorded as not retrieved, not as "no price exists" — the WebSearch results that surfaced approximate figures for each ($595 and $179–$208.99 respectively, per secondary listings) were deliberately not written down as sourced findings here, consistent with the rule that a search result is never a source of record. A resolvable product code specific to the disposable intravaginal insert device class (as distinct from the reusable pessary, product code HHW) was not located this pass.
[inference] The CFR identification text for product code HHW names only pelvic organ prolapse, not incontinence, as the pessary's stated purpose [2], while several devices cleared and recalled under that same code are named and marketed specifically for incontinence [3] — this report reads that as the classification predating a marketed use rather than as any irregularity in the clearances themselves, but that reading was not independently checked against any of the individual 510(k)s beyond K183468 and K233548 [inference].
| Proposition | Evidence class | Resolvable identifier | Dossier section |
|---|---|---|---|
| In a multicenter RCT randomizing 50 women with SUI to a continence pessary or a disposable intravaginal continence device (Poise Impressa), 17 of 50 (34%) completed 6-month follow-up | 2 published | PMID 34505171 | Reference products |
| The Uresta bladder support device achieved a 50% or greater reduction in pad-test weight in 66.7% of treated women (12/18) versus 22.2% (4/18) with a placebo vaginal ring (p=0.01) | 2 published | PMID 27438055 | Reference products |
| Uresta was cleared by FDA under 510(k) K233548 on 2024-04-03 for stress urinary incontinence in adult women | 1 registry | K233548 | Reference products |
| Rinovum's Revive Reusable Bladder Support (K183468) was the subject of a 2019 recall because the device could split or crack at the base of its "petals" within its own stated 31-use life | 1 registry | K183468; recall Z-1952-2019 | Reference products |
| 21 CFR 884.3575 classifies the vaginal pessary as a Class II device intended to treat uterine prolapse, uterine retroposition, or gynecologic hernia, with no mention of incontinence in its identification text | 1 registry | 21 CFR 884.3575 | Reference products |