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 2026-09-30 · Cadence quarterly · Evidence class 2 published · Sources 17 · Supersedes none
Domain: stress-urinary-incontinence · Scope: Published primary studies (PubMed via the literature connector, read at abstract depth) of continuation or adherence with self-inserted intravaginal products outside pelvic floor stimulation and biofeedback — vaginal dilators after pelvic radiotherapy, self-managed pessaries, the contraceptive vaginal ring versus the oral pill, the dapivirine ring versus oral PrEP, and disposable intravaginal SUI (stress urinary incontinence) inserts versus a continence pessary or behavioural therapy. Excludes the in-domain NMES (neuromuscular electrical stimulation)/EMG discontinuation series (the direct evidence, per the scope note), full-text reading of any paper, non-English literature, and any registry record other than the one 510(k) (premarket notification) lookup disclosed in section 5.
Sourcing: Rests on seventeen PubMed-indexed papers read at abstract depth — seven randomised trials, three prospective cohort analyses, one retrospective cohort, one RCT (randomised controlled trial) process evaluation, one RCT mixed-methods analysis, one RCT long-term follow-up, one MAUDE (Manufacturer and User Facility Device Experience) review, one single-arm device study and one narrative review; most per-case lines rest on one study and carry [single-source].
Adherence to self-inserted vaginal dilators after pelvic radiotherapy is low and falls over the months after initiation: two independent prospective studies report it declining from the first weeks to six and twelve months [2][3]. In two independent studies of the contraceptive vaginal ring against the oral pill, ring continuation was not materially different from pill continuation at six and twelve months, and roughly half or more of users of either method had stopped [7][8]. Where an intervention to raise continuation was randomised, results split: a written booklet raised dilator adherence in one trial [1] while an enhanced nurse-delivered education programme did not in another [2].
_Baseline (v1). No prior version; this establishes the starting point for future diffs._
Had to show: that women prescribed a self-inserted dilator (typically three times weekly for about ten minutes) keep using it for months, and that an initiation-stage intervention raises use [2][3].
What happened: In 109 women after pelvic radiotherapy (diary-recorded, 12 months), "mean percent adherence over 12months was 42%"; adherence "was highest in the first quarter (56%), but fell to 25% by the fourth" [3] [single-source]. In 42 women after vaginal brachytherapy randomised to standard nurse instruction or an enhanced educational programme, "There was no difference in adherence between arms"; 20% at 6 weeks and 8.3% at 6 months met the three-times-weekly prescription, and 64% and 16% used it at least weekly [2] [single-source]. In 82 women randomised to a psychosexual rehabilitation booklet (n=44) or standard materials (n=38), "Dilator adherence and booklet knowledge were significantly higher in the intervention group" averaged over 3, 6 and 12 months [1] [single-source].
Transfers: a self-inserted intravaginal device used at home on a prescribed schedule over weeks to months, in adult women, with adherence measured by self-report and falling over time [2][3].
Does not transfer: a dilator delivers no stimulation and gives no feedback; the users are cancer survivors recovering from radiotherapy; the prescribed frequency was three times weekly, not daily; and 48% of the brachytherapy cohort were sexually active, so dilation was tied to sexual function [2].
Had to show: that women taught to remove, clean and reinsert their own pessary do as well as clinic-managed women [4].
What happened: 340 UK women were randomised (self-management n=169, clinic care n=171). The self-management package was "a 30-minute teaching appointment, an information leaflet, a 2-week follow-up telephone call and a local clinic telephone helpline number". At 18 months there was "no group difference in prolapse-specific quality of life" and fewer complications with self-management [4] [single-source]. At four years 186 of 340 (55%) responded, with no significant quality-of-life difference [5] [single-source]. The process evaluation reports that "Pessary-related complications negatively influenced adherence in both groups" [6] [single-source]. In a separate retrospective cohort of 779 pessary users (2007–2022), median duration of use was 173 weeks; 30% opted for surgery, mostly within 4 months (median 19 weeks), and "pessary self-change not possible" was a documented reason in 1% [15] [single-source].
Transfers: a structured teaching session at initiation plus an early (2-week) follow-up call and a helpline, delivered to women self-inserting a vaginal device at home [4]; early exit concentrated in the first months [15].
Does not transfer: a pessary is worn continuously and works passively, rather than being used in a timed session; the TOPSY abstracts report quality of life and complications, not a continuation rate at 12 weeks [4][5]; the non-invasive alternative here is surgery, not a non-invasive home therapy [15]; UK NHS (National Health Service) setting with no cost share.
Had to show: that an intravaginal method is continued at least as well as a daily non-invasive one that serves the same purpose [7][8][14].
What happened: In 273 US students randomised to ring (n=136) or pill (n=137) for three cycles, ring users reported more perfect use in the first two months, but "at 6 months, only 31 (26%) of 117 contraceptive vaginal ring users and 36 (29%) of 123 OCP users had continued their assigned study method (P=.61)" [7] [single-source]. In 1,452 Contraceptive CHOICE Project women who chose pill, patch or ring at no cost, 12-month discontinuation was 47% for the pill and 49% for the ring; "Women who reported difficulty obtaining the method were more than twice as likely to discontinue (adjusted HR 2.43)" [8] [single-source]. In the wider CHOICE cohort (n=4,167), 10% chose the ring and 11% the pill [9] [single-source]. A 2007 review of twelve RCTs reports "a higher incidence of local and ring-related events led to higher discontinuation rates in the CCVR group", but also that "Ring users were more likely to continue with their method after study completion" [14] [single-source].
Transfers: a direct randomised intravaginal-versus-non-invasive comparison in women, with a daily non-invasive comparator; access difficulty measured as a discontinuation factor [7][8].
Does not transfer: the ring is inserted once a month rather than per session; the purpose is contraception in young women, not symptom relief; CHOICE provided methods at no cost, so cost share was removed rather than tested [8].
Had to show: adherence to a monthly vaginal ring comparable to daily oral PrEP in adolescent girls and young women [10].
What happened: 247 participants aged 16–21 in South Africa, Uganda and Zimbabwe (2019–2021) were randomised to 6 months of each product in crossover; "High adherence was observed in 753 (57%) of the 1316 oral PrEP visits and 806 (57%) of the 1407 dapivirine ring visits" [10] [single-source]. Adherence support comprised "monthly counselling sessions with drug-level feedback (DLF) plus optional daily short message service (SMS) reminders, weekly phone or SMS check-ins, peer support clubs"; DLF showing high adherence reached 73%–89% of ring results [11] [single-source]. The trial did not randomise the support menu, so its separate effect is not measured [11].
Transfers: objectively measured use (residual drug in returned rings) fed back to the user, plus SMS reminders and scheduled check-ins, around a self-inserted intravaginal product with a non-invasive alternative [10][11].
Does not transfer: adolescent population in sub-Saharan Africa; HIV prevention, not symptom treatment; monthly insertion rather than daily sessions; trial-provided product at no cost [10].
Had to show: that women with SUI fitted with a self-inserted insert or continence pessary stay with it, including against behavioural therapy [12][13][16].
What happened: An RCT of continence pessary versus a disposable intravaginal continence device (Poise Impressa) planned 138 participants but "Due to slow enrollment, the study was stopped after 16 months with 50 participants enrolled"; 35 of 50 (70%) completed a fitting, 22 of 50 (44%) the 4-week and 17 of 50 (34%) the 6-month follow-up [12] [single-source]. In ATLAS (446 women with SUI), treatment satisfaction at 3 months was 63% with pessary versus 75% with behavioural therapy, and "Group differences were not sustained to 12 months" [16] [single-source]. A 60-woman study of a disposable device worn 8 hours daily for 28 days reported 85% achieving ≥70% pad-weight reduction [13] [single-source]. A MAUDE review (2015–2020) of an over-the-counter intravaginal support device found 230 of 257 reports concerned the string breaking at insertion or removal [17] [single-source].
Transfers: same indication (SUI), same population, self-insertion, and a non-invasive behavioural alternative in the comparison [12][16].
Does not transfer: inserts act mechanically and passively during wear; follow-up in the device trials ran 4 weeks to 6 months with high attrition, and neither reports a 12-week continuation rate [12][13].
[1] A Psychosexual Rehabilitation Booklet Increases Vaginal Dilator Adherence and Knowledge in Women Undergoing Pelvic Radiation Therapy for Gynaecological or Anorectal Cancer: A Randomised Controlled Trial — Clinical Oncology (published 2019-02, day not given in the PubMed record; accessed 2026-09-30). PMID (PubMed identifier) 30580905 — https://pubmed.ncbi.nlm.nih.gov/30580905/ [peer-reviewed] [2] Dilator Use After Vaginal Brachytherapy for Endometrial Cancer: A Randomized Feasibility and Adherence Study — Cancer Nursing (published 2018, May–Jun issue, day not given in the PubMed record; accessed 2026-09-30). PMID 28437283 — https://pubmed.ncbi.nlm.nih.gov/28437283/ [peer-reviewed] [3] Prospective study of vaginal dilator use adherence and efficacy following radiotherapy — Radiotherapy and Oncology (published 2015-07, day not given in the PubMed record; accessed 2026-09-30). PMID 26164775 — https://pubmed.ncbi.nlm.nih.gov/26164775/ [peer-reviewed] [4] Clinical and cost-effectiveness of pessary self-management versus clinic-based care for pelvic organ prolapse in women: the TOPSY RCT with process evaluation — Health Technology Assessment (published 2024-05, day not given in the PubMed record; accessed 2026-09-30). PMID 38767959 — https://pubmed.ncbi.nlm.nih.gov/38767959/ [peer-reviewed] [5] Four Year Clinical and Cost Effectiveness of Vaginal Pessary Self-Management Versus Clinic-Based Care for Pelvic Organ Prolapse (TOPSY): Long Term Follow-Up of a Randomised Controlled Superiority Trial — BJOG (published 2025-11, day not given in the PubMed record; accessed 2026-09-30). PMID 40832737 — https://pubmed.ncbi.nlm.nih.gov/40832737/ [peer-reviewed] [6] Self-management of vaginal pessaries for pelvic organ prolapse: multi-method process evaluation, linked to the TOPSY randomised controlled trial — BMC Medicine (published 2025-12-05; accessed 2026-09-30). PMID 41350999 — https://pubmed.ncbi.nlm.nih.gov/41350999/ [peer-reviewed] [7] Adherence and acceptability of the contraceptive ring compared with the pill among students: a randomized controlled trial — Obstetrics and Gynecology (published 2010-03, day not given in the PubMed record; accessed 2026-09-30). PMID 20177280 — https://pubmed.ncbi.nlm.nih.gov/20177280/ [peer-reviewed] [8] Factors associated with 12-month discontinuation among contraceptive pill, patch, and ring users — Obstetrics and Gynecology (published 2013-02, day not given in the PubMed record; accessed 2026-09-30). PMID 23344283 — https://pubmed.ncbi.nlm.nih.gov/23344283/ [peer-reviewed] [9] Continuation and satisfaction of reversible contraception — Obstetrics and Gynecology (published 2011-05, day not given in the PubMed record; accessed 2026-09-30). PMID 21508749 — https://pubmed.ncbi.nlm.nih.gov/21508749/ [peer-reviewed] [10] Adherence, safety, and choice of the monthly dapivirine vaginal ring or oral emtricitabine plus tenofovir disoproxil fumarate for HIV pre-exposure prophylaxis among African adolescent girls and young women: a randomised, open-label, crossover trial — The Lancet HIV (published 2023-12, day not given in the PubMed record; accessed 2026-09-30). PMID 37898146 — https://pubmed.ncbi.nlm.nih.gov/37898146/ [peer-reviewed] [11] How a menu of adherence support strategies facilitated high adherence to HIV prevention products among adolescent girls and young women in sub-Saharan Africa: a mixed methods analysis — Journal of the International AIDS Society (published 2023-11, day not given in the PubMed record; accessed 2026-09-30). PMID 37936551 — https://pubmed.ncbi.nlm.nih.gov/37936551/ [peer-reviewed] [12] 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 2026-09-30). PMID 34505171 — https://pubmed.ncbi.nlm.nih.gov/34505171/ [peer-reviewed] [13] Efficacy and safety of a novel disposable intravaginal device for treating stress urinary incontinence — American Journal of Obstetrics and Gynecology (published 2008-05, day not given in the PubMed record; accessed 2026-09-30). PMID 18377862 — https://pubmed.ncbi.nlm.nih.gov/18377862/ [peer-reviewed] [14] The contraceptive vaginal ring compared with the combined oral contraceptive pill: a comprehensive review of randomized controlled trials — Contraception (published 2007-06, day not given in the PubMed record; accessed 2026-09-30). PMID 17519147 — https://pubmed.ncbi.nlm.nih.gov/17519147/ [peer-reviewed] [15] Long-term adherence to pessary use in women with pelvic organ prolapse: A retrospective cohort study — Maturitas (published 2023-12, day not given in the PubMed record; accessed 2026-09-30). PMID 37659128 — https://pubmed.ncbi.nlm.nih.gov/37659128/ [peer-reviewed] [16] Continence pessary compared with behavioral therapy or combined therapy for stress incontinence: a randomized controlled trial — Obstetrics and Gynecology (published 2010-03, day not given in the PubMed record; accessed 2026-09-30). PMID 20177294 — https://pubmed.ncbi.nlm.nih.gov/20177294/ [peer-reviewed] [17] Characterizing Adverse Events Reporting for an Over-the-Counter Disposable Intravaginal Support Device for Stress Urinary Incontinence — Female Pelvic Medicine & Reconstructive Surgery (published 2022-05-01; accessed 2026-09-30). PMID 34534195 — https://pubmed.ncbi.nlm.nih.gov/34534195/ [peer-reviewed]
Well established: that dilator adherence after pelvic radiotherapy falls over months [2][3]; that ring and pill continuation did not differ materially at 6–12 months and that about half or more of users of either had stopped [7][8].
Thin: every per-case quantity rests on one study and carries [single-source]; the two TOPSY papers [4][5][6] and the two REACH papers [10][11] and the two CHOICE papers [8][9] are each one programme and do not corroborate each other. Every source was read at abstract depth only through the literature connector; no full text was opened, so methods, attrition handling and funding are unread.
Rescoped from class 3: the pillar's implicit question — "would women keep using a self-inserted intravaginal device when a non-invasive option exists?" — is a stakeholder future. Substituted twin: "in published studies outside NMES/EMG, what fraction of women continued a self-inserted intravaginal product over weeks to months, against a non-invasive alternative where one was studied, and which randomised interventions changed that fraction?"
Out of scope: the in-domain NMES/EMG and biofeedback discontinuation series (excluded by the scope note); full texts; FDA (US Food and Drug Administration) labelling for Poise Impressa, NuvaRing or the dapivirine ring.
Not searched vs. not found: Not found — the 510k connector returned no record for device name "Impressa"; the device's clearance record was therefore not retrieved and no K-number is stated. Not found — no study in the searches reported a 12-week continuation rate for any case, and none randomised app connection, device-logged usage feedback or cost share as a continuation intervention (REACH offered drug-level feedback and SMS but did not randomise them [11]). Not searched — Cochrane reviews of dilator interventions, NuvaRing pivotal trials beyond the 2007 review, the Impressa efficacy trials behind its clearance, and non-vaginal self-inserted analogues (e.g. intermittent self-catheterisation). Studies [1][2][3] measured three-times-weekly regimens, not daily ones; nothing retrieved measured a daily session-based intravaginal regimen.
[inference] Across the cases, falls in use concentrate in the first weeks to months [3][15], which places the 12-week mark inside the window where most exit occurred in these analogues.
[inference] The only randomised initiation-stage interventions retrieved (booklet [1], enhanced education [2]) disagree, so no case here establishes that teaching at initiation raises continuation.
| Proposition | Evidence class | Resolvable identifier | Dossier section |
|---|---|---|---|
| Mean 12-month dilator adherence after pelvic radiotherapy was 42% in 109 women, falling from 56% in the first quarter to 25% in the fourth | 2 published | PMID 26164775 | reference-products |
| In 42 women after vaginal brachytherapy, an enhanced educational programme produced no difference in dilator adherence versus standard instruction; 8.3% met the three-times-weekly prescription at 6 months | 2 published | PMID 28437283 | reference-products |
| A psychosexual rehabilitation booklet raised dilator adherence versus standard materials in an 82-woman RCT | 2 published | PMID 30580905 | reference-products |
| In a 273-student RCT, 26% of ring users and 29% of pill users continued their assigned method at 6 months (P=.61) | 2 published | PMID 20177280 | reference-products |
| In 1,452 CHOICE participants, 12-month discontinuation was 47% for the pill and 49% for the ring, and reported difficulty obtaining the method carried an adjusted HR of 2.43 | 2 published | PMID 23344283 | reference-products |
| In MTN-034/REACH (n=247), high adherence was observed at 57% of oral PrEP visits and 57% of dapivirine ring visits | 2 published | PMID 37898146 | reference-products |
| A randomised trial of continence pessary versus Poise Impressa was stopped at 50 of a planned 138 participants for slow enrollment, with 44% completing 4-week follow-up | 2 published | PMID 34505171 | reference-products |
| TOPSY self-management (30-min teaching, leaflet, 2-week call, helpline) showed no 18-month quality-of-life difference from clinic care in 340 women and fewer complications | 2 published | PMID 38767959 | reference-products |
| In 779 pessary users, median duration of use was 173 weeks and 30% opted for surgery at a median of 19 weeks | 2 published | PMID 37659128 | reference-products |
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