Trial reportInternational urogynecology journal2015
InTone: a novel pelvic floor rehabilitation device for urinary incontinence.
Trial report in International urogynecology journal, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04957524 (Transvaginal Electrical Stimulation for the Treatment of OAB-dry), which is not on this map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Transvaginal Electrical Stimulation for the Treatment of OAB-dry
Who cites it
3 citing papers in PubMed, 13 citations in OpenAlex.
- Early Feasibility Study to Evaluate the Viveve System for Female Stress Urinary Incontinence: Interim 6-Month Report.Journal of women's health (2002) · 2020Trial
- A 12-month feasibility study to investigate the effectiveness of cryogen-cooled monopolar radiofrequency treatment for female stress urinary incontinence.Canadian Urological Association journal = Journal de l'Association des urologues du Canada · 2020Article
- Multimodal vaginal toning for bladder symptoms and quality of life in stress urinary incontinence.International urogynecology journal · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionInTone(TM) (InControl Medical) is a nonimplanted vaginal device providing biofeedback and electrical stimulation of pelvic floor muscles. The purpose of this study was to assess its efficacy and usability for treating urinary incontinence (UI).
methodsWomen with UI (stress, urge, mixed) were recruited for this pilot trial. InTone was used 5-6 days a week for 12 weeks. Patients were assessed at baseline and monthly with symptom questionnaires [Urinary Distress Index (UDI6), Incontinence Impact Questionnaire (IIQ7)], bladder diaries. and 24-h pad-weight testing (PWT). Efficacy was assessed by comparing 12-week results to baseline values using chi-square and Wilcoxon rank-sum tests. Usability was assessed with a device-usage log and the System Usability Scale (SUS), which evaluates patients' global impression of usability.
resultsThirty-three women were enrolled; five patients withdrew and were excluded. Median age was 50 years (range 35-69). After 12 weeks of InTone therapy, median UDI6 and IIQ7 scores improved from 50.0 to 29.2 (p < 0.001) and from 42.9 to 14.3 (p < 0.001), respectively. Statistically significant reductions in median PWT (35.5-4.6 g, p < 0.001), median daily pad use (4.0-2.0, p < 0.001), and median daily incontinence frequency (4.3-1.0, p < 0.001) were noted; 68 % of patients achieved a > 50 % reduction in daily pad usage and PWT. Device usability was good, with a median SUS of 86.3 and a median expected use of 107 % (33-140 %).
conclusionsTwelve weeks of InTone usage resulted in significant objective and subjective reductions in UI. Device usability was very good.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.