The impact of a mobile application‐based treatment for urinary incontinence in adult women: Design of a mixed‐methods randomized controlled trial in a primary care setting

Loohuis, Anne M M; Wessels, Nienke J; Jellema, Petra; Vermeulen, Karin M.; Hove, Marijke C Slieker-Ten; Gemert-Pijnen, Julia E.W.C. van; Berger, Marjolein Y.; Dekker, Janny H.; Blanker, Marco H.

doi:10.1002/nau.23507

Cited by 22 publications

(32 citation statements)

References 23 publications

(42 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The complete study protocol was published previously. 6 After trial commencement, an amendment to the protocol added a process evaluation method and changes to recruit participants from the general population because of a low accrual rate. 7 We followed the Consolidated Standards of Reporting Trials (CONSORT) guideline and the relevant extensions.…”

Section: Methodsmentioning

confidence: 99%

See 1 more Smart Citation

App-Based Treatment in Primary Care for Urinary Incontinence: A Pragmatic, Randomized Controlled Trial

et al. 2021

Self Cite

View full text Add to dashboard Cite

PURPOSE Electronic application (app)-based treatment is promising for common diseases with good conservative management options, such as urinary incontinence (UI) in women, but its effectiveness compared with usual care is unclear. This study set out to determine if app-based treatment for women with stress, urgency, or mixed UI was noninferior to usual care in the primary care setting. METHODS The URinControl trial is a pragmatic, noninferiority randomized controlled trial in Dutch primary care including adult women with 2 episodes of UI per week. From July 2015 to July 2018, we screened 350 women for eligibility. A stand-alone app-based treatment with pelvic floor muscle and bladder training (URinControl) was compared with usual care according to the Dutch general practitioner guideline for UI treatment. Outcomes measured were change in symptom severity score from baseline to 4 months (primary outcome), impact on diseasespecific quality of life, patient-perceived improvement, and number of UI episodes. Noninferiority (<1.5 points) was assessed with linear regression analysis. RESULTS A total of 262 eligible women were randomized equally; 195 of them had follow-up through 4 months. The change in symptom severity with appbased treatment (-2.16 points; 95% CI,-2.67 to-1.65) was noninferior to that with usual care (-2.56 points; 95% CI,-3.28 to-1.84), with a mean difference of 0.058 points (95% CI,-0.776 to 0.891) between groups. Neither treatment was superior to the other, and both groups showed improvements in outcome measures after treatment. CONCLUSIONS App-based treatment for women with UI was at least as effective as usual care in the primary care setting. As such, app-based treatments, with their potential advantages of privacy, accessibility, and lower cost, may provide women with a good alternative to consultation.

show abstract

Section: Methodsmentioning

confidence: 99%

“…11,12 We reported details on the development and content of this app previously. 6 Participants received a personal account and instructions to download and install the app on their smartphone or tablet. The research team provided technical support only.…”

Section: App-based Treatmentmentioning

confidence: 99%

App-Based Treatment in Primary Care for Urinary Incontinence: A Pragmatic, Randomized Controlled Trial

et al. 2021

Self Cite

View full text Add to dashboard Cite

show abstract

“…Thematic analyses provide subthemes describing these experiences and preferences, as they are closely interwoven [10]. We conducted semistructured in-person interviews as part of the URinControl study, a mixed-methods study consisting of a randomized controlled trial (RCT) with extensive process evaluation to assess the expectations and experiences of patients and care providers regarding app-based treatment of UI in women [11]. The relevant medical ethics committee approved this study (M17.207954), and the COREQ guideline was followed in this report [12].…”

Section: Methodsmentioning

confidence: 99%

“…The development of the URinControl app has been described elsewhere [11]. It provides step-by-step advice for treating stress UI, urgency UI, and mixed UI in a patient-friendly format based on the guidelines for treating female UI in primary care [13] ( Figure 1).…”

Section: The Urincontrol Appmentioning

confidence: 99%

User Experiences and Preferences Regarding an App for the Treatment of Urinary Incontinence in Adult Women: Qualitative Study

Wessels¹,

Hulshof²,

Loohuis³

et al. 2020

JMIR Mhealth Uhealth

Self Cite

View full text Add to dashboard Cite

Background Although several apps are available to support the treatment of urinary incontinence (UI), little has been reported about the experiences and preferences of their users. Objective The objective of this study was to explore the experiences and preferences of women using a mobile app for the treatment of UI and to identify potential improvements to the app. We developed this app for three types of UI: stress UI, urgency UI, and mixed UI. Methods The participants in this qualitative study were women with self-reported stress UI, urgency UI, or mixed UI who used an app-based treatment to manage their condition for at least six weeks. Following the intervention, semistructured interviews were conducted to explore the participants’ experiences and preferences regarding the app. All interviews were audio-recorded, transcribed verbatim, and analyzed separately by two researchers. Results Data saturation was reached after interviewing 9 women (aged 32-68 years) with stress UI (n=1, 11%), urgency UI (n=3, 33%), or mixed UI (n=5, 56%). Accessibility, awareness, usability, and adherence emerged as the main themes. On the one hand, participants appreciated that the app increased their accessibility to care, preserved their privacy, increased their awareness of therapeutic options, was easy to use and useful, and supported treatment adherence. On the other hand, some participants reported that they wanted more contact with a care provider, and others reported that using the app increased their awareness of symptoms. Conclusions This qualitative study indicates that women appreciate app-based treatment for UI because it can lower barriers to treatment and increase both awareness and adherence to treatment. However, the app does not offer the ability of face-to-face contact and can lead to a greater focus on symptoms.

show abstract

“…This embedded and comprehensive theoretically informed mixed-methods process evaluation is unique to the trials conducted so far in the field of PFMT. To the best of our knowledge, only one trial 11 has reported a process evaluation and this was a single-method (qualitative) approach; one new trial is planning a mixedmethod evaluation 58 and an earlier trial reported plans for a process evaluation. 59 The multiple data sources in the OPAL trial bring a richness to our understanding of trial processes and experiences of the therapists…”

Section: Resultsmentioning

confidence: 99%

Basic versus biofeedback-mediated intensive pelvic floor muscle training for women with urinary incontinence: the OPAL RCT

Hagen

Bugge

Dean

et al. 2020

Health Technol Assess

View full text Add to dashboard Cite

Background Urinary incontinence affects one in three women worldwide. Pelvic floor muscle training is an effective treatment. Electromyography biofeedback (providing visual or auditory feedback of internal muscle movement) is an adjunct that may improve outcomes. Objectives To determine the clinical effectiveness and cost-effectiveness of biofeedback-mediated intensive pelvic floor muscle training (biofeedback pelvic floor muscle training) compared with basic pelvic floor muscle training for treating female stress urinary incontinence or mixed urinary incontinence. Design A multicentre, parallel-group randomised controlled trial of the clinical effectiveness and cost-effectiveness of biofeedback pelvic floor muscle training compared with basic pelvic floor muscle training, with a mixed-methods process evaluation and a longitudinal qualitative case study. Group allocation was by web-based application, with minimisation by urinary incontinence type, centre, age and baseline urinary incontinence severity. Participants, therapy providers and researchers were not blinded to group allocation. Six-month pelvic floor muscle assessments were conducted by a blinded assessor. Setting This trial was set in UK community and outpatient care settings. Participants Women aged ≥ 18 years, with new stress urinary incontinence or mixed urinary incontinence. The following women were excluded: those with urgency urinary incontinence alone, those who had received formal instruction in pelvic floor muscle training in the previous year, those unable to contract their pelvic floor muscles, those pregnant or < 6 months postnatal, those with prolapse greater than stage II, those currently having treatment for pelvic cancer, those with cognitive impairment affecting capacity to give informed consent, those with neurological disease, those with a known nickel allergy or sensitivity and those currently participating in other research relating to their urinary incontinence. Interventions 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. Behaviour change techniques were built in to both interventions. Main outcome measures The primary outcome was urinary incontinence severity at 24 months (measured using the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form score, range 0–21, with a higher score indicating greater severity). The secondary outcomes were urinary incontinence cure/improvement, other urinary and pelvic floor symptoms, urinary incontinence-specific quality of life, self-efficacy for pelvic floor muscle training, global impression of improvement in urinary incontinence, adherence to the exercise, uptake of other urinary incontinence treatment and pelvic floor muscle function. The primary health economic outcome was incremental cost per quality-adjusted-life-year gained at 24 months. Results A total of 300 participants were randomised per group. The primary analysis included 225 and 235 participants (biofeedback and basic pelvic floor muscle training, respectively). The mean 24-month International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form score was 8.2 (standard deviation 5.1) for biofeedback pelvic floor muscle training and 8.5 (standard deviation 4.9) for basic pelvic floor muscle training (adjusted mean difference –0.09, 95% confidence interval –0.92 to 0.75; p = 0.84). A total of 48 participants had a non-serious adverse event (34 in the biofeedback pelvic floor muscle training group and 14 in the basic pelvic floor muscle training group), of whom 23 (21 in the biofeedback pelvic floor muscle training group and 2 in the basic pelvic floor muscle training group) had an event related/possibly related to the interventions. In addition, there were eight serious adverse events (six in the biofeedback pelvic floor muscle training group and two in the basic pelvic floor muscle training group), all unrelated to the interventions. At 24 months, biofeedback pelvic floor muscle training was not significantly more expensive than basic pelvic floor muscle training, but neither was it associated with significantly more quality-adjusted life-years. The probability that biofeedback pelvic floor muscle training would be cost-effective was 48% at a £20,000 willingness to pay for a quality-adjusted life-year threshold. The process evaluation confirmed that the biofeedback pelvic floor muscle training group received an intensified intervention and both groups received basic pelvic floor muscle training core components. Women were positive about both interventions, adherence to both interventions was similar and both interventions were facilitated by desire to improve their urinary incontinence and hindered by lack of time. Limitations Women unable to contract their muscles were excluded, as biofeedback is recommended for these women. Conclusions There was no evidence of a difference between biofeedback pelvic floor muscle training and basic pelvic floor muscle training. Future work Research should investigate other ways to intensify pelvic floor muscle training to improve continence outcomes. Trial registration Current Controlled Trial ISRCTN57746448. Funding This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 70. See the NIHR Journals Library website for further project information.

show abstract

The impact of a mobile application‐based treatment for urinary incontinence in adult women: Design of a mixed‐methods randomized controlled trial in a primary care setting

Cited by 22 publications

References 23 publications

App-Based Treatment in Primary Care for Urinary Incontinence: A Pragmatic, Randomized Controlled Trial

App-Based Treatment in Primary Care for Urinary Incontinence: A Pragmatic, Randomized Controlled Trial

User Experiences and Preferences Regarding an App for the Treatment of Urinary Incontinence in Adult Women: Qualitative Study

Basic versus biofeedback-mediated intensive pelvic floor muscle training for women with urinary incontinence: the OPAL RCT

Contact Info

Product

Resources

About