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Stress urinary incontinence (SUI) is a common problem with a great potential influence on quality of life. Although SUI can be treated effectively with pelvic floor muscle training (PFMT), only a minority of women with this complaint seek help. An internet-based electronic health (eHealth) intervention could make care more accessible. The Swedish eHealth intervention
The objective of this protocol is to investigate the barriers and facilitators to the adoption of an eHealth intervention for Dutch women with SUI and the effects of this intervention.
We are conducting an explanatory sequential mixed methods study among 800 Dutch women with SUI who participate in the translated version of
Enrollment started in July 2018 and will be finished by December 2019. Data analysis will start in March 2020.
An eHealth intervention for Dutch women with SUI is promising because it can make treatment more accessible. The strength of this study is that it explores the possibilities for an internet-based-only treatment for women with SUI by using both quantitative and qualitative research methodologies. The study elaborates on existing results by using a previously tested and effective eHealth program. Insight into the barriers and facilitators to using this program can enhance the implementation of the intervention in the Dutch health care system.
Netherlands Trial Registry (NTR) NTR6956; https://www.trialregister.nl/trial/6570.
DERR1-10.2196/13164
Stress urinary incontinence (SUI) is a common problem in women, which has a significant impact on their lives. SUI is defined by the International Continence Society as the complaint of any involuntary urinary leakage on effort or exertion, or sneezing or coughing [
Despite the availability of effective treatment options for SUI, only a minority (15% to 38%) of women seek help [
The delivery of web-based self-help therapy, electronic health (eHealth), is expanding rapidly and has proven to be effective for a wide range of health problems [
The results from these studies cannot be generalized because a country such as the Netherlands differs from Sweden in geographical characteristics and, hence, in the way its health care provision is organized. Compared with the Netherlands, Sweden has a large number of inhabitants who live in rural areas, which can restrict the access to the health care facilities, such as physiotherapy [
Therefore, we perform a mixed methods study with
The main objective is to investigate barriers and facilitators to the adoption of an eHealth intervention among Dutch women with SUI. The secondary objectives are to examine the effects of the intervention on symptoms of urinary incontinence and quality of life, and to study factors that are potentially associated with treatment success.
We use an explanatory sequential mixed methods design to study the barriers and facilitators to the adoption of an eHealth intervention among participating women and to gain an in-depth understanding of their experiences with the intervention [
Dutch women can subscribe to the intervention on our website (baasoverjeblaas.nl [
The following inclusion criteria are applied: women aged >18 years reported having SUI, being capable of understanding Dutch language, and having internet access. Questions to discriminate between different types of urinary incontinence (SUI, UUI, or MUI) were based on the Questionnaire for female Urinary Incontinence Diagnosis, which has proved to be an adequate tool for self-assessment [
Women are excluded if one of the following criteria applies: participation in another therapy program or trial for SUI; surgery for urinary incontinence in the last 6 months; PFMT from a pelvic physiotherapist in the last 6 months; pregnancy; vaginal delivery in the last 6 months; neurological disease affecting lower limbs (eg, Parkinson, Multiple Sclerosis, and cerebrovascular incident); and malignancy in lower abdomen currently or in the past 5 years (colon, uterus, cervix, bladder, ovary, or vagina). In case of ineligibility, an email is sent to these women, and, if applicable, we advise them to seek help from their GP or to take a look at a certified self-help website, thuisarts.nl [
Flowchart of the study. eHealth: electronic health.
After the intervention, a subset of 15 to 20 women will be asked to participate in semistructured interviews. We will use purposive sampling to study women with variability in age, education level, symptom severity, impact on quality of life, and intervention adherence. We endeavor to interview women immediately after their participation in the intervention to avoid recall bias.
In implementation science, there are multiple outcome variables that can be studied depending on the phase of the implementation, such as acceptability, adoption, feasibility, or sustainability [
According to this framework, the adoption of information technology depends on the fit between attributes of users (eg, motivation and computer anxiety), attributes of technology (eg, usability and performance), and attributes of tasks (eg, complexity). The framework was retrospectively used to study the adoption of a nursing process documentation system and to describe the barriers and facilitators to the 3 attributes in the FITT framework. We will use the same FITT framework in this study to guide our description of the barriers and facilitators to the adoption of
On the basis of the known modifiers of PFMT adherence, we hypothesize that the relevant attributes of individuals with regard to this intervention are knowledge, cognitive analysis, planning and attention, and prioritization [
The intervention is an open-access website that enables all women who search for information over Web about urinary incontinence to subscribe to this study. The website provides information about different types of urinary incontinence and about the content of the intervention by means of written text and a video. In addition, we recruit women through advertisements in local papers, posters in waiting rooms of primary care practices or pharmacies, and through other websites displaying a referral link to our website. We explain that the intervention is part of our research project at the Department of Primary and Community Care at the Radboud University Medical Center.
Women who register are requested to fill in their surname (or pseudonym), email address, age, and phone number (optional). Then, they are shown a webpage with information about the study, and they need to tick the
The eHealth intervention is based on the Swedish internet-based module named
The core content of the website is about PFMT, which is explained by text, audio fragments, and images. Webpages with information and exercises can be downloaded and printed. Next to training, information about urinary incontinence is also provided as well as lifestyle advice to reduce the impact of risk factors for SUI; the negative effect of obesity on SUI, for example, is addressed, and lifestyle advice is provided. In total, 4 different pelvic floor muscle exercises are addressed in 8 escalating modules. Each module contains background information, a training program, and a test exercise that enables women to check whether they gained the correct skills. Depending on the module, participants are recommended to train 2 to 3 times a day for 2 to 12 min, in line with existing guideline recommendations (
After completing a module, participants are requested to fill in a training report with 2 questions about the frequency and time they spent on this module. Access to the next module will automatically be provided after the report has been filled in. The intervention will take 3 months, but women can take it at their own pace. Women receive a message 3 months after their first login that their account will be inactivated within a week but that they can download the exercises to continue their training. We decided to inactivate the Web portal to have a cut-off point for the intervention and to achieve a proper measurement of the women’s login activity.
The Fit between Individuals, Task, and Technology framework.
Homepage layout of the Dutch version of
Intensity of pelvic floor muscle training per module in the intervention.
During the intervention, there is no face-to-face contact, but the researcher (a GP in training and researcher) is available for both content-related and technology-related questions through a secured email system. Technology questions are discussed with the Web developer. To stimulate adherence, email reminders are sent if participants do not log-in for 1 week. The content of the reminder is related to the content of the module in which participants are training at that time. A maximum of 2 reminders for each module will be sent, and women are able to unsubscribe themselves. Women who notice no effect of the training or who are unable to contract their pelvic floor muscles are advised to consult their GP for further treatment. This is explained in the intervention as well as in the outro of the questionnaire that is sent 3 weeks after the start of the intervention.
The website is password-protected and allows participants to create their own portal where personal learning goals or training reports can be filled in. Women can create or reset their own password. The eHealth intervention is provided at no cost to participants, and they are not reimbursed for participation.
The primary outcome of the study will be the barriers and facilitators to the adoption of
We will collect quantitative and qualitative data from women who participated in the intervention (
Participants are asked to fill in Web-based questionnaires at baseline and at 3 weeks, and 3 and 6 months after baseline (T0, 1, 2, and 3, respectively;
The barriers and facilitators to the adoption of the eHealth intervention are evaluated by means of questionnaires sent before, during, and after the intervention (T0-T3;
The questionnaire during and after the intervention (T1-T2) contains 5 closed questions about the understandability of the training information (2 times), adherence to the intervention, conditions that would enhance adherence (if applicable), and the possibility to ask questions during the intervention. Some of these questions contain response options that trigger a follow-up open question, for example, to explore reasons for nonadherence or low adherence. T1 and T2 also include 5 closed questions about positive and negative experiences with the intervention (both asked twice) and about suggestions for the intervention’s further improvement.
After the intervention (T2 and T3), we ask women multiple, self-generated questions to evaluate if they sought help since the start of the eHealth intervention or if they intend to seek help from a health care professional for urinary incontinence. The health care professionals who are mentioned in the answer options are the GP, the pelvic physiotherapist, or the specialist (urologist or gynecologist). Reasons for either seeking or not seeking help are explored with open questions that show up depending on the participants’ response to previous questions. We also assess whether participants receive another treatment during or after the eHealth intervention, and, if applicable, what kind of treatment this was. Nonresponders are approached by email first, and, second, by telephone to explore their reasons for not completing the questionnaire. They are also asked if they have any suggestions for improvement.
At baseline (T0), the situation regarding urinary incontinence is assessed by self-generated questions about symptom duration and about perceived discomfort by a 7-point Likert scale. The effect of the eHealth intervention on incontinence severity is assessed by the International Consultation on Incontinence Questionnaire Short Form (ICIQ-UI SF) at T0, T2, and T3. The ICIQ-UI SF is a validated and a highly recommended 6-item questionnaire to assess the frequency, amount of leakage, and impact on daily life [
To assess patient-reported improvement, the Patient Global Impression of Improvement (PGI-I) [
Data collection. T0: baseline; T1: 3 weeks after baseline (during treatment); T2: 3 months after baseline (posttreatment); T3: 6 months after baseline (posttreatment).
Data categories | Data variables | Quantitative data collection (content of instrument) | Qualitative data collection |
Demographic data | Age, education level, marital status, residential area, recruitment method | T0 questionnaire | —a |
Medical background | Parity, vaginal delivery, gynecological surgery, chronic diseases, defecation problems, symptoms of prolapse, medication use, BMIb, smoking, alcohol use, general physical and mental health status | T0, T2, and T3 questionnaires | — |
Barriers and facilitators to using eHealthc | Positive and negative experiences, understandability, reasons for (non) adherence, support, previous help-seeking behavior, previous treatment received, help-seeking during/after intervention, intent to seek help | T0, T1, T2, and T3 questionnaires | Interview after intervention |
Effect of eHealth on urinary incontinence | Baseline information (duration, discomfort) severity, improvement, use of incontinence pads, BMI | T0, T2, and T3 (ICIQ-UI SFd, PGI-Ie) questionnaires | Interview after intervention |
Effect of eHealth on quality of life | Urinary incontinence related and general quality of life | T0, T2, and T3 (ICIQ-LUTSqolf, Short Form-12) questionnaires | — |
Factors associated with success | Age, education level, physical activity, menopausal status, prior surgery for urinary incontinence, (expected) ability to do PFMTg, expectation of treatment success, symptom severity, improvement of pelvic floor muscle strength, BMI change, adherence to intervention, adherence to PFMT during intervention, adherence to PFMT after intervention | T0, T1, T2, T3 (ICIQ-UI SF, PGI-I) questionnaires, website data (login data, training reports) | Interview after intervention |
aNot applicable because data are collected through questionnaire only.
bBMI: body mass index.
ceHealth: electronic health.
dICIQ-UI SF: International Consultation on Incontinence Questionnaire Short Form.
ePGI-I: Patient Global Impression of Improvement.
fICIQ-LUTSqol: ICIQ-Lower Urinary Tract Symptoms Quality of Life.
gPFMT: pelvic floor muscle training.
Quality of life is assessed at T0, T2, and T3 by 2 validated questionnaires: one that is designed specifically for Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol) and another that is designed for quality of life in general Short Form-12 (SF-12) [
Several factors will be analyzed for their potential association with intervention effect. The dependent variable is
Characteristics that are collected during and after the intervention include adherence to the intervention, adherence to exercises, symptom severity (ICIQ-UI SF), self-rated improvement of pelvic floor muscle strength, difference in bodyweight compared with baseline, and the frequency of PFMT after intervention. Adherence to the intervention and to the exercises is collected by the website instead of the questionnaire (see website data). Self-rated improvement of pelvic floor muscle strength is assessed during and after the intervention. Participants are asked 3 questions are about their ability to contract the pelvic floor muscles 3 weeks after the start of the intervention (T1). At T2 and T3, participant assess the improvement of their pelvic floor muscle strength on a 5-point Likert scale, with answers ranging from
During the intervention, website usage is assessed by collecting website statistics. According to previous research, website usage can be defined by frequency, duration, and activity [
Adherence to the intervention is defined as the extent to which participants made use of the intervention. We defined 3 groups: nonadherence, intermittent adherence, and continuous adherence, based on previous research [
Exercise adherence is measured using the training reports that have to be completed during the intervention to continue to the next module. In each training report, participants need to fill in how many minutes and how often they trained for that particular module. Exercise adherence is defined as the percentage of time spent on PFMT out of expected time spent on PFMT and will be categorized in 3 levels: high (>80%), moderate (20% to 80%), and low (<20%) adherence [
As part of the intervention, participants can fill in their short-term and long-term goals for the training program, and they can make notes in their own diaries, but both are nonobligatory. Both functionalities aim to enhance adherence.
After completing the intervention, participants will be asked to participate in a semistructured interview, allowing them to provide feedback in a more narrative form. We undertake to select a subset of 15 to 20 participants with variety in age, education level, urinary incontinence severity, and adherence to the intervention to participate in the interviews. To explore reasons for nonresponse, women who dropped out during the intervention will be interviewed as well. The topics in the interview guide have been divided into the 3 components of the FITT framework [
Individually:
Reason for participation.
Previous experiences with help-seeking, receiving treatment (if applicable).
Expectations of the intervention.
Knowledge of the condition and PFMT.
Cognitive analysis, planning and attention.
Prioritization.
Attitudes toward support during this intervention (advantages/disadvantages of absence of personal contact, attitudes toward email reminders, and suggestions).
Computer skills.
Effects of the intervention (on symptoms and consulting a health care provider).
Task:
Feelings about PFMT.
Experiences with intervention adherence (including attitudes toward how to enhance adherence, integrating PFMT into daily life).
PFMT complexity (also taking into account previous experiences with PFMT).
Effect on skills gained during the training (ability to contract the pelvic floor muscles).
Technology:
Appearance.
Behavioral prescriptions.
Burden of using the website.
Content.
Delivery of the message.
Stability of the website and technical problems.
Privacy aspects.
Descriptive statistics will be used to analyze the characteristics of the participating women, and they will also be described for groups who differ in intervention adherence. The questionnaires include a mixture of open and closed questions that address barriers and facilitators to adopt the eHealth intervention. Responses to open questions will first be analyzed qualitatively, divided into barriers and facilitators, and then be categorized into one of the 3 components of the FITT framework [
On the basis of this mapping, different barriers and facilitators will be analyzed for groups that differ in age and urinary incontinence severity with a chi-square test. Treatment effects (T0 vs T2 and T0 vs T3) on the ICIQ-UI SF, ICIQ-LUTSqol, and SF-12 will be analyzed using a mixed model analysis. Missing answers are not likely as Castor EDC does not allow completion of the questionnaire before all required fields have been filled in. Nevertheless, if there are any missing values, they will be replaced with the corresponding answer at baseline and vice versa. If more than 3 answers are missing in a row, the participant will be excluded from further analysis. Descriptive statistics will be used for the analysis on the PGI-I.
Logistic regression analysis will be used to assess the association between different variables and treatment success. Before a definitive model is constructed, the variables will be tested for their unique correlation with the dependent variable, and variables with very-skewed distribution will be excluded or categorized further. Univariate analyses will be performed, and variables with a significance level of
The data that will be collected from the semistructured interviews will be analyzed thematically. With thematic analysis, one strives to identify patterns (themes) that together provide an answer to the research question [
Document analyses will be conducted with the qualitative data from the emails sent by participants during the intervention and with data from the website (short-and long-term goals for the training and the diary). These documents will not be available from all participants as email contact, diary, and goals are not compulsory.
After analyzing the quantitative and the qualitative results, we will combine these results to provide an answer to the primary outcome: barriers and facilitators to the adoption of eHealth for SUI. We will use the FITT framework by describing the
No sample size calculation is needed to provide a reliable answer to our primary outcome. However, a reasonable number of participants is needed to compare groups that differ in barriers and facilitators to the adoption of the eHealth intervention. We decided, therefore, to perform a power calculation based on one of the secondary outcomes: self-rated improvement on symptoms as assessed by the PGI-I. Improvement or success was defined as answering
We expected high drop-out rates as previous research on self-help internet interventions showed rates between 2% and 83% [
Ethical approval has been requested and granted (file number 2016-2721) by the research ethics committee of the Radboud University Medical Center, Nijmegen, the Netherlands. This study is conducted in accordance with the Medical Research Involving Human Subjects Act. The committee declared that the risks associated with participation in this trial are negligible according to the Netherlands Federation of University Medical Centers. Handling of personal data will comply with the General Data Protection Regulation (Dutch: Algemene verordening gegevensbescherming).
Enrollment of participants in the eHealth intervention started in July 2018 and will last until December 2019. Data analysis will start in March 2020.
The mixed methods design in this study allows for a comprehensive and in-depth understanding of the barriers and facilitators to the adoption of an internet-based intervention for women with SUI. The quantitative strand of this study further facilitates an analysis of the effects of the intervention on urinary incontinence symptoms, quality of life, and the factors associated with successful treatment. From previous research, we know that Swedish women were satisfied after using the intervention. Due to geographical and organizational differences with Sweden, however, we do not know whether Dutch women with SUI will also be satisfied with this eHealth intervention. It is important, therefore, to study what factors facilitate or hamper the use of the intervention in the Netherlands. These results can be used to guide health care providers and policymakers in implementing this intervention in the Dutch national health care system. Due to its anonymous and flexible character, eHealth has the potential to improve care for women with urinary incontinence as it lowers the threshold to help-seeking [
One of the strengths of this study is that it elaborates on an intervention—proven to be effective—for women with SUI [
However, we may not detect all variables as we mostly use open questions in the questionnaire, which do not guide participants to address specific items. We hope to fill this gap with the qualitative strand in this study. Another potential limitation of this study is that we are unable to study the barriers and facilitators among nonresponders or drop-outs, which might lead to selection bias. To mitigate this risk, we have embedded a brief questionnaire at T1 with questions about positive and negative experiences because we expect that more women will respond shortly after registration than at T2 or T3 [
In this study protocol, we described the methods for investigating the barriers and facilitators to the adoption of
electronic health
Fit between Individuals, Task, and Technology
general practitioner
Lower Urinary Tract Symptoms Quality of Life
International Consultation on Incontinence Questionnaire Short Form
mixed urinary incontinence
pelvic floor muscle training
Patient Global Impression of Improvement
Short Form-12
stress urinary incontinence
urgency urinary incontinence
None declared.