Objectives: In a previous study, self-management of stress urinary incontinence (SUI), via an Internet-based programme or a booklet improved symptoms and quality of life. We wanted to evaluate the effectiveness of these programmes when implemented for free use, as well as to characterize the users.

Design: Pragmatic prospective cohort study.

Setting and subjects: Information about the Internet programme and the booklet was provided at www.tät.nu and by nurse midwives. Both programmes included a three-month pelvic floor muscle training (PFMT) programme. Questionnaires were used at the start and after three months.

Main outcome measures: Characteristics of the participants regarding age and education. Reductions in symptom severity was measured using the validated ICIQ-UI SF.

Results: 109 women using the booklet, and 166 women using the Internet-based programme responded to the pre-treatment questionnaire. Of these, 53 (48.6%) in the booklet group and 27 (16.3%) in the Internet group responded to the follow-up. The mean age of booklet users was higher, 59.4 years vs. 54.5 years (p = .005). The proportion of women with post-secondary education was high, 59% in the booklet group and 67% in the Internet group. The mean reduction in the symptom score was 2.6 points (SD 3.4) in the booklet group, and 3.4 (SD 2.9) in the Internet group. These reductions were significant within both groups, with no difference between the groups, and in the same order of magnitude as in the previous randomised controlled study.

Conclusion: Two self-management programmes for SUI, one provided as a booklet and one as an Internet-based programme, also rendered clinically relevant improvements when made freely available.

Key points:

• Female stress urinary incontinence can be treated using self-management programmes focused on pelvic floor muscle training. This study evaluates the effect of two different programmes, one provided as a booklet and one Internet-based, when made freely available to the public.
• Both programmes rendered clinically relevant improvements, in the same order of magnitude as in the previous randomised controlled study.
• Self-management of stress urinary incontinence should be recommended to women that request treatment.

Background: Stress urinary incontinence (SUI) affects 10%-39% of women. Its first-line treatment consists of lifestyle interventions and pelvic floor muscle training (PFMT), which can be performed supervised or unsupervised. Health apps are increasing in number and can be used to improve adherence to treatments. We developed the Tät app, which provides a 3-month treatment program with a focus on PFMT for women with SUI. The app treatment was evaluated in a randomized controlled trial, which demonstrated efficacy for improving incontinence symptoms and quality of life. In this qualitative interview study, we investigated participant experiences of the app-based treatment.

Objective: This study aimed to explore women’s experiences of using an app-based treatment program for SUI.

Methods: This qualitative study is based on telephone interviews with 15 selected women, with a mean age of 47 years, who had used the app in the previous randomized controlled trial. A semistructured interview guide with open-ended questions was used, and the interviews were transcribed verbatim. Data were analyzed according to the grounded theory.

Results: The results were grouped into three categories: “Something new!” “Keeping motivation up!” and “Good enough?” A core category, “Enabling my independence,” was identified. The participants appreciated having a new and modern way to access a treatment program for SUI. The use of new technology seemed to make incontinence treatment feel more prioritized and less embarrassing for the subjects. The closeness to their mobile phone and app features like reminders and visual graphs helped support and motivate the women to carry through the PFMT. The participants felt confident that they could perform the treatment program on their own, even though they expressed some uncertainty about whether they were doing the pelvic floor muscle contractions correctly. They felt that the app-based treatment increased their self-confidence and enabled them to take responsibility for their treatment.

Conclusions: Use of the app-based treatment program for SUI empowered the women in this study and helped them self-manage their incontinence treatment. They appreciated the app as a new tool for supporting their motivation to carry through a slightly challenging PFMT program.

Trial Registration: ClinicalTrials.gov NCT01848938; https://clinicaltrials.gov/ct2/show/NCT01848938 (Archived by WebCite at https://clinicaltrials.gov/ct2/show/NCT01848938)

Introduction and hypothesis: Stress urinary incontinence is common among women. First-line treatment includes pelvic floor muscle training (PFMT) and lifestyle advice, which can be provided via a mobile app. The efficacy of app-based treatment has been demonstrated in a randomized controlled trial (RCT). In this study, we aimed to analyze factors associated with successful treatment.

Methods: Secondary analysis of data from the RCT. At baseline and 3-month follow-up, participants (n = 61) answered questions about symptoms, quality of life, background, and PFMT. Success was defined as rating the condition as much or very much better according to the validated Patient Global Impression of Improvement questionnaire. Factors possibly associated with success were analyzed with univariate logistic regression; if p < 0.20, the factor was entered into a multivariate model that was adjusted for age. Variables were then removed stepwise.

Results: At follow-up, 34 out of 61 (56%) of participants stated that their condition was much or very much better. Three factors were significantly associated with success: higher expectations for treatment (odds ratio [OR] 11.38, 95% confidence interval [CI] 2.02-64.19), weight control (OR 0.44 per kg gained, 95% CI 0.25-0.79), and self-rated improvement of pelvic floor muscle strength (OR 35.54, 95% CI 4.96-254.61). Together, these factors accounted for 61.4% (Nagelkerke R-2) of the variability in success.

Conclusion: These results indicate that app-based treatment effects are better in women who are interested in and have high expectations of such treatment. Also, the findings underline the importance of strengthening the pelvic floor muscles and offering lifestyle advice.

Background: Mobile apps can increase access to care, facilitate self-management, and improve adherence to treatment. Stress urinary incontinence (SUI) affects 10-35% of women and, currently, an app with instructions for pelvic floor muscle training (PFMT) is available as first-line treatment. A previous randomized controlled study demonstrated that the app benefitted symptom severity and quality of life (QoL); in this study we investigate the cost-effectiveness of the app. Objective: The objective of this study was to evaluate the health economy of the app for treating SUI. Methods: This deterministic cost-utility analysis, with a 1-year societal perspective, compared the app treatment with no treatment. Health economic data were collected alongside a randomized controlled trial performed in Sweden from March 2013 to October 2014. This study included 123 community-dwelling women participants of 18 years and above, with stress urinary incontinence >= 1 time per week. Participants were self-assessed with validated questionnaires and 2-day leakage diaries, and then randomized to 3 months of treatment (app group, n=62) or no treatment (controls, n=61). The app focused on pelvic floor muscle training, prescribed 3 times daily. We continuously registered treatment delivery costs. Data were collected on each participant's training time, incontinence aids, and laundry at baseline and at a 3-month follow-up. We measured quality of life with the International Consultation on Incontinence Modular Questionnaire on Lower Urinary Tract Symptoms and Quality of Life, and calculated the quality-adjusted life years (QALYs) gained. Data from the 3-month follow-up were extrapolated to 1 year for the calculations. Our main outcome was the incremental cost-effectiveness ratios compared between app and control groups. One-way and multiway sensitivity analyses were performed. Results: The mean age of participants was 44.7 years (SD 9.4). Annual costs were (sic)547.0 for the app group and (sic)482.4 for the control group. Annual gains in quality-adjusted life years for app and control groups were 0.0101 and 0.0016, respectively. Compared with controls, the extra cost per quality-adjusted life year for the app group ranged from -(sic) 2425.7 to (sic) 14,870.6, which indicated greater gains in quality-adjusted life years at similar or slightly higher cost. Conclusions: The app for treating stress urinary incontinence is a new, cost-effective, first-line treatment with potential for increasing access to care in a sustainable way for this patient group.

AIMS: To evaluate the effect of a mobile app treatment for stress urinary incontinence (SUI) in women.

METHODS: Randomized controlled trial, conducted 2013-2014 in Sweden. Community-dwelling adult women with ≥1 SUI episode/week recruited through our website and randomized to app treatment (n = 62) or control group (postponed treatment, n = 61). One participant from each group was lost to follow-up. Intervention was the mobile app Tät(®) with a treatment program focused on pelvic floor muscle training (PFMT), and information about SUI and lifestyle factors. Primary outcomes, 3 months after randomization: symptom severity (International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form [ICIQ-UI SF]); and condition-specific quality of life (ICIQ Lower Urinary Tract Symptoms Quality of Life [ICIQ-LUTSqol]).

RESULTS: One hundred and twenty-three women were included (mean age 44.7), with moderate/severe SUI (97.5%, 120/123), mean ICIQ-UI SF score 11.1 (SD 2.8) and mean ICIQ-LUTSqol score 34.4 (SD 6.1) at baseline. At follow-up, the app group reported improvements in symptom severity (mean ICIQ-UI SF score reduction: 3.9, 95% confidence interval 3.0-4.7) and condition-specific quality of life (mean ICIQ-LUTSqol score reduction: 4.8, 3.4-6.2) and the groups were significantly different (mean ICIQ-UI SF score difference: -3.2, -4.3to -2.1; mean ICIQ-LUTSqol score difference: -4.6, -7.8 to -1.4). In the app group, 98.4% (60/61) performed PFMT at follow-up, and 41.0% (25/61) performed it daily.

CONCLUSIONS: The mobile app treatment was effective for women with SUI and yielded clinically relevant improvements. This app may increase access to first-line treatment and adherence to PFMT.

INTRODUCTION AND HYPOTHESIS: The objective was to determine predictors of long-term success in women with stress urinary incontinence (SUI) treated with a 3-month pelvic floor muscle training (PFMT) program delivered via the Internet or a brochure.

METHODS: We included 169 women with SUI ≥1 time/week who completed the 1-year follow-up (n = 169, mean age 50.3, SD 10.1 years). Three outcome variables defined success after 1 year: Patient Global Impression of Improvement (PGI-I), International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF), and sufficient treatment. Using logistic regression, we analyzed data from the baseline, and from the 4-month and 1-year follow-ups, for potential predictors of success.

RESULTS: Of the participants, 77 % (129 out of 169) were successful in ≥1 of the outcomes, 23 % (37 out of 160) were successful in all 3. Participants with successful short-term results were more likely to succeed in the corresponding outcome at 1 year than those without successful short-term results (adjusted odds ratios [ORs]: PGI 5.15, 95 % confidence interval [CI] 2.40-11.03), ICIQ-UI SF 6.85 (95 % CI 2.83-16.58), and sufficient treatment 3.78 (95 % CI 1.58-9.08). Increasing age predicted success in PGI-I and sufficient treatment (adjusted OR 1.06, 95 % CI 1.02-1.10, and 1.08, 95 % CI, 1.03-1.13 respectively). Compared with not training regularly, regular PFMT at 1 year predicted success for PGI and sufficient treatment (adjusted OR 2.32, 95 % CI 1.04-5.20, and 2.99, 95 % CI 1.23-7.27 respectively).

CONCLUSION: The long-term success of a non-face-to-face treatment program for SUI with a focus on PFMT can be predicted by successful short-term results, increasing age, and the performance of regular PFMT after 1 year.

AIMS: To perform a deterministic cost-utility analysis, from a 1-year societal perspective, of two treatment programs for stress urinary incontinence (SUI) without face-to-face contact: one Internet-based and one sent by post. The treatments were compared with each other and with no treatment.

METHODS: We performed this economic evaluation alongside a randomized controlled trial. The study included 250 women aged 18-70, with SUI ≥ 1 time/week, who were randomized to 3 months of pelvic floor muscle training via either an Internet-based program including e-mail support from an urotherapist (n = 124) or a program sent by post (n = 126). Recruitment was web-based, and participants were self-assessed with validated questionnaires and 2-day bladder diaries, supplemented by a telephone interview with a urotherapist. Treatment costs were continuously registered. Data on participants' time for training, incontinence aids, and laundry were collected at baseline, 4 months, and 1 year. We also measured quality of life with the condition-specific questionnaire ICIQ-LUTSqol, and calculated the quality-adjusted life-years (QALYs) gained. Baseline data remained unchanged for the no treatment option. Sensitivity analysis was performed.

RESULTS: Compared to the postal program, the extra cost per QALY for the Internet-based program ranged from 200€ to 7,253€, indicating greater QALY-gains at similar or slightly higher costs. Compared to no treatment, the extra cost per QALY for the Internet-based program ranged from 10,022€ to 38,921€, indicating greater QALY-gains at higher, but probably acceptable costs.

CONCLUSION: An Internet-based treatment for SUI is a new, cost-effective treatment alternative.

AIMS: To determine whether changes in questionnaire scores on symptoms and condition-specific quality of life reflect clinically relevant improvements in women with stress urinary incontinence (SUI).

METHODS: We retrospectively analyzed questionnaires collected during a randomized controlled trial in women with SUI, that received pelvic floor muscle training (PFMT) in two different formats. We included 218 women that answered validated self-assessment questionnaires at baseline and at a 4-month follow-up. We registered changes on two questionnaires, the International Consultation on Incontinence Modular Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) and the Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol). We compared these score changes to responses from the Patient Global Impression of Improvement (PGI-I) questionnaire. Differences were analyzed with the Spearman rho and one-way-ANOVA. The minimum important difference (MID) was the mean change in score for women that experienced a small improvement.

RESULTS: The PGI-I correlated significantly to both the ICIQ-UI SF (r = 0.547, P < 0.0001) and ICIQ-LUTSqol (r = 0.520, P < 0.0001). Thus, larger reductions in symptoms or quality of life scores were associated with greater impressions of improvement. The changes in ICIQ-UI SF and ICIQ-LUTSqol scores were significant across all PGI-I groups from "no change" to "very much improved" (P < 0.05). The MIDs were 2.52 (SD 2.56) for ICIQ-UI SF and 3.71 (SD 4.95) for ICIQ-LUTSqol.

CONCLUSIONS: The change in ICIQ-UI SF and ICIQ-LUTSqol scores after PFMT reflected clinically relevant improvements in women with SUI. The MIDs established for this population may facilitate future research, treatment evaluations, and comparisons between studies. 

OBJECTIVES: To evaluate the long-term effects of two non-face-to-face treatment programmes for stress urinary incontinence (SUI) based on pelvic floor muscle training (PFMT).

SUBJECTS AND METHODS: The present study was a randomized controlled trial with online recruitment of 250 community-dwelling women aged 18-70 years with SUI ≥ one time/week. Diagnosis was based on validated self-assessed questionnaires, 2-day bladder diary and telephone interview with a urotherapist. Consecutive computer-generated block randomization was carried out with allocation by an independent administrator to 3 months of treatment with either an internet-based treatment programme (n = 124) or a programme sent by post (n = 126). Both interventions focused mainly on PFMT. The internet group received continuous e-mail support from a urotherapist, whereas the postal group trained on their own. Follow-up was performed after 1 and 2 years via self-assessed postal questionnaires. The primary outcomes were symptom severity (International Consultation on Incontinence Questionnaire Short Form [ICIQ-UI SF]) and condition-specific quality of life (ICIQ-Lower Urinary Tract Symptoms Quality of Life [ICIQ-LUTSqol]). Secondary outcomes were the Patient Global Impression of Improvement, health-specific quality of life (EQ-visual analogue scale [EQ-VAS]), use of incontinence aids, and satisfaction with treatment. There was no face-to-face contact with the participants at any time. Analysis was based on intention-to-treat.

RESULTS: We lost 32.4% (81/250) of participants to follow-up after 1 year and 38.0% (95/250) after 2 years. With both interventions, we observed highly significant (P < 0.001) improvements with large effect sizes (>0.8) for symptoms and condition-specific quality of life (QoL) after 1 and 2 years, respectively. No significant differences were found between the groups. The mean (sd) changes in symptom score were 3.7 (3.3) for the internet group and 3.2 (3.4) for the postal group (P = 0.47) after 1 year, and 3.6 (3.5) for the internet group and 3.4 (3.3) for the postal group (P = 0.79) after 2 years. The mean changes (sd) in condition-specific QoL were 5.5 (6.5) for the internet group and 4.7 the for postal group (6.5) (P = 0.55) after 1 year, and 6.4 (6.0) for the internet group and 4.8 (7.6) for the postal group (P = 0.28) after 2 years. The proportions of participants perceiving they were much or very much improved were similar in both intervention groups after 1 year (internet, 31.9% [28/88]; postal, 33.8% [27/80], P = 0.82), but after 2 years significantly more participants in the internet group reported this degree of improvement (39.2% [29/74] vs 23.8% [19/80], P = 0.03). Health-specific QoL improved significantly in the internet group after 2 years (mean change in EQ-VAS, 3.8 [11.4], P = 0.005). We found no other significant improvements in this measure. At 1 year after treatment, 69.8% (60/86) of participants in the internet group and 60.5% (46/76) of participants in the postal group reported that they were still satisfied with the treatment result. After 2 years, the proportions were 64.9% (48/74) and 58.2% (46/79), respectively.

CONCLUSION: Non-face-to-face treatment of SUI with PFMT provides significant and clinically relevant improvements in symptoms and condition-specific QoL at 1 and 2 years after treatment.