Lower Urinary Tract Symptoms Quality Research Articles

APP-based treatment of urgency and mixed urinary incontinence in women: factors associated with long-term satisfaction

PurposeApp-based treatment of urgency (UUI) and mixed (MUI) urinary incontinence has proved to be effective. To further improve treatment, it will be beneficial to analyze baseline and treatment-related factors that are associated with satisfaction.MethodsA secondary analysis was conducted of data from a randomized controlled trial (RCT) assessing an app for UUI or MUI treatment, encompassing 98 women for whom there was long-term treatment satisfaction data. All participants completed a short-term (15 weeks) and a long-term (15 months) follow-up questionnaire after being given access to treatment. The outcome was a 3-item question on current treatment satisfaction at the long-term follow-up. Factors potentially associated with the outcome were analyzed using the chi-square test, Student’s t test or logistic regression.ResultsAt the long-term follow-up, 58% of the women were satisfied with the treatment. The most important baseline variable associated with satisfaction was incontinence-related quality of life (International Consultation on Incontinence Questionnaire (ICIQ) − Lower Urinary Tract Symptoms Quality of Life Module) (OR 0.91, 95% CI 0.58–0.97). Short-term follow-up variables associated with long-term treatment satisfaction were improvement in the ability to endure urgency (OR 4.33, 95% CI 1.43–13.12), and confidence in pelvic floor contraction ability (OR 2.67, 95% CI 1.04–6.82).ConclusionApp-based treatment for UUI and MUI may be an alternative first-line treatment that is satisfactory to many women over the long-term. Furthermore, short-term treatment that focuses on improving the ability to endure urgency, and confidence in pelvic floor contraction ability, can also be recommended for long-term satisfaction.

The feasibility of a multimodal exercise program for sedentary postmenopausal women with urinary incontinence: A pilot randomized controlled trial

ObjectivesThe aim was to investigate the feasibility and effects of an eight-week multimodal exercise program in sedentary postmenopausal women with urinary incontinence (UI) compared with pelvic floor muscle training (PFMT) only. Study designThis was a pilot randomized controlled trial. The participants were randomly allocated to either the intervention group (IG), who received a multimodal exercise program that incorporated aerobic exercise, resistance exercise, and PFMT, or the control group (CG), who received PFMT only. The intervention was provided twice weekly for eight weeks. Main outcome measuresThe primary outcome was feasibility in relation to consent rate, attendance, withdrawal rate, satisfaction with program, and adverse events. The secondary outcomes included pelvic floor muscle function (assessed using digital palpation and manometry), UI-specific quality of life (QoL) (rated on the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life [ICIQ-LUTSqol]), symptom severity (assessed using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form [ICIQ-UI SF] and a bladder diary), and physical activity levels (rated on the International Physical Activity Questionnaire- short form [IPAQ]). ResultsThirty-three of 63 eligible participants (52.4 %) consented to participate in the study and 26 completed it (IG n = 13, CG n = 13); the withdrawal rate was lower in the IG than in the CG (13.3 % vs 27.8 %). In both groups the attendance rate was 100 % and the satisfaction rate was 84.6 %. No adverse events were reported. The intention-to-treat analysis showed that UI-specific QoL (p = 0.011, mean difference: -5.62, 95 % CI: −9.67 to −1.57) and symptom severity measured using the ICIQ-UI SF (p = 0.001, mean difference: -3.23, 95 % CI: −4.93 to −1.54) were significantly improved in the IG after intervention, while no significant changes were found in the CG after intervention. The daytime frequency (p = 0.001) and number of leakages (p = 0.045) recorded in the bladder diary were significantly reduced in the CG after intervention. No significant differences between groups were found on any of the outcome measurements after intervention, except the daytime frequency from the bladder diary, which was significantly more reduced in the CG than in the IG (p = 0.003, mean difference: -0.28, 95 % CI: −2.25 to 1.67). ConclusionAn eight-week multimodal exercise program is feasible for sedentary postmenopausal women with UI, and the multimodal exercise program demonstrated potential benefits for improving UI-specific QoL and symptom severity in this population.The trial was registered at ClinicalTrials.gov (NCT04351750).

Effectiveness and costs of a new framework for selecting absorbent urinary incontinence products compared with current practice: a cohort study

ObjectivesTo improve continence care in the Netherlands, a new framework has been developed in which a shift has been made from incontinence severity as the sole criterion for selecting incontinence...

Intervention effects maintenance: 6-month randomized controlled trial follow-up of standard and reflexive pelvic floor muscle training

To date, the focus of pelvic floor muscle training for women suffering from stress urinary incontinence has been on voluntary contractions although involuntary pelvic floor muscle contractions are crucial to guarantee continence in high-impact situations typically triggering this condition. The authors developed 2 pelvic floor muscle home training programs, one including standard voluntary pelvic floor muscle training and one including involuntary reflexive pelvic floor muscle training. This study aimed to test 2 pelvic floor muscle home training programs regarding maintenance of effects of a previous 16-week intervention in terms of stress urinary incontinence symptoms (International Consultation on Incontinence Modular Questionnaire-Urinary Incontinence short form, modified 20-minute pad test), impact on quality of life (Lower Urinary Tract Symptoms Quality of Life module), and digitally assessed pelvic floor muscle strength. This trial was a continuation of a previously published triple-blind prospective randomized controlled trial with a 6-month evaluation endpoint with 2 intervention groups (experimental group with involuntary reflexive home pelvic floor muscle training and control group with standard voluntary home pelvic floor muscle training). From the originally included 96 randomized and allocated participants (experimental group=46, control group=46), 33 control and 27 experimental participants completed the 6-month follow-up. From post-16-week physiotherapy intervention to 6-month follow-up (home pelvic floor muscle training), there were statistically significant improvements in pelvic floor muscle strength (control and experimental group), and no difference in the International Consultation on Incontinence Modular Questionnaire-Urinary Incontinence short form and pad test, or the Lower Urinary Tract Symptoms Quality of Life module Part B (control and experimental group) and Part A (control group). However, there was a statistically significant improvement in the Lower Urinary Tract Symptoms Quality of Life module Part A (experimental group). At no point in time (pre, post, follow-up) was there any statistically significant difference between the groups. Both groups could maintain their intervention training effects. This trial investigated involuntary reflexive pelvic floor muscle training alone, which proved to be an effective alternative to standard voluntary pelvic floor muscle training for maintenance of training effects among women suffering from stress urinary incontinence.

A mobile app for the treatment of female mixed and urgency incontinence: a cost-effectiveness analysis in Sweden

Introduction and hypothesisA previous randomized controlled trial (RCT) demonstrated that the app Tät II, for self-management of mixed urinary incontinence (MUI) and urgency urinary incontinence (UUI), yielded significant, clinically relevant improvements in symptom severity and quality of life (QoL) compared with a control group. We aimed to assess the cost-effectiveness of Tät II.MethodsA cost–utility analysis with a 1-year societal perspective was carried out, comparing Tät II with an information app. Data were collected alongside an RCT: 122 community-dwelling women aged ≥18 years with MUI or UUI ≥2 times/week were randomized to 3 months of Tät II treatment focused on pelvic floor muscle training (PFMT) and bladder training (BT; n = 60), or to an information app (n = 62). Self-assessed data from validated questionnaires were collected at baseline and at 3-month and 1-year follow-ups. Costs for assessment, treatment delivery, incontinence aids, laundry, and time for PFMT and BT were included. We calculated quality-adjusted life-years (QALYs) using the International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life. The incremental cost-effectiveness ratio (ICER) between the groups was our primary outcome. Sensitivity analyses were performed.ResultsThe mean age was 58.3 (SD = 9.6) years. Annual overall costs were €738.42 in the treatment group and €605.82 in the control group; annual QALY gains were 0.0152 and 0.0037 respectively. The base case ICER was €11,770.52; ICERs in the sensitivity analyses ranged from €−9,303.78 to €22,307.67.ConclusionsThe app Tät II is a cost-effective treatment method for women with MUI and UUI.

Quality of life in women with urinary incontinence seeking care using e-health

BackgroundQuality of life (QoL) in women with urinary incontinence (UI) is mainly affected by UI severity, but it is also affected by the UI subtype, comorbidities, age, and socioeconomic status. e-Health is a new method for providing UI treatment. This study aimed to identify factors with the highest impact on QoL in women that turned to e-health for UI self-management.MethodsWe analysed data from three randomized controlled trials (RCTs) that evaluated e-health treatments for UI. We included baseline data for 373 women with stress urinary incontinence (SUI) and 123 women with urgency/mixed UI (UUI/MUI). All participants were recruited online, with no face-to-face contact. Participants completed two questionnaires: the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF, range: 0–21 points), for assessing UI severity, and the ICIQ Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol, range: 19–76 points), for assessing condition-specific quality of life (QoL). To identify factors that impacted QoL, we constructed a linear regression model.ResultsThe mean ICIQ-LUTSqol score was 34.9 (SD 7.6). UI severity significantly affected QoL; the adjusted mean ICIQ-LUTSqol score increased by 1.5 points for each 1.0-point increase in the overall ICIQ-UI SF score (p < 0.001). The UI type also significantly affected QoL; the adjusted mean ICIQ-LUTSqol score was 2.5 points higher in women with UUI/MUI compared to those with SUI (p < 0.001).ConclusionsWe found that women that turned to e-health for UI self-management advice had a reduced QoL, as shown previously among women seeking UI care through conventional avenues, and that the severity of leakage had a greater impact on QoL than the type of UI. Condition-specific factors impacted the QoL slightly less among women that turned to e-health, compared to women that sought help in ordinary care. Thus, e-health might have reached a new group of women in need of UI treatment.

Quality of life among pregnant women with urinary incontinence: A cross-sectional study in a Malaysian primary care clinic.

Pregnant women have an increased risk of urinary incontinence (UI), affecting their quality of life (QoL). This study aims to determine UI and its relationship with QoL among incontinent pregnant women. This was a cross-sectional study in a semi-urban primary care clinic in Selangor, Malaysia, among pregnant women aged 18 years old and above. The validated study instruments consisted of questions on socio-demography, the International Consultation on Incontinence Questionnaire-UI Short Form (ICIQ-UI SF) to determine UI and the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSQoL) to assess their QoL. A generalised linear model was used to determine the association between the continent and incontinent pregnant women with QoL. Of the approached 610 respondents, 440 consented to participate in the study, resulting in a response rate of 72.1%. The mean age was 29.8 years old (SD 4.69) with 82.2% (n = 148) having stress UI. Significant independent factors related to the decreased QoL were mid to late trimester (OR 3.06, 95% CI 1.48-6.32), stress UI, (OR 6.94, 95%CI 4.00-12.04) and urge UI (OR3.87, 95%CI 0.48-31.28). Non-Malay improved QoL (OR 0.29, 95% CI 0.16-0.52). All types of UI significantly affecting pregnant women's QoL. This information is useful in enhancing antenatal management at the primary care level, whereby they should be screened for UI and provided with effective early intervention to improve their QoL.

A Mobile App for Self-management of Urgency and Mixed Urinary Incontinence in Women: Randomized Controlled Trial.

BackgroundMany women experience urgency (UUI) and mixed (MUI) urinary incontinence but commonly hesitate to seek care. Treatment access and self-management for these conditions can be supported through eHealth approaches.ObjectiveThis study aimed to investigate the efficacy of the mobile app Tät II for self-management of UUI and MUI in women.MethodsThis randomized controlled trial included women ≥18 years old with UUI or MUI and ≥2 leakages per week. Those with red-flag symptoms were excluded. Participants were recruited via analog and digital advertisements and screened for initial selection through a web-based questionnaire. Data were collected using another questionnaire and a 2-day bladder diary. A telephone interview confirmed the symptom diagnosis. Participants were randomized (1:1) to receive access to a treatment app (including pelvic floor muscle training, bladder training, psychoeducation, lifestyle advice, tailored advice, exercise log, reinforcement messages, and reminders) or an information app (control group), with no external treatment guidance provided. The primary outcome was incontinence symptoms at the 15-week follow-up, measured using the International Consultation on Incontinence Questionnaire (ICIQ)−Urinary Incontinence Short Form (ICIQ-UI SF). Urgency symptoms were assessed using the ICIQ−Overactive Bladder Module (ICIQ-OAB) and quality of life using the ICIQ−Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol). Incontinence episode frequency (IEF) was calculated per bladder diary entries. Improvement was measured using the Patient’s Global Impression of Improvement. All outcomes were self-reported. Cure was defined as no leakages per the bladder diary. Intention-to-treat analysis was performed.ResultsBetween April 2017 and March 2018, 123 women (mean age 58.3, SD 9.6 years) were randomized to the treatment (n=60, 2 lost to follow-up) or information (n=63) group. Of these, 35 (28%) women had UUI, and 88 (72%) had MUI. Mean ICIQ-UI SF score at follow-up was lower in the treatment group than in the information group (estimated difference −3.1, 95% CI −4.8 to −1.3). The estimated between-group difference was −1.8 (95% CI −2.8 to −0.99) for mean ICIQ-OAB score and −6.3 (95% CI −10.5 to −2.1) for the mean ICIQ-LUTSqol score at follow-up. IEF reduction from baseline to follow-up was greater in the treatment group (−10.5, IQR −17.5 to −3.5) than in the information group (P<.001). Improvement was reported by 87% (52/60) of treatment group participants and by 30% (19/63) of information group participants. The cure rate was 32% in the treatment group, and 6% in the information group (odds ratio 5.4, 95% CI 1.9-15.6; P=.002). About 67% (40/60) of the treatment group participants used the app more than thrice a week.ConclusionsThe treatment app was effective for improving urgency and mixed incontinence in women. When self-management is appropriate, this app may be a good alternative to pharmacological treatment or other conservative management, thus increasing access to care.Trial RegistrationClinicalTrials.gov NCT03097549; https://clinicaltrials.gov/ct2/show/NCT03097549

Urinary incontinence 6\xa0weeks to 1\xa0year post-partum: prevalence, experience of bother, beliefs, and help-seeking behavior

Introduction and hypothesisPost-partum, women often experience urinary incontinence (UI). However, the association between experienced UI bother and UI beliefs and help-seeking behavior is less known. Therefore, we aim to investigate the prevalence of self-reported UI, the level of experienced bother and beliefs, to explain help-seeking behavior for UI in women in the Netherlands from 6 weeks to one year post-partum.MethodsA digital survey among post-partum women, shared on social media, was used for recruitment. The survey consists of: 1. demographic variables, 2. International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF), 3. ICIQ Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol), and 4. questions on beliefs and help-seeking behavior. For analysis, descriptive statistics and the independent samples t-test were used to determine differences between help- and non-help-seekers.Results415 women filled in the survey. The mean age was 30.6 years (SD 4.0, range 21–40) of which 48.2% was primiparous. The overall prevalence of UI was 57.1% (95% confidence interval (CI) (52.3–61.8)). Primiparous women reported a statistically significantly lower overall prevalence than multiparous women, 52.0% and 61.9% respectively (p = .043). UI was reported as bothersome in 38% of women, 25% of all women sought help. Help-seeking women showed significantly higher scores for bother, measured by the ICIQ-UI SF, than non-help seekers (p = .001).ConclusionsMore than half of all post-partum women in the Netherlands from 6 weeks to one year post childbirth experience UI (57.1%), 38% classified their UI as bothersome. In total 25% of UI women sought professional help.

Urinary incontinence during pregnancy: prevalence, experience of bother, beliefs, and help-seeking behavior

Introduction and hypothesisPregnancy and delivery are thought to induce urinary incontinence (UI), but its clinical impact is less known. Therefore, we investigated the prevalence of self-reported UI, level of experience of bother, and beliefs to gain a greater understanding of help-seeking behavior in adult pregnant women.MethodsA digital survey shared on social media was used for recruitment. The survey consists of: (1) demographic variables, (2) International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF), (3) ICIQ Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol), and (4) questions on beliefs and help-seeking behavior. For analysis, descriptive statistics and the independent samples t-test were used to determine differences between help- and non-help-seekers.ResultsFour hundred seven women were eligible for data analysis. The prevalence of UI rises from 55.1% in the first to 70.1% in the third trimester, with an overall prevalence of 66.8%. Nearly 43.0% of the respondents reported UI occurring once a week or less; 92.5% of women lost a small amount; 90% reported slight to moderate impact on quality of life. Only 13.1% of the respondents sought help for their UI. The main reasons for not seeking help were: minimal bother and the idea that UI would resolve by itself. Help-seeking women showed significantly higher scores than non-help-seeking women regarding ICIQ-UI SF (p < 0.001), ICIQ-LUTSqol (p ≤ 0.001), and interference in daily life (p < 0.001).ConclusionsDuring pregnancy, UI affects two out of three women, but only one in eight women sought professional help. Non-help-seeking women experience less bother.

Patient-reported outcomes after buccal mucosal graft urethroplasty for bulbar urethral strictures: results of a prospective single-centre cohort study.

To describe patient-reported outcome measures (PROMs) after buccal mucosa graft (BMG) urethroplasty. We prospectively collected PROMs in patients who underwent BMG urethroplasty for bulbar urethral strictures between October 2009 and February 2017. Preoperatively and at the first, second and third postoperative follow-up visits, patients completed five PROM questionnaires: the International Prostate Symptom Score (IPSS); the IPSS Quality of Life questionnaire; the Urogenital Distress Inventory Short-Form questionnaire (UDI-6); the International Index of Erectile Function (IIEF)-5 questionnaire, combined with IIEF-Q9 and IIEF-Q10 for assessing ejaculatory and orgasmic functions; and the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTS-QOL) questionnaire. In addition to using these questionnaires, we evaluated maximum urinary flow rate (Qmax ), post-void residual urine volume and total voided urine volume at each follow-up visit. Buccal pain and discomfort were assessed using a visual analogue scale (VAS). Comparison of questionnaire scores was performed using a paired Wilcoxon rank-sum test. Treatment failure was defined as any need for urinary diversion or urethral instrumentation after surgery. A total of 97 patients met the inclusion criteria. The first postoperative follow-up visit was at a median of 2.1months (n = 97/97), and the second and third visits were after a median of 7.8 (n = 82/97) and 17.0months (n = 70/97), respectively. Significant improvements compared to baseline were observed in IPSS, and IPSS-QOL, UDI-6 and ICIQ-LUTS-QOL scores at the first follow-up, and remained improved during the follow-up period (P ≤ 0.001). Patients with mild to no baseline erectile dysfunction experienced a significant decline in erectile function at the first follow-up (median [interquartile range {IQR}] preoperative IIEF-5 score 23.0 [21.0-25.0] vs median [IQR] IIEF-5 score at first follow-up 19.5 [16.0-23.8]; P ≤ 0.001). This decline fully recovered during further follow-up (median [IQR] IIEF-5 score at third follow-up 24.0 [20.5-25.0]; P = 0.86). No significant changes in median orgasmic and ejaculatory function were noted. The first postoperative median (IQR) VAS score was 3.0 (2.0-4.45), and a significant improvement in local pain and discomfort was observed during the follow-up (median [IQR] VAS at third follow-up: 0.0 [0.0-1.0]; P ≤ 0.001). Nine patients (9/97; 9.3%) had treatment failure. Stratifying recurrence based on a difference of <10mL/s vs ≥10mL/s between preoperative and postoperative Qmax could not demonstrate a significant difference (P = 0.06). Significant improvements in voiding symptoms and quality of life after surgery were reported. Patients with good baseline erections recovered erectile function during follow-up, although a significant decrease in erectile function was observed at the first follow-up. This study highlights the importance of PROMs in urethral reconstructive surgery, emphasizing that success should not be defined only by stricture-free survival.

The Effect of Selected Exercise Programs on the Quality of Life in Women with Grade 1 Stress Urinary Incontinence and Its Relationship with Various Body Mass Indices: A Randomized Trial.

Aims The aim of the study was to analyze the influence gymnastics has on the quality of life (QOL) in women with grade 1 stress urinary incontinence (SUI) and to determine the relationship between the outcome and selected body weight indices: body mass index (BMI) and waist-to-hip ratio (WHR). Methods A randomized study of 140 women (45-60 years) with grade 1 SUI. The subjects were randomly assigned to a 3-month training for pelvic floor muscles and a transverse abdominal muscle (PFM + TrA, n = 70) or PFM alone (n = 70). The QOL was determined with the questionnaire International Consultation on Incontinence Modular Questionnaire–Lower Urinary Tract Symptoms Quality of Life (ICIQ LUTS QOL), before and after the program. Results Women with BMI < 30 kg/m2 benefited more from the PFM + TrA program with respect to physical limitations and embarrassment domains, whereas patients with a gynoid body type (WHR < 0.8) benefited more in terms of physical and social limitations, SUI-evoked emotions, severity measures, and embarrassment domains. Conclusions After the PFM + TrA training, women with WHR < 0.8 had a better QOL than those with WHR > 0.8.

Quality of Life in Women with Stage 1 Stress Urinary Incontinence after Application of Conservative Treatment-A Randomized Trial.

Stress urinary incontinence (SUI) influences quality of life in female patients. In this study, we used ICIQ LUTS QoL (The International Consultation Incontinence Questionnaire Lower Urinary Tract Symptoms quality of life) to determine the quality of life (QoL) in various domains in patients with stage 1 SUI. The study included 140 perimenopausal women subjected to urodynamic tests at the Department of Gynaecology, Endocrinology and Gynaecologic Oncology, Pomeranian Medical University, Police (Poland) in 2013–2015. The study subjects were divided into two groups, A and B. Each patient completed two questionnaires, an original survey developed by the authors and the validated ICIQ LUTS QoL. Two exercise programs, each lasting for 3 months and consisting of 4 weekly sessions, were recommended to the study subjects. The program for Group A included exercises for pelvic floor muscles (PFM) with simultaneous tension of the transverse abdominal muscle (TrA), and the program for Group B, PFM exercises without TrA tension. After completing the exercise programs, patients with stage 1 SUI, both from Group A and from Group B, showed a significant improvement in most QoL domains measured with ICIQ LUTS QoL. However, more beneficial effects of the training were observed in the group subjected to PFM exercises with TrA tension.

Reliability and Validity of the Quality of Life Questionnaire in Iranian Patients with Lower Urinary Tract Symptoms.

The aim of this study is to evaluate the psychometric properties of the Iranian version of the Quality of Life (QoL) questionnaire in patients with urinary incontinence (UI). The English questionnaire on lower urinary tract symptoms was initially translated into Persian, and then back-translated into English. Final modifications were made after testing the questionnaire on Iranian patients with UI. To validate the translated questionnaire, the following tests were undertaken: content/face validity, internal consistency/reliability and construct validity. The Lower Urinary Tract Symptoms Quality of Life (LUTS-QoL) questionnaire showed good internal consistency, content validity, and criterion validity, as measured by correlation with scores on the Short-Form 36 Health Survey (SF-36). Cronbach's alpha coefficient was 0.951, indicating a high internal consistency. Concerning criterion validity, correlations between the LUTS-QoL and subscales of the SF-36 were 0.563-0.193. The highest correlation was found between the LUTS-QoL and the social function subscale of the SF-36. The Iranian version of the LUTS-QoL questionnaire is a valid and robust instrument that can be used reliably in clinical settings and in research.

Mobile app for treatment of stress urinary incontinence: A randomized controlled trial.

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

INVESTIGATE-I (INVasive Evaluation before Surgical Treatment of Incontinence Gives Added Therapeutic Effect?): a mixed-methods study to assess the feasibility of a future randomised controlled trial of invasive urodynamic testing prior to surgery for stress urinary incontinence in women.

The position of invasive urodynamic testing in the diagnostic pathway for urinary incontinence (UI) is unclear. Systematic reviews have called for further trials evaluating clinical utility, although a preliminary feasibility study was considered appropriate. To inform the decision whether or not to proceed to a definitive randomised trial of invasive urodynamic testing compared with clinical assessment with non-invasive tests, prior to surgery in women with stress UI (SUI) or stress predominant mixed UI (MUI). A mixed-methods study comprising a pragmatic multicentre randomised pilot trial; economic evaluation; survey of clinicians' views about invasive urodynamic testing; qualitative interviews with clinicians and trial participants. Urogynaecology, female urology and general gynaecology units in Newcastle, Leicester, Swansea, Sheffield, Northumberland, Gateshead and South Tees. Trial recruits were women with SUI or stress predominant MUI who were considering surgery after unsuccessful conservative treatment. Relevant clinicians completed two online surveys. Subsets of survey respondents and trial participants took part in separate qualitative interview studies. Pilot trial participants were randomised to undergo clinical assessment with non-invasive tests (control arm); or assessment as controls, plus invasive urodynamic testing (intervention arm). Confirmation that units can identify and recruit eligible women; acceptability of investigation strategies and data collection tools; acquisition of outcome data to determine the sample size for a definitive trial. The proposed primary outcome for the definitive trial was International Consultation on Incontinence Modular Questionnaire (ICIQ) Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) (total score) 6 months after surgery or the start of non-surgical treatment; secondary outcomes included: ICIQ-FLUTS (subscales); ICIQ Urinary Incontinence Short Form; ICIQ Lower Urinary Tract Symptoms Quality of Life; Urogenital Distress Inventory; EuroQol-5D; costs, quality-adjusted life-years (QALYs) and incremental cost per QALY, Short Form 12; 3-day bladder diary. Of 284 eligible women, 222 (78%) were recruited; 165/219 (75%) returned questionnaires at baseline and 125/200 (63%) who were sent questionnaires at follow-up. There were few missing data items in returned questionnaires, with individual outcome scales calculable for 81%-94%. Most women underwent surgery; management plans were changed in 19 (19%) participants following invasive urodynamic testing. Participant Costs Questionnaires were returned by 53% 6 months after treatment; complete data to undertake cost-utility analysis were available in 27% (intervention) and 47% (control). While insufficient to recommend changes in practice, the results suggest further research would be valuable. All clinicians responding to the survey had access to invasive urodynamic testing, and most saw it as essential prior to surgery in women with SUI with or without other symptoms; nevertheless, 70% considered the research question underlying INVESTIGATE important and most were willing to randomise patients in a definitive trial. Participants interviewed were positive about the trial and associated documentation; the desire of some women to avoid invasive urodynamic testing contrasted with opinions expressed by clinicians through both survey and interview responses. All elements of a definitive trial and economic evaluation were rehearsed; several areas for protocol modification were identified. Such a trial would require to 400-900 participants, depending on the difference in primary outcome sought. A definitive trial of invasive urodynamic testing versus clinical assessment prior to surgery for SUI or stress predominant MUI should be undertaken. Current Controlled Trials ISRCTN71327395. The National Institute for Health Research Health Technology Assessment programme.

ICIQ symptom and quality of life instruments measure clinically relevant improvements in women with stress urinary incontinence.

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). 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. 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. 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.