Pelvic floor muscle training in women with urinary incontinence and pelvic organ prolapse: A protocol study.

OBJECTIVE: To evaluate the effectiveness of pelvic floor muscle training (PFMT) on pelvic floor muscle (PFM) function and quality of life (QoL) in women with stress urinary incontinence (SUI) and pelvic organ prolapse (POP). METHODS: This study will be a randomized, controlled, parallel, and blinded clinical trial. The final sample will consist of 32 women diagnosed with SUI and cystocele (stage I and II). All volunteers will be assessed and reassessed using the same protocol: assessment form, gynecological examination, functional evaluation of PFM, and questionnaires to assess quality of life, urinary function, and sexual function. All volunteers will be evaluated for satisfaction levels post-treatment. The intervention will be PFMT, totaling 16 sessions to be conducted twice a week. Reevaluation will take place at the end of treatment and 1 month after completion of PFMT. Descriptive analysis and repeated measures ANOVA will be used for result analysis. A significance level of p<0.05 will be considered for all statistical tests. ETHICS AND DISSEMINATION: This study has been submitted to the Ethics in Research Committee of the Federal University of Rio Grande do Norte and approved under protocol number 5.826.563. It has been registered with the Brazilian Clinical Trials Registry ReBec (RBR-49p6g3t). It is expected that these studies will provide a deeper understanding of the efficacy of PFMT in women with SUI and cystocele. Additionally, it aims to provide more insights into the efficacy of PFMT prior to surgery.

Effects of using a mobile application on pelvic floor training in women with stress urinary incontinence: A randomized controlled clinical study.

INTRODUCTION: Urinary incontinence (UI) is defined as any involuntary loss of urine that causes negative impacts on women's lives. Pelvic floor muscle training (PFMT) is considered to be "level A" of scientific evidence in the treatment of UI. Despite its efficacy, it is known that the effect of PFMT may depend on continuous adherence. Therefore, healthcare professionals are looking for alternatives to improve adherence in their patients. Healthcare has been innovating through mobile device apps. OBJECTIVE: Thus, the objective of this study was to verify the effects of PFMT with the use of a mobile device app in incontinent women. TRIAL DESIGN: This was a controlled, randomized clinical trial that occurred remotely. METHODS: A total of 104 women with stress UI and/or mixed incontinence, over 18 years old, literate, with preserved cognitive capacity, with internet access and a mobile device with the Android system, participated in this study. They were randomly divided into two groups: The App group and the Booklet group, which underwent a PFMT protocol guided by a mobile app and a booklet, respectively. Both groups received daily reminders to perform the exercises. Before and after 12 weeks of intervention, it was evaluated using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) and the King's Health Questionnaire (KHQ). RESULTS: Both groups showed improvements in the final ICIQ-SF score. However, superior results were shown for the Booklet group (App: pre: 11.5 [±3.8], post: 9.8 [±4.5]; Booklet: pre: 12.6 [±4.5], post: 7.4 [±4.3]; p = 0.03). CONCLUSION: It was concluded that PFMT, with the use of a mobile app, is capable of reducing UI and the impact of UI, but it is not superior to training with the use of booklet instructions.

Mobile app for pelvic floor muscle training for urinary incontinence during the coronavirus disease 2019 pandemic: clinical trial.

OBJECTIVE: The objective of this study was to evaluate the effects of home-based pelvic floor muscle training in women with urinary incontinence, addressing the difficulties arising from social isolation due to the coronavirus disease 2019 pandemic by utilizing a specialized mobile app. METHODS: This randomized, single-group clinical trial aimed to assess the efficacy of pelvic floor muscle training guided by a mobile app (Diario Saúde) in women with stress urinary incontinence. Participants were instructed via telephone to engage in pelvic floor muscle training exercises twice a day for 30 days. Pre- and post-treatment, participants completed validated questionnaires regarding urinary symptoms and quality of life through telephone interviews. Additionally, treatment adherence was evaluated. RESULTS: A total of 156 women were enrolled in the study, with a mean age of 49.3±14.2 years. Significant improvements in urinary incontinence symptoms and quality of life were observed following pelvic floor muscle training guided by the mobile app (p<0.001). Notably, 74.3% of the participants reported performing the exercises with appropriate frequency. Of the participants, 62% reported either complete or substantial improvement in urinary symptoms post-treatment. CONCLUSION: This study revealed notable enhancements in stress urinary incontinence, urinary storage, and overall quality of life subsequent to pelvic floor muscle training guided by a mobile app, particularly during the coronavirus disease 2019 pandemic. The mobile app demonstrated robust acceptance and adherence among women experiencing urinary incontinence.

Comparative analysis of pelvic floor muscle training and Pilates in managing urinary incontinence among postmenopausal women: a randomized controlled trial.

INTRODUCTION AND HYPOTHESIS: This study is aimed at comparing the effectiveness of pelvic floor muscle training (PFMT) and Pilates on the improvement of urinary incontinence (UI), strength, and endurance of the pelvic floor muscles (PFMs), and the impact of UI on the quality of life in postmenopausal women. METHODS: Forty postmenopausal women were randomly divided in to two groups: PFMT (n = 20) and Pilates (n = 20). The participants were followed for 12 weeks, three times a week on nonconsecutive days. UI was assessed using the pad test and the voiding diary, PFM strength and resistance using bidigital assessment and manometry, and the impact of UI on quality of life using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), before and after the 3-month treatment. RESULTS: There was a significant intra-group improvement in both groups for the pad test, mean daily urinary loss, and ICIQ-SF. The strength was significantly improved only in the PFMT group, and the endurance in both groups. Peak strength manometry was significantly improved only in the Pilates group, and the mean strength manometry in both groups. There was also an improvement in both groups for peak endurance manometry and mean endurance manometry. In the inter-group comparison, there was a significant improvement only in muscle strength, which was positive for group. CONCLUSIONS: There was no difference between Pilates and PFMT for the management of women in post-menopause with stress urinary incontinence, provided that voluntary contraction of the PFMs is performed. However, further randomized clinical trials need to be carried out.

Use of a Mobile Application for Pelvic Floor Muscle Training in Women With Urinary Incontinence: a Randomized Control Trial.

INTRODUCTION AND HYPOTHESIS: This study was aimed at evaluating the impact of a mobile app-guided pelvic floor muscle training (PFMT) program on urinary symptoms and quality of life in women suffering from urinary incontinence. METHODS: The study included women with stress urinary incontinence (SUI), who underwent a structured interview and completed validated questionnaires, including the Questionnaire for Urinary Incontinence Diagnosis (QUID), the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF), and the Incontinence Quality of Life Questionnaire (I-QOL). These women were randomly assigned to one of two groups: the app group, which received a visual depiction on the expected contraction pattern through a mobile app to support their PFMT exercises, and the control (paper) group. Both groups were instructed to perform PFMT exercises twice daily for 30 days. Data were collected at baseline and at 30, 60, 90, and 120 days after completing the exercises. RESULTS: A total of 154 women participated, with 76 in the app group and 78 in the paper group. The mean ages were 61 (± 6.1) and 60.6 (± 6.8) in the app and paper groups respectively (p = 0.644). Both groups showed significant improvements in QUID SUI scores (p < 0.001), overactive bladder (OAB; p < 0.001), ICIQ-SF scores (p < 0.001), and quality-of-life scores (p < 0.001). When comparing the two groups, the app group exhibited a more substantial reduction in OAB (p = 0.017) as assessed by QUID and total (p = 0.042), psychosocial (p = 0.032) and social embarrassment (p = 0.006) I-QOL scores. CONCLUSIONS: The study findings suggest that PFMT guided by a mobile app with visual guidance leads to greater improvements in storage symptoms and quality of life than the home-based PFMT guidance.

Efficacy of pelvic floor physiotherapy intervention for stress urinary incontinence in postmenopausal women: systematic review.

INTRODUCTION AND HYPOTHESIS: Our objective was to evaluate the effectiveness of pelvic floor physiotherapy interventions for stress urinary incontinence (SUI) in postmenopausal women. METHODS: Searches were performed in MEDLINE/PubMed, PEDro, Cochrane Library Registry and LILACS databases until October 2021. Only randomized controlled trials (RCTs) which had physiotherapy interventions as primary outcome were included. There were no restrictions on the year of publication or language. Qualitative methodology was evaluated using the PEDro scale. RESULTS: After applying inclusion/exclusion criteria and quality control, 6 randomized controlled trials were included in this systematic review. Methodological quality of trials varied from 5 to 8 (out of 10 possible points in PEDro scale score). Sample consisted of 715 subjects; mean age was between 51.6 and 66.3 years; SUI severity scale ranged from small to severe. Interventions were pelvic floor muscle training (PFMT); vaginal cone (VC); biofeedback (BF); electrical muscle stimulation (EMS); radiofrequency (RF) and electroacupuncture (EA). Pelvic floor physiotherapy was effective in all studies, however, meta-analysis was considered irrelevant due to the heterogeneity of the reported interventions. CONCLUSION: There is not a literature consensus about the most effective pelvic floor physiotherapy intervention applied to stress urinary incontinence in postmenopausal women. It seems appropriate to state that further randomized controlled clinical trials should be done, due to the limited number of studies and heterogeneity of physiotherapeutic interventions applied to date. TRIAL REGISTRATION: This systematic review is registered in PROSPERO in the trial registration CRD42021255062.

Eficacia y seguridad de la colocación de un sling masculino ajustable, en comparación con la colocación de un sling masculino fijo en pacientes con incontinencia urinaria de esfuerzo de intensidad leve a moderada post prostatectomía que han fallado al tratamiento conservador / Efficacy and safety of the placement of an adjustable male sling, compared with the placement of a fixed male sling in patients with post-prostatectomy mild to moderate stress urinary incontinence who have failed conservative treatment

ANTECEDENTES: En el marco de la metodología ad hoc para evaluar solicitudes de tecnologías sanitarias (ETS), aprobada mediante Resolución de Instituto de Evaluación de Tecnologías en Salud e Investigación N° 111-IETSI-ESSALUD-2021, se ha elaborado el presente dictamen, el cual expone la evaluación de la eficacia y seguridad de la colocación de un sling masculino (SM) transobturatriz ajustable con puerto de implantación subcutánea, en comparación con la colocación de un SM fijo, en pacientes varones con incontinencia urinaria (IU) de esfuerzo de intensidad leve a moderada, post prostatectomía y que han fallado al tratamiento conservador (ejercicios del piso pélvico). Mediante la Carta N° 056-DU-GQ-HNERM-GRPRESSALUD-2020, los médicos especialistas del servicio de urología general del Hospital Nacional Edgardo Rebagliati Martins (HNERM), a través de la gerencia de la Red Prestacional Rebagliati, solicitan al Instituto de Evaluación de Tecnologías en Salud e Investigación (IETSI) la evaluación de la tecnología "Sistema Ajustable Transobturatriz masculino" para evaluar su posible inclusión al listado de material médico disponible en EsSalud para su utilización en el tratamiento de la incontinencia urinaria masculina por esfuerzo. ASPECTOS GENERALES: La IU es una complicación conocida del tratamiento de la próstata que impacta de manera negativa la calidad de vida (Miller et al., 2005). Esta condición predomina después de una prostatectomía radical (PR) debido a cáncer de próstata; pero también puede aparecer después de procedimientos por otras enfermedades prostáticas benignas. La IU después de un tratamiento prostático o IU post prostatectomía (IUPP), se debe principalmente a una función inadecuada del esfínter uretral. Esta deficiencia del esfínter se debe al efecto directo de la cirugía, con el daño al esfínter estriado externo durante la ligadura del complejo venoso dorsal, el daño al musculo liso de la uretra causado por las suturas de anastomosis, y/o denervación debido a la disección de la uretra y próstata. METODOLOGÍA: Se realizó una búsqueda sistemática de información con el objetivo de identificar la mejor evidencia disponible a la fecha sobre la eficacia y seguridad del sling masculino transobturatriz ajustable con puerto de implantación subcutánea. Se realizó una búsqueda bibliográfica avanzada en las bases de datos de PubMed, Cochrane Library y LILACS (Literatura Latinoamericana y del Caribe en Ciencias de la Salud). La búsqueda sistemática fue suplementada con una búsqueda manual en la lista de referencias bibliográficas de los estudios incluidos en la ETS. Además, se realizó una búsqueda de literatura gris en el motor de búsqueda Google, a fin de poder identificar otras publicaciones de relevancia que pudiesen haber sido omitidas por la estrategia de búsqueda o que no hayan sido publicadas en las bases de datos consideradas. Asimismo, se realizó una búsqueda dentro de las páginas web pertenecientes a grupos que realizan ETS y GPC, incluyendo, el National Institute for Health and Care Excellence (NICE), la Canadian Agency for Drugs and Technologies in Health (CADTH), la Haute Autorité de Santé (HAS), el Institut für Qualitát und Wirtschaftlichkeit im Gesundheitswesen (IQWiG), además de la Base Regional de Informes de Evaluación de Tecnologías en Salud de las Américas (BRISA). Por último, se realizó una búsqueda de estudios clínicos en ejecución o aún no terminados en: ClinicalTrials.gov. RESULTADOS: No se identificaron estudios aleatorizados ni estudios observacionales con grupos de control para responder a la pregunta de interés. Para sintetizar mejor la evidencia y evaluar los aspectos de seguridad, se incluyeron un total de seis series de casos con al menos 50 participantes en cada estudio. Tres correspondieron al uso de sling masculino transobturatriz fijo (SMTF) y tres al ajustable. Además, inicialmente se incluyeron dos GPC del manejo de la incontinencia urinaria en el hombre. Sin embargo, durante la elaboración del presente dictamen, se publicó una versión actualizada (al 2022) de una de ellas, optando por su inclusión en el documento. CONCLUSIÓN: Por lo expuesto, el Instituto de Evaluación de Tecnologías en Salud e Investigación aprueba el uso del sling masculino transobturatriz fijo en el tratamiento de la incontinencia urinaria de esfuerzo post prostatectomía de intensidad leve a moderada.

Eficácia da eletroestimulação no tratamento da incontinência urinária de esforço: uma metanálise / Effectiveness of electrostimulation in treating stress urinary incontinence: a metanalysis

Introdução: A eletroestimulação é reconhecida como uma das terapias fundamentais na reeducação esfincteriana e do períneo, ao promover a contração dos músculos e permitir ao paciente tomar consciência de si mesmo. Ela induz a contração dos MAP até o restabelecimento da voluntariedade do comando contrátil e ganho de força muscular, garantindo um bom funcionamento das fibras estriadas do esfíncter uretral externo, proporcionando a continência urinária. Objetivo: Identificar a frequência mais utilizada na eletroestimulação para a recuperação da incontinência urinária de esforço (IUE) em mulheres e homens; verificar a eficácia da eletroestimulação no tratamento da incontinência urinária de esforço. Métodos: Realizou-se uma busca nas bases de dados US National Library of Medicine (Medline), Scientific Eletronic Library Online (Scielo), Physiotherapy Evidence Database (PEDro), Cochrane Library, Lilacs, Web of Science, Scopus, Cinahl e Sport Discus, com os descritores incontinência urinária, eletroestimulação e estimulação elétrica, por experimentos controlados randomizados (ECR). Foram incluídos estudos com pacientes homens e mulheres de qualquer idade com IUE, que foram submetidos a eletroestimulação, selecionados pela escala Jadad e avaliado o risco de viés pela ferramenta da Colaboração Cochrane. Dos estudos foram extraídos a idade e sexo dos pacientes, n dos grupos, frequência utilizada na eletroestimulação, duração da sessão, quantidade de sessões, duração do tratamento, avaliação da IUE e o resultado da IUE. Foi utilizado para avaliar o nível de evidência da metanálise o sistema GRADE. Foram metanalisados 8 estudos utilizando-se o RevMan 5.3. Resultados: A frequência mais utilizada na eletroestimulação foi de 50 Hz em mulheres e em homens. Foram identificados 172 ECR, dos quais 26 ECR foram revisados e 8 ECR foram metanalisados. Seis ECR eram com mulheres e apresentaram heterogeneidade (I2 = 48%), redução da IUE de -12,08 g, IC 95% de -14,08 - 10,08 g, P < 0,00001. Para homens, 2 ECR que apresentaram heterogeneidade (I2 = 0%), redução da IUE de -151,28 g, IC de -236,64 - 65,92 g, P < 0,0005. Conclusão: A frequência mais utilizada na eletroestimulação para recuperar a continência urinária de mulheres com IUE e homens com IU pós-prostatectomia foi a de 50 Hz e se mostrou eficaz na recuperação da continência. Entretanto, recomenda-se atenção em relação aos resultados obtidos com os homens, devido ao muito baixo nível de evidência encontrado. (AU)

Effects of visceral manipulation associated with pelvic floor muscles training in women with urinary incontinence: A randomized controlled trial.

AIMS: To compare the effects of manual visceral therapy (MVT) associated with pelvic floor muscle training (PFMT) on urinary incontinence (UI) symptoms, vaginal resting pressure, and maximum voluntary contraction of the pelvic floor muscles (PFM). METHODS: A double-blinded randomized controlled trial of 5 weeks duration with two active intervention arms: PFMT + MVT and PFMT + manual sham therapy (MST). Participants were women over 18 years of age with complaint or diagnosis of UI symptoms. The primary outcome was the severity of UI symptoms, assessed by the International Consultation on Incontinence Questionnaire - Short Form. The secondary outcomes measures included the vaginal resting pressure and the maximum voluntary contraction of PFM assessed by digital manometry. RESULTS: Fifty-two incontinent women participated in the study. There was no significant difference between groups in UI symptoms (F (1.74, 86.9) = 0.406; p = 0.638), vaginal resting pressure (mean difference -1.5 cmH20 [95% confidence interval [CI] -4.5 to 1.5; p = 0.33]), and maximum voluntary contraction of PFM (median 0.0 cmH20 [25%-75% interquartile range 0.0-5.6; p = 0.12]) after the intervention period. CONCLUSIONS: Combining MVT with PFMT was not more effective than PFMT alone in reducing UI symptoms, in change vaginal resting pressure and maximum voluntary contraction of PFM. Due to the limitations of the study, further investigations are still needed to confirm these findings.

Microablative radiofrequency versus pelvic floor muscle training for stress urinary incontinence: a randomized controlled trial.

INTRODUCTION AND HYPOTHESIS: The efficacy of radiofrequency (RF) in stress urinary incontinence (SUI) is as yet unknown. The aim was to compare the effect of fractional microablative RF and pelvic floor muscle training (PFMT) against the combination of both therapies (RF + PFMT) in the SUI and on genitourinary syndrome (GSM). METHODS: This was a three-arm randomized clinical trial including 117 climacteric women with SUI. In group 1 the treatment consisted of three monthly sessions of RF; in group 2 it was 12 weekly PFMT sessions; in group 3 it was RF + PFMT simultaneously. Assessments at baseline and 30 days after the end of therapy were conducted using validated questionnaires and scales for urinary, vaginal, and sexual functions and cytology for vaginal trophy. RESULTS: Urinary scores improved significantly in all three groups post-treatment (p < 0.001) with a higher improvement in the RF + PFMT group (p = 0.002). One-hour pad test results were equal in the three groups. Vaginal symptoms showed an incremental improvement in RF (p < 0.007), and vaginal laxity showed a similar improvement in the three groups (p = 0.323). Vaginal Health Index score was more significant in RF and RF + PFMT groups. Sexual function improved in RF and PFMT. CONCLUSIONS: The association between RF and PFMT showed significant improvement in the SUI symptoms assessed by questionnaire. The vaginal symptoms and dryness showed greater improvement in the RF treatment and vaginal laxity showed similar improvement in the three groups. The combination of RF and PFMT in sexual function did not show benefits superior to those achieved by the therapies alone.

Intravaginal electrical stimulation associated with pelvic floor muscle training for women with stress urinary incontinence: study protocol for a randomized controlled trial with economic evaluation.

INTRODUCTION: Pelvic floor muscle training (PFMT) exercises and neuromuscular electrical stimulation (NMES) are described as conservative interventions to prevent or treat female stress urinary incontinence (SUI). However, it has not been described yet the effect of PFMT associated to intravaginal NMES which evaluated the cost-effectiveness and cost-utility of treating. AIMS: To evaluate the effects of intravaginal NMES associated with the PFMT protocol on urinary loss and quality of life in women with SUI and to evaluate the cost-effectiveness and cost-utility and pelvic floor muscle in women with SUI. METHODS: Randomized controlled trial study with economic evaluation. Inclusion criteria are woman (biological), aged ≥ 18 years old and with a report of SUI ≥ once/week. Exclusion criteria are presence of vaginal or urinary infection, virginity, being in the gestational or puerperium period, or neurological disease. Participants will undergo physical therapy assessment and intervention: anamnesis, pelvic floor muscle assessment by vaginal palpation and manometry (PeritronTM), questionnaires (Short-Form 6 Dimensions-Brazil (SF-6D), King's Health Questionnaire (KHQ) and King´s Health Questionnaire for Scoring Algorithm), health costs, and voiding diary. Participants will be randomly allocated into 3 groups: CG (control group), IG 1 (intervention group 1, PFMT), and IG2 (intervention group 2, PFMT + NMES). The statistical analysis will be performed by intention to treat, and multivariate analysis of mixed effects will be used to compare outcomes. Effect size measurements will be calculated and will be provided by Cohen's d test. A significance level of 5% will be adopted. Additionally, the incremental cost-effectiveness and incremental cost-utility ratios will be used. DISCUSSION: This protocol can corroborate with the literature in order to identify the effect of techniques, based on the possibility of confirming the hypothesis that the NMES associated with PFMT performed concurrently will be the best treatment option; considering the effectiveness, cost-effectiveness, and cost-utility analysis, it will be used as an option for optimization of the treatment of SUI. TRIAL REGISTRATION: Brazilian Registry of Clinical Trials (ReBEC) ID: RBR-6gtzg4 . Registered on September 3, 2019.

Can Supervised Pelvic Floor Muscle Training Through Gametherapy Relieve Urinary Incontinence Symptoms in Climacteric Women? A Feasibility Study.

OBJECTIVE: To investigate the feasibility of pelvic floor muscle training (PFMT) through gametherapy for relieving urinary symptoms of climacteric women with stress or mixed urinary incontinence (UI). METHODS: Randomized clinical trial, divided into two groups: Gametherapy (G_Game) and Control (G_Control). Both groups received recommendations about unsupervised PFMT, and G_Game also received supervised PFMT through gametherapy. After 5 consecutive weeks, the feasibility was investigated considering participant adherence, urinary symptoms (evaluated by the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form [ICIQ-UI-SF] questionnaire), and pelvic floor function (PERFECT Scheme: power, endurance, repetition and fast). The Fisher exact, Kruskal-Wallis, Wilcoxon sign paired, and Mann-Whitney U tests were used by intention-to-treat analysis, using STATA 15.1 (StataCorp, College Station, TX, USA) software. RESULTS: The present study included 20 women per group and observed a higher adherence in G_Game. In the intragroup analysis, a decrease in the ICIQ-UI-SF score was observed in both groups (14.0 to 10.0; 13.5 to 0), associated with increased endurance (2.5 to 3.5; 2.5 to 4.0) in G_Control and G_Game, respectively. Moreover, there was a concomitant increase in pelvic floor muscles (PFMs) power (2.0 to 3.0), repetition (3.0 to 5.0), and fast (10.0 to 10.0) in G_Game. In the intergroup analysis, a reduction of UI was observed (p < 0.001; r = 0.8), as well an increase in PFM power (p = 0.027, r = 0.2) and endurance (p = 0.033; r = 0.3) in G_Game. CONCLUSION: The feasibility of supervised PFMT through gametherapy was identified by observing participant adherence, relief of urinary symptoms, and improvement in PFM function.

OBJETIVO: Investigar a viabilidade do treinamento dos músculos do assoalho pélvico (TMAP) por meio de gameterapia no alívio de sintomas urinários em mulheres climatéricas com incontinência urinária (IU) de esforço ou mista. MéTODOS: Ensaio clínico randomizado, dividido em dois grupos: Gameterapia (G_Game) e Controle (G_Controle). Ambos os grupos receberam recomendações sobre TMAP não supervisionado, e G_Game também recebeu TMAP supervisionado por meio de gameterapia. Após 5 semanas consecutivas, a viabilidade foi investigada considerando a aderência das participantes, sintomas urinários (avaliados pelo questionário International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form [ICIQ-UI-SF]) e função do assoalho pélvico (esquema PERFECT: power, endurance, repetition, fast). Os testes exatos de Fisher, Kruskal-Wallis, sinal de Wilcoxon pareado e Mann-Whitney U foram usados pela análise de intenção de tratar, usando o software STATA 15.1 (StataCorp, College Station, TX, EUA). RESULTADOS: O presente estudo incluiu 20 mulheres por grupo e observou uma maior adesão no G_Game. Na análise intragrupo, foi observada diminuição no escore do ICIQ-UI-SF em ambos os grupos (de 14,0 para 10,0; de 13,5 para 0), associada ao aumento da resistência (de 2,5 para 3,5; de 2,5 para 4,0) em G_Control e G_Game, respectivamente. Além disso, houve um aumento concomitante no power (de 2,0 para 3,0), repetition (de 3,0 para 5,0) e fast (de 10,0 para 10,0) dos músculos do assoalho pélvico (MAPs) no G_Game. Na análise intergrupos, foi observada redução da IU (p < 0,001; r = 0,8), assim como do power (p = 0,027; r = 0,2) e da endurance (p = 0,033; r = 0,3) dos MAPs no G_Game. CONCLUSãO: A viabilidade do TMAP supervisionado por meio de gameterapia foi identificada pela observação da aderência das participantes, pelo alívio dos sintomas urinários e pela melhora da função dos MAPs.

Effects of voluntary pre-contraction of the pelvic floor muscles (the Knack) on female stress urinary incontinence-a study protocol for a RCT.

BACKGROUND: Stress urinary incontinence (SUI) is a subtype of urinary incontinence that occurs more commonly amongst women. The pelvic floor muscle training (PFMT) is considered the gold standard for treating SUI. Another technique called the Knack postulated that pre-contraction of the pelvic floor muscles (PFM) during activities of increasing intra-abdominal pressure prevents urinary loss. Currently, there are no studies supporting the Knack for the treatment of SUI. Thus, the aim of this study is to test the hypothesis that voluntary pre-contraction of PFM can treat SUI. For this purpose, the following parameters will be analysed and compared amongst (1) the Knack, (2) PFMT and (3) the Knack + PFMT groups: urine leakage as assessed by the pad test, urinary symptoms, muscle function, quality of life, subjective cure, adherence to exercises in the outpatient setting and at home and perceived self-efficacy of PFM exercises. METHODS: A single-centre, double-blind (investigator and outcome assessor) randomised controlled trial with a 3-month follow-up of supervised treatment and an additional 3 months of follow-up (unsupervised) for a total of 6 months of follow-up. Two hundred ten women with mild to moderate SUI will be included, aged between 18 and 70 years. To compare the primary and secondary outcome measures within and between the groups studied (before and after intervention), the ANOVA statistical test will be used. Primary and secondary outcome measures will be presented as mean, standard deviation, 95% confidence interval and median and minimum and maximum values. DISCUSSION/SIGNIFICANCE: This study closes a gap, as voluntary PFM pre-contraction (the Knack) has not yet been included in the physiotherapeutic treatment of SUI, and if shown successful could be implemented in clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov NCT03722719 . Registered on October 29, 2018. Study protocol version 1. Was this trial prospectively registered? Yes Funded by: The present study did not receive funding. Anticipated completion date: The anticipated trial commencement and completion dates are October 2018 and October 2021, respectively. Provenance: Not invited. Peer reviewed. Human research ethics approval committee: Research Ethical Board of the Universidade Federal de São Paulo (UNIFESP), Brazil. Human research ethics approval number: 2.517.312.

Can Supervised Pelvic Floor Muscle Training Through Gametherapy Relieve Urinary Incontinence Symptoms in Climacteric Women? A Feasibility Study / O treinamento por meio de gameterapia pode aliviar os sintomas de incontinência urinária em mulheres climatéricas? Um estudo de viabilidade

Abstract Objective To investigate the feasibility of pelvic floor muscle training (PFMT) through gametherapy for relieving urinary symptoms of climacteric women with stress ormixed urinary incontinence (UI). Methods Randomized clinical trial, divided into two groups: Gametherapy (G_Game) and Control (G_Control). Both groups received recommendations about unsupervised PFMT, and G_Game also received supervised PFMT through gametherapy. After 5 consecutive weeks, the feasibility was investigated considering participant adherence, urinary symptoms (evaluated by the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form [ICIQ-UI-SF] questionnaire), and pelvic floor function (PERFECT Scheme: power, endurance, repetition and fast). The Fisher exact, Kruskal-Wallis, Wilcoxon sign paired, and Mann-Whitney U tests were used by intention-to-treat analysis, using STATA 15.1 (StataCorp, College Station, TX, USA) software. Results The present study included 20 women per group and observed a higher adherence in G_Game. In the intragroup analysis, a decrease in the ICIQ-UI-SF score was observed in both groups (14.0 to 10.0; 13.5 to 0), associated with increased endurance (2.5 to 3.5; 2.5 to 4.0) in G_Control and G_Game, respectively. Moreover, there was a concomitant increase in pelvic floor muscles (PFMs) power (2.0 to 3.0), repetition (3.0 to 5.0), and fast (10.0 to 10.0) in G_Game. In the intergroup analysis, a reduction of UI was observed (p<0.001; r=0.8), as well an increase in PFM power (p=0.027, r=0.2) and endurance (p=0.033; r=0.3) in G_Game. Conclusion The feasibility of supervised PFMT through gametherapy was identified by observing participant adherence, relief of urinary symptoms, and improvement in PFM function.

Resumo Objetivo Investigar a viabilidade do treinamento dos músculos do assoalho pélvico (TMAP) por meio de gameterapia no alívio de sintomas urinários em mulheres climatéricas com incontinência urinária (IU) de esforço ou mista. Métodos Ensaio clínico randomizado, dividido em dois grupos: Gameterapia (G_Game) e Controle (G_Controle). Ambos os grupos receberam recomendações sobre TMAP não supervisionado, e G_Gametambém recebeu TMAP supervisionado por meio de gameterapia. Após 5 semanas consecutivas, a viabilidade foi investigada considerando a aderência das participantes, sintomas urinários (avaliados pelo questionário International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form [ICIQ-UI-SF]) e função do assoalho pélvico (esquema PERFECT: power, endurance, repetition, fast). Os testes exatos de Fisher, Kruskal-Wallis, sinal de Wilcoxon pareado e Mann-Whitney U foram usados pela análise de intenção de tratar, usando o software STATA 15.1 (StataCorp, College Station, TX, EUA). Resultados O presente estudo incluiu 20 mulheres por grupo e observou uma maior adesão no G_Game. Na análise intragrupo, foi observada diminuição no escore do ICIQUI- SF emambos os grupos (de 14,0 para 10,0; de 13,5 para 0), associada ao aumento da resistência (de 2,5 para 3,5; de 2,5 para 4,0) em G_Control e G_Game, respectivamente. Além disso, houve um aumento concomitante no power (de 2,0 para 3,0), repetition (de 3,0 para 5,0) e fast (de 10,0 para 10,0) dosmúsculos do assoalho pélvico (MAPs) no G_Game. Na análise intergrupos, foi observada redução da IU (p<0,001; r=0,8), assim como do power (p=0,027; r=0,2) e da endurance (p=0,033; r=0,3) dos MAPs no G_Game. Conclusão A viabilidade do TMAP supervisionado por meio de gameterapia foi identificada pela observação da aderência das participantes, pelo alívio dos sintomas urinários e pela melhora da função dos MAPs.

The role of vaginal palpation in motor learning of the pelvic floor muscles for women with stress urinary incontinence: study protocol for a randomized controlled trial.

BACKGROUND: Approximately 30 to 50% of women are unable to correctly perform pelvic floor muscle (PFM) contractions. For women to benefit from a pelvic floor muscle training (PFMT) programme for stress urinary incontinence (SUI), the awareness phase of PFMT cannot be omitted. The purpose of this study is to evaluate whether vaginal palpation together with verbal instructions about PFMs and body awareness techniques helps women with SUI learn how to correctly contract the PFMs and improve their functions. METHODS: This single-centre, double-blind randomized controlled trial with two intervention groups was designed following the standard protocol items for randomized interventional trials (SPIRIT). The results will be reported in a manner consistent with the Consolidated Standards of Reporting Trials (CONSORT) guidelines. Patients with SUI (n = 172) will be recruited. The experimental group will receive verbal instructions about PFM function and body awareness techniques together with vaginal palpation; the control group will receive similar protocol without vaginal palpation. The primary outcome includes the number of fast-twitch muscle fibres assessed by vaginal palpation and visual observation. Secondary outcomes include power and muscular endurance that will be assessed by visual observation and vaginal palpation (Oxford scale), the use of accessory muscles during the voluntary contraction of PFMs, and the self-efficacy and the expectations for the results using the self-efficacy scale of pelvic floor exercises. DISCUSSION: This study will determine whether vaginal palpation can help women with SUI to correctly perform PFM contractions and improve their functions. TRIAL REGISTRATION: ClinicalTrials.gov NCT03325543 . Registered on 30 November 2017. Study protocol version 1; 30 November 2020. Prospectively registered.

Can abdominal hypropressive technique improve stress urinary incontinence? an assessor-blinded randomized controlled trial.

AIM: To verify which one improves better stress urinary incontinence (SUI) symptoms: abdominal hypopressive technique (AHT) or pelvic floor muscle training (PFMT). METHODS: Randomized controlled trial. Women with SUI who had not participated of physiotherapy program before were invited. The outcome measures were 7-day bladder diary, International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) and pelvic floor muscles (PFM) function measured by Modified Oxford grading System with vaginal palpation and manometry with Peritron. Intervention consisted by 12 weeks of exercises program including PFMT or AHT program, in groups of maximum three women, twice a week, with physiotherapist supervision. RESULTS: AHT and PFMT groups reduced urinary leakage episodes in 7 days, -0.64 and -1.91, respectively, but PFMT was superior, whit mean difference -1.27 (95% confidence interval [CI]: -1.92 to -0,62) and effect size was 0.94 in favor to PFMT. Regarding to total score of ICIQ-SF, both groups improved, with mean difference between groups -4.7 (95% CI: -6.90 to -2.50) and effect size was 1.04 in favor to PFMT. Manometry also presented improvement after treatment for both groups with mean difference between them of 11 (95% CI: 6.33-15.67) and effect size was 1.15 also in favor to PFMT. CONCLUSION: Regarding to SUI symptoms, quality of life impact and PFM function both groups presented improvement, however, PFMT was superior to AHT among all of them.

Effect of Pelvic Floor and Hip Muscle Strengthening in the Treatment of Stress Urinary Incontinence: A Randomized Clinical Trial.

OBJECTIVE: To investigate the effectiveness of strengthening the hip muscles in addition to strengthening the pelvic floor muscles (PFM) in the treatment of stress urinary incontinence. METHODS: This study used a prospective, assessor-blind, randomized clinical trial with parallel groups. We randomly allocated 47 individuals with stress urinary incontinence to 2 groups: 1 performing only pelvic floor strengthening exercises (PF, n = 21) and the other performing pelvic floor strengthening exercises plus exercises for the gluteus maximus and medius and hip adductor muscles (PFH, n = 22). Four individuals did not complete the study. Frequency of urine leakage was the primary outcome (3-day voiding diary and a follow-up voiding diary). Secondary outcomes were pelvic floor muscle strength (Ortiz scale, PERFECT scheme [Oxford Scale], and perineometry) and quality of life (QoL; International Consultation on Incontinence Questionnaire-Short Form and King's Health Questionnaire), which were evaluated by a blinded assessor before and after 20 sessions over 10 weeks. RESULTS: Regarding the daily frequency of urine loss evaluated by the follow-up voiding diary, an effect of group was observed (P < .001), with the PFH group showing a significant decrease in daily loss frequency, although no significant differences were found in the comparison between groups for the 3-day voiding diary, QoL, or functional assessment of the PFM. CONCLUSION: Strengthening the PFM together with the hip synergic muscles showed better results for frequency of daily urine loss throughout the sessions, although there was no accompanying superiority in improvement of strength, perineometry, or QoL over the group that performed only PFM-strengthening exercises.

Effects of individual pelvic floor muscle training vs individual training progressing to group training vs group training alone in women with stress urinary incontinence: A randomized clinical trial.

AIMS: To assess the effects of individual pelvic floor muscle (PFM) training vs individual training (IT) progressing to group training (GT) vs group-only training in women with stress urinary incontinence (SUI). METHODS: Randomized controlled and pragmatic clinical trials with 90 women with SUI. Participants were randomly allocated to one of three groups: IT, GT, or four individual sessions progressing to group training (IPGT). The intervention included 12 sessions, once a week, with direct supervision by a physical therapist. PRIMARY OUTCOME: severity according to the King's Health Questionnaire. SECONDARY OUTCOMES: PFM function by palpation and manometer, bladder and exercise diaries, PFM training adherence, and self-efficacy. Reassessments were conducted at the end of the intervention, 3 and 6 months after the intervention. Intra- and intergroup analysis for all outcomes was performed using a multivariate analysis of variance. In the mixed-effects model used, the evaluation groups and times and their interactions were considered. A significance level of 5% was adopted. RESULTS: After the intervention, the severity measure improved in all three groups (P < .001), without difference between them (P = .56). The benefits of the intervention were maintained 3 and 6 months after the end of the supervised training (P < .001). The IPGT group had a significant improvement in PFM function when compared to the other groups posttreatment (P < .001). CONCLUSION: PFM training improved the severity of urinary incontinence in all groups after 12 sessions of training supervised by a physical therapist. IT progressing to GT improved the function of upper PFM when compared to the other groups.

Pelvic floor muscle training for female stress urinary incontinence: a randomised control trial comparing home and outpatient training.

INTRODUCTION AND HYPOTHESIS: In the literature, it is suggested that supervised pelvic floor muscle training (PFMT) might be the first option treatment for female stress urinary incontinence (SUI). However, inadequate accessibility to health care and scarce individual resources may prevent adherence to the treatment. Our study is aimed at comparing the efficacy of performing PFMT in an outpatient clinic and at home in Brazilian incontinent women, and to verify if home PFMT may be an alternative to those not able to attend the outpatient sessions. METHODS: A total of 69 women with predominant SUI were randomised into two groups: outpatient PFMT and home PFMT. The primary outcome was the cure of SUI defined as <2 g of leakage in a 20-min pad test. Secondary outcomes were: pelvic floor muscle function; urinary symptoms; quality of life; patient satisfaction; and adherence to home exercise sets. The assessments were conducted at baseline and after 3 months of treatment. Statistical analyses consisted of Student's t, Mann-Whitney U, Chi-squared, and Wilcoxon tests, with a 5% cut-off for significance. RESULTS: A superior objective cure of SUI was observed in the outpatient clinic (62%) compared with the home (28%) PFMT groups (OR: 4.0 [95% CI: 1.4-11.0]; p = 0.011). Secondarily, there was no difference between groups regarding the following: satisfaction with the treatment; quality of life; function of the PFMs; and number of episodes of urine leakage per week. The home adherence to the exercises was superior in the outpatient PFMT group only during the first-month training. CONCLUSIONS: Outpatient PFMT was associated with a higher objective cure of SUI than home PFMT. However, subjective findings show equal benefit of home PFMT providing evidence that this may be an alternative treatment to our population.