Floor Muscle Training In Women Research Articles

Pelvic Floor Muscle Training in Women with Pelvic Organ Prolapse: A Randomised Controlled Trial

Pelvic Floor Muscle Training in Women with Pelvic Organ Prolapse: A Randomised Controlled Trial

Effects of Transcranial Direct Current Stimulation and Pelvic Floor Muscle Training in Women: protocol for a controlled, randomized, double-blind clinical trial

RESUMO A fraqueza muscular do assoalho pélvico pode gerar incontinência urinária, prolapso de órgãos pélvicos e disfunção sexual, e pode ser minimizada pelo treinamento muscular do assoalho pélvico (TMAP). No entanto, este efeito não é duradouro. Assim, terapia combinada parece ser promissora para a melhora deste quadro. Dessa forma, objetiva-se avaliar o efeito da estimulação transcraniana por corrente contínua (ETCC), combinada ao TMAP, sobre a pressão intravaginal, força muscular do assoalho pélvico (FMAP), função sexual (FS) e qualidade de vida (QV) em mulheres saudáveis. Serão 32 mulheres, entre 18 e 45 anos, que realizaram TMAP (contrações e relaxamento do períneo) e Biofeedback associados a ETCC ativa ou ETCC sham por 20 minutos, três vezes por semana, por 4 semanas, totalizando 12 sessões. Durante o protocolo, as participantes também realizarão diariamente, em domicílio, o TMAP. O eletrodo anodal da ETCC será posicionado sobre a área motora suplementar do hemisfério cortical dominante, e o catodal sobre a região supraorbital contralateral, com intensidade de 2mA, por 20 minutos. A pressão intravaginal (manômetro de pressão), FMAP (palpação digital, esquema Perfect), FS (Índice de Função Sexual Feminina) e QV (questionário SF-36) foram avaliadas antes e depois das 12 sessões, bem como após acompanhamento de 30 dias.

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

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. 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. 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. 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.

Exploring Adherence to Pelvic Floor Muscle Training in Women Using Mobile Apps: Scoping Review.

Pelvic floor dysfunction is a public health issue, with 1 in 3 women experiencing symptoms at some point in their lifetime. The gold standard of treatment for pelvic floor dysfunction is supervised pelvic floor muscle training (PFMT); however, adherence to PFMT in women is poor. Mobile apps are increasingly being used in the National Health Service to enable equity in the distribution of health care and increase accessibility to services. However, it is unclear how PFMT mobile apps influence PFMT adherence in women. We aimed to identify which behavior change techniques (BCTs) have been used in PFMT mobile apps, to distinguish the core "capability, opportunity, and motivation" (COM) behaviors targeted by the BCTs used in PFMT mobile apps, and to compare the levels of PFMT adherence in women between those using PFMT mobile apps and those receiving usual care. We conducted a scoping review of the literature. Published quantitative literature that compared the use of a PFMT mobile app to a control group was included to address the objectives of the study. The electronic bibliographic databases searched included MEDLINE, CINAHL, Scopus, Web of Science, and PEDro, along with CENTRAL. Studies were also identified from reference searching of systematic reviews. Original articles written in English from 2006 onward were included. Nonexperimental quantitative studies, qualitative studies, studies that use male participants, case studies, web-based interventions, and interventions that use vaginal probes were excluded. Narrative synthesis was conducted on eligible articles based on the aims of the study. Of the 114 records retrieved from the search, a total of 6 articles met the eligibility and inclusion criteria. The total number of participants in the studies was 471. All PFMT mobile apps used the BCT "prompts and cues." Opportunity was the core COM behavior targeted by the PFMT mobile apps. Higher levels of adherence to PFMT were observed among women using PFMT mobile apps. Digital "prompts and cues" are a BCT commonly used in PFMT mobile apps, and further research is required to practically assess whether a future randomized controlled trial that investigates the effectiveness of digital "prompts and cues" on PFMT adherence in women can be conducted.

A randomized controlled pilot trial to assess the effectiveness of a specially formulated food supplement and pelvic floor muscle training in women with stress-predominant urinary incontinence

BackgroundPelvic floor muscle training (PFMT) is the first-line treatment approach for stress urinary incontinence. Creatine and leucine have been shown to improve muscle function. Our aim was to assess the effectiveness of a food supplement and PFMT in women with stress-predominant urinary incontinence.MethodsWomen with stress-predominant urinary incontinence were randomized in 1:1 ratio to receive daily oral supplementation for six weeks with either a food supplement (treatment group) or placebo (control group). Both groups were instructed to perform standardized daily PFMT. The primary outcome was the Urogenital Distress Inventory Short Form (UDI-6) score. Secondary outcomes were the Incontinence Impact Questionnaire (IIQ-7) score, Patient’s Global Impression of Severity (PGI‐S), and Biomechanical Integrity score (BI-score) measured by Vaginal Tactile Imager. To have a power of 80% and a significance level of 5% to detect a decrease of 16 points in the UDI-6 score, a sample size of 32 was needed, with 16 patients in each arm of our trial.ResultsSixteen women in the control group and sixteen in the treatment group completed the trial. Between-group analysis revealed no significant differences between the control and treatment group except for mean change (delta) in vaginal squeeze pressure [(cmH2O, mean ± SD), 5 ± 12 vs. 15 ± 15, P = 0.04] and mean change (delta) in PGI-S score [(mean ± SD), -0.2 ± 0.9 vs. -0.8 ± 0.8, P = 0.04]. Within-group analysis showed that UDI-6 and IIQ-7 scores improved significantly from baseline to six weeks in the treatment group but not in the control group [UDI-6 score (mean ± SD) 45 ± 21 vs. 29 ± 21, P = 0.02; 43 ± 18 vs. 33 ± 26, P = 0.22] [IIQ-7 score (mean ± SD) 50 ± 30 vs. 30 ± 21, P = 0.01; 48 ± 23 vs.40 ± 28, P = 0.36]. PGI-S scores only improved in the treatment group from baseline to six weeks after treatment [PGI-S score (mean ± SD) 3.1 ± 0.8 vs. 2.3 ± 0.8, P = 0.0001]. BI-score, on average, improved significantly in the treatment and control group as well [SD unit, mean, from − 1.06 to -0.58, P = 0.001; from − 0.66 to -0.42, P = 0.04].ConclusionsWomen with stress-predominant urinary incontinence receiving a specially formulated supplement in addition to daily PFMT for six weeks had significantly improved urinary symptoms (decrease in UDI-6 score and IIQ-7) and BI-score compared to their baseline.Trial registrationClinicalTrials.gov Identifier: NCT05358769. 27/04/2022.

A Randomized Controlled Trial to Assess the Effectiveness of a Specially Formulated Food Supplement and Pelvic Floor Muscle Training in Women With Stress-Predominant Urinary Incontinence [ID: 1372768

INTRODUCTION: The objective of this study was to assess the effectiveness of a creatine-leucine-based food supplement and standardized pelvic floor muscle training (PFMT) in women with stress-predominant urinary incontinence (SUI). METHODS: Women with SUI were randomized to receive daily oral supplementation for 6 weeks with either a supplement or placebo. Both groups were instructed to perform daily PFMT at an intensity of at least 75% of one repetition maximum of 45 pelvic floor muscle contractions per day. The primary outcome was the Urogenital Distress Inventory Short Form (UDI-6) score. Secondary outcomes were the Incontinence Impact Questionnaire (IIQ-7) score, Biomechanical Integrity (BI) score measured by Vaginal Tactile Imager. To have a power of 80% and a significance level of 5%, a sample size of 32 was needed. The trial was IRB approved. RESULTS: Within-group analysis showed that UDI-6 and IIQ-7 scores improved significantly from baseline to 6 weeks in the treatment group but not in the control group (UDI-6 score [mean±SD], 45±21 versus 29±21, P=.02; 43±18 versus 33±26, P=.22) (IIQ-7 score [mean±SD], 50±30 versus 30±21, P=.01; 48±23 versus 40±28, P=.36). Out of the 52 examined VTI parameters, significantly more parameters improved in the treatment group compared to the control group (11/52 versus 3/52, P=.04). BI-score, on average, improved significantly in the treatment and control group as well (SD unit, mean, from −1.06 to −0.58, P=.001; from −0.66 to −0.42, P=.04). CONCLUSION: Women with SUI receiving a specially formulated supplement in addition to daily PFMT for 6 weeks had improved urinary symptoms (significant decrease in UDI-6 and IIQ-7 scores) and better BI score compared to baseline.

The effect of pelvic floor muscle training in women with functional bladder outlet obstruction.

Female voiding dysfunction is often due to bladder outlet obstruction (BOO). We investigated pelvic floor muscle training (PFMT) effectiveness in women with functional BOO. This is a prospective study recruiting 63 women functionally obstructed, over 18yo, maximum flow rate (Qmax) less than 12ml/sec, naïve of voiding treatment. Exclusion criteria were anatomical BOO, neurological condition, pelvic intervention, psychiatric or anticholinergic medication, diabetes mellitus and affected upper urinary tract. At baseline, women underwent uroflow, post void residual (PVR) measurement, cystoscopy, cystogram and urodynamic study (UDS) with pelvic electromyography (EMG). Blaivas-Groutz nomogram has been used to define obstruction. After diagnosis, patients underwent six-month PFMT. Re-evaluation was offered four weeks after end of treatment. Data were analyzed with SPSSv22.0. 63 women were recruited and 48 finally included. At baseline, 20 reported 3 urinary tract infections (UTIs) during last year, and 12 had one episode of urine retention. Median Qmax was 7.5ml/sec and median PVR 110ml. 40 women were obstructed. 16 (40%) had mild, 16 (40%) moderate and 8 (20%) severe obstruction. All subjects had an overactive pelvic floor on EMG. Obstructed women were re-evaluated. Median Qmax was 8.5ml/sec, close to baseline (p = 0.16). Median PVR was 65ml, reduced to baseline (p = 0.02). 33 (82.5%) remained obstructed, 22 (66.67%) with mild, 8 (24.24%) moderate and 3 (9.09%) severe obstruction. 7 (17.5%) were non-obstructed. 4 patients reported one UTI episode with no cases of retention. A 6month PFMT reduced UTIs and PVR in women with functional BOO. Additionally, most patients had a de-escalation to milder obstruction.

Developing a Clinical Care Guideline on Pelvic Floor Muscle Training for Women with Mild Stress Urinary Incontinence

&lt;p&gt;臨床上壓力性尿失禁常使用的評估診斷工具，可能造成輕度尿失禁症狀被低估而未適當治療，使病患仍受困擾。台灣健保制度完善，利用手術治療中、重度壓力性尿失禁病患，卻沒有對骨盆底肌強化訓練如何治療輕度壓力性尿失禁進行明確規範。本文發展流程為選定主題、建構問題、系統性文獻查證，根據16篇實證文獻擬定此指引，經由德菲法共識確認，隨後以AGREE II進行外部評估，結果為強烈建議使用，發展出指引範圍包含三個構面：指引的範圍界定5項，壓力性尿失禁評估診斷2項和處置建議5項。透過會議使醫師及專科護理師間達成共識；團隊成員教育訓練；建立檢核表，標準化評估處置流程，使輕度壓力性尿失禁婦女在身心完整評估下，適切接受骨盆底肌強化訓練。由於專科護理師跨醫療護理的角色功能，更能將此指引整合落實，使輕度壓力性尿失禁病患的照護更完整與持續。&lt;/p&gt; &lt;p&gt;&amp;nbsp;&lt;/p&gt;&lt;p&gt;The commonly used evaluation and diagnostic tools for clinical stress urinary incontinence may lead to underestimation of mild symptoms. Therefore, leaving patients with long-term distress when prop-erly treatment is not provided. Taiwan has a well-established health insurance system, of which sur-gery is used to treat patients with moderate to severe stress urinary incontinence, but there is no clear regulation on the use of pelvic floor muscle training to treat mild stress urinary incontinence. Through the selection of topics, construction of issues and comprehensive literature review, this guideline was developed based on 16 empirical studies. The content of this guideline was later confirmed by the Dephi method and was strongly recommended for application after externally evaluated by AGREEII. The scope of this guideline includes three facets: 5 items for scoping, 2 items for the assessment and diagnosis of stress urinary incontinence, and 5 items for treatment. Through meetings, consensus was reached between physicians and nurse practitioners; team members were educated and trained; a checklist was established to standardize the evaluation and treatment process, so that women with mild stress urinary incontinence could appropriately receive pelvic floor muscle training after a com-plete physical and mental evaluation. Since nurse practitioner plays an important role in medical care, this guideline can be integrated and implemented to comprehensively improve the care of patients with mild stress urinary incontinence.&lt;/p&gt; &lt;p&gt;&amp;nbsp;&lt;/p&gt;

Predictive Value of Pelvic Floor Muscle Morphometry Using 3D/4D Ultrasound in Relation to the Success of Pelvic Floor Muscle Training in Women with Stress Urinary Incontinence.

The aim of our study was to establish the predictive value of pelvic floor muscle morphometry using 3D/4D ultrasound in relation to the success of pelvic floor muscle training (PFMT) for 12 weeks in women with stress urinary incontinence (SUI). A total of 86 women with SUI from regional gynaecological and urological outpatient clinics were enrolled on this cross-sectional study. SUI symptoms were assessed by the International Consultation on Incontinence Questionnaire (ICIQ-UI SF). Pelvic floor muscle function was evaluated using a perineometer. Pelvic floor muscle morphometry (PFMM) was evaluated by the size of the urogenital hiatus (HA in cm2) at rest (R), at contraction (C) and during the Valsalva manoeuvre, i.e., a strong push (V), by 3D/4D USG. The intervention was PFMT for 12 weeks. After PFMT, we noted significant improvement in SUI symptoms, pelvic floor muscle function and morphometry. Moderately significant (0.001) negative correlations were confirmed between the total ICIQ-UI SF score and strength (-0.236 **) and endurance (-0.326 **) of the maximal voluntary contraction (MvC), the number of MvC lasting 3 s (-0.406 **) and 1 s (-0.338 **). Moderately significant (0.001) positive correlations were confirmed between the total ICIQ-UI SF score and R (r = 0.453 **), C (r = 0.533 **) and V (r = 0.442 **). The predictive value of PFMM reached a positive prediction of a decrease with an ICIQ-UI SF score below 8. HA during V was most strongly associated with SUI reduction, with an area under the curve (AUC) of 0.87 (p ≤ 0.001), a positive predictive value of 83.3%, a negative predictive value of 75.0%, sensitivity of 78.9% and specificity of 80.0%. The predictive values of pelvic floor muscle morphometry using 3D/4D USG confirmed the success of PFMT in women with SUI.

Effect of Electroacupuncture Added to Pelvic Floor Muscle Training in Women with Stress Urinary Incontinence: A Randomized Clinical Trial

BackgroundPelvic floor muscle training (PFMT) is a first-line conservative therapy for stress urinary incontinence (SUI). Electroacupuncture (EA) has been used to treat SUI recently. ObjectiveTo compare the effectiveness of PFMT + EA versus PFMT + sham EA for SUI in women. Design, setting, and participantsA prospective, multicenter, randomized, controlled clinical trial was conducted at four hospitals in China involving 304 women with SUI from May 20, 2014 to November 21, 2017. Data were analyzed from April 20 to December 21, 2018. InterventionParticipants were randomized to receive 8 wk of PFMT+ EA (n = 154) or PFMT + sham EA (n = 150). Outcome measurements and statistical analysisThe primary outcome was the change in the amount of urine leakage measured on a 1-hr pad test. Student’s t test, the χ2 test, and the Wilcoxon rank-sum test were used for data analysis. Results and limitationsAmong the 304 participants randomized, 286 completed the study. The mean age was 57.6 yr (standard deviation [SD] 8.9) for the PFMT + sham EA group and 57.2 yr (SD 9.1) for the PFMT + EA group. The mean urine leakage at baseline was 13.6 g for the PFMT + sham EA group and 13.9 g for the PFMT + EA group. After the 8-wk intervention, the PFMT + EA group had a greater decrease in mean urine leakage (−9.8 g) than the PFMT + sham EA group (−5.8 g) with a mean difference of 4.0 g (95% confidence interval [CI] 0.8–7.2). Significantly more patients experienced a ≥50% reduction in urine leakage and the mean number of incontinence episodes in 24 h in the PFMT + EA group than in the PFMT + sham EA group (26.3%, 95%CI 15.8–36.8%). The PFMT + EA group experienced better improvement in participant-reported SUI severity at 6 wk (p < 0.001) and 8 wk (p < 0.001) and self-evaluated therapeutic effects at 2–32 wk (p < 0.001) after the intervention. Lack of measurement of the amount of urine leakage during follow-up is a limitation. ConclusionsIn this randomized clinical trial, 8-wk combined treatment with PFMT + EA led to a greater improvement in SUI symptoms and better outcomes than with PFMT + sham EA. Patient summaryWe evaluated the effectiveness and safety of pelvic floor muscle training combined with electroacupuncture for stress urinary incontinence in women, Our results show that this is a promising therapeutic approach for the treatment of stress urinary 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.

Electroacupuntura frente al entrenamiento muscular del suelo pélvico para la incontinencia urinaria en mujeres. Un análisis retrospectivo

Introduction and objectivesUrinary incontinence is highly prevalent. The problem is not always solved with medication and/or surgery and they are not without side effects, which has led to the use of acupuncture for the condition. We compare electroacupuncture with pelvic floor muscle training in women with urinary incontinence. MethodsThis is a retrospective, randomised study of 71 women with urinary incontinence and 2 groups: 37 women received electroacupuncture at R 7 points plus pelvic floor muscle training, and another group of 34 women received only pelvic floor muscle training. Electroacupuncture was performed in one session per week for 12 weeks. All participants performed the exercises at home after prior training. Follow-up was conducted over 1 year. Efficacy was assessed using the Spanish versions of the International Consultation on Incontinence Questionnaire-Short Form and the Bladder Control Self-Assessment Questionnaire. The questionnaires were conducted at baseline and at 3, 6, and 12 months. The safety of electroacupuncture was also assessed. ResultsThe reduced score in both questionnaires was clinically and statistically more significant in the electroacupuncture group. DiscussionElectroacupuncture at the R 7 point was identified as more effective than pelvic floor muscle training in women with urinary incontinence, and with very few side effects.

The effect of pelvic floor muscle training for women with pelvic organ prolapse: a meta-analysis.

This study was aimed at evaluating the effect of pelvic floor muscle training (PFMT) as a conservative treatment for patients with pelvic organ prolapse (POP). A comprehensive search to identify eligible randomized controlled trial (RCT) studies was conducted using electronic databases including PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), and Embase up to 10 June 2021. Results were presented as risk ratio (RR), the weighted mean difference (WMD), with 95% confidence interval (95% CI) using the random effects model. Outcome variables were pooled using Review Manager version 5.3. Thirteen studies were included. Our results demonstrated that women who received PFMT intervention had a greater improvement than controls in prolapse symptom score (POP-SS; mean difference [MD] -1.66, 95% CI -2.36 to -0.97, p < 0.00001] and POP stages (risk ration [RR] 1.51, 95% CI 1.14-2.01, p = 0.004). The number of participants who felt better after PFMT was higher (RR 1.98, 95% CI 1.21-3.24, p = 0.006). Subgroup analysis showed that the symptoms of prolapse and the degree of prolapse were improved significantly in the short term, but there was no significant difference in the long-term effect. In addition, there was no significant difference in the impact of PFMT on the elderly and the quality of life. More RCTs are needed to evaluate the effect of PFMT on the elderly and whether the quality of life can be improved. We found that PFMT can improve subjective symptoms and objective POP severity. More research is needed on the long-term effect.

Impact of Urinary Incontinence on Women’s Sexuality

Objective: Globally, the prevalence of urinary incontinence (UI) in women is estimated to be in the range of 25% to 45%. Different types of UI exist, being the most frequent ones stress UI, urgency UI and mixed UI. Being affected by UI is associated with a higher risk of sexual inactivity, regardless of its type. Mechanism: It is estimated that 5–38% patients with UI are sexually inactive due to UI, whereas 25–38% sexually active women would restrict their sexual activity due to UI. The prevalence of sexual dysfunction within sexually active women with UI is 23–56%. Findings in Brief: In patients with UI, the most frequent sexual dysfunctions are dyspareunia (44%), female sexual interest/arousal disorder (34%) and orgasmic disorder (11%). Therefore, UI has a negative impact on the sexual function of sexually active women with UI. Coital incontinence is defined as the complaint of involuntary loss of urine during or after intercourse. UI with penetration represents any complaint of involuntary loss of urine with vaginal stimulation (either with a sexual toy, manually or with penetration). Orgasmic UI refers to any complaint of involuntary loss of urine occurring at orgasm, regardless of the sexual behaviour that has triggered it. Due to the high prevalence of coital UI (50–60%) in the female population and its strongly negative impact on women’s sexuality, patients should be specifically asked for coital UI in the gynecologic visits. Conclusions: UI affects between one in four and one in two women and had a negative impact on quality of life. Not only UI has an impact on female sexuality, but also different treatments which are offered to treat it can play a role. The reduction of sexual problems with pelvic floor muscle training in women with stress UI has been proved, being the rate of sexual activity doubled. A significant improvement of the overactive bladder associated to urgency UI and female sexual function has been described after the pharmacological treatment or botulinum toxin. Finally, significant improvement of the sexual function has also been found after midurethral slings for stress UI, as well as for coital UI.

Assessment of the Relative Performance of the EQ-5D-3L, ICIQ-UI SF and POP-SS Using Data from the OPAL Trial.

Conducting economic evaluations alongside randomised controlled trials (RCTs) is an efficient way to collect cost-effectiveness data. Generic preference-based measures, such as EQ-5D, are often used alongside clinical data measures in RCTs. However, in the case of female urinary incontinence (UI), evidence of the relative performance of EQ-5D with condition-specific measures such as the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF), measuring severity of UI, and Pelvic Organ Prolapse Symptom Score (POP-SS), measuring severity of prolapse symptoms, is limited. This study employed secondary analysis of outcome measures data collected during the Optimal Pelvic floor muscle training for Adherence Long-term (OPAL) RCT, which compared biofeedback-mediated pelvic floor muscle training to basic pelvic floor muscle training for women with UI. The relative performance of EQ-5D-3L and ICIQ-UI SF, and EQ-5D-3L and POP-SS was assessed for concurrent validity and known-groups validity. Data for 577 women (mean age 48) were available for EQ-5D-3L/ICIQ-UI SF, and 555 women (mean age 47) for EQ-5D-3L/POP-SS. Overall, EQ-5D-3L exhibited very weak association with the ICIQ-UI SF total score, or any subscale. EQ-5D-3L and POP-SS were found to be weakly correlated. EQ-5D-3L was able to distinguish between groups with known differences in severity of UI and also between types of UI. These findings provide useful information to guide researchers in selecting appropriate outcome measures for use in future clinical trials.

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

IntroductionPelvic 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.AimsTo 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.MethodsRandomized 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.DiscussionThis 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 registrationBrazilian Registry of Clinical Trials (ReBEC) ID: RBR-6gtzg4. Registered on September 3, 2019.

P0097 - Factors contributing to long-term adherence to pelvic floor muscle training in women suffering from stress urinary incontinence

P0097 - Factors contributing to long-term adherence to pelvic floor muscle training in women suffering from stress urinary incontinence

Completeness of exercise reporting among randomized controlled trials on pelvic floor muscle training for women with pelvic organ prolapse: A systematic review.

AimsThis systematic review aimed to assess the completeness of exercise reporting in randomized controlled trials (RCTs) on pelvic floor muscle training (PFMT) for women with pelvic organ prolapse (POP).MethodsMEDLINE, Cochrane Central, CINHAL, Embase, SCOPUS, and PEDro databases were searched up to October 2020. Full‐text RCTs comparing PFMT to any type of intervention among women with any type and stage of POP were eligible for inclusion. Completeness of intervention was evaluated with t20he template for intervention description and replication (TIDieR) and the consensus on exercise reporting template (CERT). Inter‐rater agreement for each item of the tools was calculated.ResultsTwenty‐six RCTs were included. None of the studies completely reported all intervention descriptors. On average 57.1% (6.8 ± 2.4; out of 12) of the overall TIDieR items and 35.3% (6.7 ± 2.9; out of 19) of the CERT were well described. In particular, 7 and 5 items were completely reported more than 50% of the time for the TIDieR and CERT, respectively. Frequent shortcomings were the undetailed reporting of information regarding tailoring and modifications of exercises and their adherence. Detailed descriptions of exercise repetitions to enable replication were missing in 53.8%. According to the CERT, only 11.5% of the RCTs sufficiently described the main providers' characteristics.ConclusionThe completeness of PFMT reporting for women with POP is still below desirable standards and it is insufficient to ensure transferability into practice. The present results may add relevant knowledge and contribute to improving adequate reporting of exercise.

Real-World Effectiveness of Pelvic Floor Muscle Training for Women With Urinary Tract Symptoms and/or Prolapse.

To determine the real-world effectiveness of pelvic floor muscle therapy (PFMT) recommendations for patients. We conducted a cross-sectional study of 70 women who were advised to undergo PFMT after their initial urogynaecology consultation for lower urinary tract symptoms and/or pelvic organ prolapse. About half (51%) of potential participants consented to answer our telephone survey. We calculated the proportion of patients who complied with the recommendation of PFMT, and we subjectively assessed whether these patients found PFMT to be helpful. We also collected demographic data and looked for reasons why patients did not attend PFMT. Chi-square, 2-tailed t, or Fisher exact tests were used to compare differences between patients who attended and those who did not. During the 6-month period after their initial consultation, only 28 of 70 women (40%) followed the recommendation to attend PFMT. Sixteen of the 28 women who attended PFMT (57%) reported that they found it helpful. Therefore, the "real-world effectiveness" of the entire study sample was 23%, with only 16 of 70 women benefiting from PFMT. Time constraints (27%) and cost (18%) were the top 2 reasons given for not attending. Despite evidence-based recommendations in favour of PFMT for various pelvic floor disorders, its real-world effectiveness is quite low. A public health commitment to providing access to PFMT would be of significant benefit.

Impact des sondes de biofeedback utilisées dans le cadre de l’auto-rééducation des muscles du plancher pelvien chez la femme incontinente urinaire à l’effort. Revue de la littérature

The purpose of this review was to identify the evaluated effects of the use of biofeedback probes used in the self-rehabilitation of the pelvic floor muscles, on the muscle function, symptom severity, quality of life, and compliance/adherence to exercise for women with stress urinary incontinence. A literature review was conducted in March 2020 on the PubMed, PEDro and Science Direct databases. A total of 3 randomised controlled trials (n=167 participants) were included and analysed. The different results found show significant improvements in muscle function with a percentage of 87.5% (P=0.003) of patients improved on the modified Oxford scale, as well as perineometry increasing from 23.06 to 32 (P=0.011). Symptom severity is also improved with a decrease in the number of pads and pad weight in the Pad Test (P<0.005). Concerning quality of life, significant improvements in the King's Health Questionnaire (KHQ) and the Visual Analogue Scale of Psychological Stress were found, with an improvement in the number of patients in each group at the end of the study (P<0.0005). No results showed a superiority of pelvic floor muscle training with a biofeedback probe compared to training alone. This review didn't provide real recommendations for the use of home biofeedback probes as an adjunct to pelvic floor muscle training in women with stress urinary incontinence. She suggests that the use of biofeedback probes wouldn't be more effective than training without them.