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Effects of three interventions in facilitating voluntary pelvic floor muscle contraction in women: a randomized controlled trial.

ABSTRACT: OBJECTIVE:To evaluate the effect of vaginal palpation, vaginal palpation associated with posterior pelvic tilt, and intravaginal electrical stimulation in facilitating voluntary contraction of the pelvic floor muscles in women. METHODS:A randomized controlled trial in which 132 women with pelvic floor muscles function graded at 0 or 1 using the Modified Oxford Scale were randomized into four groups: vaginal palpation (n=33); vaginal palpation with posterior pelvic tilt (n=33); intravaginal electrical stimulation (n=33) and a control group (n=33) that only received verbal instructions. The primary outcome was evaluated by the Modified Oxford Scale and the secondary using the ICIQ-UI-SF. The assessment was performed at baseline with follow-up assessment after eight weeks. RESULTS:A total of 69.7% of the women from posterior pelvic tilt; 63.6% from vaginal palpation; 33.3% from intravaginal electrical stimulation; and 18.2% from control group (p<0.001) were able to attain Modified Oxford Scale greater than or equal to 2 after eight weeks. In comparison with control group, the posterior pelvic tilt (OR=10.35; 95% CI=3.26-32.84) and vaginal palpation (OR=7.87; 95% CI=2.53-24.47) had the most significant improvement as opposed to intravaginal electrical stimulation (OR=2.25; 95% CI=0.72-7.06). There was significant improvement among all of the groups in UI. The largest changes respectively were noted in the vaginal palpation, posterior pelvic tilt, intravaginal electrical stimulation and control group. There were no reports of adverse effects. CONCLUSION:Vaginal palpation with posterior pelvic tilt and vaginal palpation were more effective interventions to facilitate pelvic floor muscles contraction when compared with intravaginal electrical stimulation and controls. Vaginal palpation was the most effective in improving urinary incontinence. Clinical Trials Identifier: ClinicalTrial.gov: NCT02062242.

SUBMITTER: Mateus-Vasconcelos ECL

PROVIDER: S-EPMC6157471 | biostudies-literature | 2018 Sep - Oct

REPOSITORIES: biostudies-literature

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Effects of three interventions in facilitating voluntary pelvic floor muscle contraction in women: a randomized controlled trial.

Mateus-Vasconcelos Elaine Cristine L ECL Brito Luiz Gustavo O LGO Driusso Patricia P Silva Thaís D TD Antônio Flávia I FI Ferreira Cristine H J CHJ

Brazilian journal of physical therapy 20180203 5

<h4>Objective</h4>To evaluate the effect of vaginal palpation, vaginal palpation associated with posterior pelvic tilt, and intravaginal electrical stimulation in facilitating voluntary contraction of the pelvic floor muscles in women.<h4>Methods</h4>A randomized controlled trial in which 132 women with pelvic floor muscles function graded at 0 or 1 using the Modified Oxford Scale were randomized into four groups: vaginal palpation (n=33); vaginal palpation with posterior pelvic tilt (n=33); int ...[more]

PMID: 29429823

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Project description:BackgroundThere is a risk of pelvic floor dysfunction (PFD) from baby delivery. Many clinical guidelines recommend pelvic floor muscle training (PFMT) as the conservative treatment for PFD because pelvic floor muscles (PFMs) play a crucial role in development of PFD. However, there is disagreement about the method and intensity of PFM training and the relevant measurements. To pilot the study in PFM training, we designed a Pelvic Floor Workout (PEFLOW) for women to train their pelvic through entire body exercises, and we planned a trial to evaluate its effectiveness through comparing the outcomes from a group of postpartum women who perform PELFLOW at home under professional guidance online with the control group.Methods/designThe randomized controlled trial was projected to be conducted from November 2021 to March 2023. A total of 260 postpartum women would be recruited from the obstetrics departments of the study hospital and women would be eligible for participation randomized into experimental or control groups (EG/CG) if their PFM strength are scaled by less than Modified Oxford grading Scale (MOS) to be less than grade 3. Women in EG would perform a 12-week PEFLOW online under the supervision and guidance of a physiotherapist, while women in CG would have no interventions. Assessments would be conducted at enrollment, post intervention (for EG) or 18th to 24th week postpartum (for CG), and 1 year postpartum. Assessment would be performed in terms of pelvic floor symptoms, including MOS, cough stress test, urinary leakage symptoms, pelvic organ prolapse quantitation (POP-Q), and vaginal relaxation, clinic examinations including Pelvic floor electrophysiological test, Pelvic floor ultrasound and Spine X-ray, overall body test including trunk endurance test, handgrip test, body composition test, and questionnaires including International Physical Activity Questionnaire Score-Short Form(IPAQ-SF), Pelvic Floor Distress Inventory Questionnaire-20 (PFDI-20), Pelvic Floor Impact Questionnaire-7 (PFIQ-7), the 6-item Female Sexual Function Index (FSFI-6), and the Pittsburgh Sleep Quality Index (PSQI). Primary analysis will be performed to test our main hypothesis that PEFLOW is effective with respect to strengthen PFM strength.DiscussionThis trial will demonstrate that pelvic floor-care is accessible to most women and clinical practice on PFD may change relevantly should this study find that Online PEFLOW approach is effective to improve PFMs.Trial registrationClinicalTrials.gov, NCT05218239.

Project description:Background: Pregnancy and high-impact activity are considered as risk factors for pelvic floor dysfunctions, including urinary incontinence. Aim: To investigate whether a structured exercise program, including high- and low-impact aerobics and supported by pelvic floor muscle exercises, improves the neuromuscular activity of the pelvic floor and does not reduce the quality of life in terms of urinary incontinence in healthy pregnant women. Methods: This was a randomized control trial among 97 Caucasian healthy nulliparas in uncomplicated pregnancies (age 30 ± 4 years, 21 ± 5 weeks of gestation; mean ± SD). Women were assessed for pelvic floor muscle functions with surface electromyography (EMG) using vaginal probes and using the Incontinence Impact Questionnaire (IIQ). Only women able to contract pelvic floor muscles and with good quality of life based on IIQ were included for the study. Seventy women in the experimental group took part in a supervised exercise program including high-low impact aerobics and pelvic floor muscle exercises three times a week. Twenty-seven controls did not receive any exercise intervention. After 6 weeks both groups were re-tested with EMG and IIQ. Post- and pre-exercise program changes in each group were analyzed using a repeated-measures ANOVA. Results: Women in the experimental group improved the neuromuscular activity of the pelvic floor in some motor tasks without any adverse outcomes of the intervention. After the exercise program we observed in the experimental group significantly higher EMG amplitude in the pelvic floor muscles during 3-s contractions (p = 0.014). We also noticed a beneficial trend in the increase of neuromuscular activity during 10- and 60-s contractions, but the changes were not statistically significant. The exercising women substantially improved their abilities for relaxation following 3- and 10-s contractions (p = 0.013 and p < 0.001). In controls, we reported no statistically significant improvement in either of the motor tasks. All study participants maintained good quality of life related to urinary incontinence. Conclusion: Prenatal exercise programs that include high- and low-impact aerobics and are supported by pelvic floor muscle exercises should be recommended for pregnant women, especially those who are accustomed to higher exercise intensity before pregnancy. Nevertheless, these recommendations can be directed to continent women who can properly contract pelvic floor muscles. ISRCTN. DOI: 10.1186/ISRCTN92265528: "Pelvic floor muscle training with surface electromyography", retrospectively registered on the 25th of July, 2016.

Project description:Background Pelvic Floor Muscle Training (PFMT) has been shown to be effective for pelvic organ prolapse in women, but its implementation in routine practice is challenging due to lack of adequate specialist staff. It is important to know if PFMT can be delivered by different staff skill mixes, what barriers and facilitators operate in different contexts, what strategies enable successful implementation and what are the underlying mechanisms of their action. PROPEL intervention was designed to maximise the delivery of effective PFMT in the UK NHS using different staff skill mixes. We conducted a realist evaluation (RE) of this implementation to understand what works, for whom, in what circumstances and why. Methods Informed by the Realist and RE-AIM frameworks, the study used a longitudinal, qualitative, multiple case study design. The study took place in five, purposively selected, diverse NHS sites across the UK and proceeded in three phases to identify, test and refine a theory of change. Data collection took place at 4 time points over an 18?month implementation period using focus groups and semi-structured interviews with a range of stakeholders including service leads/managers, senior practitioners, newly trained staff and women receiving care in the new service models. Data were analysed using thematic framework approach adapted to identify Context, Mechanism and Outcome (CMO) configurations of the RE. Results A heightened awareness of the service need among staff and management was a mechanism for change, particularly in areas where there was a shortage of skilled staff. In contrast, the most established specialist physiotherapist-delivered PFMT service activated feelings of role protection and compromised quality, which restricted the reach of PFMT through alternative models. Staff with some level of prior knowledge in women’s health and adequate organisational support were more comfortable and confident in new role. Implementation was seamless when PFMT delivery was incorporated in newly trained staff’s role and core work. Conclusion Roll-out of PFMT delivery through different staff skill mixes is possible when it is undertaken by clinicians with an interest in women’s health, and carefully implemented ensuring adequate levels of training and ongoing support from specialists, multi-disciplinary teams and management.

Project description:BackgroundPelvic 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.ObjectiveWe 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.MethodsWe 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.ResultsOf 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.ConclusionsDigital "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.

Project description:BackgroundStress 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.MethodsA 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/significanceThis 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 registrationClinicalTrials.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.

Project description:ObjectiveTo assess the effectiveness of pelvic floor muscle training (PFMT) plus electromyographic biofeedback or PFMT alone for stress or mixed urinary incontinence in women.DesignParallel group randomised controlled trial.Setting23 community and secondary care centres providing continence care in Scotland and England.Participants600 women aged 18 and older, newly presenting with stress or mixed urinary incontinence between February 2014 and July 2016: 300 were randomised to PFMT plus electromyographic biofeedback and 300 to PFMT alone.InterventionsParticipants in both groups were offered six appointments with a continence therapist over 16 weeks. Participants in the biofeedback PFMT group received supervised PFMT and a home PFMT programme, incorporating electromyographic biofeedback during clinic appointments and at home. The PFMT group received supervised PFMT and a home PFMT programme. PFMT programmes were progressed over the appointments.Main outcome measuresThe primary outcome was self-reported severity of urinary incontinence (International Consultation on Incontinence Questionnaire-urinary incontinence short form (ICIQ-UI SF), range 0 to 21, higher scores indicating greater severity) at 24 months. Secondary outcomes were cure or improvement, other pelvic floor symptoms, condition specific quality of life, women's perception of improvement, pelvic floor muscle function, uptake of other urinary incontinence treatment, PFMT self-efficacy, adherence, intervention costs, and quality adjusted life years.ResultsMean ICIQ-UI SF scores at 24 months were 8.2 (SD 5.1, n=225) in the biofeedback PFMT group and 8.5 (SD 4.9, n=235) in the PFMT group (mean difference -0.09, 95% confidence interval -0.92 to 0.75, P=0.84). Biofeedback PFMT had similar costs (mean difference £121 ($154; €133), -£409 to £651, P=0.64) and quality adjusted life years (-0.04, -0.12 to 0.04, P=0.28) to PFMT. 48 participants reported an adverse event: for 23 this was related or possibly related to the interventions.ConclusionsAt 24 months no evidence was found of any important difference in severity of urinary incontinence between PFMT plus electromyographic biofeedback and PFMT alone groups. Routine use of electromyographic biofeedback with PFMT should not be recommended. Other ways of maximising the effects of PFMT should be investigated.Trial registrationISRCTN57756448.

Project description:ObjectiveTo compare the effects of pelvic floor muscle training and watchful waiting on pelvic floor symptoms in a primary care population of women aged 55 years and over with symptomatic mild pelvic organ prolapse.DesignRandomised controlled trial.SettingDutch primary care.ParticipantsWomen aged 55 years or over with symptomatic mild prolapse (leading edge above the hymen) were identified by screening. Exclusion criteria were current prolapse treatment or treatment in the previous year, malignancy of pelvic organs, current treatment for another gynaecological disorder, severe/terminal illness, impaired mobility, cognitive impairment, and insufficient command of the Dutch language.InterventionsPelvic floor muscle training versus watchful waiting.Main outcome measuresThe primary outcome was change in bladder, bowel, and pelvic floor symptoms measured with the Pelvic Floor Distress Inventory-20 (PFDI-20), three months after the start of treatment. Secondary outcomes were changes in condition specific and general quality of life, sexual function, degree of prolapse, pelvic floor muscle function, and patients' perceived change in symptoms.ResultsOf the 287 women who were randomised to pelvic floor muscle training (n=145) or watchful waiting (n=142), 250 (87%) completed follow-up. Participants in the intervention group improved by (on average) 9.1 (95% confidence interval 2.8 to 15.4) points more on the PFDI-20 than did participants in the watchful waiting group (P=0.005). Of women in the pelvic floor muscle training group, 57% (82/145) reported an improvement in overall symptoms from the start of the study compared with 13% (18/142) in the watchful waiting group (P<0.001). Other secondary outcomes showed no significant difference between the groups.ConclusionsAlthough pelvic floor muscle training led to a significantly greater improvement in PFDI-20 score, the difference between the groups was below the presumed level of clinical relevance (15 points). Nevertheless, 57% of the participants in the intervention group reported an improvement of overall symptoms. More studies are needed to identify factors related to success of pelvic floor muscle training and to investigate long term effects.Trial registration Dutch Trial Register (www.trialregister.nl) identifier: NTR2047.

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Effects of three interventions in facilitating voluntary pelvic floor muscle contraction in women: a randomized controlled trial.

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Effects of three interventions in facilitating voluntary pelvic floor muscle contraction in women: a randomized controlled trial.

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