Dataset Information

KEPT-app trial: a pragmatic, single-blind, parallel, cluster-randomised effectiveness study of pelvic floor muscle training among incontinent pregnant women: study protocol.

ABSTRACT:

Introduction

Pelvic floor muscle training (PFMT) strongly recommended to incontinent pregnant women. The Kegel Exercise Pregnancy Training-app trial is a multicentre cluster-randomised study aims to assess the effectiveness and its cost-effectiveness of the mobile app guidance in PFMT among incontinent pregnant women.

Methods and analysis

370 pregnant women (aged 18 years old and above) will be recruited with International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form. Ten clusters (primary care clinics) will be randomly assigned to either PFMT or usual care in a 1:1 ratio by an independent researcher (sealed envelope). The primary outcome will be urinary incontinence, and the secondary outcomes (quality of life; PFMT adherence, psychological status and mobile apps' usability) will be assessed at four measurement time points (t0: baseline) and postintervention (t1: 4 weeks, t2: 8 weeks and t3: 8 weeks postnatal). T-test analysis will determine any significant differences at the baseline between the control and intervention groups. The mixed-model analysis will determine the effectiveness of the intervention at the population-average level for both the primary and secondary outcomes. For the cost-effectiveness analysis, expenditures during the study and 6?months after the intervention will be compared between the groups using the multiway sensitivity analysis. The recruitment planned will be in December 2020, and the planned end of the study will be in August 2021.

Ethics and dissemination

This study protocol was approved by the Ethics Committee for Research Involving Human Subjects, Universiti Putra Malaysia (JKEUPM-2019-368) and Medical Research and Ethics Committee (MREC), Ministry of Health Malaysia, NMRR-19-412-47116 (IIR) with the ANZCTR registration. This study will obtain informed written consent from all the study participants. The results which conform with the Consolidated Standards of Reporting Trials and the Recommendations for Interventional Trials will be published for dissemination in peer-reviewed journals and conference proceedings.

Trial registration number

ACTRN12619000379112.

SUBMITTER: Sidik SM

PROVIDER: S-EPMC7805359 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Publications

KEPT-app trial: a pragmatic, single-blind, parallel, cluster-randomised effectiveness study of pelvic floor muscle training among incontinent pregnant women: study protocol.

Sidik Sherina Mohd SM Jaffar Aida A Foo Chai Nien CN Muhammad Noor Azimah NA Abdul Manaf Rosliza R Ismail Siti Irma Fadhilah SIF Alagirisamy Parwathi P Ahmad Fazlah Amalina Farhi AF Suli Zailiza Z Goodyear-Smith Felicity F

BMJ open 20210112 1

<h4>Introduction</h4>Pelvic floor muscle training (PFMT) strongly recommended to incontinent pregnant women. The Kegel Exercise Pregnancy Training-app trial is a multicentre cluster-randomised study aims to assess the effectiveness and its cost-effectiveness of the mobile app guidance in PFMT among incontinent pregnant women.<h4>Methods and analysis</h4>370 pregnant women (aged 18 years old and above) will be recruited with International Consultation on Incontinence Questionnaire-Urinary Inconti ...[more]

PMID: 33436465

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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:BackgroundPelvic floor muscle training (PFMT) is one of the first-line treatments for stress urinary incontinence among pregnant women. Mobile health (mHealth) technology is potentially effective for delivering PFMT to pregnant women. Persuasive technology in the development of such mobile apps may facilitate behavior change by improving adherence to the exercises. The Capability, Opportunity, and Motivation-Behavior (COM-B) model is potentially useful in selecting the appropriate interventions to be incorporated into the apps.ObjectiveThis review of mHealth apps for PFMT aims to describe the principles of persuasion used for each app and to propose mHealth app design features based on the COM-B model.MethodsA systematic literature search was conducted to answer three main research questions: what are the available mHealth apps for PFMT in the published literature, what persuasive strategies were used in their studies how were they mapped to the COM-B model, and how effective were the selected persuasive strategies for PFMT adherence? We searched PubMed, CINAHL, Web of Science, Scopus, and local Malaysian databases such as MyCite and MyMedR for articles reporting mHealth apps used for the delivery of PFMT. We included original articles reporting experimental and cross-sectional studies, including pilot or feasibility trials. Systematic and narrative reviews were excluded. Narrative and thematic syntheses were conducted on the eligible articles based on the research questions. The Cochrane risk of bias tool and the Risk of Bias Assessment Tool for Non-randomized Studies were used to assess study bias.ResultsOf the 169 records from the initial search, 10 (5.9%) articles meeting the selection criteria were included in this review. There were 8 mHealth apps designed for the delivery of PFMT. The Tät, which used 3 categories of persuasive system design, improved PFMT adherence and was cost-effective. Only 1 app, the iBall app, used all categories of persuasive system design, by including social support such as "competition" in its design. The Diário Saúde app was the only app developed using operant conditioning. All apps incorporated Tailoring and Expertise as part of their PSD strategies. Only 3 apps, the Diário Saúde, Tät, and Pen Yi Kang demonstrated improved PFMT adherence.ConclusionsPersuasive technology used in mobile apps may target desired behavior change more effectively. The persuasive system design can be mapped to the COM-B model to explain its effectiveness on behaviour change outcomes.

Project description:BACKGROUND:Pelvic floor myofascial pain, which is predominantly identified in the muscles of the levator ani and obturator internus, has been observed in women with chronic pelvic pain and other pelvic floor disorder symptoms, and is hypothesized to contribute to their symptoms. OBJECTIVES:To describe the prevalence of pelvic floor myofascial pain in patients presenting with pelvic floor disorder symptoms and to investigate whether severity of pelvic floor myofascial pain on examination correlates with degree of pelvic floor disorder symptom bother. STUDY DESIGN:All new patients seen at 1 tertiary referral center between 2014 and 2016 were included in this retrospectively assembled cross-sectional study. Pelvic floor myofascial pain was determined by transvaginal palpation of the bilateral obturator internus and levator ani muscles and scored as a discrete number on an 11-point verbal pain rating scale (range, 0-10) at each site. Scores were categorized as none (0), mild (1-3), moderate (4-6), and severe (7-10) for each site. Pelvic floor disorder symptom bother was assessed by the Pelvic Floor Distress Inventory short form scores. The correlation between these 2 measures was calculated using Spearman rank and partial rank correlation coefficients. RESULTS:A total of 912 new patients were evaluated. After exclusion of 79 with an acute urinary tract infection, 833 patients were included in the final analysis. Pelvic floor myofascial pain (pain rated >0 in any muscle group) was identified in 85.0% of patients: 50.4% rated as severe, 25.0% moderate, and 9.6% mild. In unadjusted analyses and those adjusted for postmenopausal status, severity of pelvic floor myofascial pain was significantly correlated with subjective prolapse symptoms such as pelvic pressure and heaviness but not with objective prolapse symptoms (seeing or feeling a vaginal bulge or having to push up on a bulge to start or complete urination) or leading edge. Severity of myofascial pain at several individual pelvic floor sites was also independently correlated with lower urinary tract symptoms, including pain in the lower abdomen (myofascial pain at all sites) and difficulty emptying the bladder (right obturator internus and left levator ani); and with defecatory dysfunction, including sensation of incomplete rectal emptying (pain at all sites combined and the right obturator internus), anal incontinence to flatus (pain at all sites combined), and pain with defecation (pain at all sites combined, and the right obturator internus and left levator ani). CONCLUSION:Pelvic floor myofascial pain was common in patients seeking evaluation for pelvic floor disorder symptoms. Location and severity of pelvic floor myofascial pain was significantly correlated with degree of symptom bother, even after controlling for postmenopausal status. Given the high prevalence of pelvic floor myofascial pain in these patients and correlation between pain severity and degree of symptom bother, a routine assessment for pelvic floor myofascial pain should be considered for all patients presenting for evaluation of pelvic floor symptoms.

Project description:IntroductionMaternal pushing techniques during the second stage of labor may affect women's pelvic floor function. Our main objective was to assess the impact of the type of pushing used at delivery on the mother's medium-term pelvic floor function.Material and methodsThis is a secondary analysis of a randomized clinical trial (clinicaltrials.gov: NCT02474745) that took place in four French hospitals from 2015 through 2017 (n = 250). Women in labor with a singleton fetus in cephalic presentation at term who had undergone standardized training in both of these types of pushing were randomized after cervical dilation ≥7 cm. The exclusion criteria were a previous cesarean, a cesarean delivery in this pregnancy or a fetal heart rate anomaly. In the intervention group, open-glottis (OG) pushing was defined as a prolonged exhalation contracting the abdominal muscles to help move the fetus down the birth canal. Closed-glottis (CG) pushing was defined as Valsalva pushing. The principal outcome was the stage of pelvic organ prolapse (POP) assessed by the Pelvic Organ Prolapse-Quantification 2 months after delivery. A secondary outcome was incidence of urinary incontinence (UI). The results of our multivariable, modified intention-to-treat analysis are reported as crude relative risks (RRs) with their 95% confidence intervals.ResultsOur analysis included 207 women. Mode of birth was similar in both groups. The two groups did not differ for stage II POP: 10 of 104 (9.4%) in the OG group compared with 7 of 98 (7.1%) in the CG group, for a RR 1.32, 95% confidence interval [CI] 0.52-3.33, and an adjusted RR of 1.22, 95% CI 0.42-3.6. Similarly, the incidence of UI did not differ: 26.7% in the OG group and 28.6% in the CG group (aRR 0.81, 95% CI 0.42-1.53). Subgroup analysis suggests that for secundiparous and multiparous women, OG pushing could have a protective effect on the occurrence of UI (RR 0.33, 95% CI 0.13-0.80).ConclusionsThe type of directed pushing used at delivery did not impact the occurrence of pelvic organ prolapse 2 months after delivery. OG pushing may have a protective effect against UI among secundiparous and multiparous women.

Dataset Information

KEPT-app trial: a pragmatic, single-blind, parallel, cluster-randomised effectiveness study of pelvic floor muscle training among incontinent pregnant women: study protocol.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

KEPT-app trial: a pragmatic, single-blind, parallel, cluster-randomised effectiveness study of pelvic floor muscle training among incontinent pregnant women: study protocol.

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