Involuntary reflexive pelvic floor muscle training in addition to standard training versus standard training alone for women with stress urinary incontinence: study protocol for a randomized controlled trial

BACKGROUND Pelvic floor muscle training is effective and recommended as first-line therapy for female patients with stress urinary incontinence. However, standard pelvic floor physiotherapy concentrates on voluntary contractions even though the situations provoking stress urinary incontinence (for example, sneezing, coughing, running) require involuntary fast reflexive pelvic floor muscle contractions. Training procedures for involuntary reflexive muscle contractions are widely implemented in rehabilitation and sports but not yet in pelvic floor rehabilitation. Therefore, the research group developed a training protocol including standard physiotherapy and in addition focused on involuntary reflexive pelvic floor muscle contractions. METHODS/DESIGN The aim of the planned study is to compare this newly developed physiotherapy program (experimental group) and the standard physiotherapy program (control group) regarding their effect on stress urinary incontinence. The working hypothesis is that the experimental group focusing on involuntary reflexive muscle contractions will have a higher improvement of continence measured by the International Consultation on Incontinence Modular Questionnaire Urinary Incontinence (short form), and - regarding secondary and tertiary outcomes - higher pelvic floor muscle activity during stress urinary incontinence provoking activities, better pad-test results, higher quality of life scores (International Consultation on Incontinence Modular Questionnaire) and higher intravaginal muscle strength (digitally tested) from before to after the intervention phase. This study is designed as a prospective, triple-blinded (participant, investigator, outcome assessor), randomized controlled trial with two physiotherapy intervention groups with a 6-month follow-up including 48 stress urinary incontinent women per group. For both groups the intervention will last 16 weeks and will include 9 personal physiotherapy consultations and 78 short home training sessions (weeks 1-5 3x/week, 3x/day; weeks 6-16 3x/week, 1x/day). Thereafter both groups will continue with home training sessions (3x/week, 1x/day) until the 6-month follow-up. To compare the primary outcome, International Consultation on Incontinence Modular Questionnaire (short form) between and within the two groups at ten time points (before intervention, physiotherapy sessions 2-9, after intervention) ANOVA models for longitudinal data will be applied. DISCUSSION This study closes a gap, as involuntary reflexive pelvic floor muscle training has not yet been included in stress urinary incontinence physiotherapy, and if shown successful could be implemented in clinical practice immediately. TRIAL REGISTRATION NCT02318251 ; 4 December 2014 First patient randomized: 11 March 2015.

Continuous versus intermittent stochastic resonance whole body vibration and its effect on pelvic floor muscle activity

To determine the optimal stochastic whole body vibration (SR-WBV) load modality regarding pelvic floor muscle (PFM) activity in order to complete the SR-WBV training methodology for future PFM training with SR-WBV.

Pelvic floor muscle activation and strength components influencing female urinary continence and stress incontinence: A systematic review

AIMS A better understanding of pelvic floor muscle (PFM) activation and strength components is a prerequisite to get better insight in PFM contraction mechanisms and develop more specific PFM-training regimens for female stress urinary incontinence (SUI) patients. The aim of this systematic review (2012:CRD42012002547) was to evaluate and summarize existing studies investigating PFM activation and strength components influencing female continence and SUI. METHODS PubMed, EMBASE, and Cochrane databases were systematically searched for literature from January 1980 to November 2013 for cross-sectional studies comparing female SUI patients with healthy controls and intervention studies with SUI patients reporting on the association between PFM activation and strength components and urine loss. Trial characteristics, evaluated PFM components, their definitions, measurement methods, study outcomes, as well as quality measures, based on the Cochrane risk of bias tool, were independently extracted. The high heterogeneity of the retrieved data made pooling of results impossible and therefore restricted the analysis to a systematic review. RESULTS Cross-sectional studies showed group differences in favor of the continent women compared to SUI patients for PFM activation or PFM maximal strength, mean strength or sustained contraction. All intervention studies showed an improvement of PFM strength and decrease in urine loss in SUI patients after physical therapy. CONCLUSIONS Higher PFM activation and strength components influence female continence positively. This systematic review underscored the need for a standardized PFM components' terminology (similar to rehabilitation and training science), standardized test procedures and well matched diagnostic instruments. Neurourol. Urodynam. © 2014 Wiley Periodicals, Inc.

Intra-session test-retest reliability of pelvic floor muscle electromyography during running

INTRODUCTION AND HYPOTHESIS The prevalence of female stress urinary incontinence is high, and young adults are also affected, including athletes, especially those involved in "high-impact" sports. To date there have been almost no studies testing pelvic floor muscle (PFM) activity during dynamic functional whole body movements. The aim of this study was the description and reliability test of PFM activity and time variables during running. METHODS A prospective cross-sectional study including ten healthy female subjects was designed with the focus on the intra-session test-retest reliability of PFM activity and time variables during running derived from electromyography (EMG) and accelerometry. RESULTS Thirteen variables were identified based on ten steps of each subject: Six EMG variables showed good reliability (ICC 0.906-0.942) and seven time variables did not show good reliability (ICC 0.113-0.731). Time variables (e.g. time difference between heel strike and maximal acceleration of vaginal accelerator) showed low reliability. However, relevant PFM EMG variables during running (e.g., pre-activation, minimal and maximal activity) could be identified and showed good reliability. CONCLUSION Further adaptations regarding measurement methods should be tested to gain better control of the kinetics and kinematics of the EMG probe and accelerometers. To our knowledge this is the first study to test the reliability of PFM activity and time variables during dynamic functional whole body movements. More knowledge of PFM activity and time variables may help to provide a deeper insight into physical strain with high force impacts and important functional reflexive contraction patterns of PFM to maintain or to restore continence.

Pelvic floor muscle electromyography during different running speeds: an exploratory and reliability study.

PURPOSE Stress urinary incontinence (SUI) affects women of all ages including young athletes, especially those involved in high-impact sports. To date, hardly any studies are available testing pelvic floor muscles (PFM) during sports activities. The aim of this study was the description and reliability test of six PFM electromyography (EMG) variables during three different running speeds. The secondary objective was to evaluate whether there was a speed-dependent difference between the PFM activity variables. METHODS This trial was designed as an exploratory and reliability study including ten young healthy female subjects to characterize PFM pre-activity and reflex activity during running at 7, 9 and 11 km/h. Six variables for each running speed, averaged over ten steps per subject, were presented descriptively, tested regarding their reliability (Friedman, ICC, SEM, MD) and speed difference (Friedman). RESULTS PFM EMG variables varied between 67.6 and 106.1 %EMG, showed no systematic error and were low for SEM and MD using the single value model. Applying the average model over ten steps, ICC (3,k) were >0.75 and SEM and MD about 50 % lower than for the single value model. Activity was found to be highest in 11 km/h. CONCLUSION EMG variables showed excellent ICC and very low SEM and MD. Further studies should investigate inter-session reliability and PFM reactivity patterns of SUI patients using the average over ten steps for each variable as it showed very high ICC and very low SEM and MD. Subsequently, longer running distances and other high-impact sports disciplines could be studied.

Pelvic floor muscle displacement during voluntary and involuntary activation in continent and incontinent women: a systematic review.

INTRODUCTION Investigations of the dynamic function of female pelvic floor muscles (PFM) help us to understand the pathophysiology of stress urinary incontinence (SUI). Displacement measurements of PFM give insight into muscle activation and thus help to improve rehabilitation strategies. This systematic review (PROSPERO 2013: CRD42013006409) was performed to summarise the current evidence for PFM displacement during voluntary and involuntary activation in continent and incontinent women. METHODS MEDLINE, EMBASE, Cochrane and SPORTDiscus databases were searched using selected terminology reflecting the PICO approach. Screening of Google Scholar and congress abstracts added to further information. Original articles investigating PFM displacement were included if they reported on at least one of the aims of the review, e.g., method, test position, test activity, direction and quantification of displacement, as well as the comparison between continent and incontinent women. Titles and abstracts were screened by two reviewers. The papers included were reviewed by two individuals to ascertain whether they fulfilled the inclusion criteria and data were extracted on outcome parameters. RESULTS Forty-two predominantly observational studies fulfilled the inclusion criteria. A variety of measurement methods and calculations of displacement was presented. The sample was heterogeneous concerning age, parity and continence status. Test positions and test activities varied among the studies. CONCLUSIONS The findings summarise the present knowledge of PFM displacement, but still lack deeper comprehension of the SUI pathomechanism of involuntary, reflexive activation during functional activities. We therefore propose that future investigations focus on PFM dynamics during fast and stressful impact tasks.

Pelvic floor stimulation: what are the good vibrations?

OBJECTIVE: The aim of this study was to determine if two different whole body vibration, sinusoidal vibration (SV) and stochastic resonance vibration (SRV), using various intensities lead to a reactive activation of pelvic floor muscles. STUDY DESIGN: We compared the pelvic floor muscle response of a healthy control group with that of a post partum group with weakened pelvic floor contraction. Activation effects of stochastic resonance vibration and sinusoidal vibration with six increasing vibration intensities were investigated using pelvic floor EMG and compared to activity during rest and maximum voluntary contraction. RESULTS: Both whole body vibration systems were able to activate pelvic floor muscles significantly depending on vibration intensity. Generally, the SRV achieved a significantly higher activation than maximum voluntary contraction, especially in women post partum and using a frequency of 6-12 Hz. CONCLUSION: SRV, compared to SV, leads to higher pelvic floor muscle activation in subjects with weakened pelvic floor muscles and achieves higher pelvic floor activation than maximum voluntary contraction alone. Neurourol. Urodynam. 28:405-410, 2009. (c) 2009 Wiley-Liss, Inc.

Vaginal prolapse, pelvic floor function, and related symptoms 16 years after sex reassignment surgery in transsexuals

To evaluate the prevalence of prolapse and related bladder, bowel, and sexual problems in transsexual patients (TS) after sex reassignment surgery.

Effects of inspiratory muscle training in patients with heart failure with preserved ejection fraction

BACKGROUND Heart failure with preserved ejection fraction (HFpEF) is remarkably common in elderly people with highly prevalent comorbid conditions. Despite its increasing in prevalence, there is no evidence-based effective therapy for HFpEF. We sought to evaluate whether inspiratory muscle training (IMT) improves exercise capacity, as well as left ventricular diastolic function, biomarker profile and quality of life (QoL) in patients with advanced HFpEF and nonreduced maximal inspiratory pressure (MIP). DESIGN AND METHODS A total of 26 patients with HFpEF (median (interquartile range) age, peak exercise oxygen uptake (peak VO2) and left ventricular ejection fraction of 73 years (66-76), 10 ml/min/kg (7.6-10.5) and 72% (65-77), respectively) were randomized to receive a 12-week programme of IMT plus standard care vs. standard care alone. The primary endpoint of the study was evaluated by positive changes in cardiopulmonary exercise parameters and distance walked in 6 minutes (6MWT). Secondary endpoints were changes in QoL, echocardiogram parameters of diastolic function, and prognostic biomarkers. RESULTS The IMT group improved significantly their MIP (p < 0.001), peak VO2 (p < 0.001), exercise oxygen uptake at anaerobic threshold (p = 0.001), ventilatory efficiency (p = 0.007), metabolic equivalents (p < 0,001), 6MWT (p < 0.001), and QoL (p = 0.037) as compared to the control group. No changes on diastolic function parameters or biomarkers levels were observed between both groups. CONCLUSIONS In HFpEF patients with low aerobic capacity and non-reduced MIP, IMT was associated with marked improvement in exercise capacity and QoL.

Combined aerobic/inspiratory muscle training vs. aerobic training in patients with chronic heart failure: The Vent-HeFT trial: a European prospective multicentre randomized trial

AIMS Vent-HeFT is a multicentre randomized trial designed to investigate the potential additive benefits of inspiratory muscle training (IMT) on aerobic training (AT) in patients with chronic heart failure (CHF). METHODS AND RESULTS Forty-three CHF patients with a mean age of 58 ± 12 years, peak oxygen consumption (peak VO2 ) 17.9 ± 5 mL/kg/min, and LVEF 29.5 ± 5% were randomized to an AT/IMT group (n = 21) or to an AT/SHAM group (n = 22) in a 12-week exercise programme. AT involved 45 min of ergometer training at 70-80% of maximum heart rate, three times a week for both groups. In the AT/IMT group, IMT was performed at 60% of sustained maximal inspiratory pressure (SPImax ) while in the AT/SHAM group it was performed at 10% of SPImax , using a computer biofeedback trainer for 30 min, three times a week. At baseline and at 3 months, patients were evaluated for exercise capacity, lung function, inspiratory muscle strength (PImax ) and work capacity (SPImax ), quality of life (QoL), LVEF and LV diameter, dyspnoea, C-reactive protein (CRP), and NT-proBNP. IMT resulted in a significantly higher benefit in SPImax (P = 0.02), QoL (P = 0.002), dyspnoea (P = 0.004), CRP (P = 0.03), and NT-proBNP (P = 0.004). In both AT/IMT and AT/SHAM groups PImax (P < 0.001, P = 0.02), peak VO2 (P = 0.008, P = 0.04), and LVEF (P = 0.005, P = 0.002) improved significantly; however, without an additional benefit for either of the groups. CONCLUSION This randomized multicentre study demonstrates that IMT combined with aerobic training provides additional benefits in functional and serum biomarkers in patients with moderate CHF. These findings advocate for application of IMT in cardiac rehabilitation programmes.

Standardized pelvic floor exercises improve stress urinary incontinence in women with intrinsic sphincter deficiency.

OBJECTIVES Pelvic floor rehabilitation is the conservative therapy of choice for women with stress urinary incontinence (SUI). The success rate of surgical procedures in SUI patients with intrinsic sphincter deficiency (ISD) is low. The aim of this study was to analyse the effect of a standardized physiotherapy on patients with SUI and normotonic urethra and ISD. METHODS In this study, 64 patients with ISD and 69 patients with normotonic urethra were enrolled. Maximum urethral pressure (MUCP) >20 cm H2 O was considered as normotonic urethral pressure. Before and after physiotherapy MUCP was measured and cough testing was performed. Additionally, patient reported outcome was assessed using the King's Health Questionnaire (KHQ). For statistical analyses Excel 2010 (Microsoft Inc; Redmond, Washington) and SPSS 20 (SPSS Inc; Chicago, Illinois) for Windows were used. Power calculation was based on the primary endpoint incontinence impact and general health. For power calculation, GraphPad Statmate version 2.00 for Windows was used. RESULTS Sixty-four patients with ISD and 69 patients with normotonic urethra were included in the study. In SUI patients with normotonic and hypotonic urethra KHQ-scores regarding the primary endpoins "general health" and "incontinence impact" significantly improved following standardized physiotherapy. In both groups MUCP increased after physiotherapy. In SUI patients with ISD standardized physiotherapy resulted in a decreased incidence of a positive cough test. CONCLUSIONS Standardized physiotherapy should be offered to patients with SUI and ISD. Long-term results are subject to future studies. Neurourol. Urodynam. © 2015 Wiley Periodicals, Inc.

Demonstration of pelvic anatomy by modified midline transection that maintains intact internal pelvic organs

Gross dissection for demonstrating anatomy of the human pelvis has traditionally involved one of two approaches, each with advantages and disadvantages. Classic hemisection in the median plane through the pelvic ring transects the visceral organs but maintains two symmetric pelvic halves. An alternative paramedial transection compromises one side of the bony pelvis but leaves the internal organs intact. The authors propose a modified technique that combines advantages of both classical dissections. This novel approach involves dividing the pubic symphysis and sacrum in the median plane after shifting all internal organs to one side. The hemipelvis without internal organs is immediately available for further dissection of the lower limb. The hemipelvis with intact internal organs is ideal for showing the complex spatial relationships of the pelvic organs and vessels relative to the intact pelvic floor.

[Urinary incontinence]

Incontinence is a common age-dependent and increasing problem in women that may mainly present as stress incontinence, overactive bladder, mixed incontinence or other forms. A thorough history, gynaecological and neurological examination and urinalysis as initial step will lead to the diagnosis and treatment. If midstream urine is difficult to receive, a catheter urine will be easy to obtain. Further investigations as urodynamics, cystoscopy and ultrasound may be required. As initial step, stress incontinence should be treated with physiotherapy and pelvic floor exercises, if not successful with operations as suburethral slings. Slings have good long-term success rates of approximately 85 % with a low morbidity and can even be inserted under local anaesthetic. The treatment of idiopathic overactive bladder consists of bladder training, a behavioural therapy, and mainly anticholinergics. Anticholinergics may cause side effects particularly in the elderly who are under several medications that may add anticholinergic effects as antidepressants, antibiotics or antihistaminics.

Suburothelial myofibroblasts in the human overactive bladder and the effect of botulinum neurotoxin type A treatment

BACKGROUND: An increasing body of evidence suggests a possible role of suburothelial myofibroblasts (MFs) in bladder mechanosensation and in the pathophysiology of detrusor overactivity (DO). OBJECTIVE: To determine whether markers of MFs, including gap junction protein connexin43 (Cx43) and c-kit have altered immunohistochemical expression in the suburothelium of patients with neurogenic DO (NDO) or idiopathic DO (IDO) and whether this is affected by successful treatment of DO with botulinum neurotoxin type A (BoNTA). DESIGN, SETTING, AND PARTICIPANTS: Patients with NDO (n=10) or IDO (n=11) were treated in a single-centre, open-label study of intradetrusor BoNTA injections. Control tissue was obtained from 10 patients undergoing pelvic-floor repair procedures who had no overactive bladder (OAB) symptoms. This study is registered with ClinicalTrials.gov, number NCT00662064. INTERVENTIONS: Bladder biopsies performed with flexible cystoscopes were obtained from control subjects and from NDO and IDO patients before BoNTA treatment and at 4 wk and 16 wk after treatment. They were studied with quantitative immunofluorescence using antibodies to connexin 43 (Cx43), vimentin, and c-kit. MEASUREMENTS: Differences in Cx43, vimentin, and c-kit immunoreactivity between control subjects and NDO or IDO patients (primary outcomes). Changes in NDO or IDO, Cx43 immunoreactivity, and c-kit immunoreactivity after BoNTA treatment (secondary outcomes). RESULTS AND LIMITATIONS: Cx43 immunoreactivity was increased in both IDO and NDO patients compared to controls, but remained unchanged after BoNTA treatment. C-kit immunoreactivity was similar in NDO/IDO patients and controls and remained unchanged after BoNTA treatment. CONCLUSIONS: Increased gap junction formation in the suburothelium has been demonstrated in biopsies from humans with DO. It is hypothesised that this change could have a significant role in the pathogenesis of the detrusor abnormality. Successful treatment of NDO or IDO does not appear to be associated with changes in the expression of Cx43 or c-kit on suburothelial MFs.