A pilot study to evaluate changes in pelvic floor muscle tone following pelvic organ prolapse surgery using a novel intra-vaginal pressure sensor device.

INTRODUCTION AND HYPOTHESIS: Pelvic floor muscle weakness is a common cause of pelvic organ prolapse and urinary incontinence. Surgical repair of prolapse is commonly undertaken; however, the impact on pelvic floor muscle tone is unknown. The aim of this study was to compare the effect of anterior and posterior colporrhaphy on pelvic floor activation. METHODS: Patients aged under 70 undergoing primary anterior or posterior colporrhaphy were recruited. Intra-vaginal pressure was measured at rest and during pelvic floor contraction using the Femfit® device (an intra-vaginal pressure sensor device [IVPSD]). Peak pressure and mean pressure over 3 s were measured in millimetres of mercury. The pre- and post-operative measurements were compared. The difference between the means was assessed using Cohen's D test, with significance set at p<0.05 RESULTS: A total of 37 patients completed pre- and post-operative analysis, 25 in the anterior colporrhaphy group and 12 in the posterior colporrhaphy group. Anterior colporrhaphy showed no significant change in pelvic floor tone. Change in peak pressure was -1.71mmHg (-5.75 to 2.33; p=0.16) and change in mean pressure was -0.86 mmHg (-4.38 to 2.66; p=0.31). Posterior colporrhaphy showed a significant increase in peak pelvic floor muscle tone of 7.2 mmHg (0.82 to 13.58; p=0.005) and mean pressure of 4.19 mmHg (-0.09 to 8.47; p=0.016). CONCLUSIONS: Posterior colporrhaphy significantly improves pelvic floor muscle tone, whereas anterior colporrhaphy does not. Improved understanding of the impact of pelvic floor surgery may guide future management options for other pelvic floor disorders. Further work is needed to confirm the association of this improvement in pelvic floor disorders.

Are hypopressive and other exercise programs effective for the treatment of pelvic organ prolapse?

INTRODUCTION AND HYPOTHESIS: Pelvic floor muscle training (PFMT) is effective for the treatment of pelvic organ prolapse (POP), but other exercise programs have also been promoted and used. The aim of this review was to evaluate the effect of hypopressive and other exercise programs besides PFMT for POP. METHODS: A literature search was conducted on Ovid Medline, EMBASE, CINAHL, Cochrane, PEDro, and Scopus databases from January 1996 to 30 December 2021. Only randomized controlled trials (RCTs) were included. The keywords were combinations of "pelvic organ prolapse" or "urogenital prolapse," and "exercise therapy," "hypopressive exercise," "Kegel," "pelvic floor muscle training," "pelvic floor muscle exercises," "Pilates," "treatment," "yoga," "Tai Chi." Methodological quality was assessed using the PEDro rating scale (0-10). RESULTS: Seven RCTs containing hypopressive exercise, yoga or breathing and hip muscle exercises in an inverted position were retrieved and analyzed. PEDro score ranged from 4 to 7. There was no additional effect of adding hypopressive exercise to PFMT, and PFMT was more effective than hypopressive exercise alone. The studies that included the term "yoga" included regular PFMT and thus can be classified as PFMT. Hip exercises in an inverted position added to PFMT vs PFMT alone showed better improvement in some secondary outcomes but not in the primary outcome, POP stage. CONCLUSIONS: There are few RCTs assessing the effects of other exercise programs besides PFMT in the treatment of POP. To date, there is no evidence that other exercise programs are more effective than PFMT for POP.

Strenuous physical activity, exercise, and pelvic organ prolapse: a narrative scoping review.

INTRODUCTION AND HYPOTHESIS: High-intensity physical activity and exercise have been listed as possible risk factors for pelvic organ prolapse (POP). The aim of the present study is to conduct a literature review on the prevalence and incidence of POP in women who engage in regular physical activity. In addition, we review the effects of a single exercise or a single session of exercise on pelvic floor support. Finally, the effect of exercises on POP in the early postpartum period is reviewed. METHODS: This is a narrative scoping review. We searched PubMed and Ovid Medline, the Physiotherapy Evidence Database (PEDro), and the Cochrane Database of Systematic Reviews up to May 2022 with the following MeSH terms: "physical activity" AND "exercise" AND "pelvic floor" AND "pelvic organ prolapse". RESULTS: Eight prevalence studies were retrieved. Prevalence rates of symptomatic POP varied between 0 (small study within different sports) and 23% (Olympic weightlifters and power lifters). Parity was the only factor associated with POP in most studies. Three studies evaluated the pelvic floor after a single exercise or one session of exercise and found increased vaginal descent or increased POP symptoms. One prospective cohort study reported the development of POP after 6 weeks of military parashot training, and one randomized trial reported increased POP symptoms after transverse abdominal training. There is scant knowledge on exercise and POP in the postpartum period. CONCLUSIONS: Prevalence of POP in sports varies widely. Experimental and prospective studies indicate that strenuous exercise increased POP symptoms and reduced pelvic floor support.

International urogynecology consultation chapter 3 committee 2; conservative treatment of patient with pelvic organ prolapse: Pelvic floor muscle training.

INTRODUCTION AND HYPOTHESIS: This manuscript from Chapter 3 of the International Urogynecology Consultation (IUC) on Pelvic Organ Prolapse (POP) describes the current evidence and suggests future directions for research on the effect of pelvic floor muscle training (PFMT) in prevention and treatment of POP. METHODS: An international group of four physical therapists, four urogynecologists and one midwife/basic science researcher performed a search of the literature using pre-specified search terms on randomized controlled trials (RCTs) in Ovid Medline, EMBASE, CINAHL, Cochrane, PEDro and Scopus databases for publications between 1996 and 2021. Full publications or expanded abstracts in English or in other languages with abstracts in English were included. The PEDro rating scale (0-10) was used to evaluate study quality. Included RCTs were reviewed to summarize the evidence in six key sections: (1) evidence for PFMT in prevention of POP in the general female population; (2) evidence for early intervention of PFMT in the peripartum period for prevention and treatment of POP; (3) evidence for PFMT in treatment of POP in the general female population; (4) evidence for perioperative PFMT; (5) evidence for PFMT on associated conditions in women with POP; (6) evidence for the long-term effect of PFMT on POP. Full publications in English or in other languages with abstracts in English and expanded abstracts presented at international condition specific societies were included. Internal validity was examined by the PEDro rating scale (0-10). RESULTS: After exclusion of duplicates and irrelevant trials, we classified and included 2 preventive trials, 4 trials in the post-partum period, 11 treatment trials of PFMT for POP in the general female population in comparison with no treatment or lifestyle interventions, 10 on PFMT as an adjunct treatment to POP surgery and 9 long-term treatment trials. Only three treatment studies compared PFMT with the use of a pessary. The RCTs scored between 4 and 8 on the PEDro scale. No primary prevention studies were found, and there is sparse and inconsistent evidence for early intervention in the postpartum period. There is good evidence/recommendations from 11 RCTs that PFMT is effective in reducing POP symptoms and/or improving POP stage (by one stage) in women with POP-Q stage I, II and III in the general female population, but no evidence from 9/10 RCTs that adding PFMT pre- and post -surgery for POP is effective. There are few long-term follow-up studies, and results are inconsistent. There are no serious adverse effects or complications reported related to PFMT. CONCLUSIONS: There are few studies on prevention and in the postpartum period, and the effect is inconclusive. There is high-level evidence from 11 RCTs to recommend PFMT as first-line treatment for POP in the general female population. PFMT pre- and post-POP surgery does not seem to have any additional effect on POP. PFMT is effective and safe but needs thorough instruction and supervision to be effective.

Barth syndrome-related cardiomyopathy is associated with a reduction in myocardial glucose oxidation.

Heart failure presents as the leading cause of infant mortality in individuals with Barth syndrome (BTHS), a rare genetic disorder due to mutations in the tafazzin (TAZ) gene affecting mitochondrial structure and function. Investigations into the perturbed bioenergetics in the BTHS heart remain limited. Hence, our objective was to identify the potential alterations in myocardial energy metabolism and molecular underpinnings that may contribute to the early cardiomyopathy and heart failure development in BTHS. Cardiac function and myocardial energy metabolism were assessed via ultrasound echocardiography and isolated working heart perfusions, respectively, in a mouse model of BTHS [doxycycline-inducible Taz knockdown (TazKD) mice]. In addition, we also performed mRNA/protein expression profiling for key regulators of energy metabolism in hearts from TazKD mice and their wild-type (WT) littermates. TazKD mice developed hypertrophic cardiomyopathy as evidenced by increased left ventricular anterior and posterior wall thickness, as well as increased cardiac myocyte cross-sectional area, though no functional impairments were observed. Glucose oxidation rates were markedly reduced in isolated working hearts from TazKD mice compared with their WT littermates in the presence of insulin, which was associated with decreased pyruvate dehydrogenase activity. Conversely, myocardial fatty acid oxidation rates were elevated in TazKD mice, whereas no differences in glycolytic flux or ketone body oxidation rates were observed. Our findings demonstrate that myocardial glucose oxidation is impaired before the development of overt cardiac dysfunction in TazKD mice, and may thus represent a pharmacological target for mitigating the development of cardiomyopathy in BTHS.NEW & NOTEWORTHY Barth syndrome (BTHS) is a rare genetic disorder due to mutations in tafazzin that is frequently associated with infantile-onset cardiomyopathy and subsequent heart failure. Although previous studies have provided evidence of perturbed myocardial energy metabolism in BTHS, actual measurements of flux are lacking. We now report a complete energy metabolism profile that quantifies flux in isolated working hearts from a murine model of BTHS, demonstrating that BTHS is associated with a reduction in glucose oxidation.

Using codesign to develop a mobile application for pelvic floor muscle training with an intravaginal device (femfit®).

AIMS: The aim of this project was to use codesign to develop a mobile application (app) for pelvic floor muscle training, with an intravaginal device (femfit®). The objective was to obtain user feedback to guide the design and development of a mobile app, consistent with the Mobile Application Rating Scale (MARS) framework. METHODS: Twenty-six women (22-62 years) provided mobile app feedback using a Design Thinking framework and grounded theory approach. Four focus groups (2 h each) and two sets of one-to-one interviews (1 h each) were held from May 2018 to October 2019. The researchers debriefed the focus groups and interviews, and undertook analysis based on project objectives and key questions. RESULTS: Recurring themes throughout the study aligned with sections of the MARS: (A) engagement (e.g., progress tracking), (B) functionality (e.g., intuitive interface), (C) aesthetics (e.g., smart graphics and colors), (D) information (e.g., clear, concise information). An internal preliminary assessment determined a MARS Quality Mean Score of 4.1 of 5 (engagement: 3.6 of 5; functionality: 4 of 5; aesthetics: 4.3 of 5: information: 4.4 of 5). CONCLUSIONS: The development of the mobile app is on track to meet MARS requirements, and to be a fun, motivating app for women. Future work is required to investigate its efficacy.

Assessing vaginal pressure profiles before and after prolapse surgery using an intravaginal pressure sensor (femfit®).

INTRODUCTION AND HYPOTHESIS: The impact of surgery on pelvic floor muscle (PFM) function remains uncertain. There is a pressure differential along the length of the vagina, influenced by surrounding active and passive tissue structures, giving rise to a pressure profile. The aim of this study is to determine if an intravaginal pressure sensor, femfit®, can measure differences in pressure profiles before and after surgery for pelvic organ prolapse (POP). METHODS: This pilot study includes 22 women undergoing POP surgery. Intravaginal pressure profiles were measured with femfit® pre- and post-surgery and differences tested using paired Student's t-tests. Patients completed validated questionnaires for vaginal, bowel, and urinary incontinence symptoms pre- and post-POP surgery and a femfit® usability questionnaire. RESULTS: Sixteen sets of vaginal pressure data were analysed. The highest pressure generated was identified as the peak PFM pressure, whilst all sensor measurements provided a pressure profile. Intra-abdominal pressure (IAP) was measured by the most distal sensor, 8. On average, the difference between peak PFM pressure and IAP was significantly greater post-surgery (p < 0.01). Urinary and vaginal symptom questionnaire scores were significantly improved after POP surgery. Femfit® usability questionnaires demonstrated high levels of patient acceptability. CONCLUSIONS: Women generate higher peak PFM pressures compared to IAP post-POP surgery, with pressure profiles that are comparable to women without POP. This metric might be useful to assess the outcome of POP surgery and encourage women to maintain this profile via PFM training, potentially reducing POP recurrence risk.

Reliability and validity of intravaginal pressure measurements with a new intravaginal pressure device: The FemFit®.

AIMS: To test the reliability and validity of intravaginal pressure measurements acquired during pelvic floor muscle (PFM) tasks in different body positions using the FemFit®, a new intravaginal pressure device. METHODS: Twenty healthy adult women participated in this study. Two assessment sessions were conducted. Intravaginal pressure measurements using the FemFit® were repeated during PFM contraction and straining maneuvers while lying and standing. Maximal intravaginal pressures were collated and compared within and between sessions. They were also correlated to maximal force measurements obtained by dynamometry and vaginal digital palpation. Test-retest reliability was assessed using intraclass correlation coefficient, standard error of measurement and Bland-Altman plots. The validity of the pressure measurements was assessed using Pearson's correlation (dynamometry) and Spearman's rho (palpation). RESULTS: This test-retest study indicate excellent reliability for PFM contraction and straining maneuver both in lying and standing, within and between sessions. For the straining maneuver while standing, increased variability was suggested by a wider limit of agreement on Bland-Altman plots (spanning 31.3 to 43.3mm Hg). A significant moderate to strong correlation was found when comparing measurements of PFM contraction using the FemFit® and the dynamometer or the palpation (Pearson's coefficient = 0.72, P = .006; Spearman's rho = 0.68, P = .005, respectively). CONCLUSION: Our research findings suggest that intravaginal pressures can be reliably measured during PFM contraction and straining manoeuver while lying and standing, using the FemFit® device, both within and between sessions. A moderate to strong correlation between the FemFit® pressure and the force measurements obtained by dynamometry or palpation reinforce the validity of measurements.

Is it time to rethink using digital palpation for assessment of muscle stiffness?

AIM: Physiotherapists typically use digital palpation to determine residual tension in a muscle, referred to as muscle stiffness or tone. These assessments are subjective, and little is known about their accuracy or repeatability. Despite this, it is standard practice to base clinical treatment on these findings. The aim of this study was to assess physiotherapists' ability to assign a seven-point palpation scale to quantitative stiffness values generated by a novel device. METHODS: Prospective observational study involving 125 musculoskeletal and pelvic floor physiotherapists. A novel device was developed that replicates the haptic feedback that clinicians assess as muscle stiffness. Measurements of displacement, force, and stiffness were recorded. RESULTS: There was wide overlap between each scale category assigned to the stiffness values, from low stiffness at -3 (119 [106, 132] N/m) to moderate stiffness at 0 (462 [435,489] N/m); to high stiffness at +3 (897 [881,913] N/m). Consistency in applying the scale was poor, and the probability of a similar value of stiffness being assigned to the same scale category by different participants was low. CONCLUSIONS: While palpation is used globally by physiotherapists as a readily available and low-cost method of assessing muscle stiffness, these results indicate that it should be used with caution in diagnosing and defining patient care. Clinical assessment of muscle stiffness requires a validated and reliable palpation scale if this metric is to be used to diagnose pathology and develop treatment protocols. Training in this scale should then be recommended to improve reliability in patient assessment.

Change in levator ani muscle stiffness and active force during pregnancy and post-partum.

INTRODUCTION AND HYPOTHESIS: It is assumed changes occur to the biomechanics and viscoelastic response of the levator ani muscle during pregnancy; however, there is limited evidence of this. This study used instrumentation and clinical measures to determine the stiffness and active force capacity of levator ani muscle during pregnancy and post-partum, investigated any associations with delivery outcomes, and explored the biomechanical properties associated with symptoms of pelvic floor dysfunction. METHODS: This was a prospective observational study, with nulliparous women with a singleton low-risk pregnancy. Data were collected at two stages during pregnancy and post-partum. Measurements included the Australian Pelvic Floor Questionnaire, palpation of active force, and elastometry measurements. Post-partum, 3D/4D ultrasound measurements were included. Repeated measures ANOVAs, pairwise comparisons, Pearson correlation coefficients, and Student's t-tests were used as appropriate. RESULTS: Fifty-nine women took part in the study. Active force was significantly different over the pregnancy and post-partum, measured with instrumentation (p = 0.002) and palpation (p = 0.006 right, p = 0.029 left). There was no significant change in muscle stiffness during pregnancy. Post-partum muscle stiffness was significantly different between women who gave birth vaginally vs. caesarean section (p = 0.002). Post-partum there were differences in levator hiatal area, symptoms of bladder dysfunction, prolapse symptoms, and sexual dysfunction symptoms. CONCLUSIONS: Active force of the levator ani muscle was significantly reduced during pregnancy and in the post-partum period, while muscle stiffness reduced only in those who had vaginal deliveries.

Can you train the pelvic floor muscles by contracting other related muscles?

AIMS: The aim of this study is to assess whether contraction of muscles other than the pelvic floor muscles (PFM) would be of sufficient magnitude to provide a "training" effect for the pelvic floor. METHODS: Women were recruited via advertisement from a convenience sample of pelvic floor physiotherapists. A thin flexible array of pressure sensors (FemFit) was self-inserted into the vagina. Participants performed three maximum pelvic floor contractions and completed a randomized exercise protocol. Maximum pressures were determined for each sensor, for each exercise. Wilcoxon paired tests were used to ascertain the difference in pelvic floor muscle pressure between exercises, and between the pressures from the pelvic floor muscles sensors and those measuring abdominal pressure. Bonferroni correction α 0.005. RESULTS: Data was obtained from nineteen participants. Mean age 43 ± 11 years, BMI 22.4 ± 3.2 kg m-2 . Mean PFM pressure for pelvic floor muscle contractions was 16.3 ± 12.2 mmHg. Pressure in the region of the pelvic floor was significantly higher during a targeted contraction compared to that for all other exercises, except for cough and curl-ups (P = 0.009, P = 0.013 respectively). PFM pressure was significantly higher than abdominal for PFMC, internal rotators and gluteals (P < 0.001). CONCLUSION: Targeted PFM contractions develop higher pressures compared to abdominal pressure than any exercise tested in this study. The Femfit device was able to distinguish between abdominal and pelvic floor muscle pressures simultaneously. Exercising accessory muscles in an attempt to activate the pelvic floor sufficiently to illicit a training effect is not recommended.

Assessing exercises recommended for women at risk of pelvic floor disorders using multivariate statistical techniques.

INTRODUCTION AND HYPOTHESIS: There is a widely held, but untested, belief that certain exercises and activities generate intraabdominal pressure (IAP) that may compromise the function of the pelvic floor muscles. Women with, or at risk of, pelvic floor disorders are advised therefore to refrain from these exercises and activities in order to theoretically protect their pelvic floor. The aim of this study was to compare IAPs generated during exercises of different types that are recommended to women as pelvic floor "safe" with those generated during the corresponding conventional exercises that women are typically cautioned against. METHODS: This was a cross-sectional cohort study. All participants were guided by a trained exercise practitioner through a series of ten exercise pairs, one version recommended to women as pelvic floor "safe" and one conventional version which women are cautioned against. IAP components were extracted from the pressure traces from a wireless intravaginal pressure sensor and used in multivariate linear regression modelling, canonical discriminant analysis, and linear mixed modelling. RESULTS: A total of 53 participants were recruited. After adjusting for age, body mass index and parity, there was an exercise type-version effect (p < 0.01). After taking into account all pressure components of the IAP trace, there was a significant difference in IAP between the recommended and discouraged versions of the same exercise for five of the ten exercise types. Coughing and the Valsalva manoeuvre generated IAPs that were distinct from those generated by the exercises. CONCLUSIONS: No differences in IAPs were found between the recommended and discouraged versions of the same exercise for all exercise types. In particular, the IAPs generated during the two versions of ball rotations, lunges, core, push-ups and squats did not differ significantly. Performing the recommended pelvic floor "safe" version instead of the discouraged conventional version of these exercises may not necessarily protect the pelvic floor and vice versa.

Pelvic floor morphometry and function in women with and without puborectalis avulsion in the early postpartum period.

BACKGROUND: Pelvic floor muscles are subject to considerable stretching during vaginal birth. In 13-36% of women, stretching results in avulsion injury whereby the puborectalis muscle disconnects from its insertion points on the pubis bone. Until now, few studies have investigated the effect of this lesion on pelvic floor muscles in the early postpartum period. OBJECTIVE: The primary aim of this study was to compare pelvic floor muscle morphometry and function in primiparous women with and without puborectalis avulsion in the early postpartum period. Our secondary objective was to compare the 2 groups for pelvic floor disorders and impact on quality of life. STUDY DESIGN: In all, 52 primiparous women diagnosed with (n = 22) or without (n = 30) puborectalis avulsion injury were assessed at 3 months postpartum. Pelvic floor muscle morphometry was evaluated with 3-/4-dimensional transperineal ultrasound at rest, maximal contraction, and Valsalva maneuver. Different parameters were measured in the midsagittal and axial planes: bladder neck position, levator plate angle, anorectal angle, and levator hiatus dimensions. The dynamometric speculum was used to assess pelvic floor muscle function including: passive properties (passive forces and stiffness) during dynamic stretches, maximal strength, speed of contraction, and endurance. Pelvic floor disorder-related symptoms (eg, urinary incontinence, vaginal and bowel symptoms) and impact on quality of life were evaluated with the International Consultation on Incontinence Questionnaire and the Pelvic Floor Impact Questionnaire-Short Form. Pelvic Organ Prolapse Quantification was also assessed. RESULTS: In comparison to women without avulsion, women with avulsion presented an enlarged hiatus area at rest, maximal contraction, and Valsalva maneuver (P ≤ .013) and all other ultrasound parameters were found to be significantly altered during maximal contraction (P ≤ .014). They showed lower passive forces at maximal and 20-mm vaginal apertures as well as lower stiffness at 20-mm aperture (P ≤ .048). Significantly lower strength, speed of contraction, and endurance were also found in women with avulsion (P ≤ .005). They also presented more urinary incontinence symptoms (P = .040) whereas vaginal and bowel symptoms were found to be similar in the 2 groups. Pelvic Organ Prolapse Quantification revealed greater anterior compartment descent in women with avulsion (P ≤ .010). The impact of pelvic floor disorders on quality of life was found to be significantly higher in women with avulsion (P = .038). CONCLUSION: This study confirms that pelvic floor muscle morphometry and function are impaired in primiparous women with puborectalis avulsion in the early postpartum period. Moreover, it highlights specific muscle parameters that are altered such as passive properties, strength, speed of contraction, and endurance.

Characterizing levator-ani muscle stiffness pre- and post-childbirth in European and Polynesian women in New Zealand: a pilot study.

INTRODUCTION: The influence of levator-ani muscles on second-stage labor is poorly understood. The ability of these muscles to stretch without damage may affect birth outcomes, but little is known about material properties, effects of pregnancy and/or ethnicity on levator-ani stiffness. There are strong associations between muscle damage and subsequent pelvic floor disorders. This study aimed to quantify levator-ani muscle stiffness during the third trimester of pregnancy and postpartum in European and Polynesian women. Associations between stiffness, obstetric variables, and the risk of intrapartum levator-ani injury (avulsion) were investigated. MATERIAL AND METHODS: This was a prospective observational pilot study. A total of 167 (106 European and 61 Polynesian) nulliparous women were recruited antenatally; 129 returned postnatally. Participants were assessed between 36 and 38 weeks' gestation and three to five months postpartum. Assessments included pelvic floor ultrasound, elastometry testing, and validated questionnaires on pelvic floor function. Logistic regression, Student t-, Chi-square and Mann-Whitney tests were used as appropriate. RESULTS: There are significant differences between antenatal and postnatal muscle stiffness measurements (p < 0.01). Stiffness was significantly higher in the European cohort (p = 0.03). There were more avulsion injuries in European (20%) than in Polynesian (9%) women. There were no significant differences in antenatal stiffness between women with and without avulsion, but change in stiffness (antenatal to postnatal) was significantly less in the avulsion group. There were no associations between stiffness, and other obstetric variables, epidural anesthesia seemed protective (p = 0.03). CONCLUSIONS: Quantification of levator-ani muscle stiffness is feasible. Muscle stiffness is significantly different before and after birth.

Effect of Spinal Manipulation on Pelvic Floor Functional Changes in Pregnant and Nonpregnant Women: A Preliminary Study.

OBJECTIVE: The aim of this study was to investigate whether a single session of spinal manipulation of pregnant women can alter pelvic floor muscle function as measured using ultrasonographic imaging. METHODS: In this preliminary, prospective, comparative study, transperineal ultrasonographic imaging was used to assess pelvic floor anatomy and function in 11 primigravid women in their second trimester recruited via notice boards at obstetric caregivers, pregnancy keep-fit classes, and word of mouth and 15 nulliparous women recruited from a convenience sample of female students at the New Zealand College of Chiropractic. Following bladder voiding, 3-/4-dimensional transperineal ultrasonography was performed on all participants in the supine position. Levator hiatal area measurements at rest, on maximal pelvic floor contraction, and during maximum Valsalva maneuver were collected before and after either spinal manipulation or a control intervention. RESULTS: Levator hiatal area at rest increased significantly (P < .05) after spinal manipulation in the pregnant women, with no change postmanipulation in the nonpregnant women at rest or in any of the other measured parameters. CONCLUSION: Spinal manipulation of pregnant women in their second trimester increased the levator hiatal area at rest and thus appears to relax the pelvic floor muscles. This did not occur in the nonpregnant control participants, suggesting that it may be pregnancy related.

An automated hand-held elastometer for quantifying the passive stiffness of the levator ani muscle in women.

AIM: Design and develop an automated, hand-held instrument (elastometer) to assess in vivo passive stiffness of the pelvic floor muscle. MATERIALS AND METHODS: The elastometer system consisted of a hand piece, real-time controller, and laptop computer. A cable connected the hand-piece to the controller, which communicated with a laptop computer via an ethernet connection. Force sensitivity calibration and displacement accuracy were determined experimentally using a spring load and an Instron mechanical tester. A test re-test series quantified the in vivo repeatability (within a procedure) and reproducibility (between procedures after a 5 min delay) of passive stiffness in volunteers (n = 20). Stiffness was determined from the gradient of the force-displacement curve for each cycle. RESULTS: The force-aperture spring measurements from the elastometer showed consistent (r(2) = 1.0000) agreement with those measured by the Instron. The difference between spring stiffness as measured by the elastometer and the Instron (388.1 N/m cf. 388.5 N/m, respectively) was negligible. The intra-class correlation coefficient for repeatability within procedures was 0.986 95% CI (0.964-0.994) n = 20, and reproducibility between procedures ICC 0.934 (95% CI 0.779-0.981) n = 12. Bland-Altman analysis determined a bias of 0.3 and 18.5 N/m, for repeatability and reproducibility respectively. Neither bias is likely to be clinically significance. CONCLUSION: The elastometer demonstrated very good repeatability and accuracy in the measurement of force/displacement during in vitro testing. There was a high degree of repeatability and reproducibility in stiffness measurements in a test re-test series. Our results demonstrate the elastometer is accurate and reliable and thereby suitable for larger clinical trials.

Clinical evaluation of a high-fidelity wireless intravaginal pressure sensor.

INTRODUCTION AND HYPOTHESIS: A wireless intravaginal pressure sensor (IVPS) has been developed to quantify abdominal pressure (P(abd)) changes during exercise and activities of daily living to guide post-operative advice given to women. In this pilot study, we aimed to compare IVPS performance, comfort, retention, and acceptability to a standard fluid-filled intrarectal pressure catheter currently used to measure P(abd) during routine urodynamics. METHODS: A Life-Tech 3-mm urodynamic intrarectal catheter and IVPS were inserted concurrently in volunteers attending a urodynamics clinic. The IVPS was positioned above the levator plate and the intrarectal catheter positioned in routine fashion well above the anal sphincter. Routine urodynamics was undertaken, with women asked to perform star jumps if coughing or Valsalva did not invoke leakage. Subjects rated device comfort using a visual analogue scale (0-10). Repeated measures Bland-Altman analysis determined level of agreement (LOA) between the two devices for peak pressures for each activity. RESULTS: Twenty-seven women were recruited, 67% of the participants preferred the IVPS, 18% the intrarectal catheter, while 15% had no preference. Mean comfort score was 0.9 ± 1.7 and 2.1 ± 2.6 (p = 0.049) for the IVPS and intrarectal catheter respectively. Bland-Altman analysis demonstrated minimal bias for cough and Valsalva, however LOA were wide. Differences were more prominent during star jumps where rapid dynamic pressure changes occurred. CONCLUSIONS: The IVPS had a higher comfort score and was well retained. The LOA between the two systems was moderate, but the high sampling rate and lower susceptibility to motion artefacts of the IVPS may provide more accurate information that will be important clinically.

Comparison between transperineal ultrasound and digital detection of levator ani trauma. Can we improve the odds?

AIMS: To investigate the predictive ability of four digital assessment parameters to detect levator ani (LA) muscle defects (avulsion injury) and compare these to transperineal tomographic ultrasound images. METHODS: This was an observational study imbedded in a larger quasi-experimental cohort study for women with urinary incontinence. Seventy-two women, ≥ 60 years who had attended or were going to attend physiotherapy for treatment of urinary incontinence, were included in the study. Inclusion criteria from the parent study were symptoms of stress, urge or both types of urinary incontinence. The predictive ability of the following digital parameters: direct palpation of a discontinuity of the LA muscle from insertion on the pubic ramus; palpation of the distance between the muscle insertion sites; palpation of LA strength; palpation of LA tone, were analyzed against findings from tomographic transperineal ultrasound images. Correlation between methods was measured using Cohen's kappa for each of the individual parameters. RESULTS: Seventeen women (24%) presented with a complete or partial avulsion of the puborectalis muscle as diagnosed with tomographic ultrasound imaging. Nine women (13%) had complete avulsions, one of which was bilateral. The predictive ability of the digital assessment parameters varied from poor (k = 0.187, 95% CI [0.02-0.36]) to moderate (k = 0.569, 95% CI [0.31-0.83]). The new parameter of 'width between insertion sites' performed best. CONCLUSIONS: Adding the parameter of "width between insertion sites" appears to enhance our ability to detect avulsion of the levator ani (LA) muscle by digital examination however it does not distinguish between unilateral or bilateral avulsion.

Design and development of a novel intra-vaginal pressure sensor.

INTRODUCTION AND HYPOTHESIS: The influence of intra-abdominal pressure (IAP) on prolapse development is poorly understood. Nonetheless, chronic cough, high BMI, or heavy lifting predisposes women to pelvic organ prolapse (POP). This study aims to develop and test a novel, wireless intra-vaginal pressure sensor (IVPS) to quantify intra-abdominal pressure changes across a range of well-defined activities. METHODS: The IVPS shape was based on silicone moulds of the vagina and was designed to sit in the proximal vagina. It is thin, compliant and negligibly distorts the surrounding tissues. Repeatability was assessed in 14 volunteers performing three sets of activities (cycles). Each cycle consisted of 18 activities. The IVPS was removed and reinserted after completing either the first or second of the three-cycle exercise routine (order). Participants independently inserted and removed the device. A nested split-plot, factorial ANOVA determined the effect of order using mean IAP increase (mean) and peak-to-peak fluctuations in IAP (amplitude) as dependent variables. Descriptive analysis examined the relative change in IAP across the activities. Cronbach's alpha) determined repeatability. RESULTS: All women found the IVPS comfortable and easy to insert. There was excellent correlation between cycles across all variables, r > 0.935 (mean) and r > 0.964 (amplitude). The order was not statistically significant, demonstrating a highly repeatable measurement. CONCLUSION: This is the first device to measure IAP at high frequency with the freedom of a wireless system. The IVPS aims to provide information to advise women better on suitable pre- and post-operative activities.