Randomised controlled pilot trial to assess effect of electrical stimulation of weak pelvic floor muscles.

INTRODUCTION AND HYPOTHESIS: Pelvic floor muscle training (PFMT) has level 1A scientific evidence for the treatment of urinary incontinence and pelvic organ prolapse. Past studies, however, have often excluded women with very weak pelvic floor muscles (PFM). The aim was to investigate the hypothesis that intravaginal electrical stimulation (iES) improves PFM strength more than PFMT in women with weak PFM, and to use these results to calculate sample size required for a future large randomised controlled trial (RCT). METHODS: This assessor-blinded pilot RCT had a two arm, parallel design with computer-generated Randomisation. Both groups were offered 12 one-to-one physiotherapy sessions over a 6-month period. The iES group received individual tailored electrical pulse parameters. The PFMT group received PFM exercises, with the addition of facilitation techniques at therapy sessions. A power calculator was used to calculate sample size. RESULTS: Fifteen women were recruited. Eight were randomised to iES and 7 to PFMT. Two subjects dropped out of the iES group. Median age was 49 years (range 36-77) and parity 2.1 (range 1-3). Both groups showed increases in PFM strength measured by manometery (iES 12.3, SD 12.0 vs PFMT 10.0, SD 8.1) cmH2O. There was no significant difference between groups. With a power of 0.80 we need a sample size of 95 women in each group to detect a difference between groups. CONCLUSION: There was no significant difference between the groups in improvements in PFM strength. To detect a difference, we would have required 95 women in each group.

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.

Reliability, validity and responsiveness of pelvic floor muscle surface electromyography and manometry.

INTRODUCTION AND HYPOTHESIS: Vaginal surface electromyography (sEMG) is commonly used to assess pelvic floor muscle (PFM) function and dysfunction but there is a lack of studies regarding the assessment properties. The aim of the study was to test the hypotheses that sEMG has good test-retest intratester reliability, good criterion validity and is responsive to changes compared to manometry. METHODS: PFM resting tone, maximum voluntary contraction (MVC) and endurance were measured in 66 women with pelvic floor dysfunction. One assessment by manometry was followed by two testing sessions with sEMG at baseline. After 4 to 42 weeks of supervised PFM strength training, 29 participants were retested with both devices. RESULTS: Median age of the participants was 41 years (range 24-83) and parity 2 (range 0-10). Very good test-retest intratester reliability was found for all three sEMG measurements. The correlation between sEMG and manometry was moderate for vaginal resting tone (r = 0.42, n = 66, p < 0.001) and strong for MVC (r = 0.66, n = 66, p < 0.001) and endurance (r = 0.67, n = 66, p < 0.001). Following the strength training period, participants demonstrated increased MVC and endurance measured with manometry, but not with sEMG. A significant reduction in resting tone was found only with sEMG. CONCLUSION: sEMG is reliable and correlates well with manometry. However, sEMG is not as responsive as manometry for changes in PFM MVC and endurance. For measurement of PFM resting tone, sEMG seems more responsive than manometry, but this requires further investigation.

Pelvic floor muscle training programme in pregnant Nepalese women-a feasibility study.

INTRODUCTION AND HYPOTHESIS: Pelvic floor muscle training (PFMT) is internationally recommended for prevention and treatment of urinary incontinence (UI) and pelvic organ prolapse (POP). However, there is lack of knowledge about PFMT among pregnant Nepalese women. The objectives of this study were to develop a PFMT programme and to assess the feasibility of the programme. METHODS: A feasibility study was conducted to address aspects of the PFMT programme provided to pregnant women attending antenatal check-ups at Kathmandu University Dhulikhel Hospital. The women were recruited consecutively from June 2017 to April 2018. The PFMT programme consisted of attending a minimum of four supervised PFMT follow-up visits after inclusion to the programme and performing PFMT daily at home. Feasibility was assessed in terms of the recruitment capability, sample characteristics, data collection procedures, outcome measures, and acceptability (attendance to PFMT visits, PFMT adherence, participant experiences) of the programme. Data were collected using self-reported questionnaires. Educational material (video, leaflet, and exercise diary) was developed in Nepali. RESULTS: Among 253 women included, 144 (57%) attended four or more supervised PFMT visits. No significant differences were found in the symptoms of UI (0.89) and POP (0.44) between those attending and those not attending four PFMT visits. Half of the women adhered to 50-100% of PFMT daily at home. The supervised PFMT and the educational material motivated the women to daily PFMT. CONCLUSION: The PFMT programme was acceptable, at least to those living in the district of the study site. The results and experiences from the current study may guide implementation and future studies on the effectiveness of PFMT in Nepal.

Convergent validity of the Timed Up and Go Test and Ten-metre Timed Walk Test in pregnant women with pelvic girdle pain.

Pregnant women with pelvic girdle pain (PGP) often experience functional difficulties, in particular walking difficulties. Currently, however, there is a lack of validated performance-orientated outcome measures available for use in this population. The Timed Up and Go (TUG) test and Ten-metre Timed Walk Test (10 mTWT) are two short-distance walking tests that have demonstrated reliability in pregnant women with PGP, but as yet have no established validity. The aim of the present study was to evaluate the convergent validity of the TUG and 10 mTWT by comparing performances on these two walking tests with scores achieved on the Active Straight Leg Raise (ASLR) test and the Pelvic Girdle Questionnaire (PGQ). Eighteen pregnant women with PGP aged 31.4 years (SD = 2.7) and 28.9 weeks pregnant (SD = 7.3) were included. Spearman rank correlation coefficient (rs) was used to determine convergent validity. Strong correlations were found between the TUG and ASLR (rs = 0.73, p = 0.001), and the 10 mTWT and ASLR (rs = -0.65, p = 0.003). Relationships between the TUG and PGQ were moderate (rs = 0.41 to 0.52) and between the 10 mTWT and PGQ low to moderate (rs = -0.25 to -0.56). The strong relationships between the walking tests and the ASLR may suggest these tests all assess the same construct. The weaker relationships found between the walking tests and the PGQ may be related to the self-report and multiple functional activities nature of the questionnaire. This study found both the TUG and 10 mTWT to be valid weight-bearing physical performance measures, although more research is warranted due to the small study sample.

Are pelvic floor muscle thickness and size of levator hiatus associated with pelvic floor muscle strength, endurance and vaginal resting pressure in women with pelvic organ prolapse stages I-III? A cross sectional 3D ultrasound study.

AIMS: To investigate if pelvic floor muscle (PFM) thickness and area of levator hiatus (LH) are associated with manometry measured PFM function in 109 women with pelvic organ prolapse (POP) stages I-III. METHODS: In this cross-sectional study pubovisceral muscle thickness and LH area were assessed with three-dimensional transperineal ultrasound at rest and analyzed in the axial plane. PFM function was assessed with manometry and included strength, endurance, and vaginal resting pressure. Relationships were investigated using univariate linear logistic regressions models, Pearson product-moment correlation coefficient and hierarchical multiple regression. RESULTS: The mean age was 49 (SD 12). There was a significant positive moderate association between muscle thickness and PFM strength (r = 0.49, P < 0.001) and endurance (r = .45, P < 0.001). A moderate negative association was found between LH area and vaginal resting pressure (r = -0.46, P < 0.001), strength (r = -0.41, P < 0.001) and endurance (r = -0.40, P < 0.001). Multivariate analyses included PFM strength, endurance, vaginal resting pressure, age, parity, BMI and socioeconomic status. Muscle thickness was best explained by PFM strength and LH area was best explained by vaginal resting pressure. However, PFM function explained only 20.0% and 26.4% of the variance in muscle thickness and LH area after controlling for age, parity, BMI, and socioeconomic status. CONCLUSION: There are moderate associations between measurements using ultrasound and manometry in POP women. Thicker muscles and smaller LH were associated with higher strength and endurance. Smaller LH was additionally associated with higher vaginal resting pressure. Ultrasound and manometry measure different aspects of the PFM and cannot be used interchangeably.

Impact of childbirth and mode of delivery on vaginal resting pressure and on pelvic floor muscle strength and endurance.

OBJECTIVE: We sought to study impact of delivery mode on vaginal resting pressure (VRP) and on pelvic floor muscle (PFM) strength and endurance, and whether these measurements differed in women with and without urinary incontinence. STUDY DESIGN: We conducted a cohort study following 277 nulliparous women from midpregnancy to 6 weeks postpartum. Manometer was used for PFM measurements; differences were analyzed by t test (within groups) and analysis of variance (between groups). RESULTS: Only VRP changed significantly (10% reduction, P = .001) after emergency cesarean section. After normal and instrumental vaginal delivery, VRP was reduced by 29% and 30%; PFM strength by 54% and 66%; and endurance by 53% and 65%, respectively. Significant differences for all PFM measures (P < .001) were found when comparing cesarean vs normal and instrumental vaginal delivery, respectively. Urinary continent women at both time points had significantly higher PFM strength and endurance than incontinent counterparts (P < .05). CONCLUSION: Pronounced reductions in VRP and in PFM strength and endurance were found after vaginal delivery. Continent women were stronger than incontinent counterparts.

Continence and pelvic floor status in nulliparous women at midterm pregnancy.

INTRODUCTION AND HYPOTHESIS: A Cochrane review recommends antenatal pelvic floor muscle training (PFMT) in urinary incontinence (UI) prevention. The aim of the study was to investigate nulliparous pregnant women's knowledge about and practising of PFMT, their pelvic floor muscle (PFM) function, and ability to contract correctly. It was hypothesized that continent women had higher PFM strength and endurance than women with UI. METHODS: Three hundred nulliparous women at gestational week 18-22 were included in a cross-sectional study. Vaginal resting pressure, maximum voluntary contraction, and PFM endurance were measured by manometer. UI was assessed by International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF). Comparisons of PFM function in continent women and women with UI were analyzed using independent-samples t test. Mean differences with 95 % confidence interval (CI) are presented. RESULTS: Of 300 women, 89 % had heard of PFMT at mid pregnancy, and 35 % performed PFMT once or more a week. After thorough instruction 4 % were unable to contract correctly. Thirty-five percent reported UI, of whom 48 % performed PFMT once or more a week. Continent women had significantly higher PFM strength and endurance when compared with women having UI, with mean differences of 6.6 cmH(2)O (CI 2.3-10.8, p = 0.003), and 41.5 cmH(2)Osec (CI 9.8-73.1, p = 0.010), respectively. No difference was found for vaginal resting pressure (p = 0.054). CONCLUSIONS: Most nulliparous pregnant women knew about PFMT. Thirty-five percent performed PFMT once or more a week. Incontinent nulliparous pregnant women had weaker PFM than their continent counterparts. More emphasis on information regarding PFM function and PFMT is warranted during pregnancy.

The association between pelvic floor muscle function and pelvic girdle pain--a matched case control 3D ultrasound study.

There is uncertainty regarding the association between the function of the pelvic floor muscles (PFM) and pelvic girdle pain (PGP), and whether exercises to strengthen the PFM should be recommended for patients with PGP. This one-to-one matched case-control study examined whether there is any difference in voluntary PFM function between women with and without clinically diagnosed PGP. PFM function was assessed by manometry and three-dimensional ultrasound. Images were saved anonymously and analyses were performed offline by one investigator. A special Cox regression model was used to fit a conditional logistic regression procedure for one-to-one matched case-control studies. Forty-nine pairs of women were successfully matched according to age and parity. The study showed no difference in voluntary PFM function measured by palpation, manometry or ultrasound. The size of the levator hiatus area, together with BMI, was significantly associated with PGP. Women with PGP had statistically significantly smaller levator hiatus areas and a tendency for higher vaginal resting pressure compared to the control group. A significantly smaller levator hiatus and a tendency for higher vaginal resting pressure may indicate increased activity of the PFM. Hence, no evidence was found to recommend strengthening exercises for the PFM in patients with PGP. It is important to note that in this study we examined only voluntary contractions and not an automatic response of the PFM to a functional activity.

Can the Paula method facilitate co-contraction of the pelvic floor muscles? A 4D ultrasound study.

INTRODUCTION AND HYPOTHESIS: The aim was to compare constriction of the levator hiatus (LH) and reduction of pelvic floor muscle (PFM) length during instruction of the Paula method (contraction of ring musculature of the mouth) and contraction of the PFM. METHODS: Seventeen pregnant or postpartum women, mean age 28.6 (range 20-35) participated. A Voluson E8 ultrasound machine with 4-8 MHz curved array 3D/4D transducer (RAB 4-7l/obstetric) was used. Measurements were performed in the axial plane of minimal hiatal dimensions. Muscle length was calculated as circumference of the LH minus the suprapubic arch. Differences between groups were analyzed using Wilcoxon signed rank test. Significance level was set to 0.05. RESULTS: There was a significant reduction of the LH area (p<0.001) and muscle length (p<0.001) during PFM contraction, but not during contraction according to the Paula method, p=0.51 and p=0.31, respectively. CONCLUSIONS: The Paula method did not facilitate PFM contraction.

Can pelvic floor muscle training reverse pelvic organ prolapse and reduce prolapse symptoms? An assessor-blinded, randomized, controlled trial.

OBJECTIVE: The aim of this study was to investigate the effectiveness of pelvic floor muscle training in reversing pelvic organ prolapse and alleviating symptoms. STUDY DESIGN: This assessor-blinded, parallel group, randomized, controlled trial conducted at a university hospital and a physical therapy clinic randomly assigned 109 women with prolapse stages I, II, and III to pelvic floor muscle training (n = 59) or control (n = 50). Both groups received lifestyle advices and learned "the Knack." In addition, pelvic floor muscle training comprised individual physical therapy sessions and home exercise. Student t test, Mann-Whitney U test, odds ratio, and effect size were used to compare groups. RESULTS: Eleven (19%) women in the pelvic floor muscle training group improved 1 Pelvic Organ Prolapse Quantification System stage vs 4 (8%) controls (P = .035). Compared with controls, the pelvic floor muscle training group elevated the bladder (difference: 3.0 mm; 95% confidence interval, 1.5-4.4; P < .001) and rectum (5.5 mm; 95% confidence interval, 1.4-7.3; P = .022) and reduced frequency and bother of symptoms compared with controls. CONCLUSION: Pelvic floor muscle training is without adverse effects and can be used as treatment for prolapse.

Test-retest reliability of pelvic floor muscle contraction measured by 4D ultrasound.

AIMS: The aim of the present study was to evaluate test-retest measurements of functional aspects of pelvic floor muscle (PFM) contraction using four dimensional (4D) ultrasound. METHODS: Seventeen females preformed three maximal PFM contractions in standing, recorded by 4D real time ultrasound, on two separate occasions. RESULTS: Very good and good reliability was fond for measurement of: Levator hiatus (LH) area, LH antero-posterior dimension, LH transverse dimension, puborectal muscle length and LH narrowing. Shortening of LH transverse distance and muscle length during contraction showed poor and fair reliability, respectively. In the mid sagittal plane the displacement of bladder neck, rectal ampulla and back sling of the poborectal muscle measured with on screen vector assessment demonstrated good reliability. During contraction the LH area was reduced 25% from resting area of 19.7 cm(2) (95% CI = 16.8-22.7) to 14.70 cm(2) (95% CI = 12.82-16.58). The muscle length shortened 21%, from 12.5 cm (95% CI = 11.1-13.8) to 9.70 cm (95% CI = 8.73-10.67). The mid urethra moved 1.1 mm (95% CI = 0.1-2.2) towards the pubic bone during contraction. The back sling of the puborectal muscle and the rectal ampulla had a greater displacement than the bladder neck (P > .004). The displacement of the pelvic organs was two times, or more, greater in the cranial versus anterior direction. CONCLUSIONS: 4D ultrasound can reliable assess muscle length, narrowing of LH area, reduction of LH antero-posterior dimension and lift of BN, rectal ampulla and back sling of the puborectal muscle. Hence, both squeeze and lift can be quantified during PFM contraction.

Test-retest and intra-observer repeatability of two-, three- and four-dimensional perineal ultrasound of pelvic floor muscle anatomy and function.

The aims of the present study were to evaluate test-retest intra-observer repeatability of ultrasound measurement of the morphology and function of the pelvic floor muscles (PFMs). Seventeen subjects were tested twice. Two-, three- and four- dimensional ultrasound recorded cough, huff, muscle morphology and PFM contraction, respectively. Analyses were conducted offline. Measurements of levator hiatal dimensions demonstrated intra-class correlation coefficient (ICC) values of 0.61, 0.72, 0.86 and 0.92, for the anterior-posterior dimension, transverse dimension, resting area and narrowing during contraction, respectively. Muscle thickness showed variable reliability. ICC values for measurement of the position of the bladder neck were 0.86 and 0.82 at rest, in the vertical and horizontal direction. Displacement of the bladder neck during contraction, huff and cough demonstrated ICC values of 0.56, 0.59 and 0.51, respectively. Perineal ultrasound is a reliable method for measuring most of the tested parameters of morphology and function of the PFMs.

Prevention of noncontact anterior cruciate ligament injuries in elite and adolescent female team handball athletes.

To assess the effect of a neuromuscular training program on the incidence of anterior cruciate ligament (ACL) injuries in female team handball athletes, a prospective intervention study of female team handball athletes from divisions I, II, and III in Norway was conducted. The control season (1998-1999) included 60 teams (942 athletes), the first intervention season (1999-2000) included 58 teams (855 athletes), and the second intervention season (2000-2001) included 52 teams (850 athletes). For the intervention teams, a five-phase program (duration, 15 minutes) with three different balance exercises focusing on neuromuscular control and planting and landing skills was developed and introduced to the athletes in the autumn of 1999 and revised before the start of the season in 2000. Each intervention team was instructed in the program and supplied with an instructional video, poster, six balance mats, and six wobble boards. Additionally, a physical therapist was assigned to each team for follow-up during the second intervention season. The number of ACL injuries during the three seasons and compliance with the program were assessed. Twenty-nine ACL injuries occurred during the control season, 23 during the first intervention season (odds ratio [OR], 0.87 [0.50-1.52]; P = 0.62), and 17 during the second intervention season (OR, 0.64 [0.35-1.18]; P = 0.15). In the elite division, 13 injuries occurred during the control season, 6 during the first intervention season (OR, 0.51 [0.19-1.35]; P = 0.17), and 5 during the second intervention season (OR, 0.37 [0.13-1.05]; P = 0.06). For the entire cohort, no difference in injury rates was noted during the second intervention season between compliers and noncompliers (OR, 0.52 [0.15-1.82], P = 0.31). In the elite division, the risk of injury was reduced among athletes who completed the ACL injury prevention program (OR, 0.06 [0.01-0.54], P = 0.01) compared with those who did not. The results demonstrate that it is possible to prevent ACL injuries with specific neuromuscular training.

Prevention of anterior cruciate ligament injuries in female team handball players: a prospective intervention study over three seasons.

OBJECTIVE: To assess the effect of a neuromuscular training program on the incidence of anterior cruciate ligament injuries in female team handball players. DESIGN: Prospective intervention study. SETTING: Female team handball: Division I-III in Norway. PARTICIPANTS: Players from the three top divisions: control season (1998-1999), 60 teams (942 players); first intervention season (1999-2000), 58 teams (855 players); second intervention season (2000-2001), 52 teams (850 players). INTERVENTION: A five-phase program (duration, 15 min) with three different balance exercises focusing on neuromuscular control and planting/landing skills was developed and introduced to the players in the autumn of 1999 and revised before the start of the season in 2000. The teams were instructed in the program and supplied with an instructional video, poster, six balance mats, and six wobble boards. Additionally, a physical therapist was attached to each team to follow up with the intervention program during the second intervention period. MAIN OUTCOME MEASURES: The number of anterior cruciate ligament injuries during the three seasons and compliance with the program. RESULTS: There were 29 anterior cruciate ligament injuries during the control season, 23 injuries during the first intervention season (OR, 0.87; CI, 0.50-1.52; p = 0.62), and 17 injuries during the second intervention season (OR, 0.64; CI, 0.35-1.18; p = 0.15). In the elite division, there were 13 injuries during the control season, six injuries during the first intervention season (OR, 0.51; CI, 0.19-1.35; p = 0.17), and five injuries in the second intervention season (OR, 0.37; CI, 0.13-1.05; p = 0.06). For the entire cohort, there was no difference in injury rates during the second intervention season between those who complied and those who did not comply (OR, 0.52; CI, 0.15-1.82; p = 0.31). In the elite division, the risk of injury was reduced among those who completed the anterior cruciate ligament injury prevention program (OR, 0.06; CI, 0.01-0.54; p = 0.01) compared with those who did not. CONCLUSIONS: This study shows that it is possible to prevent anterior cruciate ligament injuries with specific neuromuscular training.