Exosomes isolated from TNF-α-treated bone marrow mesenchymal stem cells ameliorate pelvic floor dysfunction in rats.

Exosomes derived from bone marrow-derived mesenchymal stem cells (BMSCs) can alleviate the symptoms of pelvic floor dysfunction (PFD) in rats. However, the potential therapeutical effects of exosomes derived from BMSCs treated with tumour necrosis factor (TNF)-α on the symptoms of PFD in rats are unknown. Exosomes extracted from BMSCs treated with or without TNF-α were applied to treat PFD rats. Our findings revealed a significant elevation in interleukin (IL)-6 and TNF-α, and matrix metalloproteinase-2 (MMP2) levels in the vaginal wall tissues of patients with pelvic organ prolapse (POP) compared with the control group. Daily administration of exosomes derived from BMSCs, treated either with or without TNF-α (referred to as Exo and TNF-Exo), resulted in increased void volume and bladder void pressure, along with reduced peak bladder pressure and leak point pressure in PFD rats. Notably, TNF-Exo treatment demonstrated superior efficacy in restoring void volume, bladder void pressure and the mentioned parameters compared with Exo treatment. Importantly, TNF-Exo exhibited greater potency than Exo in restoring the levels of multiple proteins (Elastin, Collagen I, Collagen III, IL-6, TNF-α and MMP2) in the anterior vaginal walls of PFD rats. The application of exosomes derived from TNF-α-treated BMSCs holds promise as a novel therapeutic approach for treating PFD.

Assessing the efficacy of pelvic floor muscle training and duloxetine on urinary continence recovery following radical prostatectomy: A randomized clinical trial.

BACKGROUND: Urinary incontinence (UI) can negatively impact quality of life (QoL) after robot-assisted radical prostatectomy (RARP). Pelvic floor muscle training (PFMT) and duloxetine are used to manage post-RARP UI, but their efficacy remains uncertain. We aimed to investigate the efficacy of PFMT and duloxetine in promoting urinary continence recovery (UCR) after RARP. METHODS: A randomized controlled trial involving patients with urine leakage after RARP from May 2015 to February 2018. Patients were randomized into 1 of 4 arms: (1) PFMT-biofeedback, (2) duloxetine, (3) combined PFMT-biofeedback and duloxetine, (4) control arm. PFMT consisted of pelvic muscle exercises conducted with electromyographic feedback weekly, for 3 months. Oral duloxetine was administered at bedtime for 3 months. The primary outcome was prevalence of continence at 6 months, defined as using ≤1 security pad. Urinary symptoms and QoL were assessed by using a visual analogue scale, and validated questionnaires. RESULTS: From the 240 patients included in the trial, 89% of patients completed 1 year of follow-up. Treatment compliance was observed in 88% (92/105) of patients receiving duloxetine, and in 97% (104/107) of patients scheduled to PFMT-biofeedback sessions. In the control group 96% of patients had achieved continence at 6 months, compared with 90% (p = 0.3) in the PMFT-biofeedback, 73% (p = 0.008) in the duloxetine, and 69% (p = 0.003) in the combined treatment arm. At 6 months, QoL was classified as uncomfortable or worse in 17% of patients in the control group, compared with 44% (p = 0.01), 45% (p = 0.008), and 34% (p = 0.07), respectively. Complete preservation of neurovascular bundles (NVB) (OR: 2.95; p = 0.048) was the only perioperative intervention found to improve early UCR. CONCLUSIONS: PFMT-biofeedback and duloxetine demonstrated limited impact in improving UCR after RP. Diligent NVB preservation, along with preoperative patient and disease characteristics, are the primary determinants for early UCR.

A Predictive Model to Identify the Effects of Transcutaneous Sacral Nerve Stimulation With Pelvic Floor Exercises in Fecal Incontinence After Surgery for Anorectal Malformation.

INTRODUCTION: Although the combination of transcutaneous sacral nerve stimulation (tSNS) and pelvic floor exercises (PFEs) has shown significant effectiveness in treating fecal incontinence (FI) after surgery for congenital anorectal malformation (CARM), not all patients achieve satisfactory continence. Therefore, identifying which individuals will benefit from this method is crucial. METHODS: A prospective cohort study enrolled 92 children with FI. All patients underwent tSNS with PFE treatment, and an improved outcome was defined as a Wexner score ≤4. A predictive model to identify the effects of tSNS with PFEs in FI was developed based on the analysis of magnetic resonance imaging and high-resolution anorectal manometry with area under the receiver-operating characteristic curve to evaluate the predictive value of external anal sphincter (EAS) thickness index and anal squeezing pressure (ASP). RESULTS: tSNS with PFEs improved outcomes in 72 patients and led to poor outcomes in 20 (4 had their rectums deviate from the puborectalis muscle center or puborectal muscle ruptures while 16 lacked EAS with a lower ASP). The areas under the receiver-operating characteristic curve for EAS thickness index and ASP in predicting the effects of tSNS with PFEs were 0.915 (95% confidence interval 0.846-0.983, P = 0.000) and 0.886 (95% confidence interval 0.819-0.952, P = 0.000), respectively. By applying cutoff values of 0.076 for EAS thickness index and 21.95 mm Hg for ASP, tSNS with PFEs was found to be ineffective. DISCUSSION: tSNS with PFEs is effective for most patients with FI after CARM surgery, except when the rectum deviates from the puborectal muscle center, puborectal muscle rupture occurs, or EAS is absent with a low ASP.

Twisted orientation of the muscle bundles in the levator ani functional parts in women: Implications for pelvic floor support mechanism.

This study presents a comprehensive investigation of the anatomical features of the levator ani muscle. The levator ani is a critical component of the pelvic floor; however, its intricate anatomy and functionality are poorly understood. Understanding the precise anatomy of the levator ani is crucial for the accurate diagnosis and effective treatment of pelvic floor disorders. Previous studies have been limited by the lack of comprehensive three-dimensional analyses; to overcome this limitation, we analysed the levator ani muscle using a novel 3D digitised muscle-mapping approach based on layer-by-layer dissection. From this examination, we determined that the levator ani consists of overlapping muscle bundles with varying orientations, particularly in the anteroinferior portion. Our findings revealed distinct muscle bundles directly attached to the rectum (LA-re) and twisted muscle slings surrounding the anterior (LA-a) and posterior (LA-p) aspects of the rectum, which are considered functional parts of the levator ani. These results suggest that these specific muscle bundles of the levator ani are primarily responsible for functional performance. The levator ani plays a crucial role in rectal elevation, lifting the centre of the perineum and narrowing the levator hiatus. The comprehensive anatomical information provided by our study will enhance diagnosis accuracy and facilitate the development of targeted treatment strategies for pelvic floor disorders in clinical practice.

Pelvic floor muscle training as treatment for female sexual dysfunction: a systematic review and meta-analysis.

OBJECTIVE: This study aimed to investigate the efficacy of pelvic floor muscle training in treating female sexual dysfunction. DATA SOURCES: A systematic review of databases, including PubMed, Ovid Medline, CINAHL, Embase, BVSalud, Scopus, and Cochrane Library, was performed in July 2021 and updated in May 2023. STUDY ELIGIBILITY CRITERIA: Full-text articles of randomized controlled trials comparing pelvic floor muscle training with no intervention or another conservative treatment were included. At least 1 arm of these trials aimed to improve women's sexual function or treat sexual dysfunction. METHODS: The data for this review were extracted and analyzed by 2 independent reviewers. Data on the characteristics of each intervention were extracted using the Consensus on Exercise Reporting Template. The risk of bias and certainty of evidence were assessed using the Physiotherapy Evidence Database (PEDro) scale and the GRADE (Grading of Recommendations Assessment, Development and Evaluation) criteria, respectively. A meta-analysis was conducted considering the posttreatment mean score difference in the Female Sexual Function Index between the control and treatment groups. RESULTS: A total of 21 randomized controlled trials were included in this review. The Consensus on Exercise Reporting Template revealed varying quality of the pelvic floor muscle training protocols. Four studies were included in the meta-analysis showing that pelvic floor muscle training improved arousal (1.49; 95% confidence interval, 0.13-2.85), orgasm (1.55; 95% confidence interval, 0.13-2.96), satisfaction (1.46; 95% confidence interval, 0.14-2.77), pain (0.74; 95% confidence interval, 0.11-1.37), and the Female Sexual Function Index overall score (7.67; 95% confidence interval, 0.77-14.57). Very low certainty of evidence due to the data's high clinical and statistical heterogeneity was found according to the GRADE criteria. No side effects of the interventions were reported. CONCLUSION: This systematic review and meta-analysis showed that pelvic floor muscle training improved female Female Sexual Function Index total score and several subscales; however, the certainty of the evidence is low.

Evolution of the human birth canal.

It seems puzzling why humans have evolved such a small and rigid birth canal that entails a relatively complex process of labor compared with the birth canal of our closest relatives, the great apes. This study reviewed insights into the evolution of the human birth canal from recent theoretical and empirical studies and discussed connections to obstetrics, gynecology, and orthopedics. Originating from the evolution of bipedality and the large human brain million years ago, the evolution of the human birth canal has been characterized by complex trade-off dynamics among multiple biological, environmental, and sociocultural factors. The long-held notion that a wider pelvis has not evolved because it would be disadvantageous for bipedal locomotion has not yet been empirically verified. However, recent clinical and biomechanical studies suggest that a larger birth canal would compromise pelvic floor stability and increase the risk of incontinence and pelvic organ prolapse. Several mammals have neonates that are equally large or even larger than human neonates compared to the size of the maternal birth canal. In these species, the pubic symphysis opens widely to allow successful delivery. Biomechanical and developmental constraints imposed by bipedality have hindered this evolutionary solution in humans and led to the comparatively rigid pelvic girdle in pregnant women. Mathematical models have shown why the evolutionary compromise to these antagonistic selective factors inevitably involves a certain rate of fetopelvic disproportion. In addition, these models predict that cesarean deliveries have disrupted the evolutionary equilibrium and led to new and ongoing evolutionary changes. Different forms of assisted birth have existed since the stone age and have become an integral part of human reproduction. Paradoxically, by buffering selection, they may also have hindered the evolution of a larger birth canal. Many of the biological, environmental, and sociocultural factors that have influenced the evolution of the human birth canal vary globally and are subject to ongoing transitions. These differences may have contributed to the global variation in the form of the birth canal and the difficulty of labor, and they likely continue to change human reproductive anatomy.

Pelvic floor injury during vaginal birth is life-altering and preventable: what can we do about it?

Pelvic floor disorders after childbirth have distressing lifelong consequences for women, requiring more than 300,000 women to have surgery annually. This represents approximately 10% of the 3 million women who give birth vaginally each year. Vaginal birth is the largest modifiable risk factor for prolapse, the pelvic floor disorder most strongly associated with birth, and is an important contributor to stress incontinence. These disorders require 10 times as many operations as anal sphincter injuries. Imaging shows that injuries of the levator ani muscle, perineal body, and membrane occur in up to 19% of primiparous women. During birth, the levator muscle and birth canal tissues must stretch to more than 3 times their original length; it is this overstretching that is responsible for the muscle tear visible on imaging rather than compression or neuropathy. The injury is present in 55% of women with prolapse later in life, with an odds ratio of 7.3, compared with women with normal support. In addition, levator damage can affect other aspects of hiatal closure, such as the perineal body and membrane. These injuries are associated with an enlarged urogenital hiatus, now known as antedate prolapse, and with prolapse surgery failure. Risk factors for levator injury are multifactorial and include forceps delivery, occiput posterior birth, older maternal age, long second stage of labor, and birthweight of >4000 g. Delivery with a vacuum device is associated with reduced levator damage. Other steps that might logically reduce injuries include manual rotation from occiput posterior to occiput anterior, slow gradual delivery, perineal massage or compresses, and early induction of labor, but these require study to document protection. In addition, teaching women to avoid pushing against a contracted levator muscle would likely decrease injury risk by decreasing tension on the vulnerable muscle origin. Providing care for women who have experienced difficult deliveries can be enhanced with early recognition, physical therapy, and attention to recovery. It is only right that women be made aware of these risks during pregnancy. Educating women on the long-term pelvic floor sequelae of childbirth should be performed antenatally so that they can be empowered to make informed decisions about management decisions during labor.

Effect of nonsteroidal anti-inflammatory drugs on pelvic floor muscle regeneration in a preclinical birth injury rat model.

BACKGROUND: Pelvic floor muscle injury is a common consequence of vaginal childbirth. Nonsteroidal anti-inflammatory drugs are widely used postpartum analgesics. Multiple studies have reported negative effects of these drugs on limb muscle regeneration, but their impact on pelvic floor muscle recovery following birth injury has not been explored. OBJECTIVE: Using a validated rat model, we assessed the effects of nonsteroidal anti-inflammatory drug on acute and longer-term pelvic floor muscle recovery following simulated birth injury. STUDY DESIGN: Three-month old Sprague Dawley rats were randomly assigned to the following groups: (1) controls, (2) simulated birth injury, (3) simulated birth injury+nonsteroidal anti-inflammatory drug, or (4) nonsteroidal anti-inflammatory drug. Simulated birth injury was induced using a well-established vaginal balloon distension protocol. Ibuprofen was administered in drinking water (0.2 mg/mL), which was consumed by the animals ad libitum. Animals were euthanized at 1, 3, 5, 7, 10, and 28 days after birth injury/ibuprofen administration. The pubocaudalis portion of the rat levator ani, which, like the human pubococcygeus, undergoes greater parturition-associated strains, was harvested (N=3-9/time point/group). The cross-sectional areas of regenerating (embryonic myosin heavy chain+) and mature myofibers were assessed at the acute and 28-day time points, respectively. The intramuscular collagen content was assessed at the 28-day time point. Myogenesis was evaluated using anti-Pax7 and anti-myogenin antibodies to identify activated and differentiated muscle stem cells, respectively. The overall immune infiltrate was assessed using anti-CD45 antibody. Expression of genes coding for pro- and anti-inflammatory cytokines was assessed by quantitative reverse transcriptase polymerase chain reaction at 3, 5, and 10 days after injury. RESULTS: The pubocaudalis fiber size was significantly smaller in the simulated birth injury+nonsteroidal anti-inflammatory drug compared with the simulated birth injury group at 28 days after injury (P<.0001). The median size of embryonic myosin heavy chain+ fibers was also significantly reduced, with the fiber area distribution enriched with smaller fibers in the simulated birth injury+nonsteroidal anti-inflammatory drug group relative to the simulated birth injury group at 3 days after injury (P<.0001), suggesting a delay in the onset of regeneration in the presence of nonsteroidal anti-inflammatory drugs. By 10 days after injury, the median embryonic myosin heavy chain+ fiber size in the simulated birth injury group decreased from 7 days after injury (P<.0001) with a tight cross-sectional area distribution, indicating nearing completion of this state of regeneration. However, in the simulated birth injury+nonsteroidal anti-inflammatory drug group, the size of embryonic myosin heavy chain+ fibers continued to increase (P<.0001) with expansion of the cross-sectional area distribution, signifying a delay in regeneration in these animals. Nonsteroidal anti-inflammatory drugs decreased the muscle stem cell pool at 7 days after injury (P<.0001) and delayed muscle stem cell differentiation, as indicated by persistently elevated number of myogenin+ cells 7 days after injury (P<.05). In contrast, a proportion of myogenin+ cells returned to baseline by 5 days after injury in the simulated birth injury group. The analysis of expression of genes coding for pro- and anti-inflammatory cytokines demonstrated only transient elevation of Tgfb1 in the simulated birth injury+nonsteroidal anti-inflammatory drug group at 5 but not at 10 days after injury. Consistently with previous studies, nonsteroidal anti-inflammatory drug administration following simulated birth injury resulted in increased deposition of intramuscular collagen relative to uninjured animals. There were no significant differences in any outcomes of interest between the nonsteroidal anti-inflammatory drug group and the unperturbed controls. CONCLUSION: Nonsteroidal anti-inflammatory drugs negatively impacted pelvic floor muscle regeneration in a preclinical simulated birth injury model. This appears to be driven by the negative impact of these drugs on pelvic muscle stem cell function, resulting in delayed temporal progression of pelvic floor muscle regeneration following birth injury. These findings provide impetus to investigate the impact of postpartum nonsteroidal anti-inflammatory drug administration on muscle regeneration in women at high risk for pelvic floor muscle injury.

Soft-tissue dystocia due to paradoxical contraction of the levator ani as a cause of prolonged second stage: concept, diagnosis, and potential treatment.

Smaller pelvic floor dimensions seem to have been an evolutionary need to provide adequate support for the pelvic organs and the fetal head. Pelvic floor dimension and shape contributed to the complexity of human birth. Maternal pushing associated with pelvic floor muscle relaxation is key to vaginal birth. Using transperineal ultrasound, pelvic floor dimensions can be objectively measured in both static and dynamic conditions, such as pelvic floor muscle contraction and pushing. Several studies have evaluated the role of the pelvic floor in labor outcomes. Smaller levator hiatal dimensions seem to be associated with a longer duration of the second stage of labor and a higher risk of cesarean and operative deliveries. Furthermore, smaller levator hiatal dimensions are associated with a higher fetal head station at term of pregnancy, as assessed by transperineal ultrasound. With maternal pushing, most women can relax their pelvic floor, thus increasing their pelvic floor dimensions. Some women contract rather than relax their pelvic floor muscles under pushing, which is associated with a reduction in the anteroposterior diameter of the levator hiatus. This phenomenon is called levator ani muscle coactivation. Coactivation in nulliparous women at term of pregnancy before the onset of labor is associated with a higher fetal head station at term of pregnancy and a longer duration of the second stage of labor. In addition, levator ani muscle coactivation in nulliparous women undergoing induction of labor is associated with a longer duration of the active second stage of labor. Whether we can improve maternal pelvic floor relaxation with consequent improvement in labor outcomes remains a matter of debate. Maternal education, physiotherapy, and visual feedback are promising interventions. In particular, ultrasound visual feedback before the onset of labor can help women increase their levator hiatal dimensions and correct levator ani muscle coactivation in some cases. Ultrasound visual feedback in the second stage of labor was found to help women push more efficiently, thus obtaining a lower fetal head station at ultrasound and a shorter duration of the second stage of labor. The available evidence on the role of any intervention aimed to aid women to better relax their pelvic floor remains limited, and more studies are needed before considering its routine clinical application.

Physiotherapy for continence and muscle function in prostatectomy: a randomised controlled trial.

OBJECTIVE: To assess the effectiveness of pre- and postoperative supervised pelvic floor muscle training (PFMT) on the recovery of continence and pelvic floor muscle (PFM) function after robot-assisted laparoscopic radical prostatectomy (RARP). PATIENTS AND METHODS: We carried out a single-blind randomised controlled trial involving 54 male patients scheduled to undergo RARP. The intervention group started supervised PFMT 2 months before RARP and continued for 12 months after surgery with a physiotherapist. The control group was given verbal instructions, a brochure about PFMT, and lifestyle advice. The primary outcome was 24-h pad weight (g) at 3 months after RARP. The secondary outcomes were continence status (assessed by pad use), PFM function, and the Expanded Prostate Cancer Index Composite (EPIC) score. RESULTS: Patients who participated in supervised PFMT showed significantly improved postoperative urinary incontinence (UI) compared with the control group (5.0 [0.0-908.0] g vs 21.0 [0.0-750.0] g; effect size: 0.34, P = 0.022) at 3 months after RARP based on 24-h pad weight. A significant improvement was seen in the intervention compared with the control group (65.2% continence [no pad use] vs 31.6% continence, respectively) at 12 months after surgery (effect size: 0.34, P = 0.030). Peak pressure during a maximum voluntary contraction was higher in the intervention group immediately after catheter removal and at 6 months, and a longer duration of sustained contraction was found in the intervention group compared with the control group. We were unable to demonstrate a difference between groups in EPIC scores. CONCLUSION: Supervised PFMT can improve postoperative UI and PFM function after RARP. Further studies are needed to confirm whether intra-anal pressure reflects PFM function and affects continence status in UI in men who have undergone RARP.

Investigating the role of the pelvic floor muscles in sexual function and sexual response: a systematic review and meta-analysis.

INTRODUCTION: The pelvic floor muscles (PFMs) have been suggested to play a key role in sexual function and response in women. However, syntheses of the evidence thus far have been limited to interventional studies in women with pelvic pain or pelvic floor disorders, and these studies have failed to fully capture the involvement of the PFMs in a broader population. AIM: We sought to appraise the evidence regarding the role of the PFMs in sexual function/response in women without pelvic pain or pelvic floor disorders. More specifically, we examined the following: (1) effects of treatment modalities targeting the PFMs on sexual function/response, (2) associations between PFM function and sexual function/response, and (3) differences in PFM function between women with and those without sexual dysfunction. METHODS: We searched for all available studies in eight electronic databases. We included interventional studies evaluating the effects of PFM modalities on sexual outcomes, as well as observational studies investigating the association between PFM function and sexual outcomes or the differences in PFM function in women with and those without sexual dysfunction. The quality of each study was assessed using the Mixed Methods Appraisal Tool. Estimates were pooled using random-effects meta-analyses whenever possible, or a narrative synthesis of the results was provided. MAIN OUTCOMES: The main outcomes were sexual function (based on a questionnaire)/sexual response (based on physiological test), and PFM function (assessment of the PFM parameters such as strength and tone based on various methods). RESULTS: A total of 33 studies were selected, including 14 interventional and 19 observational studies, most of which (31/33) were deemed of moderate or high quality. Ten out of 14 interventional studies in women with and without sexual dysfunctions showed that PFM modalities had a significant effect on sexual function. Regarding the observational studies, a meta-analysis revealed a significant moderate association between PFM strength and sexual function (r = 0.41; 95% CI, 0.08-066). Of the 7 observational studies performed to assess sexual response, all showed that the PFMs were involved in arousal or orgasm. Conflicting results were found in the 3 studies that evaluated differences in PFM function in women with and those without sexual dysfunction. CLINICAL IMPLICATIONS: Our results highlight the contribution of the PFMs in sexual function/response. STRENGTHS AND LIMITATIONS: One strength of this review is the inclusion of a broad range of study designs and outcomes, allowing a thorough synthesis of evidence. However, interpretations of these data should consider risk of bias in the studies, small sample sizes, and the absence of control/comparison groups. CONCLUSION: The findings of this review support the involvement of the PFMs in sexual function/response in women without pelvic pain or pelvic dysfunction. Well-designed studies should be performed to further investigate PFM modalities as part of the management of sexual dysfunction.

Pelvic floor muscle training vs radiofrequency for women with vaginal laxity: randomized clinical trial.

BACKGROUND: Vaginal laxity (VL) is a complaint of excessive vaginal looseness with a prevalence ranging from 24% to 38% across studies. AIM: The study sought to compare the effect of radiofrequency (RF) and pelvic floor muscle training (PFMT) on the treatment of women with VL. METHODS: From February 2020 to December 2021, a prospective, parallel, noninferiority, randomized clinical trial was carried out in women ≥18 years of age and complaining of VL in a tertiary hospital. Two groups (RF and PFMT) were evaluated at the beginning of the study and 30 days and 6 months postintervention. A total of 42 participants per arm was sufficient to demonstrate a difference in sexual function on the Female Sexual Function Index at 90% power, 1-sided type 1 error of 0.025 with a noninferiority margin of 4 on the FSFI total score. Analysis was intention-to-treat and per-protocol based. OUTCOMES: The primary endpoint was the change of FSFI score after treatment, and the secondary outcomes were improvement in symptoms of VL and changes in questionnaire scores of sexual distress, vaginal symptoms, and urinary incontinence, in the quantification of pelvic organ prolapse, and pelvic floor muscle (PFM) contraction. RESULTS: Of 167 participants recruited, 87 were included (RF: n = 42; PFMT: n = 45). All questionnaires improved (P < .05) their total scores and subscales in both groups and during the follow-ups. After 30 days of treatment, RF was noninferior to PFMT to improving FSFI total score (mean difference -0.08 [95% confidence interval, -2.58 to 2.42]) in the per-protocol analysis (mean difference -0.46 [95% confidence interval, -2.92 to 1.99]) and in the intention-to-treat analysis; however, this result was not maintained after 6 months of treatment. PFM contraction improved significantly in both groups (RF: P = .006, 30 days; P = .049, 6 months; PFMT: P < .001, 30 days and 6 months), with better results in the PFMT group. CLINICAL IMPLICATIONS: Sexual, vaginal, and urinary symptoms were improved after 30 days and 6 months of treatment with RF and PFMT; however, better results were observed in the PFMT group after 6 months. STRENGTHS & LIMITATIONS: The present randomized clinical trial used several validated questionnaires evaluating quality of life, sexual function and urinary symptoms, in addition to assessing PFM contraction and classifying the quantification of pelvic organ prolapse aiming at anatomical changes in two follow-up periods. The limitations were the lack of a sham-controlled group (third arm) and the difficulty of blinding researchers to assess treatments due to the COVID-19 pandemic. CONCLUSION: After 30 days and 6 months of treatment, sexual, vaginal, and urinary symptoms improved with RF and PFMT; however, better results were observed in the PFMT group after 6 months. RF was noninferior to PFMT in improving FSFI total score after 30 days; however, this result was not maintained after 6 months of treatment.

Treatment of women with vaginal laxity: systematic review with meta-analysis.

BACKGROUND: Despite several treatments that have been used for women reporting vaginal laxity (VL), to our knowledge no systematic review is available on the topic so far. AIM: In this study, we sought to summarize the best available evidence about the efficacy and safety of interventions for treating VL, whether conservative or surgical. METHODS: A comprehensive search strategy was performed in Medline, Embase, Scopus, Web of Science, and Cochrane Library for reports of clinical trials published from database inception to September 2022. Studies selected for inclusion were in the English language and were performed to investigate any type of treatment for VL, with or without a comparator, whether nonrandomized studies or randomized controlled trials (RCTs). Case reports and studies without a clear definition of VL were excluded. OUTCOMES: The outcomes were interventions (laser, radiofrequency, surgery, and topical treatment), adverse effects, sexual function, pelvic floor muscle (PFM) strength, and improvement of VL by the VL questionnaire (VLQ). RESULTS: From 816 records, 38 studies remained in the final analysis. Laser and radiofrequency (RF) were the energy-based treatment devices most frequently studied. Pooled data from eight observational studies have shown improved sexual function assessed by a Female Sexual Function Index score mean difference (MD) of 6.51 (95% CI, 5.61-7.42; i2 = 85%, P < .01) before and after intervention, whether by RF (MD, 6.00; 95% CI, 4.26-7.73; i2 = 80%; P < .001) or laser (MD, 6.83; 95% CI, 5.01-8.65; i2 = 92%; P < .01). However, this finding was not shown when only 3 RCTs were included, even when separated by type of intervention (RF or laser). When RF treatment was compared to sham controls, VLQ scores did not improve (MD, 1.01; 95% CI, -0.38 to 2.40; i2 = 94%; P < .001). Patient PFM strength improved after interventions were performed (MD, 4.22; 95% CI, 1.02-7.42; i2 = 77%; P < .001). The ROBINS-I (Risk Of Bias In Nonrandomized Studies of Interventions) tool classified all non-RCTs at serious risk of bias, except for 1 study, and the risk of bias-1 analysis found a low and unclear risk of bias for all RCTs. The GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) certainty of the evidence was moderate for sexual function and the VLQ questionnaire and low for PFM strength. CLINICAL IMPLICATIONS: Sexual function in women with VL who underwent RF and laser treatment improved in observational studies but not in RCTs. Improvement in PFM strength was observed in women with VL after the intervention. STRENGTHS AND LIMITATIONS: Crucial issues were raised for the understanding of VL, such as lack of standardization of the definition and for the development of future prospective studies. A limitation of the study was that the heterogeneity of the interventions and different follow-up periods did not make it possible to pool all available data. CONCLUSIONS: Vaginal tightening did not improve sensation in women with VL after intervention, whereas RF and laser improved sexual function in women with VL according to data from observational studies, but not from RCTs. PFM strength was improved after intervention in women with VL.

Pain with orgasm in endometriosis: potential etiologic factors and clinical correlates.

BACKGROUND: Pelvic pain worsened by orgasm is a poorly understood symptom in patients with endometriosis. AIM: To assess the prevalence of pelvic pain worsened by orgasm in patients with endometriosis and explore its association with potential etiologic factors, including pelvic floor myalgia, uterine tenderness and adenomyosis, and central nervous system sensitization. METHODS: An analysis was done of a prospective data registry based at a tertiary referral center for endometriosis. Eligible participants were patients aged 18 to 50 years who were referred between January 1, 2018, and December 31, 2019, diagnosed with endometriosis, and subsequently underwent surgery at the center. Clinical features were compared between participants reporting worsening pelvic pain with orgasm and those without worsening pain with orgasm, including patient-reported variables, physical examination findings, and anatomic phenotyping at the time of surgery. Pelvic floor myalgia and uterine tenderness were assessed by palpation on pelvic examination, adenomyosis by ultrasound, and central nervous system sensitization via the Central Sensitization Inventory (range, 0-100). OUTCOMES: Outcomes included pelvic or lower abdominal pain in the last 3 months that worsened with orgasm (yes/no). RESULTS: Among 358 participants with endometriosis, 14% (49/358) reported pain worsened by orgasm while 86% (309/358) did not. Pain with orgasm was significantly associated with pelvic floor myalgia (55% [27/49] vs 35% [109/309]; Cohen's h = 0.40, P = .01) and higher scores on the Central Sensitization Inventory (mean ± SD, 53.3 ± 17.0 vs 42.7 ± 18.2; Cohen's d = 0.60, P < .001) but not with uterine tenderness or adenomyosis. Other clinical features associated with pain with orgasm were poorer sexual health (higher scores: deep dyspareunia, Cohen's h = 0.60; superficial dyspareunia, Cohen's h = 0.34; and Female Sexual Distress Scale-Revised, Cohen's d = 0.68; all P < .05) and poorer mental health (higher scores: Patient Health Questionnaire-9, 12.9 ± 6.7 vs 9.1 ± 6.3, Cohen's d = 0.59, P < .001; Generalized Anxiety Disorder-7, 9.4 ± 5.6 vs 6.8 ± 5.5, Cohen's d = 0.48, P = .002). Anatomic findings at the time of surgery did not significantly differ between the groups. CLINICAL IMPLICATIONS: Interventions targeting pelvic floor myalgia and central nervous system sensitization may help alleviate pain worsened by orgasm in patients with endometriosis. STRENGTHS AND LIMITATIONS: A strength is that pain worsened by orgasm was differentiated from dyspareunia. However, pain with orgasm was assessed by only a binary question (yes/no). Also, the study is limited to a single center, and there were limited data on sexual function. CONCLUSION: Pelvic pain exacerbated by orgasm in people with endometriosis may be related to concurrent pelvic floor myalgia and central sensitization.

The effect of pelvic floor muscle training in men with benign prostatic hyperplasia and overactive bladder.

BACKGROUND: Men with overactive bladder (OAB) and benign prostatic hyperplasia (BPH), will have deterioration in the quality of life. OBJECTIVE: The aim of this study was to evaluate the effect of combining pelvic floor muscle training with the urgency suppression technique (PFMT-st) and silodosin in comparison with silodosin in men with benign prostatic hyperplasia (BPH) and overactive bladder (OAB) after 12 weeks of treatment. PATIENTS AND METHODS: A total of 158 patients were randomized into two groups. The control group received oral silodosin at a daily dose of 8 mg. The experimental group was administered PFMT-st and silodosin. The evaluation methods included the number of voids and intensity of urgencies over 24 h using a micturition diary, the International Prostate Symptom Score (IPSS), the Overactive Bladder Questionnaire (OAB-q), and the patient global impression of improvement (PGI-I). RESULTS: 142 of 172 (86.6%) men were assessed (70 in the control group, 72 in the experimental group). The significant changes were in favor of the experimental group (p < 0.001) in the number of voids per 24 h (- 1.95 ± 1.94 vs. - 0.90 ± 1.44), the OAB-q symptom score (- 14.25 ± 10.05 vs. - 9.28 ± 10.60), the intensity of urgencies (- 0.97 ± 0.53 vs. 0.24 ± 0.57), the IPSS (- 4.59 ± 3.00 vs. - 2.30 ± 3.63), and in the PGI-I (2.24 ± 0.79 vs. 3.60 ± 0.92). CONCLUSIONS: The addition of PFMT-st to silodosin treatment significantly improved OAB in men with BPH. This is the first study to confirm that PFMT-st should be the first-choice treatment for OAB in BPH.

Effects of external neuromuscular electrical stimulation in women with urgency urinary incontinence: a randomized sham-controlled study.

BACKGROUND AND PURPOSE: The present study aims to investigate the effects of external neuromuscular electrical stimulation (NMES) on urinary symptoms, pelvic floor muscle strength (PFMS), quality of life (QoL), sexual function, perception of subjective improvement (PSI), and satisfaction in urgency urinary incontinence (UUI). MATERIALS AND METHODS: The randomized sham-controlled study design was employed in this study. Women aged 18-65 years, who were diagnosed with UUI, were randomly allocated into the NMES (external NMES + lifestyle advice, n = 15) and sham groups (sham NMES + lifestyle advice, n = 15). Both groups performed the application for 30 min, three days a week for eight weeks. Urinary symptoms were evaluated by using the International Incontinence Consultation Questionnaire-Short Form (ICIQ-SF) and a 3-day bladder diary. PFMS was assessed using the Modified Oxford Scale (MOS), QoL using the King's Health Questionnaire (KHQ), and sexual function using the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12). The PSI and satisfaction were questioned. RESULTS: There was a higher level of decrease in the ICIQ-SF score, the mean number of voids/night and UI, all scores related to the KHQ (excluding interpersonal relationships), and a higher level of increase in maximum voiding volume, MOS scores, PISQ-12-emotional, PISQ-12-physical, and PISQ-12-total scores in the NMES group when compared to the sham group (p < 0.05). PSI and satisfaction were at higher levels in the NMES group than in the sham group (p < 0.05). CONCLUSIONS: External NMES was an effective and complementary method in reducing urinary symptoms and improving PFMS, QoL, sexual function, PSI, and satisfaction level in women with UUI. CLINICAL TRIAL REGISTRATION: NCT04727983.

Sexual function and pelvic floor function in men with systemic sclerosis compared to healthy controls: a cross-sectional study.

OBJECTIVES: This cross-sectional study aimed to compare the sexual function (SF) and pelvic floor function of men with systemic sclerosis (SSc) with age-matched healthy controls (HC) and to identify the implications of clinical features on SF. MATERIAL AND METHOD: Twenty SSc males and 20 HC aged 18-70 years completed eleven questionnaires assessing SF [International Index of Erectile Function (IIEF), Male Sexual Health Questionnaire (MSHQ)]; sexual quality of life: Sexual Quality of Life Questionnaire-Male (SQoL-M); pelvic floor function: Pelvic Floor Impact Questionnaire-Short Form 7 (PFIQ-7), fatigue, depression, physical fitness, functional disability, and quality of life. Clinical data were collected. RESULTS: Significantly worse SF was observed in patients (median IIEF erectile function 12 in SSc versus 29 in HC, p < 0.001), with 70% reporting erectile dysfunction (ED) compared to 15% in HC. However, no significant difference was observed regarding pelvic floor function (median PFIQ7 8.8 in SSc versus 7.0 in HC, p = 0.141). Impaired SF was associated with higher disease activity, increased systemic inflammation, more pronounced fatigue, reduced physical fitness, severe depression, impaired overall quality of life, dyspepsia, and arthralgias (p < 0.05 for all). CONCLUSIONS: Sexual dysfunction is highly prevalent in our SSc patients, whereas pelvic floor dysfunction is unlikely to be associated with these problems.

Pelvic floor muscle strength and influencing factors based on vaginal manometry among healthy women at different life stages: A multicentre cross-sectional study.

OBJECTIVE: To assess pelvic floor muscle (PFM) strength and influencing factors among healthy women at different life stages. DESIGN: Multicentre cross-sectional study. SETTING: Fourteen hospitals in China. POPULATION: A total of 5040 healthy women allocated to the following groups (with 1680 women per group): premenopausal nulliparous, premenopausal parous and postmenopausal. METHODS: The PFM strength was evaluated by vaginal manometry. Multivariate logistic regression was used to determine the influencing factors for low PFM strength. MAIN OUTCOME MEASURES: Maximum voluntary contraction pressure (MVCP). RESULTS: The median MVCP values were 36, 35 and 35 cmH2O in premenopausal nulliparous (aged 19-51 years), premenopausal parous (aged 22-61 years), and postmenopausal (aged 40-86 years) women, respectively. In the premenopausal nulliparous group, physical work (odds ratio, OR 2.05) was the risk factor for low PFM strength, which may be related to the chronic increased abdominal pressure caused by physical work. In the premenopausal parous group, the number of vaginal deliveries (OR 1.28) and diabetes (OR 2.70) were risk factors for low PFM strength, whereas sexual intercourse (<2 times per week vs. none, OR 0.55; ≥2 times per week vs. none, OR 0.56) and PFM exercise (OR 0.50) may have protective effects. In the postmenopausal group, the number of vaginal deliveries (OR 1.32) and family history of pelvic organ prolapse (POP) (OR 1.83) were risk factors for low PFM strength. CONCLUSIONS: Physical work, vaginal delivery, diabetes and a family history of POP are all risk factors for low PFM strength, whereas PFM exercises and sexual life can have a protective effect. The importance of these factors varies at different stages of a woman's life.

Pelvic Floor Therapy and Initial Interventions for Pelvic Floor Dysfunction in Gynecologic Malignancies.

PURPOSE OF REVIEW: This review provides evidence-based updates for the first-line management approaches for pelvic floor disorders in patients with gynecologic malignancies, as well as important provider considerations when referring for pelvic floor physical therapy. RECENT FINDINGS: Currently, there is strong evidence to recommend pelvic floor muscle training as initial treatment for urinary incontinence and for pelvic organ prolapse; some evidence to recommend a more targeted pelvic floor muscle training program for fecal incontinence; and mostly expertise-based evidence to recommend vaginal gels or estrogen to aid with dyspareunia causing sexual dysfunction. More research is greatly needed to understand the role of overactive pelvic floor muscles in survivors with chronic pelvic pain and the treatment of post-radiation pelvic complications such as vaginal stenosis and cystitis. While pelvic floor disorders are common concerns in gynecologic cancer survivors, there are evidence-based initial noninvasive treatment approaches that can provide relief for many individuals.

Efficacy of educational instructions on pelvic floor muscle training in the treatment of urinary incontinence: Systematic review and meta-analysis.

OBJECTIVE: The present study aimed to investigate the efficacy of educational interventions on pelvic floor (PF) muscle training in the treatment of urinary incontinence (UI). METHODS: This is a systematic review of literature with meta-analysis, performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA). To do so, randomized clinical trials that performed educational interventions of PF, UI, and developed the training of PF muscles (TPFM) for incontinent women, performing group or individual comparisons, with control and experimental groups or with two or more experimental groups were selected. The search for papers was performed in the following databases: PubMed, Scopus, Embase, Web of Science, and SciELO, no specific publication date was chosen. The risk of bias was performed using the PEDro scale and the quality of the evidence was performed using GRADE. RESULTS: The review included six studies with 1003 participants. Most studies presented 5-8 points regarding risk of bias. Most of the studies were performed in the last 5 years, with women of various ages, high educational level and prevalence of UI of effort. The present study showed that offering educational instructions and guiding women on TPFM was capable of reducing urinary symptoms. When compared to control, significant between-group differences were found in the studies, in which the control group did not receive any kind of instructions or treatment (p < 0.05). The use of technologies through mobile apps was efficient in the treatment of incontinent women (p < 0.05). Performing TPFM individually or in groups did not present differences in the results, with both improving urinary symptoms. The meta-analysis presented a mean effect and a clinically important difference in three studies. CONCLUSION: The interventions involving instructions to TPFM associated to health education brought improvements to urinary symptoms.