Observations on the Therapeutic Efficacy of Biomimetic Physiotherapy Combined with Manipulation Therapy in Managing Myofascial Pelvic Pain Syndrome in Women.

Objective: This study aims to investigate the clinical efficacy of biomimetic physiotherapy combined with manipulation therapy in the management of female myofascial pelvic pain syndrome (MPPS). Methods: A total of 120 patients diagnosed with MPPS at our hospital from June 2018 to June 2021 were included. All patients had a history of sexual activity, met the diagnostic criteria for female chronic pelvic pain, and exhibited pelvic floor muscle and myofascial trigger points in gynecological examinations. Based on treatment methods, patients were categorized into a control group (n=64, treated with biomimetic physiotherapy) and an experimental group (n=56, treated with biomimetic physiotherapy plus manipulation therapy). Pre- and post-treatment assessments in both groups included pelvic floor muscle surface electromyogram, Visual Analogue Scale (VAS) score, pelvic floor muscle tenderness score, and pelvic floor muscle strength. Results: After treatment, in the control group, the mean values of pre-resting potential and post-resting potential declined significantly, from (9.58±2.22) to (4.06±0.77) and from (8.18±1.78) to (3.56±0.61), respectively. In the experimental group, these values decreased from (9.61±2.77) to (3.15±0.58), and from (8.16±1.78) to (2.79±0.59). The VAS score exhibited a noteworthy decrease from (6.18±1.00) to (3.15±0.56) in the control group and from (6.20±1.13) to (2.04±0.68) in the experimental group. The pelvic floor muscle tenderness score decreased from (8.14±0.86) to (3.78±0.77) in the control group and from (7.91±1.03) to (1.93±0.80) in the experimental group. Furthermore, the percentage of patients whose pelvic floor muscle strength increased from

Efficacy of Rehabilitative Techniques on Pain Relief in Patients With Vulvodynia: A Systematic Review and Meta-Analysis.

OBJECTIVE: Vulvodynia is a chronic clinical condition characterized by provoked or non-provoked vulvar pain for at least 3 months of unknown etiology. The onset of vulvodynia involves a complex interplay of peripheral and central pain mechanisms, such as pelvic floor muscle and autonomic dysfunction, and interpersonal factors. A stepwise approach of pelvic floor physical therapy as medical management is suggested. In this scenario, by this meta-analysis of randomized controlled trials, we aimed to evaluate the efficacy of rehabilitation interventions in patients with vulvodynia. METHODS: On October 13, 2022, PubMed, Scopus, and Web of Science were systematically searched for randomized controlled trials that assessed the efficacy of the rehabilitative approach to pain during intercourse in patients with vulvodynia. The quality assessment was performed with the Cochrane risk-of-bias tool for randomized trials. The trial registration number is CRD42021257449. At the end of the search, 9 studies were included for a total of 332 patients. A pairwise meta-analysis was performed to highlight the efficacy of rehabilitative approaches for reducing pain during intercourse, as measured with a visual analog scale or a numerical rating scale. RESULTS: Meta-analysis showed that all these rehabilitative approaches had an overall effect size of -1.43 (95% CI = -2.69 to -0.17) in decreasing vulvodynia pain in terms of the visual analog scale. In the subgroup analysis, a significant effect size in acupuncture (effect size = -2.36; 95% CI = -3.83 to -0.89) and extracorporeal shockwave therapy (effect size = -2.94; 95% CI = -4.31 to -1.57; I2 = 58%) was observed. According to the Cochrane risk-of-bias tool, a low risk of bias for outcome selection in 89% of studies. CONCLUSION: Findings from this meta-analysis suggested that the physical agent modalities and complementary medicine techniques in people with vulvodynia appear to be more effective than placebo, sham, or waiting list. Further evidence on physical agent modalities and complementary therapies are warranted in the future. IMPACT: This was the first systematic review and meta-analysis of randomized controlled trials to provide evidence on the efficacy of rehabilitation interventions in patients with vulvodynia.

Exercise Position to Improve Synergy Between the Diaphragm and Pelvic Floor Muscles in Women With Pelvic Floor Dysfunction: A Cross Sectional Study.

OBJECTIVE: This study aimed to investigate the synergy between the diaphragm and pelvic floor muscles (PFM) according to different exercise positions in women with pelvic floor dysfunction. Our secondary aim was to determine the short-term effects of single-week pelvic floor muscle training (PFMT) program on diaphragmatic function. METHODS: The cross-sectional study included 64 women with pelvic floor dysfunction. The participants' diaphragm and abdominal muscle functions during voluntary PFM contraction and relaxation were assessed by surface electromyography and ultrasonography. The surface electromyography assessments were performed in supine (P1), crawling (P2) and sitting (P3) positions. A single week-PFMT was conducted on women who agreed to determine the short-term responses of the diaphragm function. The muscle functions according to exercise positions were compared with Friedman Analysis of Variance, and the short-term effects of single-week PFMT on diaphragm function was analyzed with Wilcoxon Signed-Ranks Test. RESULTS: The diaphragm activity during voluntary PFM contraction was highest in P2 before and after single-week PFMT (P < .001). Positive significant correlations were found between the activities diaphragm and abdominal muscles in different exercise positions (P < .05). After single-week PFMT, diaphragm thickness increased (P = .030) in P1, but diaphragm activity did not change in all 3 exercise positions (P > .05). CONCLUSION: The synergy between the diaphragm and PFM was greater in the crawling position in women with pelvic floor dysfunction. The abdominal muscles seemed to contribute to maintaining this synergy. Therefore, PFMT combined with diaphragmatic breathing exercises in the crawling position should be considered. In addition, single-week PFMT may positively affect diaphragm function in the short-term.

The Effectiveness of Pelvic Floor Muscle Training in Men after Radical Prostatectomy Measured with the Insert Test.

A commonly used physiotherapeutic method for the treatment of urinary incontinence (UI) after radical prostatectomy (RP) is pelvic floor muscle training (PFMT). The aim of this study was to evaluate the effectiveness of PFMT by enhanced biofeedback using the 1h pad-weighing test. The following factors were taken into consideration in the analysis of PFMT effectiveness: the relevance of the patients' age, time from RP, BMI, mental health, functional state, and depression. A total of 60 post-RP patients who underwent 10-week PFMT were studied. They were divided into groups: A (n = 20) and B (n = 20) (random division, time from RP: 2−6 weeks) and group C (time from RP > 6 weeks). Group B had enhanced training using EMG biofeedback. UI improved in all groups: A, p = 0.0000; B, p = 0.0000; and C, p = 0.0001. After the completion of PFMT, complete control over miction was achieved by 60% of the patients in group A, 85% in group B, and 45% in group C. There was no correlation between the results of PFMT efficacy and patients' age, BMI, time from RP, mental health, functional state, and depression. PFMT is highly effective in UI treatment. The enhancement of PFMT by EMG biofeedback seems to increase the effectiveness of the therapy.

Prospective evaluation of the connected biofeedback EMY Kegel trainer in the management of stress urinary incontinence.

INTRODUCTION: The aim of this study was to evaluate changes in the quality of life with the connected biofeedback EMY Kegel trainer in patients suffering from stress urinary incontinence. Materiel and methods: This was a prospective, single-center, non-comparative study, which took place between September 2019 and October 2020, in the University Hospitals of Strasbourg. Eligible patients were instructed to use the EMY probe for a minimum of 10 min per day for five days per week. To assess quality of life and urinary symptoms, the Contilife and ICIQ-SF scores were completed each month until the final visit (M3). The PGI-I was also completed at 3 months to assess the benefit of the EMY Kegel Trainer. RESULTS: A total of 55 patients were included. At the inclusion visit (M0), the mean Contilife and ICIQ-SF scores were respectively at 6.6 ± 1.5 and 10.5 ± 3.0 points. At the final visit (M3), the mean Contilife score increased to 9.2 ± 1.0, indicating an improvement in quality of life. The mean ICIQ-SF score decreased to 4.2 ± 4.0, indicating an improvement in urinary symptoms. The PGI-I questionnaire identified a positive assessement of the EMY Kegel trainer. On the 55 patients included, 35 (64%) reported completing at least 36 sessions during the study, i.e. an average of 3 sessions per week. CONCLUSIONS: This study suggests that perineal rehabilitation by biofeedback using the EMY Kegel trainer might be beneficial.

Do resistance exercises during biofeedback therapy enhance the anal sphincter and pelvic floor muscles in anal incontinence?

AIM: To determine if a biofeedback therapy that includes concentric resistance exercise for the anal sphincter muscles can improve muscle strength/function and improve AI symptoms compared to the traditional/non-resistance biofeedback therapy. BACKGROUND: Biofeedback therapy is the current gold standard treatment for patients with anal incontinence (AI). Lack of resistance exercise biofeedback programs is a limitation in current practice. METHODS: Thirty-three women with AI (mean age 60 years) were randomly assigned to concentric (resistance) or isometric (non-resistance) biofeedback training. Concentric training utilized the Functional Luminal Imaging Probe to provide progressive resistance exercises based on the patient's ability to collapse the anal canal lumen. Isometric training utilized a non-collapsible 10 mm diameter probe. Both groups performed a biofeedback protocol once per week in the clinic for 12 weeks and at home daily. High definition anal manometry was used to assess anal sphincter strength; symptoms were measured using FISI and UDI-6. 3D transperineal ultrasound imaging was used to assess the anal sphincter muscle integrity. RESULTS: Concentric and isometric groups improved FISI and UDI-6 scores to a similar degree. Both the concentric and isometric groups showed small improvement in the anal high-pressure zone; however, there was no difference between the two groups. Ultrasound image analysis revealed significant damage to the anal sphincter muscles in both patient groups. CONCLUSIONS: Concentric resistance biofeedback training did not improve the anal sphincter muscle function or AI symptoms beyond traditional biofeedback training. Anal sphincter muscle damage may be an important factor that limits the success of biofeedback training.

A importância da intervenção fisioterapêutica no vaginismo: uma revisão sistemática / The importance of physiotherapeutic intervention in vaginism: a systematic review

Objetivo: Descrever a importância da intervenção fisioterapêutica para mulheres com vaginismo. Fonte de dados: Foram utilizadas as bases de dados SciELO, PubMed, Biblioteca Virtual de Saúde (BVS) e Literatura Cinza, incluindo artigos nacionais e internacionais, sem delimitação temporal. Foram propostas para as buscas as seguintes palavras-chave e operadores boleanos: [("vaginismus") AND ("physiotherapy" OR "intervention" OR "efficiency")], sendo esses posteriormente adequados para as demais bases que foram utilizadas nesta revisão sistemática. Seleção dos estudos: A seleção dos estudos foi realizada por três examinadores independentes. Coleta de dados: Inicialmente foram excluídos estudos com base no título, em seguida os resumos foram analisados e, dos 353 artigos encontrados inicialmente, quatro foram elegíveis para esta revisão. Síntese dos dados: Os artigos incluídos descreveram que o tratamento fisioterapêutico é de extrema importância para as mulheres com vaginismo, pois aumenta a força e o controle sobre a musculatura do assoalho pélvico, diminuindo os sintomas do vaginismo e promovendo o incremento da satisfação sexual. Conclusão: A intervenção fisioterapêutica é imprescindível para mulheres que apresentam vaginismo, tendo em vista que suas técnicas têm efetividade na prevenção e tratamento do vaginismo, além de promover melhora importante na qualidade de vida e na satisfação sexual das mulheres.(AU)

Objective: To describe the importance of physical therapy intervention for women with vaginismus. Data source: The SciELO, PubMed, Virtual Health Library (BVS) and Gray Literature databases were used, including national and international articles, without temporal delimitation. The following keywords and Boolean operators were proposed for the searches: [("vaginismus") AND ("physiotherapy" OR "intervention" OR "efficiency")], which were later suitable for the other bases that were used in this systematic review. Study selection: Study selection was performed by three independent examiners. Data collection: Initially, studies were excluded based on the title, then the abstracts were analyzed and of the 353 articles found initially, 4 were eligible for this review. Data synthesis: The articles included described that physical therapy treatment is extremely important for women with vaginismus, as it increases strength and control over the pelvic floor muscles, decreasing the symptoms of vaginismus and promoting increased sexual satisfaction. Conclusion: Physical therapy intervention is essential for women who have vaginismus, considering that its techniques are effective in preventing and treating vaginismus, in addition to promoting an important improvement in women's quality of life and sexual satisfaction.(AU)

Therapeutic efficacy of biofeedback pelvic floor muscle exercise in women with dysfunctional voiding.

Dysfunctional voiding (DV), a voiding dysfunction due to hyperactivity of the external urethral sphincter or pelvic floor muscles leading involuntary intermittent contractions during voiding, is not uncommon in neurologically normal women with lower urinary tract symptoms (LUTS). We aimed to investigate the therapeutic efficacy of biofeedback pelvic floor muscle training (PFMT) in female patients with DV and to identify the therapeutic efficacy. Thirty-one patients diagnosed with DV. All participates completed the 3-month biofeedback PFMT program, which was conducted by one experienced physiotherapist. At 3 months after treatment, the assessment of treatment outcomes included global response assessment (GRA), and the changes of clinical symptoms, quality of life index, and uroflowmetry parameters. 25 (80.6%) patients had successful outcomes (GRA ≥ 2), and clinical symptoms and quality of life index significantly improved after PFMT. Additionally, uroflowmetry parameters including maximum flow rate, voided volume, voiding efficiency, total bladder capacity, voiding time, and time to maximum flow rate significantly improved after PFMT treatment. Patients with the history of recurrent urinary tract infection in recent 1 year were found to have unsatisfied therapeutic outcomes. In conclusion, biofeedback PFMT is effective in female patients with DV with significant improvements in clinical symptoms, quality of life, and uroflowmetry parameters. The history of urinary tract infection in recent 1 year is a negative predictor of successful outcome.

Non-venous Pelvic Pain and Roles for Pelvic Floor PT or Pudendal Nerve Blocks.

Non-venous pelvic pain is a dilemma that can frustrate even the most patient of providers. Managing these conditions can be even more bewildering as they require a multidisciplinary approach in most cases. Diet and lifestyle modifications in addition to physical therapy, biofeedback, medications, surgery and integrative medicine modalities can be used alone or in combination to relieve symptoms and should be individualized after proper evaluation and diagnosis. Because most of these conditions are located in the area of pudendal nerve distribution, pudendal nerve blocks have been very successful in helping to control the pain symptoms and should be used judiciously. Here we discuss the common conditions and how physical therapy and pudendal nerve blocks play a significant role in treatment.

Effects of Biofeedback Combined With Pilates Training on Post-prostatectomy Incontinence.

OBJECTIVE: To verify the effect of Pilates training combined with biofeedback training, Kegel training combined with biofeedback training, and Kegel training alone on post-prostatectomy incontinence in male patients. MATERIAL AND METHODS: Forty-two patients were randomly divided into 3 groups. The changes occurring to the 3 groups before and after treatment and the differences between the 3 groups were assessed using a 1-hour pad test, number of incontinent episodes, the ICIQ questionnaire, and the Oxford Grading Scale. The 3 groups were required to undergo daily training for an 8-week period. RESULTS: At 8 weeks, groups A, B and C experienced a 34.3%, 61.9%, and 67% improvement in the 1-hour pad test, respectively, and 32.1%, 52.9%, and 58.8% reduction in the number of urinary incontinence episodes, respectively, and a 29.4%, 50%, and 64.7% reduction in the ICIQ Scale, respectively, and a 33.3%, 50%, and 50% in Oxford Grading Scale improvement, respectively. The graph results showed that the effect was noted after 3 weeks of treatment and a significant effect occurred by the eighth week of treatment. CONCLUSION: Three methods were shown to optimize urinary continence and pelvic floor muscle strength of patients with post-prostatectomy incontinence. The treatment effect of group C was better than group B, but there was no statistically significant difference in the 1-hour pad tests. It is particularly important to understand the time sensitivity for patient training.

The Effect of Electrical Stimulation Therapy With Pelvic Floor Muscle Exercise on Stress Urinary Incontinence in Middle-Aged Women: A Nonequivalent Comparison Cohort Study.

PURPOSE: The purpose of this study was to evaluate the effects of combined pelvic floor muscle exercises (PFMEs) and a novel electrical stimulation (ES) device versus PFMEs alone on lower urinary tract symptoms, urinary incontinence-related quality of life, and pelvic floor muscle contractions (PFMCs). DESIGN: Nonrandomized comparison cohort study. SUBJECTS AND SETTING: The sample comprised 54 community-dwelling middle-aged women with stress urinary incontinence recruited from churches and cultural centers in Gyeonggi Province, South Korea. Comparisons of demographic and pertinent clinical characteristics revealed no significant differences between the experimental and comparison groups. METHODS: Participants allocated to the combined intervention group (n = 27) performed self-exercises of the pelvic floor muscles 3 times a day under weekly telephone coaching, and they used the ES device twice daily for 8 weeks. Participants in the comparison group (n = 27) received the PFMEs alone without telephone coaching. The 3 main outcomes including lower urinary tract symptoms, urinary incontinence-related quality of life, and PFMCs were measured using the Bristol Female Lower Urinary Tract Symptom instrument (BFLUTS), King's Health Questionnaire (KHQ), and a perineometer, respectively. Study outcomes were measured at baseline and at the end of the 8-week period. RESULTS: Participants in the experimental group achieved significantly greater reductions in lower urinary tract symptoms (t = -4.07, P < .001) and improvement in urinary incontinence-related quality of life (P = .006), peak PFMC pressure (P = .004), mean pelvic muscle contraction (PMC) pressure (P < .001), and duration of PFMCs (P < .001) when compared to participants undergoing PFMEs alone. CONCLUSIONS: Combined ES and pelvic floor exercise was more effective in reducing severity of lower urinary tract symptoms, enhancing health-related quality of life, and increasing PMC pressure in middle-aged women with stress urinary incontinence than PFMEs alone.

Physiotherapeutic assessment and management of chronic pelvic pain syndrome: A case report.

INTRODUCTION: Chronic pelvic pain syndrome is difficult for the diagnosis and therapy and that means the patient attending the physician or physiotherapist may present various symptoms. There are no guidelines concern physiotherapy diagnosis and treatment of chronic pelvic pain syndrome. This study presents the physiotherapeutic assessment and management in men with pelvic pain symptoms. PATIENT CONCERNS: Forty-six-year-old man attended the physiotherapy consulting room due to symptoms of pain in the perineum, lower abdomen, urethra, and scrotum for a year. Earlier, the patient had consulted a urologist who made a diagnosis of cystitis and prescribed medications that did not get results. DIAGNOSIS: Ultrasound imaging and manual inspection (per rectum) of the pelvic floor was conducted by physiotherapist. Also, the abdominal and lower extremities muscles were assessed. Patient reported pain symptoms during examination of the musculus ischiocavernosus, puboanalis, pubococcygeus, iliococcygeus, coccygeus, and canalis pudentalis seu Alcocki. INTERVENTIONS: The patient was given physiotherapeutic interventions consisting in the manual therapy of the lumbopelvic hip complex and the manual therapy per rectum. OUTCOMES: During 10th session of the physiotherapeutic treatment, patient reported improvement in pain symptoms. A month later, patient reported total alleviation of the pain symptoms during control visit. CONCLUSION: Therapy of chronic pelvic pain syndrome is a process that involves application of different therapies and different approaches. Functional and structural assessment and also therapy conducted by physiotherapist is becoming an integral part of urology and represents 1 possible conservative treatment form.

Effects of Biofeedback-Guided Pelvic Floor Muscle Training With and Without Extracorporeal Magnetic Innervation Therapy on Stress Incontinence: A Randomized Controlled Trial.

PURPOSE: We evaluated the effects of biofeedback-guided pelvic floor muscle training (EMG-BF), with and without extracorporeal magnetic innervation (EMG-BF+ExMI) therapy on lower urinary tract symptoms based on frequency of stress urinary incontinence (SUI) and grams of urine loss, health-related quality of life, and sexual function in women with SUI. DESIGN: This was a randomized controlled trial. SUBJECTS AND SETTING: The sample comprised 51 adult women with SUI. Their mean age was 50.92 years (SD 8.88). Twenty-six were randomly allocated to EMG-BF alone and 25 were allocated to undergo EMG-BF+ExMI. METHODS: This study's main outcome was lower urinary tract symptoms measured via the 1-hour pad test (grams of urine loss) and a 3-day bladder diary (frequency of stress incontinence episodes). Additional outcome measures were health-related quality of life measured with the Incontinence Quality of Life (I-QOL) questionnaire, sexual function evaluated via the Female Sexual Function Index (FSFI), and pelvic floor muscle contraction force measured via a perineometer and Modified Oxford Scale (MOS). All participants underwent biofeedback-enhanced pelvic floor muscle training using EMG during 20-minute sessions twice weekly for a period of 8 weeks. In addition to the EMG-BF+ExMI group, ExMI was applied during 20-minute sessions twice weekly for a period of 8 weeks. Participants from both groups were asked to perform pelvic floor muscle exercises at home (60 pelvic floor muscle contractions daily, divided into 3 sessions of 20 contractions each). Outcome measures were made at baseline and repeated at the end of treatment. RESULTS: Fifteen (57.7%) in the EMG-BF group and 13 (52.0%) in the EMG-BF+ExMI group achieved dryness. Four participants (15.4%) in the EMG-BF group and 5 (20%) in the EMG-BF+ExMI group experienced improvement. Seven patients (26.9%) in the EMG-BF group and 7 (28%) in the EMG-BF+ExMI group did not benefit from the treatments. There was no statistically significant difference between the groups in terms of cure and improvement (P = .895). CONCLUSIONS: Findings indicate that use of magnetic innervation does not improve lower urinary tract symptoms, health-related quality of life, sexual function, and pelvic floor muscle strength when compared to pelvic floor muscle training alone.

Early postpartum biofeedback assisted pelvic floor muscle training in primiparous women with second degree perineal laceration: Effect on sexual function and lower urinary tract symptoms.

OBJECTIVE: To evaluate the short-term effect of routine early postpartum electromyographic biofeedback assisted pelvic floor muscle training on sexual function and lower urinary tract symptoms. MATERIALS AND METHODS: From December 2016 to November 2017, primiparous women with vaginal delivery, who experienced non-extended second-degree perineal laceration were invited to participate. Seventy-five participants were assigned into a pelvic floor muscle training (PFMT) group or control group. Women in the PFMT group received supervised biofeedback-assisted pelvic floor muscle training at the 1st week and 4th week postpartum. Exercises were performed at home with the same protocol until 6 weeks postpartum. The Pelvic Organ Prolapse Urinary Incontinence Sexual Questionnaire (PISQ-12) and the Urinary Distress Inventory short form questionnaire (UDI-6) were used to evaluate sexual function and lower urinary tract symptoms respectively at immediate postpartum, 6 weeks, 3 months, and 6 months postpartum. RESULTS: Forty-five women (23 in PFMT group,22 in control group) completed all questionnaires at 6 months postpartum. For overall sexual function and the three sexual functional domains, no statistically significant difference was found in PISQ scores from baseline to 6 weeks, 3 months, and 6 months postpartum between the PFMT and control groups. For postpartum lower urinary tract symptoms, all symptoms gradually improved over time for both groups without a statistically significant difference between groups. CONCLUSION: Our study showed that supervised biofeedback-assisted pelvic floor muscle training started routinely at one week postpartum did not provide additional improvement in postpartum sexual function and lower urinary tract symptoms.

Physiotherapist management of a patient with spastic perineal syndrome and subsequent constipation: a case report.

Background and Purpose: The purpose of this case report is to describe the benefits of manual therapy techniques, including mobilization and stretching, in the management of a patient with chronic constipation. Case Description: A 17-year-old male with an 8-month history of constipation and complaint of incomplete evacuation after defecation was referred for therapy. The patient was diagnosed with a spastic perineal syndrome. Isolated puborectalis relaxation exercise was not successful in alleviating constipation. Physical examination showed tightness of left side piriformis, thoracic kyphosis, apparent limb shortening on the left side, and a right-on-right sacrum forward torsion. The patient was treated with stretching of left piriformis and mobilization of thoracic and lumbar vertebrae and sacroiliac joints along with puborectalis relaxation exercises. Outcomes: After 4 weeks of treatment, there was a reduction in Bowel Function Index (BFI) from 74.6 to 27.2. The patient also reported spending less time (<3 minutes) during defecation. The patient maintained his improvement at 7 months. Discussion: A detailed neuromuscular examination assisted in identifying the pathophysiology related to obstructive defecation for this patient. Controlled studies regarding the effectiveness of various physiotherapy interventions in the treatment of obstructive constipation are warranted.

Sacral Neuromodulation: Determining Predictors of Success.

OBJECTIVE: To determine predictors of success for sacral neuromodulation in women with overactive bladder, urinary retention, and fecal incontinence. METHODS: A retrospective chart review was performed on women who underwent a staged sacral neuromodulation implantation between 2007 and 2018. Clinical and procedural characteristics were recorded. Presence of intraoperative motor responses in either all 4 or <4 electrodes were used to group women. Endpoints included completion of stage II implant, tined lead revision, and patient-reported success. RESULTS: In 198 women with a mean age of 62.9 years (SD+/- 14.7), completion of stage II implant occurred in 92.4% of women, and 83.3% of these women reported success at the first postoperative visit. Continued success at 6 months was reported in 70.3%. Lead revision was noted in 23.0%. Age >65 years (odds ratio [OR] = 0.2, 95% confidence interval [CI] = 0.06-0.8) and prior onabotulinumtoxinA (onaBoNT-A) (OR = 0.2, 95% CI = 0.06-0.9) were negative predictors for completion of stage II implant on multivariable analysis. Also, prior pelvic floor physical therapy was a significant negative predictor of postoperative patient-reported success on multivariable analysis (OR = 0.25, 95% CI = 0.1-0.6). There were no differences seen in women who had motor responses with either all 4 electrodes or <4 electrodes in any endpoint (P > .05). CONCLUSION: Patient age >65 and history of prior onaBoNT-A were associated with failure to complete stage II implant. Women with prior pelvic floor physical therapy were less likely to report success after sacral neuromodulation. Motor responses in <4 electrodes during lead testing did not impact patient-reported success.

National Trends in Neuromodulation for Urinary Incontinence Among Insured Adult Women and Men, 2004-2013: The Urologic Diseases in America Project.

OBJECTIVE: To examine US trends in neuromodulation for urinary incontinence (UI) treatment from 2004 to 2013. METHODS: This study utilized 2 data sources: the Optum© de-identified Clinformatics® Data Mart Database for privately insured adults aged 18-64 years with a UI diagnosis (N≈40,000 women and men annually) and the Medicare 5% Sample for beneficiaries aged ≥65 years with a UI diagnosis (N≈65,000 women and men annually). We created annual cross-sectional cohorts and assessed prevalence of UI-related neuromodulation procedures among men and women separately from 2004 to 2013. Analyses were conducted overall and stratified by age, race/ethnicity, and geographic region. RESULTS: Nearly all neuromodulation procedures occurred in outpatient settings. Sacral neuromodulation (SNM) procedures for UI in both women and men grew steadily from 2004 to 2013, with more procedures performed in women than men. Among women with UI, SNM prevalence grew from 0.1%-0.2% in 2004 to 0.5%-0.6% in 2013. Posterior tibial nerve stimulation (PTNS) experienced growth from 2011 to 2013. Chemodenervation of the bladder with onabotulinumtoxinA (BTX) combined with other injectable procedures (including urethral bulking) remained stable over time. CONCLUSIONS: From 2004 to 2013, SNM procedures remained relatively uncommon but increased consistently. PTNS experienced growth starting in 2011 when PTNS-specific insurance claims became available. BTX trends remain unclear; future studies should assess it separately from other injectable procedures. Neuromodulation has a growing role in UI treatment, and ongoing trends will be important to examine.

Basic versus biofeedback-mediated intensive pelvic floor muscle training for women with urinary incontinence: the OPAL RCT.

BACKGROUND: Urinary incontinence affects one in three women worldwide. Pelvic floor muscle training is an effective treatment. Electromyography biofeedback (providing visual or auditory feedback of internal muscle movement) is an adjunct that may improve outcomes. OBJECTIVES: To determine the clinical effectiveness and cost-effectiveness of biofeedback-mediated intensive pelvic floor muscle training (biofeedback pelvic floor muscle training) compared with basic pelvic floor muscle training for treating female stress urinary incontinence or mixed urinary incontinence. DESIGN: A multicentre, parallel-group randomised controlled trial of the clinical effectiveness and cost-effectiveness of biofeedback pelvic floor muscle training compared with basic pelvic floor muscle training, with a mixed-methods process evaluation and a longitudinal qualitative case study. Group allocation was by web-based application, with minimisation by urinary incontinence type, centre, age and baseline urinary incontinence severity. Participants, therapy providers and researchers were not blinded to group allocation. Six-month pelvic floor muscle assessments were conducted by a blinded assessor. SETTING: This trial was set in UK community and outpatient care settings. PARTICIPANTS: Women aged ≥ 18 years, with new stress urinary incontinence or mixed urinary incontinence. The following women were excluded: those with urgency urinary incontinence alone, those who had received formal instruction in pelvic floor muscle training in the previous year, those unable to contract their pelvic floor muscles, those pregnant or < 6 months postnatal, those with prolapse greater than stage II, those currently having treatment for pelvic cancer, those with cognitive impairment affecting capacity to give informed consent, those with neurological disease, those with a known nickel allergy or sensitivity and those currently participating in other research relating to their urinary incontinence. INTERVENTIONS: Both groups were offered six appointments over 16 weeks to receive biofeedback pelvic floor muscle training or basic pelvic floor muscle training. Home biofeedback units were provided to the biofeedback pelvic floor muscle training group. Behaviour change techniques were built in to both interventions. MAIN OUTCOME MEASURES: The primary outcome was urinary incontinence severity at 24 months (measured using the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form score, range 0-21, with a higher score indicating greater severity). The secondary outcomes were urinary incontinence cure/improvement, other urinary and pelvic floor symptoms, urinary incontinence-specific quality of life, self-efficacy for pelvic floor muscle training, global impression of improvement in urinary incontinence, adherence to the exercise, uptake of other urinary incontinence treatment and pelvic floor muscle function. The primary health economic outcome was incremental cost per quality-adjusted-life-year gained at 24 months. RESULTS: A total of 300 participants were randomised per group. The primary analysis included 225 and 235 participants (biofeedback and basic pelvic floor muscle training, respectively). The mean 24-month International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form score was 8.2 (standard deviation 5.1) for biofeedback pelvic floor muscle training and 8.5 (standard deviation 4.9) for basic pelvic floor muscle training (adjusted mean difference -0.09, 95% confidence interval -0.92 to 0.75; p = 0.84). A total of 48 participants had a non-serious adverse event (34 in the biofeedback pelvic floor muscle training group and 14 in the basic pelvic floor muscle training group), of whom 23 (21 in the biofeedback pelvic floor muscle training group and 2 in the basic pelvic floor muscle training group) had an event related/possibly related to the interventions. In addition, there were eight serious adverse events (six in the biofeedback pelvic floor muscle training group and two in the basic pelvic floor muscle training group), all unrelated to the interventions. At 24 months, biofeedback pelvic floor muscle training was not significantly more expensive than basic pelvic floor muscle training, but neither was it associated with significantly more quality-adjusted life-years. The probability that biofeedback pelvic floor muscle training would be cost-effective was 48% at a £20,000 willingness to pay for a quality-adjusted life-year threshold. The process evaluation confirmed that the biofeedback pelvic floor muscle training group received an intensified intervention and both groups received basic pelvic floor muscle training core components. Women were positive about both interventions, adherence to both interventions was similar and both interventions were facilitated by desire to improve their urinary incontinence and hindered by lack of time. LIMITATIONS: Women unable to contract their muscles were excluded, as biofeedback is recommended for these women. CONCLUSIONS: There was no evidence of a difference between biofeedback pelvic floor muscle training and basic pelvic floor muscle training. FUTURE WORK: Research should investigate other ways to intensify pelvic floor muscle training to improve continence outcomes. TRIAL REGISTRATION: Current Controlled Trial ISRCTN57746448. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 70. See the NIHR Journals Library website for further project information.

Urinary incontinence (accidental leakage of urine) is a common and embarrassing problem for women. Pregnancy and childbirth may contribute by leading to less muscle support and bladder control. Pelvic floor exercises and 'biofeedback' equipment (a device that lets women see the muscles working as they exercise) are often used in treatment. There is good evidence that exercises (for the pelvic floor) can help, but less evidence about whether or not adding biofeedback provides better results. This trial compared pelvic floor exercises alone with pelvic floor exercises plus biofeedback. Six hundred women with urinary incontinence participated. Three hundred women were randomly assigned to the exercise group and 300 women were randomised to the exercise plus biofeedback group. Each woman had an equal chance of being in either group. Women were offered six appointments with a therapist over 16 weeks to receive their allocated treatment. After 2 years, there was no difference between the groups in the severity of women's urinary incontinence. Women in both groups varied in how much exercise they managed to do. Some managed to exercise consistently over the 2 years and others less so. There were many factors (other than the treatment received) that affected a woman's ability to exercise. Notably, women viewed the therapists' input very positively. The therapists reported some problems fitting biofeedback into the appointments, but, overall, they delivered both treatments as intended. Women carried out exercises at home and many in the biofeedback pelvic floor muscle training group also used biofeedback at home; however, for both groups, time issues, forgetting and other health problems affected their adherence. There were no serious complications related to either treatment. Overall, exercise plus biofeedback was not significantly more expensive than exercise alone and the quality of life associated with exercise plus biofeedback was not better than the quality of life for exercise alone. In summary, exercises plus biofeedback was no better than exercise alone. The findings do not support using biofeedback routinely as part of pelvic floor exercise treatment for women with urinary incontinence.

Effectiveness of pelvic floor muscle training with and without electromyographic biofeedback for urinary incontinence in women: multicentre randomised controlled trial.

OBJECTIVE: To assess the effectiveness of pelvic floor muscle training (PFMT) plus electromyographic biofeedback or PFMT alone for stress or mixed urinary incontinence in women. DESIGN: Parallel group randomised controlled trial. SETTING: 23 community and secondary care centres providing continence care in Scotland and England. PARTICIPANTS: 600 women aged 18 and older, newly presenting with stress or mixed urinary incontinence between February 2014 and July 2016: 300 were randomised to PFMT plus electromyographic biofeedback and 300 to PFMT alone. INTERVENTIONS: Participants in both groups were offered six appointments with a continence therapist over 16 weeks. Participants in the biofeedback PFMT group received supervised PFMT and a home PFMT programme, incorporating electromyographic biofeedback during clinic appointments and at home. The PFMT group received supervised PFMT and a home PFMT programme. PFMT programmes were progressed over the appointments. MAIN OUTCOME MEASURES: The primary outcome was self-reported severity of urinary incontinence (International Consultation on Incontinence Questionnaire-urinary incontinence short form (ICIQ-UI SF), range 0 to 21, higher scores indicating greater severity) at 24 months. Secondary outcomes were cure or improvement, other pelvic floor symptoms, condition specific quality of life, women's perception of improvement, pelvic floor muscle function, uptake of other urinary incontinence treatment, PFMT self-efficacy, adherence, intervention costs, and quality adjusted life years. RESULTS: Mean ICIQ-UI SF scores at 24 months were 8.2 (SD 5.1, n=225) in the biofeedback PFMT group and 8.5 (SD 4.9, n=235) in the PFMT group (mean difference -0.09, 95% confidence interval -0.92 to 0.75, P=0.84). Biofeedback PFMT had similar costs (mean difference £121 ($154; €133), -£409 to £651, P=0.64) and quality adjusted life years (-0.04, -0.12 to 0.04, P=0.28) to PFMT. 48 participants reported an adverse event: for 23 this was related or possibly related to the interventions. CONCLUSIONS: At 24 months no evidence was found of any important difference in severity of urinary incontinence between PFMT plus electromyographic biofeedback and PFMT alone groups. Routine use of electromyographic biofeedback with PFMT should not be recommended. Other ways of maximising the effects of PFMT should be investigated. TRIAL REGISTRATION: ISRCTN57756448.

Contracción paradojal del puborrectal como causa de defecación obstructiva: resultados a corto plazo del tratamiento con biofeedback y rehabilitación pelviperineal / Puborectal paradoxical contraction as a cause of obstructive defecation: short-term outcomes of treatment with biofeedback and pelviperineal rehabilitation

Resumen Introducción: En pacientes constipados crónicos por obstrucción de salida, la contracción paradojal del puborrectal (CPP) o "anismo" es frecuente. El tratamiento con Biofeedback y rehabilitación pelviperineal presenta resultados exitosos entre el 40-90%. Objetivo: Evaluar el resultado del tratamiento con Biofeedback y rehabilitación pelviperineal en pacientes con CPP a corto plazo. Materiales y Método: Serie de casos. Datos obtenidos prospectivamente de la Unidad de Piso Pelviano. Se incluyó pacientes entre 2008 y 2015 que cumplían criterios de constipación crónica secundaria a CPP, confirmado por manometría anorrectal y/o defeco-resonancia. Se analizaron datos demográficos, frecuencia de evacuaciones, uso de laxantes, enemas, pujo, Score de Altomare y Score de constipación de Wexner pre y post-tratamiento. Resultados: 43 pacientes, de los cuales 39 son mujeres. Edad media de 40 años (rango: 14-84). Duración de síntomas fue ≥ 5 años en el 72,5%. Mediana de sesiones de Biofeedback de 8 (6-10). El 62,8% presenta ≤ 2 evacuaciones semanales y disminuye a un 29,3% post-tratamiento (p < 0,001). El 76,2% requiere laxantes orales y el 42,9% enemas, disminuyendo a 35,1% (p < 0,001) y 5,4% (p < 0,001) respectivamente post-tratamiento. Sensación de evacuación incompleta/fragmentada en todos los intentos mejoró de 67,4% a 14,6% (p < 0,001) y el pujo excesivo en más de la mitad de intentos mejoró de 76,1% a 10,8% (p < 0,001). Score de Wexner para constipación y Altomare mejoró de 18 a 7 (p < 0,001) y de 16 a 5 (p < 0,001) respectivamente. Conclusión: El biofeedback y la rehabilitación pelviperineal son efectivas en el tratamiento de la CPP.

Introduction: In patients with chronic constipation by obstructive defecation syndrome Paradoxical Puborectalis Contraction or "anismus" is important. Successful results for Biofeedback treatment and Pelviperineal Rehabilitation it described between 40-90%. Aim: To evaluate the outcome of biofeedback and pelviperineal rehabilitation in patients with CPP in the short-term. Materials and Method: Case series. Data was obtained from the prospective database of Pelvic Floor Unit of Universidad Católica de Chile. Patients with anismus were included between 2008 and 2015. Diagnostic criteria were chronic constipation patients by anismus with anorectal manometry and/or defecoresonancy that confirms this disorder and discards other causes of obstruted defecation síndrome. Demographic variables, frequency of bowel movements, use of laxatives, enemas, pushing, Altomare Score and Wexner constipation Score were analyzed pre and post-treatment. Results: Series of 43 patients, 39 of whom where women. Median age: 40 years (range: 14-84). Duration of symptoms ≥ 5 years in 72.5%. Median of Biofeedback sessions: 8 (range 6-10). Pre-treatment, 62.8% had ≤ 2 evacuations weekly and 29.3% post-treatment (p < 0.001). Oral laxatives were required in 76.2% and 42.9% enemas, decreasing to 35.1% (p < 0.001) and 5.4% (p < 0.001) post-treatment respectively. Feeling of incomplete/evacuation fragmented all the time improved from 67.4% to 14.6% (p < 0.001) and excessive pushing in more than half of time improved from 76.1% to 10.8% (p < 0.001). Wexner Score for and Altomare Score improved from 18 to 7 (p < 0.001) and 16 to 5 (p < 0.001) respectively. Conclusion: Adult with chronic constipation by anismus can be treated effectively with Biofeedback and Pelviperineal Rehabilitation.