Objective evaluation of the acute effects of pelvic floor muscle training on vaginal dryness in postmenopausal women: a randomized controlled pilot study

Objective: To examine the effects of pelvic floor muscle training (PFMT) on the contractility of pelvic floor muscle and lower urinary tract symptoms in female stroke patients. Design: Randomized, single-blind controlled study. Setting: Outpatient rehabilitation hospital. Subjects: Thirty one female patients who were more than three months post-stroke and stress urinary incontinence. Interventions: The subjects were randomized to either a PFMT group (n = 16), or a control group (n = 15). Both groups received general rehabilitation exercise for 6 weeks, but the PFMT group additionally received PFMT for 6 weeks. Main measures: Vaginal function test using a perineometer (maximal vaginal squeeze pressure) and intra-vaginal electromyography (activity of pelvic floor muscle), and urinary symptoms and quality of life using a Bristol Female Lower Urinary Tract Symptom questionnaire. Results: After intervention, the maximal vaginal squeeze pressures for the PFMT and control groups were 18.35 (5.24) and 8.46 (3.50) mmHg, respectively. And the activities of pelvic floor muscle of the PFMT and control groups was 12.09 (2.24) ㎶ and 9.33 (3.40) ㎶, respectively. After intervention, the changes of scores for inconvenience in the activity of daily living of the PFMT and control groups were −15.00 (6.25) and −0.17 (1.59), respectively. In addition, the changes of score for lower urinary tract symptom was improved more in the PFMT group (-4.17 (4.00)) than in the control group (-0.25 (1.29)) (P < 0.05). Conclusions: These findings suggest that PFMT is beneficial for the management of urinary incontinence in female stroke patients.

The objective was to investigate the effects of pelvic floor muscle training (PFMT) on urinary incontinence (UI) and quality of life (QoL) during the late third trimester of pregnancy. A total of 131 singleton nulliparous women without pre-existing UI who attended the antenatal clinic at Rajavithi Hospital between August 2019 and May 2020 were randomly allocated into PFMT (n=63) or usual care (n=68; controls). The PFMT group watched the video education and was taught to contract the pelvic floor muscle. The control group received standard routine care. Baseline characteristics were recorded. At the gestational age of 36-38 weeks before delivery, UI was evaluated using the Urogenital Distress Inventory (UDI-6), and a score of at least 16.7 was used as a cut-off for diagnosing UI. Incontinence-related QoL was evaluated by the Incontinence Impact Questionnaire (IIQ-7). Baseline characteristics between groups were similar. The mean age of women in the PFMT group was 23.7 years versus 24.1 years in the control group. Pre-pregnancy body mass index was 21.1 kg/m2 and 21.3 kg/m2 in the PFMT and control groups respectively. The PFMT group reported fewer UI than the control group (20.6% vs 94.1%, p<0.001). The PFMT group also had a lower UDI-6 score (5.5 vs 27.7, p<0.001) and lower IIQ-7 score (0 vs 14.3, p<0.001) compared with the control group. From this study, the PFMT program is effective at preventing UI in the late third trimester of pregnancy and improves QoL. Therefore, we encourage PFMT to be implemented in clinical practice.

Background: Current evidence on the effect of pelvic floor muscle (PFM) training for promoting sexual function is limited. Recent reviews indicate need for high quality trials in this area. Objectives: To examine the effect of PFM training on sexual function (primary outcome), sexual quality of life, and PFM strength (secondary outcomes) in pregnant and postpartum women. Methods: This was an assessor-blind two parallel arm superiority trial. A total of 84 nulliparous women with a singleton pregnancy at 17 - 20 weeks, aged 18 - 35 years, were recruited using purposive sampling among clients of five public health centers or two governmental maternity clinics in Sari-Iran. The recruitment was done from May to November 2014 and follow up ended on July 2015. Participants were equally allocated into either PFM training or routine care groups using block randomization. Women allocated to the PFM group received 4 sessions of supervised training, with practical, oral, and written instructions on how to continue performing regular PFM exercises at home. Female sexual function index, sexual quality of life questionnaire-female, and Oxford scoring were used to assess the outcomes at 28 - 30 weeks gestation and 80 - 90 days following birth. Results: There was one loss to follow-up from each group. A total of 6 women had not exercised regularly. Compared with the control group, the mean total sexual function score was significantly greater in the PFM training group during both pregnancy (29.3 vs 21.1; adjusted difference 9.4, 95%CI 7.7 to 11.0, P < 0.001) and postpartum (28.7 vs 16.0; adjusted difference 13.0, 95%CI 12.1 to 13.9, P < 0.001). Also, almost all domains of sexual function, sexual quality of life, and PFM strength during both periods improved significantly in women who received the PFM training compared with the controls. Conclusions: Based on the results, PFM training during pregnancy and postpartum could improve sexual function in nulliparous women. Therefore, it should be recommended to all of the women.

Pain Reduction Following Treatment of Bleeding Episodes with Eptacog Beta in Adults and Adolescents with Hemophilia A or B Complicated By Inhibitors

Transcranial direct current stimulation (tDCS) and neural mobilization (NM) are widely used in clinical practice as two effective treatment. However, there have existed few studies of the combination of these two treatments, particularly in cervical radiculopathy (CR). To explore the value of combined tDCS and NM for the management of pain, disability, and quality of life (QoL) in patients with CR, authors designed this study. According to certain inclusion criteria, 36 subjects were selected from 224 patients with CR enrolled in Zhejiang Provincial People's Hospital between June 2021 and December 2021. Subjects were divided into two groups based on the treatment they had already received at the hospital. Patients in the combined tDCS group received tDCS and NM therapy, while patients in the NM group received NM therapy alone. Visual analog scale (VAS), Neck Disability Index (NDI), and EuroQuol-5 dimensions (EQ-5D) scores were assessed at baseline, immediately after treatment, and at the 4-week follow-up to evaluate pain, neck disability, and the QoL of patients. SPSS 22.0 software (IBM Corp., Armonk, NY, USA) is used as main tool for data analysis. A total of 36 patients were enrolled (19 in the combined tDCS group and 17 in the NM group). The baseline VAS, NDI, and EQ-5D scores in the combined tDCS group were 54.3±16.4 mm, 35.1±14.7, and 0.62±0.15, respectively, while the baseline VAS, NDI, and EQ-5D scores in the NM group were 54.0±16.5 mm, 31.8±12.8, and 0.64±0.15, respectively. There was no significant difference in baseline data between the two groups. At the 4-week post-treatment follow-up, the VAS score was significantly lower in the combined tDCS group than in the NM group (24.5±16.1 and 40.7±17.3 mm, respectively, P=0.008), and the NDI was also significantly lower in the combined tDCS group than in the NM group (16.1±11.5 vs. 26.6±17.7, P=0.045). There was no significant difference between the combined tDCS and NM groups in EQ-5D (0.75±0.15 vs. 0.69±0.09, P=0.192). Compared with NM therapy alone, combined tDCS and NM therapy may play a role in pain relief and neck disability improvement in CR patients.

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. 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. 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. This trial was set in UK community and outpatient care settings. 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. 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. 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. 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. Women unable to contract their muscles were excluded, as biofeedback is recommended for these women. There was no evidence of a difference between biofeedback pelvic floor muscle training and basic pelvic floor muscle training. Research should investigate other ways to intensify pelvic floor muscle training to improve continence outcomes. Current Controlled Trial ISRCTN57746448. 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.

Background: Thermal Microcautery (TMC) is a form of peripheral nerve field stimulation and is a technique used in Traditional Indian Medicine (Agnikarma) to manage chronic pain. The aim was to asses TMC in painful knee osteoarthritis (PKO). Methods: A non-randomized controlled trial was employed. All PKO patients on a waiting list for knee replacement were offered PNFS-TMC. Patients in the intervention group received 4 sessions (2 weeks apart) of PNFS-TMC by a pin-point tip of a metal rod. The rod was heated over a flame for 5 minutes before being used to induce a single 1 mm second-degree burn over points of tenderness. The control group was selected from the same waiting list. The primary outcome was assessed by Visual Analogue Scale (VAS) scores. The secondary outcomes were changes in levels of physical day to day activity, sleep and analgesics. Results: 16 PNFS-TMC intervention group patients and 15 control group patients were subject to analysis. Baseline VAS score was higher in PNFS-TMC group [9 ± 1.23 (95% CI 8.38 - 9.61) versus 5.93 ± 2.11 (95% CI 4.81 - 7.06) in the control, P < 0.0001]. VAS scores after 8 weeks (i.e. 4 sessions) were lower in the PNFS-TMC group [4.64 ± 2.08 (95% CI 3.57 - 5.72) versus 6.73 ± 2.01 (95% CI 5.61 - 7.85) respectively with P = 0.0058]. In the PNFS-TMC group, VAS score decreased from 9 ± 1.23 (95% CI 8.38 - 9.61) at baseline to 4.64 ± 2.08 (95% CI 3.57 - 5.72) after 4 sessions (P < 0.0001). In control group, VAS score showed a non-significant increase in VAS score from 5.93 ± 2.11 (95% CI 4.81 - 7.06) to 6.73 ± 2.01 (95% CI 5.61 - 7.85) (P = 0.2844). Results indicate reduction of pain VAS scores in the PNFS-TMC group (P < 0.0001). Eleven patients (68.7%) experienced increased capacity to perform daily physical activities P < 0.0001 and 5 (31.2%) showed no change in activity P < 0.0418. 5 (33.3%) of the patients in the control group became worse and 10 (66.7%) experienced no change. Conclusions: PNFS-TMC could offer a simple, safe, cheap and effective method of pain management in chronic PKO patients.

Based on the data available, we can be confident that PFMT can cure or improve symptoms of SUI and all other types of UI. It may reduce the number of leakage episodes, the quantity of leakage on the short pad tests in the clinic and symptoms on UI-specific symptom questionnaires. The authors of the one economic evaluation identified for the Brief Economic Commentary reported that the cost-effectiveness of PFMT looks promising. The findings of the review suggest that PFMT could be included in first-line conservative management programmes for women with UI. The long-term effectiveness and cost-effectiveness of PFMT needs to be further researched.

The efficacy of radiofrequency (RF) in stress urinary incontinence (SUI) is as yet unknown. The aim was to compare the effect of fractional microablative RF and pelvic floor muscle training (PFMT) against the combination of both therapies (RF + PFMT) in the SUI and on genitourinary syndrome (GSM). This was a three-arm randomized clinical trial including 117 climacteric women with SUI. In group 1 the treatment consisted of three monthly sessions of RF; in group 2 it was 12 weekly PFMT sessions; in group 3 it was RF + PFMT simultaneously. Assessments at baseline and 30days after the end of therapy were conducted using validated questionnaires and scales for urinary, vaginal, and sexual functions and cytology for vaginal trophy. Urinary scores improved significantly in all three groups post-treatment (p < 0.001) with a higher improvement in the RF + PFMT group (p = 0.002). One-hour pad test results were equal in the three groups. Vaginal symptoms showed an incremental improvement in RF (p < 0.007), and vaginal laxity showed a similar improvement in the three groups (p = 0.323). Vaginal Health Index score was more significant in RF and RF + PFMT groups. Sexual function improved in RF and PFMT. The association between RF and PFMT showed significant improvement in the SUI symptoms assessed by questionnaire. The vaginal symptoms and dryness showed greater improvement in the RF treatment and vaginal laxity showed similar improvement in the three groups. The combination of RF and PFMT in sexual function did not show benefits superior to those achieved by the therapies alone.

Chronic neck pain is common among Japanese individuals, but few receive treatment. This randomized controlled trial aimed to evaluate the efficacy of acupuncture using press needles in the self-treatment of chronic neck pain and preliminarily identify the characteristics of patients likely to benefit from this treatment. Fifty participants with chronic neck pain were allocated to receive either press needle or placebo treatment for 3 weeks. The visual analogue scale (VAS) and motion-related VAS (M-VAS) scores for neck pain, Neck Disability Index score, and pressure pain threshold were measured at baseline, after the first session, at the end of the last session, and 1 week after the last session. Changes in the outcomes were analyzed using analysis of variance, and the relationships between the variables were evaluated using structural equation modeling. Intervention results as assessed by VAS score revealed no significant differences in the ANOVA. A between-groups comparison of M-VAS scores at the end of the last session and baseline showed a significant difference (press needle: -21.64 ± 4.47, placebo: -8.09 ± 3.81, p = 0.025, d = -0.65). Structural equation modeling revealed a significant pain-reducing effect of press needle treatment (β = -0.228, p = 0.049). Severity directly affected efficacy (β = -0.881, p < 0.001). Pain duration, baseline VAS and Neck Disability Index scores were variables explaining severity, while age and occupational computer use were factors affecting severity. Self-treatment with press needles for chronic neck pain did not significantly reduce the VAS score compared to placebo but reduced the motion-related pain as assessed by M-VAS score. A direct association was observed between pain severity and the effectiveness of press needles, and the impact of age and computer were indirectly linked by pain severity. Identifier UMIN-CTR, UMIN000044078.

We evaluated whether vaginal tampon training (VTT) combined with pelvic floor muscle training (PFMT) results in better outcomes than PFMT alone for treating stress urinary incontinence (SUI). This was a randomized, controlled study. Patients were allocated to either the combined program, consisting of PFMT and VTT over 12weeks [PFMT and VTT group (n = 24)] or to PFMT alone [PFMT group (n = 24)]. The primary outcome measure was self-reported improvement, while secondary outcome measures were severity of incontinence, quality of life (QoL), urinary parameters, and pelvic floor muscle strength (PFMS) and endurance (PFME). Values were analyzed with Friedman, Mann-Whitney U, Wilcoxon, and chi-square tests. Between-group analysis showed no statistically significant differences in self-reported improvement, severity of incontinence, symptom distress score, PFMS, PFME, urinary parameters, and all domains of QoL scores, except social limitations, at weeks 4, 8, and 12 (p > 0.05). However, the increase in PFMS and PFME between baseline and week 12 and earlier improvement was significantly greater in the PFMT and VTT than in the PFMT group (both p < 0.05) CONCLUSION: Short-term results demonstrated that PFMT with and without VT exercises had similar effectiveness on the symptoms of SUI and QoL.

Objective:To evaluate the safety and efficacy of ospemifene for the treatment of moderate to severe vaginal dryness in postmenopausal women with vulvovaginal atrophy (VVA).Methods:This 12-week, multicenter, double-blind phase 3 study randomized postmenopausal women (aged 40-80 years) with VVA and moderate to severe vaginal dryness as their most bothersome symptom to daily oral ospemifene 60 mg or placebo. Coprimary efficacy endpoints included changes from baseline to week 12 in percentages of vaginal parabasal and superficial cells, vaginal pH, and vaginal dryness severity with ospemifene versus placebo; other secondary endpoints were evaluated (weeks 4, 8, and 12). Safety was assessed by treatment-emergent adverse events (TEAEs) and endometrial biopsies.Results:Women (n = 631; ospemifene [n = 316], placebo [n = 315]) had a mean age of 59.8 years, a mean body mass index of 27.2 kg/m2, and most were white. Ospemifene significantly improved (P < 0.0001) the percentages of parabasal and superficial cells, vaginal pH, and severity of vaginal dryness severity compared with placebo at week 12; significant between-group differences were noted by week 4. Secondary endpoints of dyspareunia (P < 0.001), maturation value (P < 0.0001), and the Female Sexual Function Index (P < 0.05) also significantly improved with ospemifene versus placebo at week 12. Significantly more women responded (31.5% vs 6.0%; P < 0.0001) or were satisfied (49.2% vs 33.8%; P = 0.0007) with ospemifene versus placebo at week 12. No unexpected TEAEs, treatment-related serious TEAEs, thrombotic events, or endometrial hyperplasia or carcinoma were observed.Conclusions:Ospemifene was effective and well tolerated for the treatment of moderate-to-severe vaginal dryness in postmenopausal women with VVA.

BackgroundLittle is known regarding treatment of urinary incontinence (UI) in women with chronic obstructive pulmonary disease (COPD). The aim of the study was to explore the efficacy of pelvic floor muscle training (PFMT) or cough-suppression techniques (CST) on UI in women with COPD.MethodsA three-armed, two-centred, single-blinded, randomised controlled study was performed. Subjects were randomised to (a) PFMT for 16 weeks, (b) 2–3 educational sessions in CST, or (c) written information only. All participants completed questionnaires about UI, cough symptoms, and health status and underwent clinical examinations to evaluate the strength of the pelvic floor muscles and exercise capacity. Daily physical activity levels were measured using an activity monitor and lung function with spirometry. With a significance level of 5% and an 80% chance of detecting a significant difference between groups of 2.5 points on the ICIQ UI SF score, our sample size calculation showed that a total of 78 women, 26 in each group, was required to complete the study.ResultsDuring the period 2016 to 2018, 95 women were invited to the study. A total of 42 were recruited, three were excluded and 10 (24%) dropped out during the follow-up period. Mean ICIQ-UI SF total baseline score was 9.6 (range: 1–17) and 7.0 (range: 0–16) at follow-up. Changes in subjective UI as measured with the ICIQ-UI SF questionnaire were seen in the PFMT group and control group, but not in the CST group.ConclusionDue to the low number of available participants and recruitment difficulties including practical issues such as travel distance, lack of interest, poor state of health, and high number of comorbidities, our results are inconclusive. However, reduced subjective UI was observed in the PFMT and control groups with a trend towards best effect in the PFMT group. Screening for UI is advisable in all women with COPD to be able to identify and treat these women to reduce symptom burden and improve quality of life. Future studies should focus on barriers to recruitment as well as randomised controlled studies with larger sample sizes.Trial registrationClinicalTrials.gov NCT02614105. 25th November 2015.

Evaluation of the Efficacy and Safety of Hyaluronic Acid Vaginal Gel to Ease Vaginal Dryness: A Multicenter, Randomized, Controlled, Open‐Label, Parallel‐Group, Clinical Trial

Vaginal dryness assessment in postmenopausal women using pH test strip