Pelvic floor muscle training as a treatment for genitourinary syndrome of menopause: A single-arm feasibility study.

OBJECTIVES: Treatments for genitourinary syndrome of menopause (GSM) may not be suitable for all women, may not be completely effective, and may cause adverse effects. Therefore, there is a need to explore new treatment approaches. The objectives were to evaluate the feasibility of using a pelvic floor muscle training (PFMT) program in postmenopausal women with GSM, and to investigate its effect on symptoms, signs, activities of daily living (ADL), quality of life (QoL) and sexual function. STUDY DESIGN: Postmenopausal women with GSM participated in a single-arm feasibility study embedded in a randomized controlled trial (RCT) on PFMT for urinary incontinence. This substudy was composed of two pre-intervention evaluations, a 12-week PFMT program and a post-intervention evaluation. MAIN OUTCOME MEASURES: Feasibility was defined as study completion and participation in physiotherapy sessions and in-home exercises. The effects of the PFMT program were assessed by measuring GSM symptoms ('Most Bothersome Symptom' approach, ICIQ-UI SF), GSM signs (Vaginal Health assessment scale), GSM's impact on ADL (Atrophy Symptom questionnaire), QoL and sexual function (ICIQ-VS, ICIQ-FLUTSsex) and leakage episodes. RESULTS: Thirty-two women participated. The study completion rate was high (91%), as was participation in treatment sessions (96%) and in-home exercises (95%). Post-intervention, there were significant reductions in GSM symptoms and signs (p < 0.01) as well as in its impacts on ADL, QoL and sexual function (p < 0.05). CONCLUSIONS: A study including a PFMT program is feasible, and the outcomes indicate PFMT to be an effective treatment approach for postmenopausal women with GSM and urinary incontinence. This intervention should be assessed through a RCT.

A non-inferiority randomized controlled trial comparing a home-based aerobic exercise program to a self-administered cognitive-behavioral therapy for insomnia in cancer patients.

Study Objectives: Thirty to sixty percent of cancer patients have insomnia symptoms, a condition which may lead to numerous negative consequences and for which an efficacious management is required. This randomized controlled trial aimed to assess the efficacy of a 6-week home-based aerobic exercise program (EX) compared to that of a 6-week self-administered cognitive-behavioral therapy for insomnia (CBT-I) to improve sleep in cancer patients. Method: Forty-one patients (78.1% female, mean age 57 years) with various types of cancer and having insomnia symptoms (Insomnia Severity Index [ISI] score ≥ 8) were randomized to the EX (n = 20) or the CBT-I (n = 21) groups. Measures were completed at pretreatment and posttreatment, as well as at 3- and 6-month follow-ups. Results: The EX intervention was statistically inferior to CBT-I in reducing ISI scores at posttreatment but was non-inferior at follow-up. However, no significant group-by-time interaction was found on any outcome and both interventions led to a significant improvement of subjectively-assessed sleep impairments on the ISI, the Pittsburgh Sleep Quality Index (PSQI) and most sleep parameters from a daily sleep diary at posttreatment corresponding to medium to large time effects (ds > 0.50 for ISI, PSQI, sleep onset latency, wake after sleep onset, total wake time and sleep efficiency). Conclusion: Both interventions produced significant improvements of sleep. However, EX was found to be significantly inferior to CBT-I in reducing ISI scores at posttreatment, which contradicts the initial non-inferiority hypothesis. These findings suggest that CBT-I remains the treatment of choice for cancer-related insomnia, although EX can lead to some beneficial effects. ClinicalTrials.gov Identifier: NCT02774369 https://clinicaltrials.gov/ct2/show/NCT02774369?term=NCT02774369&rank=1.

Test-retest reliability of clitoral blood flow measurements using color Doppler ultrasonography at rest and after a pelvic floor contraction task in healthy adult women.

AIMS: Test-retest reliability assessment of the dorsal clitoral artery's blood flow at rest and after muscle activation has never been documented. If this outcome measure is to be used in conditions impeding vascularity, it requires a psychometric evaluation. The aim of this study was to assess the inter-session test-retest reliability of clitoral blood flow in healthy women using color Doppler ultrasonography at rest and after a pelvic floor muscle (PFM) contraction task. METHODS: Two assessment sessions were conducted using a clinical ultrasound system. Clitoral blood flow measurements were repeated at rest and after a PFM contraction task. Measurements of the peak systolic velocity (PSV), time-averaged maximum velocity (TAMX), end-diastolic velocity (EDV), pulsatility index (PI), and resistance index (RI) were taken. The test-retest reliability was assessed using paired t-test, intraclass correlation coefficient (ICC), and Bland-Altman plots. RESULTS: For reliability at rest, ICC values were 0.95 for PSV, 0.87 for TAMX, and 0.67 for both PI and RI. The variability between measurements, as per Bland-Altman plots, was small for PSV, TAMX, and RI and acceptable for PI. For reliability after the PFM contractions task, ICC values were 0.85 for PSV, 0.77 for TAMX, 0.79 for PI, and 0.81 for RI. The variability between measurements was small for PSV and RI and acceptable for TAMX and PI. EDV parameter did not perform as well in both conditions. CONCLUSIONS: Assessment of the clitoral blood flow with color Doppler ultrasound is reliable at rest and after a PFM contraction task.

Test-retest reliability of internal pudendal artery blood flow using color Doppler ultrasound in healthy women.

INTRODUCTION AND HYPOTHESIS: The internal pudendal artery (IPA) is one of the main arteries supplying the pelvic floor muscles (PFMs) and vulvo-vaginal tissues. Its assessment with color Doppler ultrasound has been documented previously, but the reliability of IPA measurements has never been assessed. This study evaluates the test-retest reliability of IPA blood flow parameters measured by color Doppler ultrasound under two conditions: at rest and after a PFM contraction task. METHODS: Twenty healthy women participated in this study. One observer performed two measurement sessions using a clinical ultrasound system with a curved-array probe on the participant's gluteal area. IPA measurements were repeated: at rest and after a PFM contraction task. Peak systolic velocity (PSV), time-averaged maximum velocity (TAMX), end-diastolic velocity (EDV), pulsatility index (PI), and resistance index (RI) were measured. Test-retest reliability was assessed using a paired t test, intraclass correlation coefficient (ICC), and Bland and Altman plots. RESULTS: There was no significant difference for all IPA blood flow measurements between the two repeated sessions. At rest, reliability was excellent for PSV and TAMX and the variability between measurements, as per Bland and Altman plots, was small. After PFM contractions, reliability was excellent for PSV and TAMX and fair to good for PI. The variability between measurements was small for PSV and acceptable for TAMX and PI. EDV and RI parameters did not perform as well. CONCLUSION: The assessment of IPA blood flow with color Doppler ultrasound to evaluate vascular change in women is reliable.

Genitourinary syndrome of menopause symptom severity and impact outcome measures: are they reliable and correlated?

OBJECTIVE: The Most Bothersome Symptom Approach (MBSA) assesses symptom severity of genitourinary syndrome of menopause (GSM), and identifies the symptom with the greatest burden. The Atrophy Symptoms Questionnaire (ASQ) assesses the impact of GSM symptoms on the activities of daily living. The psychometric properties of these outcomes remain to be completely assessed. This study aimed to assess the test-retest reliability of the MBSA and the ASQ and their convergent validity. METHOD: One evaluator administered the outcomes twice 2 weeks apart to postmenopausal women with GSM and urinary incontinence. MBSA reliability was assessed with the graphical analysis of paired differences, Kappa coefficients and intraclass correlation coefficient (ICC), and the ASQ reliability, with paired t test and ICC. The convergent validity of both outcomes was investigated through their association with the Pearson correlation coefficient. RESULTS: Thirty-one women participated in the study. For the MBSA, the severity of the most bothersome symptom obtained a good reliability with 80% observed agreement between sessions, a substantial kappa (0.67 ±â€Š0.12) and excellent ICC (0.88 [95% confidence interval 0.75-0.94]). For the ASQ, no significant difference was found between sessions (P = 0.146) and ICC indicated excellent reliability (0.85 [95% confidence interval 0.69-0.93]). There was a large, positive correlation between the severity of the most bothersome symptom selected by the participants in the MBSA and the ASQ total score for the two measurement sessions (T1: r = 0.587, P = 0.001 and T2: r = 0.601, P < 0.001). CONCLUSIONS: The MBSA and the ASQ are reliable outcome measures in postmenopausal women with GSM and urinary incontinence. Our findings support good convergent validity of those two outcomes as they showed a significant positive correlation between the severity of GSM symptoms and their impact on activities of daily living.

Exercise interventions to improve sleep in cancer patients: A systematic review and meta-analysis.

Exercise leads to several positive outcomes in oncology. However, the question as to whether exercise is a valuable option for improving patients' sleep, which is frequently disturbed in cancer patients, remains unanswered. The aims of this study were to conduct a systematic review and meta-analysis of randomized and non-randomized clinical trials that have investigated the effect of exercise on sleep outcomes, assessed subjectively and objectively. Relevant studies, published before May 2016, were traced through a systematic search of PubMed, Embase, PsycINFO, SportDiscus and Cochrane library databases. The review looked at twenty one trials, including 17 randomized controlled trials. Most interventions were home-based aerobic walking programs and breast cancer patients were the subgroup most represented. Sleep variables were most commonly used as secondary outcomes in the reviewed studies. Studies were highly heterogeneous in terms of methodology. The qualitative review of available evidence suggested a beneficial effect of exercise interventions on sleep in several studies (48%). However, the meta-analysis conducted on RCTs revealed no significant effect either on subjective or on objective sleep measures. This lack of significant effect could be due, at least in part, to a floor effect. More rigorous studies are needed to assess the effect of exercise interventions in cancer patients, in particular randomized controlled trials conducted in patients with clinically significant sleep disturbances at baseline.

Pelvic floor muscles training to reduce symptoms and signs of vulvovaginal atrophy: a case study.

OBJECTIVE: Vulvovaginal atrophy (VVA), caused by decreased levels of estrogen, is a common problem in aging women. Main symptoms of VVA are vaginal dryness and dyspareunia. First-line treatment consists of the application of local estrogen therapy (ET) or vaginal moisturizer. In some cases however, symptoms and signs persist despite those interventions. This case study describes a 77-year-old woman with severe VVA symptoms despite use of local ET and the addition of pelvic floor muscle (PFM) training to her treatment. METHODS: A patient with stress urinary incontinence and VVA was referred to a randomized clinical trial on PFM training. On pretreatment evaluation while on local ET, she showed VVA symptoms on the ICIQ Vaginal Symptoms questionnaire and the ICIQ-Female Sexual Matters associated with lower urinary tract Symptoms questionnaire, and also showed VVA signs during the physical and dynamometric evaluation of the PFM. She was treated with a 12-week PFM training program. RESULTS: The patient reported a reduction in vaginal dryness and dyspareunia symptoms, as well as a better quality of sexual life after 12 weeks of PFM training. On posttreatment physical evaluation, the PFMs' tone and elasticity were improved, although some other VVA signs remained unchanged. CONCLUSIONS: Pelvic floor muscle training may improve some VVA symptoms and signs in women taking local ET. Further study is needed to investigate and confirm the present case findings and to explore mechanisms of action of this intervention for VVA.

Physical therapy for urinary incontinence in postmenopausal women with osteoporosis or low bone density: a randomized controlled trial.

OBJECTIVE: To assess the effectiveness of 12 weekly physical therapy sessions for urinary incontinence (UI) compared with a control intervention, for reducing the number of UI episodes measured with the 7-day bladder diary, at 3 months and 1 year postrandomization. METHODS: A single parallel-group randomized controlled trial was conducted at one outpatient public health center, in postmenopausal women aged 55 years and over with osteoporosis or low bone density and UI. Women were randomized to physical therapy (PT) for UI or osteoporosis education. The primary outcome measure was number of leakage episodes on the 7-day bladder diary, assessed at baseline, after treatment and at 1 year. The secondary outcome measures included the pad test and disease-specific quality of life and self-efficacy questionnaires assessed at the same timepoints. RESULTS: Forty-eight women participated (24 per group). Two participants dropped out of each group and one participant was deceased before 3-month follow-up. Intention-to-treat analysis was undertaken. At 3 months and 1 year, there was a statistically significant difference in the number of leakage episodes on the 7-day bladder diary (3 mo: P = 0.04; 1 y: P = 0.01) in favor of the PT group. The effect size was 0.34 at 1 year. There were no harms reported. CONCLUSIONS: After a 12-week course of PT once per week for UI, PT group participants had a 75% reduction in weekly median number of leakage episodes, whereas the control group's condition had no improvement. At 1 year, the PT group participants maintained this improvement, whereas the control group's incontinence worsened.

Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women: a short version Cochrane systematic review with meta-analysis.

BACKGROUND: Pelvic floor muscle training (PFMT) is a commonly used physical therapy for women with urinary incontinence (UI). OBJECTIVES: To determine the effects of PFMT for women with UI in comparison to no treatment, placebo or other inactive control treatments. SEARCH METHODS: Cochrane Incontinence Group Specialized Register, (searched 15 April 2013). SELECTION CRITERIA: Randomized or quasi-randomized trials in women with stress, urgency or mixed UI (based on symptoms, signs, or urodynamics). DATA COLLECTION AND ANALYSIS: At least two independent review authors carried out trial screening, selection, risk of bias assessment and data abstraction. Trials were subgrouped by UI diagnosis. The quality of evidence was assessed by adopting the (GRADE) approach. RESULTS: Twenty-one trials (1281 women) were included; 18 trials (1051 women) contributed data to the meta-analysis. In women with stress UI, there was high quality evidence that PFMT is associated with cure (RR 8.38; 95% CI 3.68 to 19.07) and moderate quality evidence of cure or improvement (RR 17.33; 95% CI 4.31 to 69.64). In women with any type of UI, there was also moderate quality evidence that PFMT is associated with cure (RR 5.5; 95% CI 2.87-10.52), or cure and improvement (RR 2.39; 95% CI 1.64-3.47). CONCLUSIONS: The addition of seven new trials did not change the essential findings of the earlier version of this review. In this iteration, using the GRADE quality criteria strengthened the recommendations for PFMT and a wider range of secondary outcomes (also generally in favor of PFMT) were reported.