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.

Impact of pelvic floor muscle training on sexual function in women affected by stress urinary incontinence.

Background: Pelvic floor muscle training can effectively improve pelvic floor muscle strength and activities; however, its impact on sexual function in women with stress urinary incontinence remains unclear. Aim: The study sought to investigate the impact of pelvic floor muscle training on pelvic floor muscle and sexual function in women with stress urinary incontinence. Methods: This was a retrospective observational study involving women who visited a urogynecologic clinic at a tertiary medical center. Patients with stress urinary incontinence without pelvic organ prolapse underwent pelvic floor muscle training programs that included biofeedback and intravaginal electrostimulation. Other evaluations included pelvic floor manometry, electromyography, and quality-of-life questionnaires, including the short forms of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, Urogenital Distress Inventory, and Incontinence Impact Questionnaire. Outcomes: Clinical characteristics, vaginal squeezing and resting pressure, maximal pelvic floor contraction, duration of sustained contraction, quality-of-life scores, and sexual function were compared between baseline and after the pelvic floor muscle training programs. Results: There were 61 women included in the study. The mean number of treatment sessions was 12.9 ± 6.3, and the mean treatment duration was 66.7 ± 32.1 days. The short forms of the Urogenital Distress Inventory (7.7 ± 3.8 vs 1.8 ± 2.1; P < .001) and Incontinence Impact Questionnaire (5.9 ± 4.3 vs 1.8 ± 2.0; P < .001) scores significantly improved after the pelvic floor muscle training program. In addition, all pelvic floor muscle activities significantly improved, including maximal vaginal squeezing pressure (58.7 ± 20.1 cmH2O vs 66.0 ± 24.7 cmH2O; P = .022), difference in vaginal resting and maximal squeezing pressure (25.3 ± 14.6 cmH2O vs 35.5 ± 16.0 cmH2O; P < .001), maximal pelvic muscle voluntary contraction (24.9 ± 13.8 µV vs 44.5 ± 18.9 µV; P < .001), and duration of contraction (6.2 ± 5.7 s vs 24.9 ± 14.6 s; P < .001). Nevertheless, the short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire score demonstrated no significant improvement (28.8 ± 9.7 vs 29.2 ± 12.3; P = .752). Clinical Implications: Pelvic floor muscle training programs may not improve sexual function in women with stress urinary incontinence. Strengths and Limitations: The strength of this study is that we evaluated sexual function with validated questionnaires. The small sample size and lack of long-term data are the major limitations. Conclusion: Pelvic floor muscle training can improve pelvic floor muscle activities and effectively treat stress urinary incontinence; however, it may not improve sexual function.

Basic vs electromyographic biofeedback-assisted pelvic floor muscle training for the improvement of sexual function after total hysterectomy: a prospective study.

Background: Pelvic floor muscle training (PFMT) has emerged as a potential intervention to improve post-total hysterectomy (TH) sexual function. Electromyographic (EMG) biofeedback is an adjunct that may improve outcomes. Aim: In this study we aimed to compare the EMG biofeedback-assisted PFMT and PFMT alone for improving sexual function in women after TH. Methods: For this prospective study we enrolled women undergoing TH in our hospital between January 2022 and April 2023. Participants were divided according to the treatment they selected: EMG biofeedback-assisted PFMT or PFMT alone. Outcomes: The primary study outcome was change in patient sexual function evaluated by use of the Female Sexual Function Index. Secondary outcomes were changes in anxiety and depression evaluated with the Hospital Anxiety and Depression Scale score and pelvic floor muscle strength was evaluated with the Glazer assessment performed from before to after treatment. Results: A total of 73 patients were included, with 38 patients treated with Electromyographic biofeedback-assisted pelvic floor muscle training. After treatment, sexual function was significantly improved compared to baseline in all patients (all P < .001). Compared to patients with pelvic floor muscle training, the changes in total Female Sexual Function Index scores from before to after treatment in patients with Electromyographic biofeedback-assisted pelvic floor muscle training were significantly higher (all P < .05). There were no significant differences between the 2 groups in the changes in the Glazer score and Hospital Anxiety and Depression Scale scores from before to after treatment (both P > .05). Clinical Translation: The results demonstrate that Electromyographic biofeedback-assisted pelvic floor muscle training may be used to improve the sexual function of patients following TH. Strengths and Limitations: This study is limited by its single-center design, small sample size, lack of randomization, and absence of estrogen monitoring in enrolled participants. Conclusions: Electromyographic biofeedback-assisted pelvic floor muscle training appears to be more effective than pelvic floor muscle training alone in improving sexual function among patients after total hysterectomy.

Real-World Evidence From a Digital Health Treatment Program for Female Urinary Incontinence: Observational Study of Outcomes Following User-Centered Product Design.

BACKGROUND: Urinary incontinence (UI) affects millions of women with substantial health and quality-of-life impacts. Supervised pelvic floor muscle training (PFMT) is the recommended first-line treatment. However, multiple individual and institutional barriers impede women's access to skilled care. Evidence suggests that digital health solutions are acceptable and may be effective in delivering first-line incontinence treatment, although these technologies have not yet been leveraged at scale. OBJECTIVE: The primary objective is to describe the effectiveness and safety of a prescribed digital health treatment program to guide PFMT for UI treatment among real-world users. The secondary objectives are to evaluate patient engagement following an updated user platform and identify the factors predictive of success. METHODS: This retrospective cohort study of women who initiated device use between January 1, 2022, and June 30, 2023, included users aged ≥18 years old with a diagnosis of stress, urgency, or mixed incontinence or a score of >33.3 points on the Urogenital Distress Inventory Short Form (UDI-6). Users are prescribed a 2.5-minute, twice-daily, training program guided by an intravaginal, motion-based device that pairs with a smartphone app. Data collected by the device or app include patient-reported demographics and outcomes, adherence to the twice-daily regimen, and pelvic floor muscle performance parameters, including angle change and hold time. Symptom improvement was assessed by the UDI-6 score change from baseline to the most recent score using paired 2-tailed t tests. Factors associated with meeting the UDI-6 minimum clinically important difference were evaluated by regression analysis. RESULTS: Of 1419 users, 947 met inclusion criteria and provided data for analysis. The mean baseline UDI-6 score was 46.8 (SD 19.3), and the mean UDI-6 score change was 11.3 (SD 19.9; P<.001). Improvement was reported by 74% (697/947) and was similar across age, BMI, and incontinence subtype. Mean adherence was 89% (mean 12.5, SD 2.1 of 14 possible weekly uses) over 12 weeks. Those who used the device ≥10 times per week were more likely to achieve symptom improvement. In multivariate logistic regression analysis, baseline incontinence symptom severity and maximum angle change during pelvic floor muscle contraction were significantly associated with meeting the UDI-6 minimum clinically important difference. Age, BMI, and UI subtype were not associated. CONCLUSIONS: This study provides real-world evidence to support the effectiveness and safety of a prescribed digital health treatment program for female UI. A digital PFMT program completed with visual guidance from a motion-based device yields significant results when executed ≥10 times per week over a period of 12 weeks. The program demonstrates high user engagement, with 92.9% (880/947) of users adhering to the prescribed training regimen. First-line incontinence treatment, when implemented using this digital program, leads to statistically and clinically substantial symptom improvements across age and BMI categories and incontinence subtypes.

Real-world clinical effectiveness of nonsurgical treatments for female with POP-Q stage II cystocele: a retrospective analysis of therapeutic efficacy.

Background: Patients with cystocele of pelvic organ prolapse quantification (POP-Q) stage II and below can be treated conservatively, but there are few reports on non-surgical treatment for these patients. This study aimed to present the real-world clinical effectiveness of nonsurgical treatment, including pelvic floor muscle training (PFMT), PFMT combined with pessary (PFMT + P), or non-ablative radiofrequency (PFMT + RF) for female with POP-Q stage II cystocele. Methods: We retrospectively analyzed females with POP-Q stage II cystocele between January 2020 and January 2022 who received PFMT, PFMT + P, or PFMT + RF treatment and were followed up for 12 months. Clinical parameters including Pelvic Floor Distress Inventory-20 questionnaire (PFDI-20), Persian version urinary incontinence quality of life questionnaire (I-QOL), POP-Q, pelvic floor Glazer evaluation, and trans-labial ultrasound at different time points were analyzed. Results: There were 147 participants enrolled. PFDI-20 and I-QOL scores were improved in all groups, but the mean decrement in the PFDI-20 scores (-14.28±8.57 and -9.78±8.25) was higher in the PFMT + P group than in the PFMT group and PFMT + RF group at both 6 and 12 months (P<0.05), and the mean I-QOL score (3.82±23.43 and 3.47±22.06) was higher in the PFMT + RP group at both 6 months and 12 months (P<0.05). The PFMT + P group also showed higher improvement rate (43.3%, P=0.03) in terms of changing the severity of cystocele (point Ba) and delta bladder neck-symphyseal distance (ΔBSD) (P<0.05) than the other 2 groups at 12 months. No statistical difference was found in the type-I and type-II myofiber function-based Glazer assessment among 3 groups. Conclusions: The combination of 2 treatment strategies seems to be superior to PFMT only for stage-II cystocele. Specific prolapse-related symptoms and objective indicators did improve more in the PFMT + P group, whereas stress urinary incontinence (SUI) symptoms and quality of life were improved in the PFMT + RP group.

Pelvic floor muscle training patient reported Outcome Measures (PROM) (PFMT-P): Turkish adaptation and its validity and relibiality.

OBJECTIVE: Although there are several patient reported outcome measures (PROM) regarding knowledge, source of knowledge and practice about pelvic floor muscle training (PFMT), there is a lack of a valid and reliable PROM that includes the practice component of PFMT along with knowledge and source of knowledge. There is no valid and reliable measurement tool in Turkish used for this purpose. In this context, the aim of our study is to evaluate the psychometric properties of Pelvic Floor Muscle Training Patient Reported Outcome Measures (PROM) (PFMT-P) and to test whether it is a valid and reliable measurement tool for Turkish women. STUDY DESIGN: This study has been carried out psychometric testing (validity and reliability) of a new assessment tool concerning PFMT-P. A total of 170 female healthcare professionals (midwives, nurses, doctors, physiotherapists) who were between the ages of 23 and 49 and who volunteered to participate were included in the study. SPSS 25.0 and LISREL 8.80 statistical programs were used for the analysis of data. Descriptive statistics were evaluated with numbers, percentages and means. Content validity index and confirmatory factor analysis were used for validity. Cronbach Alpha value and test-retest were used for reliability. Level of significance was p < 0.05. RESULTS: Content validity index (CVI) was found to be 0.96 for the overall scale. Model fit indices were found as perfect and good matched. Cronbach's alpha coefficient was found as 0.813 for the overall scale. Test-retest correlation was found as 0.658, it was 0.998 for practice component and 0.997 for source of knowledge component and a positive, significant and high correlation was found. CONCLUSIONS: It has been determined that PFMT-P is a valid and reliable measurement tool suitable for Turkish culture. With this, it is a short, comprehensive and useful tool that can be used in both pregnancy and the postpartum period for women of reproductive age or menopause.

Pelvic Floor Muscle Training on Stress Urinary Incontinence in Power- and Weightlifters: a Pilot Study.

INTRODUCTION AND HYPOTHESIS: Stress urinary incontinence (SUI) is defined as involuntary leakage of urine on physical effort and is prevalent among power- and weightlifters. However, there is scant knowledge on treatment options for this population. The aim of this pilot study was to evaluate the potential outcomes and feasibility of a pelvic floor muscle training (PFMT) program on SUI in nulliparous female power- and weightlifters. METHODS: This was a case-series study, including one weightlifter and two powerlifters aged 21-32 years. The participants conducted 12 weeks of PFMT at home, with weekly follow-up by a physiotherapist. Change in total score of the International Consensus of Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF) was the primary outcome. Secondary outcome was perceived change assessed by the Patient Global Impression of Improvement (PGI-I) Scale and impact on sport participation. PFM strength, endurance, and resting pressure was measured using vaginal manometry. Feasibility was evaluated as adherence to training and self-efficacy (Self Efficacy Scale for Practicing Pelvic Floor Exercises). RESULTS: One athlete reduced their ICIQ-UI-SF score and experienced improvement in symptoms. One athlete reported no change, and one reported a worsening of symptoms. All three participants improved PFM strength and endurance, completed the testing, and 12 weeks of PFMT, but adherence varied between 40 and 80%. Participants reported a lack of time and energy and forgetting to perform the exercises, as reasons for low adherence. CONCLUSION: There were varying effects of a 12-week PFMT program on SUI in three strength athletes. The results can create the basis for a future randomized controlled trial.

Conservative Interventions for Urinary Incontinence on Postpartum Women: A Systematic Review and Meta-Analysis.

INTRODUCTION: Urinary incontinence (UI) is common in postpartum women and can lead to a reduced quality of life and withdrawal from fitness and exercise activities. Conservative management interventions such as pelvic floor muscle training (PFMT), use of vaginal cones, and biofeedback have been recommended as first-line treatment. We aimed to explore the effects of conservative interventions on UI rate, severity, and incontinence-specific quality of life in postpartum women with UI. METHODS: Nine databases were searched from inception to August 2022: PubMed, EMBASE, Web of Science, Cochrane Central Register of Controlled Trials, CINAHL, Wanfang, China National Knowledge Infrastructure, China Biological Medicine, and VIP Journal Integration Platform. Randomized controlled trials examining the effects of conservative interventions on postpartum UI were included. RESULTS: Initial searches produced 1839 results, of which 17 studies were eligible. All included studies had a low to moderate risk of bias. Supervised PFMT and use of a vaginal cone were more effective than individual PFMT in decreasing rates of UI (odds ratio, 0.29; 95% CI, 0.14-0.61). Individual PFMT combined with acupuncture (mean difference, -1.91; 95% CI, -2.46 to -1.37) or electroacupuncture and supervised PFMT combined with moxibustion were more effective than individual supervised PFMT alone in improving the severity of symptoms. Furthermore, electrical stimulation and biofeedback combined with acupoint stimulation or core training were more effective than electrical stimulation and biofeedback alone. For improving the incontinence-specific quality of life, supervised PFMT was more efficacious than individual PFMT; electrical stimulation and biofeedback plus core training were more beneficial than electrical stimulation and biofeedback alone. DISCUSSION: Supervised PFMT and use of a vaginal cone were more beneficial in decreasing rates of UI compared with individual PFMT. Superior effects in decreasing UI severity may be achieved by combining PFMT or electrical simulation and biofeedback with other therapies. Electrical stimulation and biofeedback plus core training, as well as supervised PFMT, are most effective in improving incontinence-specific quality of life. Further research is required to provide more evidence on the efficacy of these therapies.

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.

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.

Knowledge of urinary incontinence among women 6 weeks to 1 year after delivery.

BACKGROUND: Urinary incontinence (UI) is common among postpartum women, but many do not seek medical help due to limited knowledge. Understanding the level of knowledge about UI in this population is essential for improving care-seeking behaviors and implementing targeted interventions. OBJECTIVE: The objective was to examine knowledge regarding UI among postpartum women with UI within 6 weeks to 1 year after delivery. METHODS: A cross-sectional study was conducted at obstetric clinic in two level-three grade A hospitals in Shenzhen, China, from January 2023 to June 2023. Women in their 6 weeks to 1 year after delivery with UI were asked to complete a questionnaire comprising three sections: (1) demographic variable; (2) International Consultation on Incontinence Questionnaire Short Form (ICIQ-UI SF); and (3) The Urinary Incontinence Quiz (UIQ). RESULTS: A total of 1228 women completed the questionnaire. Their mean UIQ score was 6.63 ± 3.51 (minimum = 2, maximum = 15), indicating the deficiency of UI knowledge among Chinese postpartum women. A total of 86.4% of participants experienced slight or moderate postpartum UI. The results of multivariate linear regression models for UIQ reveal significant independent associations between questionnaire scores and two variables: experience in pelvic floor muscle training (PFMT) (p < 0.001) and UI treatment in the past (p < 0.001). The overall model fit was R2 = 0.559 (p < 0.001). The regression coefficients for the experience in PFMT and UI treatment in the past were 2.301 and 4.916, respectively. However, no other discernible factors were identified to distinguish between those with and without adequate knowledge. CONCLUSIONS: Postpartum women with UI within 6 weeks to 1 year after delivery had poor knowledge of UI. Targeted educational interventions focusing on PFMT and early treatment for UI are essential.

Effects of different treatment frequencies of electromagnetic stimulation for urinary incontinence in women: study protocol for a randomized controlled trial.

BACKGROUND: Urinary incontinence is highly prevalent in women while pelvic floor muscle training is recommended as the first-line therapy. However, the exact treatment regimen is poorly understood. Also, patients with pelvic floor muscle damage may have decreased muscle proprioception and cannot contract their muscles properly. Other conservative treatments including electromagnetic stimulation are suggested by several guidelines. Thus, the present study aims to compare the effectiveness of electromagnetic stimulation combined with pelvic floor muscle training as a conjunct treatment for urinary incontinence and different treatment frequencies will be investigated. METHODS/DESIGN: This is a randomized, controlled clinical trial. We will include 165 patients with urinary incontinence from the outpatient center. Participants who meet the inclusion criteria will be randomly allocated to three groups: the pelvic floor muscle training group (active control group), the low-frequency electromagnetic stimulation group (group 1), and the high-frequency electromagnetic stimulation group (group 2). Both group 1 and group 2 will receive ten sessions of electromagnetic stimulation. Group 1 will be treated twice per week for 5 weeks while group 2 will receive 10 days of continuous treatment. The primary outcome is the change in International Consultation on Incontinence Questionnaire-Short Form cores after the ten sessions of the treatment, while the secondary outcomes include a 3-day bladder diary, pelvic floor muscle function, pelvic organ prolapse quantification, and quality of life assessed by SF-12. All the measurements will be assessed at baseline, after the intervention, and after 3 months of follow-up. DISCUSSION: The present trial is designed to investigate the effects of a conjunct physiotherapy program for urinary incontinence in women. We hypothesize that this strategy is more effective than pelvic floor muscle training alone, and high-frequency electromagnetic stimulation will be superior to the low-frequency magnetic stimulation group.

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

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

Comparison of Vaginal Pessaries to Standard Care or Pelvic Floor Muscle Training for Treating Postpartum Urinary Incontinence: a Pragmatic Randomized Controlled Trial.

Introduction: To compare three conservative treatment options, standard care, pelvic floor muscle training (PFMT), and vaginal pessaries, for postpartum urinary incontinence (UI) that are accessible to most patients and practitioners in a generalizable cohort. Materials and Methods: A multicenter, open-label, parallel group, pragmatic randomized controlled clinical trial comparing standard care, PFMT, and vaginal cube pessary for postpartum urinary incontinence was conducted in six outpatient clinics. Sample size was based on large treatment effects (Cramers' V > 0.35) with a power of 80% and an alpha of 0.05 for a 3 × 3 contingency table, 44 patients needed to be included in the trial. Outcomes were analyzed according to the intention-to-treat principle. Group comparisons were made using analysis of variance (ANOVA), Kruskal-Wallis, and chi-square test as appropriate. P < 0.05 was considered statistically significant. Results: Of the 516 women screened, 111 presented with postpartum UI. Of these, 52 were randomized to one of three treatment groups: standard care (n = 17), pelvic floor muscle training (n = 17), or vaginal cube pessary (n = 18). After 12 weeks of treatment, treatment success, as measured by patient satisfaction, was significantly higher in the vaginal pessary group (77.8%, n = 14/18), compared to the standard care group (41.2%, n = 7/17), and the PFMT (23.5%, n = 4/17; χ 2 2,n = 52  = 14.55; p = 0.006, Cramer-V = 0.374). No adverse events were reported. SUI and MUI accounted for 88.4% of postpartum UI. Conclusion: Vaginal pessaries were superior to standard care or PFMT to satisfyingly reduce postpartum UI symptoms. No complications were found.

The relation between usage of an eHealth intervention for stress urinary incontinence and treatment outcomes: an observational study.

BACKGROUND: Stress urinary incontinence (SUI), though a prevalent condition among women, is undertreated in primary care. EHealth with pelvic floor muscle training is an evidence-based alternative to care-as-usual. It is unknown, however, how eHealth usage is related to treatment outcome, and this knowledge is required for general practitioners to implement eHealth in their practice. This study examines the relation between usage of eHealth for SUI and treatment outcomes by examining log data. Baseline factors were also explored for associations with treatment success. METHOD: In this pre-post study, women with SUI participated in "Baasoverjeblaas.nl", a web-based intervention translated from the Swedish internet intervention "Tät®-treatment of stress urinary incontinence". Usage was based on log data and divided into three user groups (low, intermediate and high). Online questionnaires were sent before, after treatment and at six-months follow-up. The relation between usage and the primary outcome - treatment success (PGI-) - was studied with a binomial logistic regression analysis. Changes in the secondary outcomes - symptom severity (ICIQ-UI SF) and quality of life (ICIQ-LUTSqol) - were studied per user group with linear mixed model analysis. RESULTS: Included were 515 users with a mean age of 50.5 years (12.0 SD). The majority were low users (n = 295, 57.3%). Treatment success (PGI-I) was reached by one in four women and was more likely in high and intermediate users than in low users (OR 13.2, 95% CI 6.1-28.5, p < 0.001 and OR 2.92, 95% CI 1.35-6.34, p = 0.007, respectively). Symptom severity decreased and quality of life improved significantly over time, especially among high users. The women's expected ability to train their pelvic floor muscles and the frequency of pelvic floor muscle exercises at baseline were associated with treatment success. CONCLUSION: This study shows that usage of eHealth for SUI is related to all treatment outcomes. High users are more likely to have treatment success. Treatment success is more likely in women with higher expectations and pelvic floor muscle training at baseline. These findings indicate that general practitioners can select patients that would be more likely to benefit from eHealth treatment, and they can enhance treatment effect by stimulating eHealth usage. TRIAL REGISTRATION: Landelijk Trial Register NL6570;  https://onderzoekmetmensen.nl/nl/trial/25463 .

Effect of Pilates combined with pelvic floor muscle training on continence of post-prostatectomy incontinence in patients with different body mass index.

BACKGROUND: Urinary incontinence symptoms severely affect older people with different body mass index (BMI).To compare the efficacy of the pelvic floor muscle training (PFMT) in patients with post-prostatectomy incontinence with different BMI. METHODS: Thirty-seven patients with post-prostatectomy incontinence were included. They were divided into group A (BMI ≤ 25,12), group B (26 ≤ BMI ≤ 30,14), and group C (BMI ≥ 31,11) based on difference BMI. Three groups of patients underwent the same Pilates combined with kegel training. Participants were assessed with 1-hour pad test, the number of incontinence episodes, International Consultation on Incontinence Questionnaire and Oxford Grading Scale. RESULTS: In the 1-hour pad test, the differences before and after training were statistically significant in all three groups of participants. Group A decreased from 81.83 ± 8.79 to 31.08 ± 5.64 g (P < 0.01). Group B decreased from 80.57 ± 8.87 to 35.85 ± 5.66 g (P < 0.01). Group C decreased from 83.55 ± 10.24 to 40.18 ± 7.01 g (P < 0.01). The number of incontinent episodes in group A decreased from 9.33 ± 1.07 to 3.25 ± 0.62 (P < 0.01). Group B decreased from 8.86 ± 1.09 to 3.79 ± 0.80 (P < 0.01). Group C decreased from 9.27 ± 1.10 to 4.09 ± 0.70 (P < 0.01). The correlation between the three groups of participants and the 1-hour pad test, with an R2 of 0.51. The correlation between the three groups of participants and the number of urinary incontinence episodes with a R2 of 0.43. CONCLUSIONS: Pelvic floor muscle training can affect the recovery of urinary continence in patients with different BMI. Maintaining a lower BMI can be beneficial for improving urinary control. TRIAL REGISTRATION: Date of trial registration: November 27, 2023.

Six-Month Prostate Cancer Empowerment Program (PC-PEP) Improves Urinary Function: A Randomized Trial.

Purpose: This is a secondary analysis examining a six-month home-based Prostate Cancer-Patient Empowerment Program (PC-PEP) on patient-reported urinary, bowel, sexual, and hormonal function in men with curative prostate cancer (PC) against standard of care. Methods: In a crossover clinical trial, 128 men scheduled for PC surgery (n = 62) or radiotherapy with/without hormones (n = 66) were randomized to PC-PEP (n = 66) or waitlist-control and received the standard of care for 6 months, and then PC-PEP to the end of the year. PC-PEP included daily emails with video instructions, aerobic and strength training, dietary guidance, stress management, and social support, with an initial PFMT nurse consultation. Over 6 months, participants in the PC-PEP received optional text alerts (up to three times daily) reminding them to follow the PFMT video program, encompassing relaxation, quick-twitch, and endurance exercises; compliance was assessed weekly. Participants completed baseline, 6, and 12-month International Prostate Symptom Score (IPSS) and Expanded Prostate Cancer Index Composite (EPIC) questionnaires. Results: At 6 months, men in the PC-PEP reported improved urinary bother (IPSS, p = 0.004), continence (EPIC, p < 0.001), and irritation/obstruction function (p = 0.008) compared to controls, with sustained urinary continence benefits at 12 months (p = 0.002). Surgery patients in the waitlist-control group had 3.5 (95% CI: 1.2, 10, p = 0.024) times and 2.3 (95% CI: 0.82, 6.7, p = 0.11) times higher odds of moderate to severe urinary problems compared to PC-PEP at 6 and 12 months, respectively. Conclusions: PC-PEP significantly improves lower urinary tract symptoms, affirming its suitability for clinical integration alongside established mental health benefits in men with curative prostate cancer.

Online Group-based Pelvic Floor Muscle Training for Urinary Incontinence in Older Women: a Pilot Study.

INTRODUCTION AND HYPOTHESIS: Urinary incontinence (UI) is prevalent among older women, but conservative treatment rates remain low due to limited accessibility, despite evidence supporting pelvic floor muscle training (PFMT) efficacy. Group-based approaches, including online options, could offer cost-effective alternatives. Recent evidence supports the feasibility of online group-based PFMT for treating UI in older women. This pilot study now evaluated the clinical effects of this program on the number of leakage episodes per day, additional UI-specific outcomes, and other symptoms and indicators. METHODS: Community-dwelling women aged 65 and over, with stress or mixed UI, were recruited. Eligibility was assessed through in-person evaluations conducted by pelvic floor physiotherapists, who instructed participants on pelvic floor muscle contraction using digital palpation. Participants engaged in a 12-week group-based PFMT program with weekly 1-h sessions. Data were collected at three time points: recruitment (PRE1), before the first session (PRE2), and after the program (POST). Participants recorded UI symptoms using 7-day bladder diaries and standardized questionnaires on UI symptoms, quality of life (QoL), UI self-efficacy, and perceived costs. After the program (POST), participants provided feedback on their impression of improvement and satisfaction. RESULTS: Participants reported a significant reduction in their number of leakage episodes per day. Standardized questionnaire scores also supported the positive effects of the program on UI symptoms and QoL, self-efficacy in avoiding leakage and performing PFMT exercises, and monthly costs for continence products. Older women expressed high satisfaction with symptom improvement and the program. CONCLUSIONS: Online group-based PFMT improved UI symptoms, QoL, UI self-efficacy, and perceived UI costs among older women. Pragmatic randomized controlled trials are necessary for further validation.

Minimum important difference of the ICIQ-UI SF score after self-management of urinary incontinence.

BACKGROUND: This study aimed to evaluate clinically relevant improvement after conservative self-management of urinary incontinence via a mobile app. It further aimed to establish Minimum Important Differences (MIDs) based on the severity and type of urinary incontinence. METHODS: Data was collected in a prospective cohort study that evaluated the freely available app Tät®. The app provided pelvic floor muscle training (PFMT) and life-style advice. Non-pregnant, non-postpartum women (≥ 18 years) who downloaded the app to treat urinary incontinence were included, if they completed the Patient Global Impression of Improvement (PGI-I) question at the 3-month follow-up (n = 1,733). Participants answered the International Consultation on Incontinence Questionnaire (ICIQ-UI SF) at baseline and after 3 months. The score change was analysed for correlation (Spearman) with the PGI-I. We then analysed one-way ANOVAs to determine whether there were significant differences between the groups based on the answers to the PGI-I. The MID was set to the mean change of the group that selected the answer "a little better" to the PGI-I question. RESULTS: The one-way ANOVA showed significant differences between PGI-I groups (p < 0.001). The MID for the general group was set to 1.46 (95% Confidence Interval [CI] 1.26-1.67). In the sub-group analyses, a MID for the group with slight incontinence could not be determined. For the group with moderate severity the MID was determined to be 1.33 (95% CI 1.10-1.57) and for the severe/very severe group it was 3.58 (95% CI 3.08-4.09). Analysis of different types of incontinence showed no difference in MIDs. CONCLUSIONS: The MID for self-management via a mobile app was lower than previously established MIDs, but differed depending on baseline severity. This study shows that MIDs need adjustment for baseline severity and treatment intensity when interpreting clinical trial results. If using MIDs as exact numbers, the study population and the treatment must be comparable.

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.