Restoring both continence and micturition after chronic spinal cord injury by pudendal neuromodulation.

Neurogenic bladder management after spinal cord injury (SCI) is very challenging. Daily urethral catheterization is most commonly used to empty the bladder, which causes frequent infections of the lower urinary tract. This study reports a novel idea to restore both continence and micturition after SCI by an implantable pudendal nerve stimulator (PNS). The PNS was surgically implanted in four cats with complete SCI at T9-T10 spinal level and tested weekly for 13-14 weeks under awake conditions. These chronic SCI cats consistently exhibited large residual bladder volumes (average 40-50 ml) due to their inability to void efficiently, while urine leakage also occurred frequently. The PNS which consisted of stimulating the pudendal nerve at 20-30 Hz to trigger a spinal reflex bladder contraction and at the same time blocking the pudendal nerves bilaterally with 10 kHz stimulation to relax the external urethral sphincter and reduce the urethral outlet resistance successfully induced highly efficient (average 80-100%), low pressure (<50 cmH2O) voiding. The PNS at 5 Hz also promoted urine storage by inhibiting reflex bladder activity and increasing bladder capacity. At the end of 14-week chronic testing, low pressure efficient voiding induced by PNS was further confirmed under anesthesia by directly measuring voiding pressure using a bladder catheter inserted through the bladder dome. This study demonstrated the efficacy and safety of the PNS in awake chronic SCI cats, suggesting that a novel neuroprosthesis can be developed for humans to restore bladder function after SCI by stimulating and/or blocking the pudendal nerves.

Efficacy of transcutaneous posterior tibial nerve stimulation in children with functional voiding disorders.

AIMS: To assess the efficacy of transcutaneous posterior tibial nerve stimulation (TPTNS) on functional voiding disorder (FVD) and investigate the utility of urine biomarkers (UBs: nerve growth factor, transforming growth factor-beta 1, and tissue inhibitor of metalloproteinases 2) in diagnosis and follow-up. METHODS: A total of 44 children were included to this randomized controlled trial prospectively. After randomization, 20 of 30 children with storage phase dysfunction those were unresponsive or noncompliant to medical treatment received TPTNS treatment (test group) and 10 children underwent TPTNS with no current (sham group) for 12 weeks. Fourteen healthy children constituted the nonsymptomatic group. UB levels, dysfunctional voiding and incontinence scoring system (DVISS), voiding diary, and quality of life (QoL) scores were assessed before and after treatment in the treatment groups. RESULTS: QoL scores, overall and day-time DVISS scores were significantly decreased in both sham and test groups (p < 0.05). In addition to these findings, the frequency of incontinence and urgency episodes were also significantly reduced (p < 0.05) in the TPTNS treatment group. This effect in the test group was still valid 2 years after intervention. There was no significant difference in UBs measurements between treatment and nonsymptomatic groups and between pretreatment and posttreatment measurements of test and sham groups. CONCLUSIONS: TPTNS is an efficient minimally invasive treatment in children with FVD who do not respond to medical treatment. TPTNS provides a significant improvement on episodes of frequency, episodes of incontinence, overall and day-time DVISS scores, and QoL scores. The effectiveness of treatment continues even at the end of the second year of intervention. UBs were not found to be predictive in terms of diagnosis and evaluating the treatment response.

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.

Early 3-month treatment with comprehensive physical therapy program restores continence in urinary incontinence patients after radical prostatectomy: A randomized controlled trial.

AIMS: The objective of this study is to ascertain whether an early three-month treatment with electrotherapy and biofeedback restores continence in urinary incontinence patients after radical prostatectomy (RP). METHODS: Design: The study performed a randomized, controlled trial of parallel and open groups. Configuration: Secondary care, urology department of a university hospital complex. PARTICIPANTS: Patients sent for RP due to prostate cancer (n = 60), 47 patients finally completed the study. INTERVENTIONS: The treatment group (TG) received physiotherapy consisting of electrotherapy and biofeedback, 3 days a week for 3 months, while the control group (CG) received no specific treatment. Both groups received a guide to perform pelvic floor exercises at home. The measurement instruments used were the 1- and 24-hour pad tests and the International Consultation on Incontinence Questionnaire Short-Form. The recording method used was a micturition (urinary) diary. RESULTS: The results of the 1-hour pad test (PT) show statistically significant differences between groups at 3 months (P = .001) and 6 months (P = .001), in favor of those in the TG. Sixty-four percent of patients in the TG recovered continence as against 9.1% in the CG after 3 months in the 1-hour PT, in line with the objective of this study. CONCLUSIONS: An early physiotherapy program helps RP patients with urinary incontinence recover continence after 3 months. Moreover, they lead a better quality life.

Acupuncture in the treatment of HTLV-I-associated myelopathy / tropical spastic Paraparesis.

We investigate the possible effects of acupuncture on the improvement of neurological problems in HTLV-I-associated myelopathy/tropical spastic paraparesis (HAM/TSP)disease. Twenty patients with HAM/TSP were studied in this pre and post-test clinical trial. Urinary incontinence, global motor disability, spasticity, and pain severity were evaluated before, one month, and three-month after the intervention. Analyses demonstrated a significant reduction of urinary symptoms one month after acupuncture (P = 0.023). A significant improvement was observed in patients' pain and the spasticity at the upper extremity joints, one and three-month after the intervention (P < 0.05). This study suggests that body acupuncture can be used as a complementary treatment to improve HAM/TSP neurological symptoms.

Iodine-123-Iomazenil SPECT Revealed Recovery of Neuronal Viability in Association with Improvement in Symptoms Following Treatment for Obstructive Hydrocephalus due to a Giant Posterior Cerebral Artery Aneurysm.

BACKGROUND: Early and late images of 123I-iomazenil (123I-IMZ) single-photon emission computed tomography (SPECT) are considered to show cerebral blood flow and neuronal activity, respectively, and this modality may demonstrate temporal dysfunction of the frontal lobes in obstructive hydrocephalus. In this report, we examined 123I-IMZ SPECT in a patient with chronic obstructive hydrocephalus owing to compression of the aqueduct by a partially thrombosed aneurysm of the left posterior cerebral artery for the first time. CASE DESCRIPTION: A woman aged 77 years presented with progression of cognitive decline, gait disturbance, and urinary incontinence. She had a medical history of epilepsy and subarachnoid hemorrhage due to a ruptured left posterior cerebral artery aneurysm, treated conservatively when she was age 56 years. Magnetic resonance imaging revealed a mass lesion in the pineal region, which showed a target sign with gadolinium-based contrast agents, causing obstructive hydrocephalus owing to compression of the cerebral aqueduct. A right vertebral angiogram confirmed the presence of a partially thrombosed giant aneurysm at the left posterior cerebral artery. To rule out the involvement of nonconvulsive status epilepticus in her pathology, we performed 123I-IMZ SPECT, and both early and late images demonstrated low uptake in the bilateral frontal cortex. After surgical trapping of the parent artery and resection of the aneurysm, hydrocephalus was relieved, and the symptoms disappeared along with improvement in early and late 123I-IMZ SPECT images. CONCLUSIONS: The findings in the present case indicate that 123I-IMZ SPECT can detect reversible cerebral blood flow reduction and neuronal viability in the frontal lobes, which may affect the clinical manifestation of obstructive hydrocephalus.

Outcomes following percutaneous tibial nerve stimulation (PTNS) treatment for neurogenic and idiopathic overactive bladder.

PURPOSE: Percutaneous tibial nerve stimulation is a minimally invasive neuromodulation technique for treating overactive bladder symptoms. The aim of this study was to assess safety, efficacy and impact on quality of life of percutaneous tibial nerve stimulation in neurological patients reporting overactive bladder symptoms. METHODS: In this retrospective evaluation over 18 months at a tertiary healthcare centre, patients finding first-line treatments for overactive bladder ineffective or intolerable underwent a standard 12-week course of percutaneous tibial nerve stimulation (Urgent PC, Uroplasty). Symptoms were evaluated using standardised International Consultation on Incontinence Questionnaires and bladder diaries. RESULTS: Of 74 patients (52 women, 22 men, mean age 56 years), 49 (66.2%) patients had neurological disorder [19 (25.7%) multiple sclerosis and 30 (40.5%) other neurological conditions] and 25 (33.8%) idiopathic overactive bladder. Overall for the entire cohort significant improvements were recorded after 12 weeks in the following domains: 24-h frequency on bladder diary - 1.67 (- 3.0, 0.33) (p = 0.002), number of incontinent episodes on bladder diary - 0.0 (- 1, 0) (p = 0.01), incontinence severity on bladder diary 0 (- 0.33, 0) (p = 0.007), OAB symptoms - 3 (- 11.5, 5) (p = 0.01), and quality of life - 16 (- 57, 6.5) (p = 0.004). There were no significant differences in outcomes between patients with idiopathic and neurogenic overactive bladder. CONCLUSIONS: Percutaneous tibial nerve stimulation appears to be a possible promising alternative for patients with neurological disorder reporting overactive bladder symptoms who find first-line treatments either ineffective or intolerable. However, a properly designed study is required to address safety and efficacy.

The mechanical stop test and isovolumetric detrusor contractile reserve are associated with immediate spontaneous voiding after transurethral resection of prostate.

PURPOSE: To identify urodynamic factors associated with the mechanical stop test and immediate spontaneous voiding following transurethral resection of prostate (TURP). METHODS: We identified 90 men who underwent TURP over a 12-month period. Forty-three (mean age 68 years) underwent urodynamic evaluation prior to TURP. Isovolumetric detrusor contractile pressure (Piso) was obtained using the mechanical stop test during the voiding phase, and used to calculate detrusor contractile reserve (Pres = Piso - Pdet@Qmax). Primary outcome was spontaneous voiding after TURP. RESULTS: Preoperative catheter-free spontaneous voiding was present in 63% of men (27/43) with a urodynamic (mean ± SD): Qmax 6.2 ± 2.7 mL/s, Pdet@Qmax 102 ± 47 cmH2O, Piso 124 ± 49 cmH2O, Pres 22 ± 16 cmH2O, bladder outlet obstruction index (BOOI) 90 ± 49, and bladder contractility index (BCI) 132 ± 44. The remaining 16 catheter-dependent men demonstrated a urodynamic (mean ± SD): Qmax 3.6 ± 3.3 mL/s, Pdet@Qmax 87 ± 38 cmH2O, Piso 99 ± 51 cmH2O, Pres 10 ± 18 cmH2O, BOOI 82 ± 36, and BCI 106 ± 48. Following TURP, 67% of men voided spontaneously with their first void trial, and in receiver operator analysis of urodynamic measures (Pdet@Qmax, Piso, Pres, BOOI and BCI), only Pres was significantly associated with immediate spontaneous voiding after TURP (threshold Pres ≥ 9 cmH2O, AUC = 0.681, p = 0.035). CONCLUSIONS: In men who underwent TURP, a Pres ≥ 9 cmH2O was associated with immediate spontaneous voiding and may be easily incorporated into the postoperative pathway.

Effect of personalized extracorporeal biofeedback device for pelvic floor muscle training on urinary incontinence after robot-assisted radical prostatectomy: A randomized controlled trial.

AIMS: To investigate the effectiveness of a novel personalized extracorporeal biofeedback device (Anykegel) for pelvic floor muscle training (PFMT) on the recovery of postprostatectomy urinary incontinence (PPI) after robot-assisted laparoscopic radical prostatectomy (RARP) through a randomized controlled trial. METHODS: A total of 84 patients who underwent RARP were randomized either to the intervention group (42) (receiving biofeedback-PFMT using a novel device in addition to verbal and written instruction) or to the control group (42). Patients were evaluated 1, 2, and 3 months after surgery. Incontinence severity was measured by the 24-hour pad test. The International Prostate Symptom Score (IPSS) and the International Index of Erectile Function (IIEF-5) questionnaire were also assessed. RESULTS: The intervention group showed a significantly smaller volume of urine loss at the 1-month follow-up than the control group on a 24-hour pad test (71.0 g vs 120.8 g; P = .028). However, from the 2-month follow-up visit, no significant differences were observed between the two groups. In addition, in the 1-month follow-up data of the IPSS-total score, the intervention group demonstrated significantly favorable changes from baseline with improved scores compared to the control group (0.25 ± 9.15 vs -3.81 ± 8.98; P = .046). Regarding the IIEF-5 score changes, no significant differences were reported throughout the study periods. CONCLUSIONS: The personalized extracorporeal biofeedback device for PFMT offers a significant positive effect on the recovery of PPI after RARP, especially in the early postoperative period. Furthermore, patients can be offered more convenience through performing the regular exercise at any place with ease.

Effects of perioperative pelvic floor muscle training on early recovery of urinary continence and erectile function in men undergoing radical prostatectomy: a randomized clinical trial.

AIMS: Radical prostatectomy (RP) can result in urinary incontinence (UI) and erectile dysfunction (ED), which negatively impact quality of life (QoL). This study aimed to evaluate the effects of a perioperative pelvic floor muscle training (PFMT) program versus usual care on early recovery of urinary continence and erectile function after RP. MATERIALS AND METHODS: Of 59 eligible men, 31 were randomly allocated into 2 groups: Group 1 (Control, N=15) received usual post-RP care; and Group 2 (Physical therapy, N=16) received two pre-RP physical therapist-guided PFMT sessions, including exercises and electromyographic biofeedback, and verbal and written instructions to continue PFMT until RP, which was then resumed after urethral catheter removal. The International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) and the 5-item version of the International Index of Erectile Function (IIEF-5) questionnaire were used to evaluate UI and ED, respectively. RESULTS: Demographic characteristics were similar in both groups. Three months after RP, the UI rate was 72.7% and 70.0% in Groups 1 and 2, respectively (P >0.05). The severity and frequency of UI and its impact on QoL were evaluated by the ICIQ-Short Form, with scores of 6.9±6.26 in Group 1 and 7.0±5.12 in Group 2 (P >0.05). The IIEF-5 scores were similar in Groups 1 and 2 (5.73±7.43 vs. 6.70±6.68, respectively) (P >0.05). CONCLUSION: Our pre-RP protocol of two physical therapist-assisted sessions of PFMT plus instructions did not signifi cantly improve urinary continence or erectile function at 3 months after RP.

ELECtric Tibial nerve stimulation to Reduce Incontinence in Care homes: protocol for the ELECTRIC randomised trial.

BACKGROUND: Urinary incontinence (UI) is highly prevalent in nursing and residential care homes (CHs) and profoundly impacts on residents' dignity and quality of life. CHs predominantly use absorbent pads to contain UI rather than actively treat the condition. Transcutaneous posterior tibial nerve stimulation (TPTNS) is a non-invasive, safe and low-cost intervention with demonstrated effectiveness for reducing UI in adults. However, the effectiveness of TPTNS to treat UI in older adults living in CHs is not known. The ELECTRIC trial aims to establish if a programme of TPTNS is a clinically effective treatment for UI in CH residents and investigate the associated costs and consequences. METHODS: This is a pragmatic, multicentre, placebo-controlled, randomised parallel-group trial comparing the effectiveness of TPTNS (target n = 250) with sham stimulation (target n = 250) in reducing volume of UI in CH residents. CH residents (men and women) with self- or staff-reported UI of more than once per week are eligible to take part, including those with cognitive impairment. Outcomes will be measured at 6, 12 and 18 weeks post randomisation using the following measures: 24-h Pad Weight Tests, post void residual urine (bladder scans), Patient Perception of Bladder Condition, Minnesota Toileting Skills Questionnaire and Dementia Quality of Life. Economic evaluation based on a bespoke Resource Use Questionnaire will assess the costs of providing a programme of TPTNS. A concurrent process evaluation will investigate fidelity to the intervention and influencing factors, and qualitative interviews will explore the experiences of TPTNS from the perspective of CH residents, family members, CH staff and managers. DISCUSSION: TPTNS is a non-invasive intervention that has demonstrated effectiveness in reducing UI in adults. The ELECTRIC trial will involve CH staff delivering TPTNS to residents and establish whether TPTNS is more effective than sham stimulation for reducing the volume of UI in CH residents. Should TPTNS be shown to be an effective and acceptable treatment for UI in older adults in CHs, it will provide a safe, low-cost and dignified alternative to the current standard approach of containment and medication. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03248362. Registered on 14 August 2017. ISRCTN, ISRCTN98415244. Registered on 25 April 2018. https://www.isrctn.com/.

Effects of perioperative pelvic floor muscle training on early recovery of urinary continence and erectile function in men undergoing radical prostatectomy: a randomized clinical trial

ABSTRACT Aims: Radical prostatectomy (RP) can result in urinary incontinence (UI) and erectile dysfunction (ED), which negatively impact quality of life (QoL). This study aimed to evaluate the effects of a perioperative pelvic floor muscle training (PFMT) program versus usual care on early recovery of urinary continence and erectile function after RP. Materials and Methods: Of 59 eligible men, 31 were randomly allocated into 2 groups: Group 1 (Control, N=15) received usual post-RP care; and Group 2 (Physical therapy, N=16) received two pre-RP physical therapist-guided PFMT sessions, including exercises and electromyographic biofeedback, and verbal and written instructions to continue PFMT until RP, which was then resumed after urethral catheter removal. The International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) and the 5-item version of the International Index of Erectile Function (IIEF-5) questionnaire were used to evaluate UI and ED, respectively. Results: Demographic characteristics were similar in both groups. Three months after RP, the UI rate was 72.7% and 70.0% in Groups 1 and 2, respectively (P >0.05). The severity and frequency of UI and its impact on QoL were evaluated by the ICIQ-Short Form, with scores of 6.9±6.26 in Group 1 and 7.0±5.12 in Group 2 (P >0.05). The IIEF-5 scores were similar in Groups 1 and 2 (5.73±7.43 vs. 6.70±6.68, respectively) (P >0.05). Conclusion: Our pre-RP protocol of two physical therapist-assisted sessions of PFMT plus instructions did not significantly improve urinary continence or erectile function at 3 months after RP.

Pelvic floor rehabilitation in children with functional LUTD: does it improve outcome?

INTRODUCTION: If children do not experience satisfactory relief of lower urinary tract dysfunction (LUTD) complaints after standard urotherapy is provided, other treatment options need to be explored. To date, little is known about the clinical value of pelvic floor rehabilitation in the treatment of functional voiding disorders. OBJECTIVE: Therefore, we compared pelvic floor rehabilitation by biofeedback with anal balloon expulsion (BABE) to intensive urotherapy in the treatment of children with inadequate pelvic floor control and functional LUTD. STUDY DESIGN: A retrospective chart study was conducted on children with functional incontinence and inadequate pelvic floor control. All children referred for both intensive inpatient urotherapy and pelvic floor rehabilitation between 2010 and 2018 were considered for inclusion. A total of 52 patients were eligible with 25 children in the group who received BABE before inpatient urotherapy, and 27 children in the group who received BABE subsequently to urotherapy. Main outcome measurement was treatment success according to International Children's Continence Society criteria measured after treatment rounds and follow-up. RESULTS: Baseline characteristics demonstrate no major differences between the BABE and control group. There was a significant difference in improvement between BABE and inpatient urotherapy after the first and second round of treatment (round 1: BABE vs urotherapy; 12% vs 70%, respectively, round 2: urotherapy vs BABE; 92% vs 34%, respectively, both P < .001). In both cases, the urotherapy group obtained greater results (Fig. 1). When the additional effect of BABE on urotherapy treatment is assessed, no significant difference is found (P = .355) in the children who received BABE; 30 (58%) showed improvement on pelvic floor control. DISCUSSION: Our findings imply that training pelvic floor control in combination with inpatient urotherapy does not influence treatment effectiveness on incontinence. Intensive urotherapy contains biofeedback by real-time uroflowmetry; children receive direct feedback on their voiding behaviour. Attention offered to the child and achieving cognitive maturity with corresponding behaviour is of paramount importance. It is known that combining several kinds of biofeedback does not enhance the outcome. However, our results do not provide a conclusive answer to the effectiveness of pelvic floor physical therapy in the treatment of children with LUTD because we specifically investigated BABE. CONCLUSION: In this study, we could not prove that pelvic floor rehabilitation by BABE has an additional effect on inpatient urotherapy on incontinence outcomes. Considering the invasive nature of BABE, the use of BABE to obtain continence should therefore be discouraged.

Pelvic floor muscle function and symptoms of dysfunctions in midwifes and nurses of reproductive age with and without pelvic floor dysfunction.

OBJECTIVES: This study aims to compare pelvic floor muscle (PFM) functions in midwifes and nurses of reproductive age with and without pelvic floor dysfunction (PFD) and investigate the relationship between PFM function and the number, type and symptoms of PFDs. MATERIALS AND METHODS: 82 midwifes and nurses of reproductive age with (n = 51) and without PFD (n = 31) participated in the study. PFM function was assessed by digital palpation using PERFECT scale. Gynecological examination, ultrasonography, disease-specific questionnaires, questions and tests were used to assess symptoms of PFD. PFD was assessed in terms of risk factors, urinary incontinence, fecal incontinence, pelvic organ prolapse (POP), pelvic pain and sexual dysfunctions. RESULTS: Power parameter of PERFECT scheme was significantly lower in subjects with PFD compared to Non-PFD group (p = 0.002). 41% of the subjects with Power 5 PFM strength in PFD group were diagnosed as stage 1 POP, 5.8% as stage 2 POP, 15.7% of urge incontinence, 23.3% of stress incontinence and 10.5% of mixed incontinence. Both urinary incontinence and POP were detected in 15.7% of them. Among all subjects, incontinence symptoms decreased whereas POP and sexual function did not change as PFM increased. PFM strength was negatively correlated with the number of PFD (p = 0.002, r = -0.34). The type of dysfunction did not correlate with PFM strength (p > 0.05). CONCLUSION: PFM strength only affects of urinary incontinence sypmtoms among all PFDs in midwifes and nurses of reproductive age. PFM strength may not be the main factor in the occurrence of PFDs as pelvic floor does not consist solely of muscle structure. However, it strongly affects the number of dysfunctions. Therefore, PFM training should be performed to prevent the occurrence of extra dysfunctions in addition to the existing ones even if it does not alter the symptoms.

Efficacy of transcutaneous stimulation of the posterior tibial nerve compared to percutaneous stimulation in idiopathic overactive bladder syndrome: Randomized control trial.

AIM: To evaluate the non-inferiority of the transcutaneous electrical stimulation technique, as compared with the percutaneous therapy (PTNS), regarding the efficacy in symptoms and QoL improvement in patients with overactive bladder (iOAB). METHODS: Patients with overactive detrusor (DO) and persisting symptoms after first-line or second-line treatment were randomized to receive either transcutaneous therapy or PTNS 1 day a week (30 min at 20 Hz and 200 cycles/s) for 12 weeks. Data from a 3-day voiding diary and a self-reported QoL-questionnaire were collected pre-treatment and at week 12. Non-inferiority was analyzed by estimating the mean change (95% confidence interval) of daytime micturition frequency. Statistical significance level was set at P < 0.05. RESULTS: Sixty-eight patients were included (67.6% women), mean age 59.6 years (SD 16.1). According to ITT analysis, daytime frequency decreased in both groups without statistically significant differences between them at the end of the treatment (adjusted difference 0.8; 95%CI; -0.1; 1.7); nor were differences in symptoms improvement for the variables collected through the 3-day voiding diary. Both techniques lessened urgency incontinence episodes by more than 50% and greatly improved the QoL. There were no relevant side effects and overall adherence to the treatment was 89.7%. CONCLUSIONS: This is the first RCT that evaluates the efficacy of the transcutaneous technique compared to the PTNS, and demonstrates non-inferiority in decreasing daytime frequency. Reduction in urgency incontinence episodes and improvement of QoL were also observed. These results and ease of application of transcutaneous neuromodulation may lead to a greater prescribing of this technique.

Effectiveness of neuromuscular electrical stimulation therapy in patients with urinary incontinence after stroke: A randomized sham controlled trial.

BACKGROUND: This study aimed to evaluate the effectiveness of neuromuscular electrical stimulation (NMES) therapy in patients with urinary incontinence after stroke (UIAS). METHODS: A total of 82 patients with UIAS were randomly assigned to 2 groups that received NMES therapy (NMES group) or sham NMES (sham group) for 10 weeks. The primary efficacy endpoints were measured by urodynamic values, and Overactive Bladder Symptom Score (OABSS). The secondary efficacy endpoints were assessed by International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) score, Barthel Index (BI) scale, and adverse events. All outcomes were evaluated at baseline and at the end of 10 weeks treatment. RESULTS: After 10-week treatment, the patients received NMES therapy showed better efficacy in primary endpoints of urodynamic values (P <.01) and OABSS (P <.01), and secondary endpoints of ICIQ-SF (P <.01) and BI (P <.01), compared with patients who underwent sham NMES. No adverse events were recorded in both groups. CONCLUSIONS: In summary, we demonstrated that 10 weeks of NMES therapy was efficacious in patients with UIAS.

Fibrosis and the bladder, implications for function ICI-RS 2017.

AIMS: Most benign bladder pathologies are associated with an increase of extracellular matrix (ECM-fibrosis) and may progress from formation of stiffer matrix to a more compliant structure. The aims were to summarize current knowledge of the origins of bladder fibrosis and consequences in bladder function. METHODS: A meeting at the International Consultation on Incontinence Research Society 2017 congress discussed the above aims and considered paradigms to reduce the extent of fibrosis. Discussants based their arguments on the basis of their own expertise, supplemented by review of the literature through PubMed. Proposals for future work were derived from the discussion. RESULTS: Altered urodynamic compliance when ECM deposition is increased is mirrored by changes in the elastic modulus of isolated tissue, whether compliance is decreased or increased. No changes to compliance or fibrosis have been reported after botulinum toxin injections. Several paracrine and autocrine agents increase ECM deposition, the role of TGF-ß was particularly emphasized. None of these agents has a net long-term effect on detrusor contractility and the reduction of contractile performance with increased ECM is due solely to a loss of detrusor mass. Several strategies to reduce fibrosis were described, ranging from potential therapeutic roles for vitamin-D or endostatin, manipulation of intracellular pathways that mediate myofibroblast differentiation and the potential role of the anti-fibrotic hormone relaxin. An understanding of epigenetic regulation of ECM deposition was also considered. CONCLUSIONS: The conclusion that reduced bladder contractile function with increased fibrosis is due largely to the replacement of detrusor with ECM offers a way forward for future research to consider approaches that will restore bladder function by reducing ECM deposition.

Development of a prediction model for late urinary incontinence, hematuria, pain and voiding frequency among irradiated prostate cancer patients.

BACKGROUND AND PURPOSE: Incontinence, hematuria, voiding frequency and pain during voiding are possible side effects of radiotherapy among patients treated for prostate cancer. The objective of this study was to develop multivariable NTCP models for these side effects. MATERIAL AND METHODS: This prospective cohort study was composed of 243 patients with localized or locally advanced prostate cancer (stage T1-3). Genito-urinary (GU) toxicity was assessed using a standardized follow-up program. The GU toxicity endpoints were scored using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE 3.0) scoring system. The full bladder and different anatomical subregions within the bladder were delineated. A least absolute shrinkage and selection operator (LASSO) logistic regression analysis was used to analyze dose volume effects on the four individual endpoints. RESULTS: In the univariable analysis, urinary incontinence was significantly associated with dose distributions in the trigone (V55-V75, mean). Hematuria was significantly associated with the bladder wall dose (V40-V75, mean), bladder dose (V70-V75), cardiovascular disease and anticoagulants use. Pain during urinating was associated with the dose to the trigone (V50-V75, mean) and with trans transurethral resection of the prostate (TURP). In the final multivariable model urinary incontinence was associated with the mean dose of the trigone. Hematuria was associated with bladder wall dose (V75) and cardiovascular disease, while pain during urinating was associated with trigone dose (V75) and TURP. No significant associations were found for increase in voiding frequency. CONCLUSIONS: Radiation-induced urinary side effects are associated with dose distributions to different organs as risk. Given the dose effect relationships found, decreasing the dose to the trigone and bladder wall may reduce the incidence of incontinence, pain during voiding and hematuria, respectively.

Pelvic floor muscle training increases pelvic floor muscle strength more in post-menopausal women who are not using hormone therapy than in women who are using hormone therapy: a randomised trial.

QUESTION: Are there differences in the effectiveness of pelvic floor muscle training on pelvic floor muscle strength and urinary incontinence symptoms in postmenopausal women who are and are not using hormone therapy? DESIGN: Randomised, controlled trial with concealed allocation, blinded assessors, and intention-to-treat analysis. PARTICIPANTS: Ninety-nine postmenopausal women, 38 of whom were using daily systemic oestrogen/progestogen therapy. INTERVENTION: The experimental group (n=51) received an intensive supervised pelvic floor muscle training protocol, and the control group (n=48) received no intervention. The randomisation was stratified by hormone therapy use. OUTCOME MEASURES: Change in pelvic floor muscle strength assessed with manometry at 12 weeks. Prevalence and severity of urinary incontinence symptoms were assessed using questionnaires. RESULTS: Eighty-eight women provided data that could be included in the analysis. Pelvic floor muscle training increased pelvic floor muscle strength by 8.0 cmH2O (95% CI 3.4 to 12.6) in women not using hormone therapy and by -0.9 cmH20 (95% CI -6.5 to 4.8) in women using hormone therapy (interaction p=0.018). A sensitivity analysis showed that the greater training effect in women who were not using hormone therapy was still apparent if the analysis was conducted on percentage change in strength rather than absolute change in strength. There was also a significantly greater effect of training in women not using hormone therapy on prevalence of urinary incontinence symptoms (ratio of odds ratios=7.4; interaction p=0.028). The difference in effects on severity of urinary incontinence symptoms was not statistically significant (interaction p=0.37). CONCLUSION: Pelvic floor muscle training increases pelvic floor muscle strength more in women who are not using hormone therapy than in women using hormone therapy. TRIAL REGISTRATION: ClinicalTrials.gov NCT02549729. [Ignácio Antônio F, Herbert RD, Bø K, Rosa-e-Silva ACJS, Lara LAS, Franco MdM, Ferreira CHJ (2018) Pelvic floor muscle training increases pelvic floor muscle strength more in post-menopausal women who are not using hormone therapy than in women who are using hormone therapy: a randomised trial. Journal of Physiotherapy 64: 166-171].

The effect of pelvic floor muscle training and intravaginal electrical stimulation on urinary incontinence in women with incomplete spinal cord injury: an investigator-blinded parallel randomized clinical trial.

INTRODUCTION AND HYPOTHESIS: Urinary incontinence is a prevalent problem in women with spinal cord injury. The aim of this study was to examine the effect of pelvic floor muscle training (PFMT) alone and combined with intravaginal electrical stimulation (IVES) on urinary incontinence in women with incomplete spinal cord injury. METHODS: In this investigator-blinded randomized clinical trial, we recruited women aged 18-75 with incomplete spinal cord injury and urinary incontinence from a single spinal cord injury clinic in Denmark. Women were randomly assigned to either PFMT or PFMT combined with IVES daily at home for 12 weeks. All women were trained by a physiotherapist using vaginal palpation and electromyography biofeedback. Outcome measures were recorded at baseline (week 0), post-intervention (week 12) and follow-up (week 24) and included change in the total score on the International Consultation on Incontinence Questionnaire urinary incontinence short form (ICIQ-UI-SF) and daily episodes of urinary incontinence. RESULTS: From 27 April 2015-9 September 2016, we randomly assigned 36 women (17 in the PFMT group and 19 in the PFMT+IVES group); 27 completed the interventions (13 in the PFMT group and 14 in the PFMT+IVES group). The results showed no difference between the groups on ICIQ-UI-SF or episodes of urinary incontinence at 12 and 24 weeks. Only the PFMT group had a significant change from baseline on ICIQ-UI-SF [-2.4 (95% CI -4.3--0.5), p = 0.018] and daily episodes of urinary incontinence [-0.4 (95% CI -0.8--0.1), p = 0.026] at 12 weeks. CONCLUSIONS: PFMT+IVES is not superior to PFMT alone in reducing urinary incontinence in women with incomplete spinal cord injury.