Percutaneous tibial nerve stimulation in the treatment of neurogenic detrusor overactivity in multiple sclerosis patients: a historically controlled study.

Background: Percutaneous tibial nerve stimulation (PTNS) is widely used in the treatment of neurogenic detrusor overactivity (NDO) in multiple sclerosis (MS); however, controlled studies are still lacking.Objective:: To assess effectiveness of PTNS in MS patients with NDO unresponsive to pharmacological and behavioural therapies. Methods: MS patients with NDO were enrolled. Inclusion criteria were NDO not responding to pharmacological and behavioural therapies. Exclusion criteria were the presence of relevant comorbidities and urinary tract infections. Patients were evaluated using 3-day bladder diaries and validated questionnaires at baseline, after 4 weeks of educational therapy and after 12 PTNS sessions. The primary outcome measure was the percentage of patients considered responders after the behavioural therapy and after the PTNS in a historical controlled fashion (definition of 'responder' was reduction ⩾50% of urgency episodes). Results: A total of 33 patients (26 women, 7 men) were enrolled. Two patients dropped out for reasons not related to the protocol. Two out of 31 patients (6.5%) and 21/29 (72.4%) were considered responders at visits 1 and 2, respectively. In PTNS responders, a statistically significant improvement in both bladder diary results and standardized questionnaire scores was recorded, compared with that obtained with behavioural therapy alone. No serious adverse events were reported. Conclusion: This historically controlled study suggests that PTNS may be effective in improving NDO in MS patients.

Ejaculatory function following transperineal laser ablation vs TURP for benign prostatic obstruction: a randomized trial.

OBJECTIVES: To evaluate the reliability of transperineal interstitial laser ablation of the prostate (TPLA) in preserving antegrade ejaculation compared to transurethral resection of the prostate (TURP). PATIENTS AND METHODS: In this single-centre, prospective, randomized, open-label study, consecutive patients with indication for surgical treatment for benign prostatic obstruction (BPO) were enrolled between January 2020 and September 2021 (NCT04781049). Patients were randomized to one of two treatment arms: Group A: TPLA (experimental group) and Group B: TURP (reference standard group). The primary endpoint was change in ejaculatory function (assessed by the Male Sexual Health Questionnaire - Ejaculatory function domain [EJ-MSHQ]) at 1 month after surgery. Secondary endpoints included comparison of visual analogue scale (VAS) scores, changes in sexual function (assessed using the five-item International Index of Erectile Function [IIEF-5]), change in International Prostate Symptom Score [IPSS], change in quality of life score, and maximum urinary flow rate [Qmax ] improvement at 1-6 months, as appropriate. RESULTS: Fifty-one patients (26 TPLA vs 25 TURP) were analysed. No differences in the perception of pain assessed by VAS and no differences in IIEF-5 score were found between the groups. The distribution of ejaculatory function assessed by the EJ-MSHQ remained unmodified after TPLA (P = 0.2), while a median 30% decrease in EJ-MSHQ score was observed after TURP (P = 0.01). Absence of antegrade ejaculation was reported in one patient in the TPLA group (vs 18 patients in the TURP group). A statistically significant difference between the treatment groups was found in terms of postoperative Qmax (TPLA vs TURP: 15.2 [interquartile range 13.5-18.3] mL/s vs 26.0 [interquartile range 22.0-48.0] mL/s; P < 0.001). Both treatments significantly improved Qmax , with a mean 23.9 mL/s improvement after TURP (95% confidence interval [CI] 17.1-30.7) vs 6.0 mL/s after TPLA (95% CI 5.0-7.0), and IPSS, with a mean decrease of 11.6 (95% CI 9.7-13.5) vs 5.8 after TPLA (95% CI.2-9.6) with respect to baseline. CONCLUSION: In our study, TPLA preserved ejaculatory function in 96% of cases in addition to providing significant relief from BPO.

The efficacy of a suppository based on Phenolmicin P3 and Bosexil (Mictalase®) in control of irritative symptoms in patients undergoing thulium laser enucleation of prostate: a single-center, randomized, controlled, open label, phase III study.

BACKGROUND: Several studies described post-operative irritative symptoms after laser enucleation of prostate, sometimes associated with urge incontinence, probably linked to laser-induced prostatic capsule irritation, and potential for lower urinary tract infections We aimed to evaluate the efficacy of a suppository based on Phenolmicin P3 and Bosexil (Mictalase®) in control of irritative symptoms in patients undergoing thulium laser enucleation of prostate (ThuLEP). METHODS: In this single-center, prospective, randomized, open label, phase-III study, patients with indication to ThuLEP were enrolled (Dec2019-Feb2021-Institutional ethics committee STS CE Lazio approval no.1/N-726-ClinicalTrials.gov NCT05130918). The report conformed to CONSORT 2010 guidelines. Eligible patients were 1:1 randomized. Randomization defined Group A: patients who were administered Mictalase® suppositories twice a day for 5 days, then once a day for other 10 days; Group B: patients who did not receive Mictalase® ("controls"). Study endpoints were evaluated at 15 and 30 days postoperation. Primary endpoint included evaluation of effects of the suppository on irritative symptoms by administering IPSS + QoL questionnaire. Secondary endpoint included evaluation of effects on urinary tract infections by performance of urinalysis with urine culture. RESULTS: 111 patients were randomized: 56 in Group A received Mictalase®. Baseline and perioperative data were comparable. At 15-days, no significant differences were found in terms of IPSS + QoL scores and urinalysis parameters. A significant difference in the rate of positive urine cultures favored Group A (p = 0.04). At 30-days follow-up, significant differences were found in median IPSS score (6 [IQR 3-11] versus 10 [5-13], Group A vs B, respectively, p = 0.02). Urinalysis parameters and rate of positive urine cultures were not significantly different. CONCLUSIONS: The present randomized trial investigated the efficacy of Mictalase® in control of irritative symptoms and prevention of lower urinary tract infections in patients undergoing ThuLEP. IPSS improvement 30-days postoperation was more pronounced in patients who received Mictalase®. Lower rate of positive urine culture favored Mictalase® group 15-days postoperatively. TRIAL REGISTRATION: The clinical trial has been registered on ClinicalTrials.gov on November 23rd, 2021-Registration number NCT05130918.

Is thulium laser vapoenucleation of the prostate equally safe and effective in elderly patients? A propensity score matched analysis of early perioperative and functional outcomes.

PURPOSE: To evaluate if thulium laser vapoenucleation of the prostate (ThuVEP) is equally safe and effective in a selected cohort of elderly patients when compared to "younger" patients. MATERIALS AND METHODS: We performed a retrospective analysis of consecutive patients who underwent ThuVEP between September 2018 and February 2020. After application of the inclusion/exclusion criteria, patients were stratified according to the 75 years-old cut-off point suggested by the WHO. Group A included patients ≤75 years-old; Group B included patients >75 years-old. Preoperative assessment included urological consultation, prostate specific antigen (PSA), International Prostate Symptom Score (IPSS) and quality of life index, transrectal ultrasound to estimate prostate volume (PVol), and uroflowmetry to assess preoperative Qmax, Qave and post-void residual volume (PVR). Perioperative and postoperative data were analyzed during 3-month follow-up. RESULTS: After propensity-score analysis, 51 versus 51 patients were 1:1 matched according to PVol, PSA, Qmax, IPSS and QoL. Patients were comparable at baseline excluding age (65 (IQR 59-70) versus 79 (IQR 77-82) years, Group A versus B, respectively, P-value <.001). No differences were found in terms of hemoglobin drop, complications rate, catheterization time and length of hospital stay. Group A (younger) patients had more significant improvement in 30-days absolute Qmax, Qave and ΔQmax. At 90-days follow-up, the differences between the groups disappeared. Within the 90-days follow-up, no significant differences were found in the readmission rate, with no need of reinterventions. CONCLUSIONS: In our hands, even in elderly patients affected by BPH, ThuVEP appears to be a safe and effective treatment option.

Real-life data on long-term follow-up of patients successfully treated with percutaneous tibial nerve stimulation.

BACKGROUND: The aim of this cross-sectional study is to evaluate the "real-life" data of patients following successful treatment with PTNS for overactive bladder syndrome (OAB) or non-obstructive voiding dysfunction (NOVD) at a seven-year follow-up after the procedure. METHODS: Patients who were successfully treated with PTNS for OAB or NOVD between February 2008 and January 2009 were contacted for a telephonic interview seven years after the end of their PTNS stimulation protocol. Patients who agreed to the interview were asked to complete a global response assessment (GRA). Patients in the OAB category completed the OAB short-form questionnaire Symptom Bother Scale (OAB-q SF) and the OAB Health-Related Quality of Life Scale (OAB HRQL), and NOVD patients were evaluated using the International Prostate Symptom Score - voiding questions (v-IPSS). Results of both questionnaires were compared with those obtained seven years previously, at the time of the initial PTNS treatment. RESULTS: Seventeen patients were identified in our database. Sixteen agreed to the interview, but the remaining patient was unreachable and was therefore considered as lost at follow-up. Eight patients were classified into the OAB group, and eight were classified into the NOVD group. No patient reported a worsening condition after PTNS. Six of the eight patients (75%) in the OAB group gave positive responses in the GRA. All patients in the NOVD group gave positive responses in the GRA. CONCLUSIONS: Despite some limitations, this study shows that the majority of patients who responded to PTNS considered themselves still improved at a seven-year follow-up. Larger studies are needed to confirm our results, but our study has the novel advantage of showing data derived from "real life" over the longest follow-up yet considered in the literature.

Robot-assisted re-do sacrohysteropexy after anterior abdominal wall hysteropexy.

INTRODUCTION AND HYPOTHESIS: We report the case of a 49-year-old woman who came to our institution complaining of bowel constipation and bladder outlet obstruction due to the recurrence of a pelvic prolapse after anterior abdominal wall hysteropexy performed 1 year before. METHODS: The patient was counseled to undergo robot-assisted re-do sacrohysteropexy performed using the da Vinci Xi surgical system. The step-by-step technique used for the herein reported clinical case of robot-assisted re-do sacrohysteropexy is shown in the accompanying video. RESULTS: Operative time was 120 min. There was virtually no blood loss. No intraoperative complications occurred. Use of analgesic drugs was stopped on the 1st postoperative day. The patient was mobilized on postoperative day 2. The catheter was removed on the 3rd postoperative day, and the patient got back to spontaneous micturition with no post-voiding residual. On the same day, the patient was discharged. At 3-month follow-up, the patient was well with neither bowel nor bladder symptoms. Uroflowmetry was normal. CONCLUSION: We demonstrated the feasibility of robot-assisted re-do sacrohysteropexy. In the surgical technique herein reported, we showed how we were able to partially re-use a previously implanted mesh together with a new one to ensure fixation of a multi-compartment pelvic organ prolapse.

Rotigotine Effects on Bladder Function in Patients with Parkinson's Disease.

BACKGROUND: The objective of this study was to assess the effect of rotigotine treatment on bladder function in patients with Parkinson's disease (PD) who have urinary urgency. METHODS: in total, 20 patients with PD underwent urodynamic evaluation and completed International Prostate Symptoms questionnaires in off-rotigotine condition and after 3 months of rotigotine patch monotherapy administration. In both sessions, clinical motor condition was evaluated with the Unified Parkinson Disease Rating Scale, Part III (motor part). RESULTS: Rotigotine administration significantly ameliorated the first sensation of bladder filling, the neurogenic detrusor overactive contractions threshold and bladder capacity compared with the off-treatment condition. Moreover, the total score on the International Prostate Symptoms questionnaire revealed a decrease of filling (irritative) symptoms after rotigotine treatment compared with the off-treatment condition. CONCLUSION: The positive effects of rotigotine may be due to its balanced agonism to D1 and D2 receptors and in particular to its stimulation of D1 receptors in the anterior cingulate cortex and insula, which are known as areas involved in bladder-inhibitory functions.

[What to do if percutaneous tibial nerve stimulation (PTNS) works? A pilot study on home-based transcutaneous tibial nerve stimulation]. / Che fare se l'elettrostimolazione percutanea del nervo tibiale funziona? Studio pilota sull'elettrostimolazione trans- dermica domiciliare del nervo tibiale.

INTRODUCTION: Aim of this pilot study was to assess the feasibility of a home-based transcutaneous tibial nerve stimulation (TTNS) protocol in patients responding to percutaneous tibial nerve stimulation (PTNS ). MATERIALS AND METHODS: 16 overactive bladder syndrome (OAB) patients, responding to PTNS, were included. Patients performed a flexible home protocol of TTNS. Satisfied patients were considered "subjective responders"; patients not showing a ≥10% increase of urgency/urgency incontinence episodes/day were considered "objective responders". RESULTS: 14/16 patients were followed up for a mean of 19.7 months. All patients were considered subjective responders; 13 were considered objective responders. The mean number of stimulations/week was 1.6 (1-3). CONCLUSIONS: After this pilot study, it is possible to conclude that home-based TTNS is feasible. Nevertheless, further randomized trials are needed before drawing any conclusions.

Percutaneous tibial nerve stimulation effects on detrusor overactivity incontinence are not due to a placebo effect: a randomized, double-blind, placebo controlled trial.

PURPOSE: This is a prospective, double-blind, placebo controlled study, based on an original placebo technique, performed to evaluate the efficacy of percutaneous tibial nerve stimulation in female patients with detrusor overactivity incontinence. MATERIALS AND METHODS: A total of 35 female patients presenting with detrusor overactivity incontinence that did not respond to antimuscarinic therapy were randomly assigned to percutaneous tibial nerve stimulation or to a control group. The percutaneous tibial nerve stimulation group (18 patients) was treated with 12 percutaneous tibial nerve stimulation sessions. The control group (17 patients) received an original placebo treatment using a 34 gauge needle placed in the medial part of the gastrocnemius muscle. The sessions lasted for 30 minutes and were performed 3 times weekly as percutaneous tibial nerve stimulation sessions. All patients were evaluated with bladder diaries as well as quality of life scores before and after treatment. Patients showing a reduction in urge incontinence episodes greater than 50% were considered responders. RESULTS: Some patients (1 in the percutaneous tibial nerve stimulation group and 2 in the placebo group) did not complete the study for reasons not related to the technique. Of 17 patients in the percutaneous tibial nerve stimulation group 12 (71%) and of 15 in placebo group 0 were considered responders according to the previously reported definition (p <0.001). Improvement in the number of incontinence episodes, number of voids, voided volume and incontinence quality of life score were statistically significant in the percutaneous tibial nerve stimulation group but not in the placebo group. CONCLUSIONS: Percutaneous tibial nerve stimulation can be considered an effective treatment for detrusor overactivity incontinence with 71% of patients considered responders, while none of those treated with placebo was considered a responder. The relevance of a placebo effect seems to be negligible in this patient population.

Effects of inhibitory rTMS on bladder function in Parkinson's disease patients.

Patients affected by Parkinson's disease (PD) may present with lower urinary tract (LUT) dysfunction characterized by involuntary detrusor overactivity. We evaluated possible impact of a 2-week course of low frequency 1 Hz repetitive transcranial magnetic stimulation (rTMS) on LUT behavior in eight advanced PD patients complaining of urinary disturbances. We tested the effects of rTMS measuring urodynamic examination and the International Prostate Symptoms Score (IPSS) questionnaire, used for evaluation of subjective LUTS. rTMS was able to improve temporarily LUT behavior in PD patients, increasing bladder capacity and the first sensation of filling phase. Moreover, a reduction of IPSS score was noticed, due to an improvement on filling phase symptoms. The beneficial effects assessed with the IPSS lasted for up to 2 weeks after the end of the stimulation. rTMS seems to be an effective, noninvasive alternative treatment for PD patients with urinary disturbances.

Percutaneous tibial nerve stimulation produces effects on brain activity: study on the modifications of the long latency somatosensory evoked potentials.

OBJECTIVE: Long-latency somatosensory evoked potentials (LL-SEP) provide information on the function of somatosensory cortical structures. Percutaneous tibial nerve stimulation (PTNS) is indicated in the treatment of lower urinary tract dysfunction. Aim of this study was to evaluate LL-SEP in patients with overactive bladder syndrome (OAB) treated by means of PTNS. METHODS: Sixteen female patients with a diagnosis of pharmacoresistant OAB underwent PTNS while eight female patients with the same diagnosis underwent sham stimulation. LL-SEP were performed at baseline and at the end of PTNS or sham stimulation. Peak latency and peak to peak amplitude of P80, P100, and P200 waves were measured. RESULTS: Mean latency of P80, P100, and P200 and mean amplitude of P200 did not show any significant change after both stimulation. Mean amplitude of P80 and P100 waves increased significantly after PTNS while it did not vary after sham stimulation. CONCLUSION: The P80 and P100 amplitude increase might reflect long-term modifications in synaptic efficiency through the somatosensory pathway. The plastic reorganization of cortical network triggered by peripheral neuromodulation can be hypothesized as a mechanism of action of PTNS. Further studies are needed to correlate LL-SEP modifications after PTNS with the success of the treatment.

Central acute D2 stimulation worsens bladder function in patients with mild Parkinson's disease.

PURPOSE: The different roles of D1 and D2 dopamine receptors in LUT behavior have been demonstrated in animal studies. In particular D2 selective agonists and D1 selective antagonists seem to produce a reduction of the bladder capacity in conscious rats. This finding has never been confirmed in human studies. Thus, in this study we investigated the role of D1 and D2 agonists/antagonists on LUT behavior in patients with PD. MATERIALS AND METHODS: A total of 87 patients with mild PD were evaluated. Patients were evaluated with urodynamic studies (cystometry followed by a pressure flow study with perineal floor electromyography) performed in off status and after oral administration of 250 mg of LD. In 70 patients a third urodynamic evaluation was conducted in one of the following conditions: after simultaneous administration of 250 mg oral LD and 60 or 120 mg oral domperidone (D2 peripheral antagonist); after simultaneous administration of 250 mg oral LD and 25, 50 or 150 mg intramuscular L-sulpiride (D2 central and peripheral antagonist). Several urodynamic parameters were evaluated and results obtained in different conditions compared. RESULTS: LD alone worsened detrusor overactivity: in particular, a reduction of first urinary sensation, involuntary detrusor contraction threshold (reflex volume) and bladder capacity was observed. L-sulpiride (central and peripheral D2 antagonist) coadministration counteracted the worsening in a dose dependent manner. Domperidone (peripheral D2 antagonist) coadministration failed to determine the same counteraction. CONCLUSIONS: According to our results, a central acute D2 stimulation seems to be responsible of a reduction of bladder capacity with worsening of detrusor overactivity in patients with mild PD.

Percutaneous tibial nerve stimulation in the treatment of overactive bladder: urodynamic data.

AIM: The aim of this study was to evaluate urodynamic changes after percutaneous tibial nerve stimulation (PTNS) for the treatment of complaints related to overactive bladder syndrome and to search for urodynamic-based predictive factors. METHODS: Ninety consecutive patients with symptoms related to overactive bladder syndrome were enrolled in this study. Patients underwent 12 PTNS sessions. For evaluating objective success, the primary outcome measure was a reduction in number of urinary leakage episodes of 50% or more per 24 hours. Patients' request for continuation of therapy was considered subjective success. This study focussed on urodynamic features at baseline and on changes found after 12 PTNS treatments. RESULTS: The objective success rate was 56% (leakages/24 hours). Subjective success rate was 64%. Frequency/volume chart data and quality of life scores improved significantly (P < 0.01). Pre- and posturodynamic data were available from 46 participants. Detrusor instabilities (DI) could be abolished in a few cases only. Increments in cystometric bladder capacity and in volume at DI were significant (P = 0.043 and 0.012, respectively). Subjects without detrusor instabilities at baseline were 1.7 times more prone to respond to PTNS (odds ratio, 1.75; 95% confidence interval [CI], 0.67-4.6). The more the bladder overactivity was pronounced, the less these patients were found to respond to PTNS, the area under the receiver operating curve was 0.644 (95% CI, 0.48-0.804). CONCLUSION: PTNS could not abolish DI. PTNS increased cystometric capacity and delayed the onset of DI. Cystometry seemed useful to select good candidates: patients without DI or with late DI onset proved to be the best candidates for PTNS.

Effects of subthalamic nucleus stimulation on urodynamic findings in patients with Parkinson's disease.

PURPOSE: Although the effects of subthalamic nucleus stimulation on the control of motor symptoms in patients with Parkinson's disease have been demonstrated, to our knowledge there are no data on effects of this treatment on voiding. We evaluated differences in urodynamic findings in patients with Parkinson's disease during on and off subthalamic nucleus stimulation status. MATERIALS AND METHODS: We evaluated 3 males and 2 females with Parkinson's disease. All patients had undergone surgical bilateral implantation of subthalamic nucleus electrodes 4 to 9 months before our observation. Urodynamic evaluation was performed during chronic subthalamic nucleus stimulation and 30 minutes after turning off the stimulators. Certain parameters were evaluated, including bladder compliance and capacity, first desire to void volume, bladder volume of appearance (reflex volume) and amplitude of detrusor hyperreflexic contractions, maximum flow, detrusor pressure at maximum flow and detrusor-sphincter coordination. Results were compared statistically. RESULTS: Statistically significant differences in urodynamic data obtained during on and off subthalamic nucleus stimulation status were noted. In particular bladder capacity and reflex volume were increased for on status (median 320 versus 130 ml., p = 0.043 and 250 versus 110, p = 0.043, respectively). The amplitude of detrusor hyperreflexic contractions was decreased for on status but the difference was not significant (median 23 versus 37 cm. H2O, p = 0.223). No differences were noted in the other urodynamic parameters considered during the filling and voiding phases. CONCLUSIONS: Our experience shows that subthalamic nucleus stimulation seems to be effective for decreasing detrusor hyperreflexia in Parkinson's disease cases. This finding confirms a role for basal ganglia in voiding control.

Posterior tibial nerve stimulation in the treatment of idiopathic nonobstructive voiding dysfunction.

OBJECTIVES: To evaluate the effect of stimulation of the posterior tibial nerve in the treatment of voiding dysfunction. METHODS: Thirty-nine patients with chronic voiding dysfunction necessitating clean intermittent catheterization were enrolled in a prospective multicenter trial in the Netherlands (n = 19) and Italy (n = 20). They underwent 12 weekly sessions of posterior tibial nerve stimulation. Frequency/volume charts, an incontinence quality-of-life instrument, and the MOS 36-item Short-Form Health Survey were completed at 0 and 12 weeks. Subjective success was defined by the patient's positive response resulting in a request to continue treatment. Efficacy was based on analysis of the frequency/volume charts comparing the baseline values with the data at 12 weeks. A reduction of 50% or more in total catheterized volume was considered as an objective success (primary outcome measurement). RESULTS: Of the 39 patients, 23 (59%) chose to continue treatment. The frequency/volume charts showed a 50% decrease in total catheterized volume in 16 (41%) of 39 patients. Additionally, 10 patients (26%) noted a reduction of 25% to 50% in their total catheterized volume. For all patients, the total catheterized volume decreased by a mean of -228 mL (range -49 to -528). The incontinence quality-of-life instrument and Short-Form Health Survey parameters improved significantly. CONCLUSIONS: Percutaneous stimulation of the posterior tibial nerve seems to be an effective, minimally invasive option worth trying in patients with idiopathic voiding dysfunction. Improvement was seen in objective micturition parameters, as well as in subjective quality-of-life data.

Posterior tibial nerve stimulation in the treatment of urge incontinence.

AIMS: The objective of this study was to evaluate the effect of posterior tibial nerve stimulation (PTNS) for treatment of urge incontinence. METHODS: In a prospective multicentre study, 35 patients with complaints of urge incontinence underwent 12 weekly sessions of PTNS at one of five sites in the Netherlands and one site in Italy. Frequency/volume charts and I-QoL and SF-36 questionnaires were completed at 0 and 12 weeks. Success was analysed by using subjective and objective criteria. Overall subjective success was defined as the willingness to continue treatment, whereas objective success was defined as a significant decrease (to<50%) in total number of leakage episodes. RESULTS: Twenty-two patients (63%) reported a subjective success. Twenty-four patients (70%) showed a 50% or greater reduction in total number of leakage episodes. Sixteen (46%) of these-patients were completely cured (i.e., no leakage episodes) after 12 sessions. Quality of life parameters improved significantly. CONCLUSIONS: We conclude that posterior tibial nerve stimulation is an effective, minimally invasive option for treatment of patients with complaints of urge incontinence, as improvement was seen in subjective as well as objective parameters.