Symptom Assessment of Candidates for Sacral Neuromodulation Therapy With Urologic and Colorectal Conditions: Time for a Holistic Approach? Results and Findings From a Prospective Single-Center Study.

OBJECTIVES: Sacral neuromodulation (SNM) has evolved as a therapeutic intervention for various pelvic floor dysfunctions. However, the traditional approach primarily assesses discipline-specific symptoms, potentially overlooking holistic symptom improvement. We aimed to investigate whether a more comprehensive evaluation of pelvic floor symptoms enhances the assessment of SNM's test phase. MATERIAL AND METHODS: A prospective single-center trial (Optimization of Lower Urinary Tract Symptoms study) assessed SNM efficacy from March 2018 to December 2021 in patients from the urology department (UD) and colorectal surgery department (CRD) with a follow-up of 12 months. Objective and subjective outcomes were examined using diaries and patient-reported outcome measures. Statistical analyses were conducted to determine predictive factors for treatment success, expressed by the patient global impression of change. SPSS 29.0 was used. RESULTS: A total of 85 participants were included, displaying concomitant pelvic floor symptoms. After the first phase, significant improvements on all pelvic floor domains questionnaires were seen for both patients from UD and those from CRD. Although improvements were observed in bladder and bowel diaries, the traditional criteria for success (≥50% improvement in diary variables) did not consistently correlate with the patients' global impression of change. The absolute reductions in bother sum scores from multiple domains were significant predictors for the patients' global impression of change, outperforming discipline-specific assessments. Patients from UD benefit from both a urologic and pelvic pain symptom evaluation, and those from CRD, from both a urologic and bowel symptom evaluation. CONCLUSIONS: SNM shows positive effects across various pelvic floor domains, even beyond the primary intended indication of implantation. The rather rigid approach of patient selection of discipline-specific symptoms alone can be questioned. A more comprehensive evaluation encompassing various pelvic floor symptoms with the emphasis on subjective outcome measures could enhance SNM's efficacy assessment during the test phase. CLINICAL TRIAL REGISTRATION: The Clinicaltrials.gov registration number for the study is NCT05313984.

Nocturia through the menopausal transition and beyond: a narrative review.

INTRODUCTION AND HYPOTHESIS: Nocturia, defined as the act of waking to pass urine during sleeping, is a common problem in older women and is associated with significant morbidity and impairments in health-related quality of life. The aim of this review was to synthesize the current evidence regarding the incidence, impact, pathophysiology, and specific diagnostic approach of nocturia in the postmenopausal population. METHODS: We searched PubMed and Web of Science databases to identify relevant studies published through June 2020. Reference lists of the reviews obtained were screened for other articles deemed pertinent by the authors. RESULTS: Genitourinary symptoms attributed to the menopause have been reported to occur in nearly 90% of postmenopausal women, and nocturia is one of the most common. The relative deficiency in endogenous estrogen production after the menopause is thought to exacerbate all major pathophysiological mechanisms that may underlie nocturia, including reduced bladder capacity, nocturnal polyuria, global polyuria, and sleep disorders. Diminished estrogen may induce anatomical and physiological bladder changes, contributing to a reduction in functional bladder capacity. Excess nocturnal urine production can also be provoked by estrogen depletion, either via free water-predominant diuresis by an impaired secretion of antidiuretic hormone, or a salt-predominant diuresis owing to diminished activation of the renin-angiotensin-aldosterone axis. Additionally, a relationship between the transition to menopause and impaired sleep has been described, mediated by increased incidence in vasomotor symptoms and obstructive sleep apnea signs during the menopause. CONCLUSION: Further research is necessary to better characterize and manage nocturia in postmenopausal women.

Primary care providers' knowledge about the therapeutic management of refractory pelvic floor dysfunctions in Flanders, Belgium: a cross-sectional study.

BACKGROUND: Pelvic floor dysfunctions (PFD) are prevalent conditions in primary care practice. Basic knowledge of second-line therapies among primary care providers (PCPs) is indispensable to well-inform refractory patients and improve their access to specialized care. OBJECTIVES: Getting insight into the extent of knowledge about second-line therapies for refractory PFD among PCPs in Flanders, Belgium. METHODS: From January to March 2019 Flemish PCPs participated in the OptiLUTS trial - Part A (EC/2018/0244), by the completion of a 22-item online Dutch questionnaire. Prevalence of PCPs having awareness about sacral neuromodulation (SNM), intradetrusor botulinum toxin injections (BTX) and percutaneous tibial nerve stimulation (PTNS) was explored. Descriptive statistics, univariate analyses, and multiple logistic regression analyses were performed. RESULTS: Sixty PCPs, 55% GPs, 45% GP trainees, median age 29 years, participated. Respectively, 90, 73 and 5% had ever heard about BTX, SNM and PTNS. The profession was an independent predictive factor for never having heard of SNM therapy, GPs being more likely to have a lack of knowledge than trainees (OR = 29, 95%CI [1.9-442.5]). Ninety-three percent want to learn more about these therapies. CONCLUSION: There is a margin for improvement in the knowledge of PCPs regarding therapies for refractory PFD. Awareness among PCPs should be increased for the optimization of patient care.

Development of a flowchart reflecting the current attitude and approach towards idiopathic overactive bladder treatment in Belgium: A Delphi study.

AIMS: Idiopathic overactive bladder syndrome (iOAB) is a prevalent condition in urological practice. The variability in management between specialists and between centers remains high. Even existing guidelines contain inconsistencies. We aimed to develop a treatment algorithm for iOAB for use in daily clinical practice. METHODS: From October 2018 till November 2019, a Delphi study was conducted to obtain expert consensus on the management of iOAB. Members from the Belgian Working Group of Functional Urology were asked to rate online statements, based on gaps and variabilities between the American Urology Association (AUA), European Association of Urology (EAU) and International Consultation on Incontinence (ICI) guidelines on iOAB. The consensus was reached if ≥75% of the panel agreed on the level of appropriateness. Two Delphi rounds and an open discussion session were held. RESULTS: Twenty out of 49 members completed the first round and 18 completed the second round. The consensus was reached on 44/143 statements and 15/56 statements in the first and second round, respectively. The consensus was reached on criteria by which to phenotype OAB patients, the terminology relating to the first-, second- and third-line treatment, the duration of therapies, the chronological order, and the choice between therapies. No consensus was reached on the role of percutaneous tibial nerve stimulation (PTNS) in the treatment algorithm. CONCLUSIONS: A flowchart reflecting the current attitude and approach of a Delphi expert panel towards the treatment of iOAB was developed. We propose its use in daily clinical practice to increase the standardization of OAB treatment.

Clinical efficacy of transcutaneous tibial nerve stimulation (TTNS) versus sham therapy (part I) and TTNS versus percutaneous tibial nerve stimulation (PTNS) (part II) on the short term in children with the idiopathic overactive bladder syndrome: protocol for part I of the twofold double-blinded randomized controlled TaPaS trial.

BACKGROUND: Transcutaneous tibial nerve stimulation (TTNS) and percutaneous tibial nerve stimulation (PTNS) are effective and safe therapies for overactive bladder (OAB) syndrome in adults. However, few randomized sham-controlled trials have been conducted in a pediatric population. To our knowledge, both therapies never have been compared in children. AIM: The aim of the complete study is twofold: (1) to assess the efficacy of TTNS therapy on bladder symptoms after 12 weeks of treatment in a pediatric population with idiopathic overactive bladder syndrome (iOAB) and/or nocturnal enuresis (part I) and (2) to assess the effect of TTNS compared to PTNS (part II). In this article, we aim to present the protocol of the first part of the TaPaS trial (TTNS, PTNS, sham therapy). METHODS: Part I of the TaPaS trial is set up as a single-center randomized-controlled trial. Children, aged from 5 to 12 years with iOAB and/or nocturnal enuresis, are assigned to two groups by computer-generated randomization: TTNS therapy (intervention) and sham therapy (control). The primary outcome is the percentage difference in average voided volume (AVV) between baseline and after 12 weeks of treatment. Secondary endpoints are the percentage difference in supervoid volumes, number of urinary incontinence episodes/24 h and in voiding frequency, the difference in parent reported outcomes between baseline and after 12 weeks of treatment, and the duration of clinical response. DISCUSSION: We hypothesize that TTNS is a non-inferior treatment for iOAB in children compared to PTNS therapy. Since literature is inconclusive about the efficacy of TTNS in a pediatric population, a sham-controlled RCT on TTNS will be conducted (part I). A protocol for a prospective randomized sham-controlled trial has been developed. Enrolment has started in November 2018. Study completion of part I is expected by August 2021. TRIAL REGISTRATION: ClinicalTrials.gov NCT04256876 . Retrospectively registered on February 5, 2020.

Characterizing nocturia among Belgian healthy postmenopausal women: Prevalence, degree of bother, etiology and risk factors for nocturia.

INTRODUCTION: Limited literature concerning nocturia in early postmenopausal women is available. However, due to the lack of endogenous estrogen in these women, an increased prevalence of nocturia is expected. MATERIAL AND METHODS: This prospective observational trial recruited 210 'early' postmenopausal women consulting the Ghent University menopause clinic. Postmenopausal status was biochemically confirmed. Women completed 3 questionnaires: the ICI questionnaire on nocturia (ICIQ-N); 'Targeting the individual's Aetiology of Nocturia to Guide Outcomes' (TANGO) and the Perceived Stress Scale (PSS). Moreover, information concerning women's age, anthropometrics and lifestyle was collected. Nocturia was defined as two or more nocturnal voids. RESULTS: Nocturia was reported in 24.8% (52/210) of the postmenopausal women. Bother increased with every nocturnal void. Women with two or more nighttime voids were found to have significantly increased prevalence of urgency compared with women with only one (p < 0.001; 38.5% versus 22.7%). Trouble initiating sleep at the start of the night and insomnia during the night were significantly different in women with a different nocturnal frequency (initiating sleep p = 0.09, no voids 34.4 %, 1 void 39.2 %, ≥ 2 voids 53.8 %; insomnia p < 0.001; no voids 1.6%, 1 void 22.7 %, ≥ 2 voids 53.8 %). In addition to bladder and sleep dysfunctions, waist circumference was a risk factor for nocturia (OR 1.04; 95 % CI: 1.01-1.08). CONCLUSION: Nocturia is an important problem in early postmenopausal women, affecting a quarter of the questioned women. Etiology of nocturia in this population is multifactorial as estrogen withdrawal is accompanied by bladder and sleep dysfunctions.

Hormone therapy as a possible solution for postmenopausal women with nocturia: results of a pilot trial.

OBJECTIVE: To observe the impact of different hormonal treatment options on nocturia, its causative factors and bother in postmenopausal women. METHODS: This prospective study recruited 245 postmenopausal women and divided them into four treatment groups based on patient's choice: Estrogen + Progesterone (E+P), Estrogen-only in patients with a prior hysterectomy, tissue-selective estrogen complex (TSEC) and no treatment. Nocturia and its causative factors were observed using two standardized questionnaires before and after treatment: the International Consultation on Incontinence Questionnaire Nocturia Module and the Targeting the individual's Aetiology of Nocturia to Guide Outcomes (TANGO). The results of the Targeting the individual's Aetiology of Nocturia to Guide Outcomes were divided in four influencing topics of which the sum score was calculated. RESULTS: A significant reduction in prevalence of nocturia ≥ twice per night was seen after treatment, as the prevalence decreased from 27.7% (59/213) to 16.4% (35/213). Specified per therapy, a significant reduction in nocturnal voiding frequency was observed in patients treated with E+P and TSEC (P = 0.018 and P = 0.018, respectively). This improvement could be explained by a significant reduction in SLEEP sum score in patients treated with E+P and TSEC (P < 0.001, P = 0.013, respectively). Estrogen-only led to a significant change in URINARY TRACT sum score, which is the result of a reduction in urgency prevalence (P = 0.039). CONCLUSIONS: E+P and TSEC treatment led to a significant reduction in nocturia prevalence and bother in women with ≥ 2 nocturnal voids. This effect is mainly the result of improvement in sleep disorders, however an improvement in bladder disorders can be suggested as well. More research is necessary to confirm these findings.

Video Summary:http://links.lww.com/MENO/A710 .

The OptiLUTS trial: improving care for therapy-resistant symptoms of the pelvis in Belgium.

INTRODUCTION/BACKGROUND: The management of therapy-resistant lower urinary tract symptoms (LUTS) and symptoms resulting from pelvic organ dysfunctions are subject to a high variability in the Belgian health-care centres. Practical guidelines and standardized patient clinical care pathways are often lacking and unadapted to the Belgian healthcare system. OBJECTIVES: The OptiLUTS trial aims to improve the multidisciplinary care of therapy-resistant symptoms of the pelvis in the Belgian healthcare setting. Project A aims for the improvement of knowledge of 2nd line treatments for LUTS among general practitioners. In project B a treatment algorithm for the overactive bladder syndrome and non-obstructive urinary retention will be developed specifically for Belgium. In Project C a patient customized sacral neuromodulation (SNM) care pathway will be set up. METHODS: Part A: Explorative study among general practitioners by distribution of a  questionnaire. Part B: Review of existing guidelines and use of the Delphi method to obtain expert consensus. Part C: A single center comparative study to compare outcomes before and after implementation of the SNM care pathway. Patients scheduled for the first stage of Interstim therapy™ will be included (N=100). Primary endpoints are the sensitivity and specificity of a new pelvic symptom assessment tool, the conversion to implant and explantation rates. CONCLUSION: There is a margin for improvement in the care process of patients with therapy-resistant symptoms of the pelvis in the Belgium healthcare system. In the OptiLUTs trial adapted guidelines and a clinical care pathway will be developed to standardize and increase the efficiency of care. TRIAL REGISTRATION: Approval for the trial by the Ethics Committee of the Ghent University hospital: EC/2018/0244.