Transcutaneous electrical nerve stimulation for women with primary dysmenorrhea: Study protocol for a randomized controlled clinical trial with economic evaluation.

Primary dysmenorrhea (PD) is a common gynecological disorder characterized by cramping pain in the lower abdomen during menstruation, in the absence of identifiable pathology. While Transcutaneous Electrical Nerve Stimulation (TENS) is used to promote PD pain relief, there is still a need to understand the parameters and cost-effectiveness of this intervention. As such, this study aims to disclose a study that will evaluate the effectiveness and cost-effectiveness of TENS on pain intensity in women with PD. This is a protocol for an assessor-blinded randomized controlled trial that includes 174 women with PD, >18 years old, with menstrual pain greater than or equal to four points in the Numerical Rating Scale. Participants will be randomized into three groups (active TENS, placebo TENS, and educational booklet). Participants allocated to the active TENS group will receive electrical stimulation (F = 100 Hz, pulse duration = 200 µs, for 30 min). In contrast, the placebo TENS group will receive placebo stimulation (same parameters, but for only 30 s, and then the current will be ramped off over a 15-s time frame) for three consecutive months during menstruation. Participants allocated to the educational booklet group will receive instructions about health promotion and education actions related to PD. A blinded assessor will evaluate the pain intensity (Numerical Rating Scale), presenteeism (Stanford Presenteeism Scale), Health-Related Quality of Life (Short-Form 6 dimensions and SF-36), and health costs of menstrual pain. This is the first study to propose a health economic evaluation while assessing the benefits of using TENS to treat PD symptoms. It is hypothesized that active TENS will be more effective than placebo TENS or the educational booklet in improving clinical outcomes in the short-, medium- and long-term. The study will also provide information about the cost-effectiveness of TENS, which can be used by policy makers to improve PD care in public and private health systems.

National Trends in Neuromodulation for Urinary Incontinence Among Insured Adult Women and Men, 2004-2013: The Urologic Diseases in America Project.

OBJECTIVE: To examine US trends in neuromodulation for urinary incontinence (UI) treatment from 2004 to 2013. METHODS: This study utilized 2 data sources: the Optum© de-identified Clinformatics® Data Mart Database for privately insured adults aged 18-64 years with a UI diagnosis (N≈40,000 women and men annually) and the Medicare 5% Sample for beneficiaries aged ≥65 years with a UI diagnosis (N≈65,000 women and men annually). We created annual cross-sectional cohorts and assessed prevalence of UI-related neuromodulation procedures among men and women separately from 2004 to 2013. Analyses were conducted overall and stratified by age, race/ethnicity, and geographic region. RESULTS: Nearly all neuromodulation procedures occurred in outpatient settings. Sacral neuromodulation (SNM) procedures for UI in both women and men grew steadily from 2004 to 2013, with more procedures performed in women than men. Among women with UI, SNM prevalence grew from 0.1%-0.2% in 2004 to 0.5%-0.6% in 2013. Posterior tibial nerve stimulation (PTNS) experienced growth from 2011 to 2013. Chemodenervation of the bladder with onabotulinumtoxinA (BTX) combined with other injectable procedures (including urethral bulking) remained stable over time. CONCLUSIONS: From 2004 to 2013, SNM procedures remained relatively uncommon but increased consistently. PTNS experienced growth starting in 2011 when PTNS-specific insurance claims became available. BTX trends remain unclear; future studies should assess it separately from other injectable procedures. Neuromodulation has a growing role in UI treatment, and ongoing trends will be important to examine.

Contemporary Patterns of Third-line Treatments for Privately Insured Individuals With Overactive Bladder in the United States.

OBJECTIVE: To evaluate utilization of third-line overactive bladder (OAB) treatments including percutaneous tibial nerve stimulation (PTNS), sacral nerve stimulation (SNS), and intradetrusor botulinum toxin A (BTX) among privately insured patients and examine factors associated with their use. MATERIALS AND METHODS: Using MarketScan claims (2015-2017), we identified patients who underwent third-line OAB treatments based on procedure codes. Factors of interest included location, age, health plan, among others. We fit multivariable logistic regression models to estimate associations between pertinent factors with receipt of PTNS and SNS relative to BTX and associations between provider type and practice location with each treatment modality. RESULTS: We identified 7383 patients (mean age 50.9) in our cohort. SNS was used most frequently (n = 3602, 48.8%), while PTNS was used least frequently (n = 955, 12.9%). PTNS patients were more likely to reside in metropolitan areas (vs BTX: OR 1.6, 95%CI 1.3-2.1; vs SNS: OR 2.2, 95%CI 1.7-2.8), be aged 55 years or older (vs BTX: 54% vs 47%, OR 1.6, 95%CI 1.2-2.1; vs SNS: 54% vs 45%, OR 1.6, 95%CI 1.2-2.0), and be covered under a health maintenance organization (vs BTX: 17% vs 10%; vs SNS: 17% vs 10%, P <.01). Urologists were most likely to perform SNS, and gynecologists were most likely to perform BTX. 91% of PTNS procedures were performed in office settings. CONCLUSION: Among patients receiving third-line OAB treatment, PTNS was used infrequently. PTNS utilization was concentrated within urban areas, and among older patients and those covered by cost-conscious health maintenance organizations.

Real World Performance of Sacral Neuromodulation and OnabotulinumtoxinA for Overactive Bladder: Focus on Safety and Cost.

PURPOSE: We aimed to determine the real world safety and cost of third line overactive bladder therapies, including onabotulinumtoxinA and sacral neuromodulation. MATERIALS AND METHODS: We performed an all-inclusive, population based cohort study of third line therapies of overactive bladder (sacral neuromodulation or onabotulinumtoxinA) using the statewide surgical data captured in the New York Statewide Planning and Research Cooperative System. The main outcome measures were 30-day safety events, and 1 and 3-year health care utilization costs. Propensity score matching was done to control for confounding factors and comparative analyses of safety events were also performed. RESULTS: Our cohort included 2,680 patients, of whom 1,328 underwent sacral neuromodulation and 1,352 received onabotulinumtoxinA from January 1, 2013 through December 31, 2016. Average ± SD age was 61.7 ± 16.3 years and 82.7% of the patients were female. Sacral neuromodulation implantation led to re-intervention in 15.8% of cases within 1 year and in 26.1% at 3 years. In this comparative analysis patients who received onabotulinumtoxinA therapy were at higher risk for urinary tract infection, hematuria, urinary retention and an emergency room visit compared to those treated with sacral neuromodulation. The overall cost of onabotulinumtoxinA was lower than the cost of the sacral neuromodulation device (cost at 1 year $2,896 vs $15,343 and at 3 years $3,454 vs $16,189, each p <0.01). CONCLUSIONS: Sacral neuromodulation implantation was more expensive than onabotulinumtoxinA injection. However, patients who underwent sacral neuromodulation had a lower complication rate than patients treated with onabotulinumtoxinA. A quality improvement collective database must be created to track information on onabotulinumtoxinA and sacral neuromodulation treatment. This would help generate better performance and comparative data for patient and physician decision making.

Cost-Effectiveness of Sacral Neuromodulation versus OnabotulinumtoxinA for Refractory Urgency Urinary Incontinence: Results of the ROSETTA Randomized Trial.

PURPOSE: Sacral neuromodulation and intradetrusor onabotulinumtoxinA injection are therapies for refractory urgency urinary incontinence. Sacral neuromodulation involves surgical implantation of a device that can last 4 to 6 years while onabotulinumtoxinA therapy involves serial office injections. We assessed the cost-effectiveness of 2-stage implantation sacral neuromodulation vs 200 units onabotulinumtoxinA for the treatment of urgency urinary incontinence. MATERIALS AND METHODS: Prospective economic evaluation was performed concurrent with the ROSETTA (Refractory Overactive Bladder: Sacral NEuromodulation vs. BoTulinum Toxin Assessment) randomized trial of 386 women with 6 or more urgency urinary incontinence episodes on a 3-day diary. Analysis is from the health care system perspective with primary within-trial analysis for 2 years and secondary 5-year decision analysis. Costs are in 2018 U.S. dollars. Effectiveness was measured in quality adjusted life-years (QALYs) and reductions in urgency urinary incontinence episodes per day. We generated incremental cost-effectiveness ratios and cost-effectiveness acceptability curves. RESULTS: Two-year costs were higher for sacral neuromodulation than for onabotulinumtoxinA ($35,680 [95% CI 33,920-37,440] vs $7,460 [95% CI 5,780-9,150], p <0.01), persisting through 5 years ($36,550 [95% CI 34,787-38,309] vs $12,020 [95% CI 10,330-13,700], p <0.01). At 2 years there were no differences in mean reduction in urgency urinary incontinence episodes per day (-3.00 [95% CI -3.38 - -2.62] vs -3.12 [95% CI -3.48 - -2.76], p=0.66) or QALYs (1.39 [95% CI 1.34-1.44] vs 1.41 [95% CI 1.36-1.45], p=0.60). The probability that sacral neuromodulation is cost-effective relative to onabotulinumtoxinA is less than 0.025 for all willingness to pay values below $580,000 per QALY at 2 years and $204,000 per QALY at 5 years. CONCLUSIONS: Although both treatments were effective, the high cost of sacral neuromodulation is not good value for treating urgency urinary incontinence compared to 200 units onabotulinumtoxinA.

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/.

Medical Methods Patents in Neuromodulation.

There is a rapidly growing number of patents on methods of modulating brain regions. Despite this trend, and the massive potential of neuromodulation for treating patients, researchers and physicians who use neuromodulation techniques and technologies often have little idea of the significant ways these patents could affect their work. This article describes medical method patents, including a brief history of their development, and analyzes their potential direct and indirect effects on neuromodulation treatment and research efforts. As neuromodulation rapidly matures into a commercial and medical reality it is important to consider these effects in a forward thinking and value driven manner. The paper concludes with recommendations concerning how neuromodulation method patents may be used, or not, depending on the values of the inventor.

Review of Economic Value Drivers of the Treatment of Overactive Bladder.

Overactive bladder (OAB) is a symptom-driven condition with economic burden estimated to be on the order of several hundred dollars or euros per patient in some North American and European countries. This work reviews recently published economic models to evaluate how health states are defined, what cost components are considered, and what utility values are used to estimate the cost effectiveness of OAB pharmacotherapies, botulinum toxin, or sacral neuromodulation. It was found that no clear standard exists for determining OAB health states, although most were defined by some measure of incontinence frequency. Costs of physician visits and incontinence pads were included in nearly all models; however, OAB-associated depression and nursing home costs were rarely included, despite being large cost drivers of global economic burden studies. Utility values used in the models ranged from 0.544 to 0.933, highlighting the uncertainty associated with how OAB patients value health-related quality of life. More research is warranted so that health states providing delineations among OAB symptom severity and quality of life are clinically and economically meaningful as well as meaningful to affected patients.

Cost-effectiveness of sacral neuromodulation for chronic refractory constipation in children and adolescents: a Markov model analysis.

AIM: This study aimed to assess the cost-effectiveness of sacral neuromodulation (SNM) compared with conservative treatment in children and adolescents with constipation refractory to conservative management. METHOD: A Markov probabilistic model was used, comparing costs and effectiveness of SNM and conservative treatment in children and adolescents aged 10-18 years with constipation refractory to conservative management. Input for the model regarding transition probabilities, utilities and healthcare costs was based on data from a cohort of patients treated in our centre. This cohort consisted of 30 female patients (mean age 16 years) with functional constipation refractory to conservative management. The mean duration of laxative use in this group was 5.9 years. All patients had a test SNM, followed by a permanent SNM in 27/30. Median follow-up was 22.1 months (range 12.2-36.8). The model was run to simulate a follow-up period of 3 years. RESULTS: The mean cumulative costs for the SNM group and the conservative treatment group were €17 789 (SD €2492) and €7574 (SD €4332) per patient, respectively. The mean quality adjusted life years (QALYs) in the SNM group was 1.74 (SD 0.19), compared with 0.86 (SD 0.14) in the conservatively managed group. The mean incremental cost-effectiveness ratio was €12 328 per QALY (SD €4788). Sensitivity analysis showed that the outcomes were robust to a wide range of model assumptions. CONCLUSION: Chronic constipation seriously affects the quality of life of children and adolescents. Preliminary evidence suggests that SNM can improve symptoms and quality of life at a reasonable cost.

An Economic Evaluation of TENS in Addition to Usual Primary Care Management for the Treatment of Tennis Elbow: Results from the TATE Randomized Controlled Trial.

BACKGROUND: The TATE trial was a multicentre pragmatic randomized controlled trial of supplementing primary care management (PCM)-consisting of a GP consultation followed by information and advice on exercises-with transcutaneous electrical nerve stimulation (TENS), to reduce pain intensity in patients with tennis elbow. This paper reports the health economic evaluation. METHODS AND FINDINGS: Adults with new diagnosis of tennis elbow were recruited from 38 general practices in the UK, and randomly allocated to PCM (n = 120) or PCM plus TENS (n = 121). Outcomes included reduction in pain intensity and quality-adjusted-life-years (QALYs) based on the EQ5D and SF6D. Two economic perspectives were evaluated: (i) healthcare-inclusive of NHS and private health costs for the tennis elbow; (ii) societal-healthcare costs plus productivity losses through work absenteeism. Mean outcome and cost differences between the groups were evaluated using a multiple imputed dataset as the base case evaluation, with uncertainty represented in cost-effectiveness planes and through probabilistic cost-effectiveness acceptability curves). Incremental healthcare cost was £33 (95%CI -40, 106) and societal cost £65 (95%CI -307, 176) for PCM plus TENS. Mean differences in outcome were: 0.11 (95%CI -0.13, 0.35) for change in pain (0-10 pain scale); -0.015 (95%CI -0.058, 0.029) for QALYEQ5D; 0.007 (95%CI -0.022, 0.035) for QALYSF6D (higher score differences denote greater benefit for PCM plus TENS). The ICER (incremental cost effectiveness ratio) for the main evaluation of mean difference in societal cost (£) relative to mean difference in pain outcome was -582 (95%CI -8666, 8113). However, incremental ICERs show differences in cost-effectiveness of additional TENS, according to the outcome being evaluated. CONCLUSION: Our findings do not provide evidence for or against the cost-effectiveness of TENS as an adjunct to primary care management of tennis elbow.

Efficacy and quality of life after transcutaneous posterior tibial neuromodulation for faecal incontinence.

AIM: The aim of this study was to evaluate the efficacy of transcutaneous neuromodulation of the posterior tibial nerve for faecal incontinence and to assess quality of life after the procedure. METHOD: A prospective non-randomized cohort study was conducted in a tertiary centre from September 2010 to May 2013. All patients with faecal incontinence who met the inclusion criteria were included and were treated as outpatients during a 3-month period by unilateral neuromodulation of the posterior tibial nerve. The patients were followed 3-monthly for 1 year. Severity scales, a bowel diary and quality of life scales were evaluated prospectively before and after treatment. RESULTS: Twenty-seven patients of median age 67 (interquartile range 60-69) years and a male to female ratio of 1/6 were included. Faecal incontinence was for solid stools in 48.1% of patients with urgency in 55.6%. About one-third (34.6%) had a sphincter defect on ultrasound and reduction of anal canal pressure in 85.2%. There was a significant improvement in episodes of incontinence on the Wexner score and visual analogue scale assessment and a decrease in the number of episodes of incontinence per unit time. The Fecal Incontinence Quality of Life score was improved at the end of the follow-up. No adverse effects were observed. The cost of the treatment was €135 per patient. CONCLUSION: Transcutaneous posterior tibial nerve neuromodulation provides good treatment for faecal incontinence in terms of efficacy and quality of life.

[Use of transcutaneous electrical nerve stimulation in the Unit of Pain Management of the Alcorcón Foundation University Hospital]. / Características del uso de estimulación nerviosa eléctrica transcutánea en la Unidad del Dolor del Hospital Universitario Fundación Alcorcón.

Transcutaneous electrical nerve stimulation (TENS) is a non-pharmacological therapy used to alleviate pain and is among the current available treatments offered by the Units of Pain Management (Unidades del Dolor) in Spanish Hospitals. The goal of this study was to identify the characteristics of portable electro-stimulator use, and its costs in the Unit of Pain Management of the Alcorcón Foundation University Hospital (Hospital Universitario Fundación Alcorcón). A retrospective descriptive study was carried out between January, 1999, and October, 2010, in the Unit of Pain Management of the Alcorcón Foundation University Hospital. The information on TENS delivery forms and its supplies was collected, and the characteristics of use and the associated costs were calculated. It was observed that the longest period of time used was less than a year. The cost of delivery for the portable equipment was 148 050 euros and the average annual cost for the use of TENS by a patient was 854 euros. From the information gathered, it can be concluded that the use of electro-analgesia is a valid option in terms of expenses for long periods of use, thereby allowing a reduction in costs and decreasing the use of other healthcare treatments.

A new job for an old device: a novel use for nerve stimulators in anorectal malformations.

Muscle stimulation of the perineum is a crucial step in the repair of anorectal malformations. This allows the surgeon to assess muscle function and locate precisely the sphincter muscles during a pull-through operation. Presently, the device commonly used is very expensive. In searching for a cheaper and amenable device we explored utilizing the nerve stimulator MiniStim (model MS-IIIA, Life-Tech, Inc., Houston, TX) normally used for the "train of four" sign in assessing paralysis during general anesthesia. We have used this device in seven consecutive posterior sagittal anorectoplasties and compared its effectiveness with the regular muscle stimulator. In our experience, the nerve stimulator is easier to work with and is a common device in the operating theater. It gave us information that was at least equal to the regular muscle stimulator.

Assessing the effectiveness and cost effectiveness of subcutaneous nerve stimulation in patients with predominant back pain due to failed back surgery syndrome (SubQStim study): study protocol for a multicenter randomized controlled trial.

BACKGROUND: Chronic radicular pain can be effectively treated with spinal cord stimulation, but this therapy is not always sufficient for chronic back pain. Subcutaneous nerve stimulation (SQS) refers to the placement of percutaneous leads in the subcutaneous tissue within the area of pain. Case series data show that failed back surgery syndrome (FBSS) patients experience clinically important levels of pain relief following SQS and may also reduce their levels of analgesic therapy and experience functional well-being. However, to date, there is no randomized controlled trial evidence to support the use of SQS in FBSS. METHODS/DESIGN: The SubQStim study is a multicenter randomized controlled trial comparing SQS plus optimized medical management ('SQS arm') versus optimized medical management alone ('OMM arm') in patients with predominant back pain due to FBSS. Up to 400 patients will be recruited from approximately 33 centers in Europe and Australia and will be randomized 1:1 to the SQS or OMM arms. After 9 months, patients who fail to reach the primary outcome will be allowed to switch treatments. Patients will be evaluated at baseline (prior to randomization) and at 1, 3, 6, 9, 12, 18, 24, and 36 months after randomization. The primary outcome is the proportion of patients at 9 months with a ≥50% reduction in back pain intensity compared to baseline. The secondary outcomes are: back and leg pain intensity score, functional disability, health-related quality of life, patient satisfaction, patient global impression of change, healthcare resource utilization/costs, cost-effectiveness analysis and adverse events. Outcomes arms will be compared between SQS and OMM arms at all evaluation points up to and including 9 months. After the 9-month assessment visit, the main analytic focus will be to compare within patient changes in outcomes relative to baseline. DISCUSSION: The SubQStim trial began patient recruitment in November 2012. Recruitment is expected to close in late 2014. TRIAL REGISTRATION: ClinicalTrials.gov NCT01711619.

Cost of neuromodulation therapies for overactive bladder: percutaneous tibial nerve stimulation versus sacral nerve stimulation.

PURPOSE: Conservative therapy and antimuscarinic agents are first line therapies for overactive bladder. Patients refractory to treatment are candidates for neuromodulation therapy. We estimated the costs and cost-effectiveness of percutaneous tibial nerve stimulation and sacral nerve stimulation. MATERIALS AND METHODS: A Markov model was constructed to simulate the total costs and effectiveness of percutaneous tibial and sacral nerve stimulation during 2 years. Cost data used average Medicare national physician payments, and ambulatory payment classification and diagnosis related group payments for hospital based care and office visits. Clinical effectiveness, and the rates of patient adherence to treatment and adverse events were estimated by a review of the literature. RESULTS: The costs of initial therapy were $1,773 for 12 weekly percutaneous tibial nerve stimulation treatments and $1,857 for test sacral nerve stimulation. For ongoing therapy the cost of the sacral nerve stimulation surgical implant was $22,970. Cumulative discounted 2-year costs were $3,850 for percutaneous tibial nerve stimulation and $14,160 for sacral nerve stimulation, including those who discontinued therapy. Of the patients 48% and 49%, respectively, remained on therapy. The incremental cost-effectiveness ratio was $573,000 per additional patient on sacral nerve stimulation. When considering only patients who completed initial stimulation successfully, the costs were $4,867 and $24,342 for percutaneous tibial and sacral nerve stimulation with 71% and 90%, respectively, remaining on therapy for an incremental cost-effectiveness ratio of $99,872. CONCLUSIONS: Percutaneous tibial nerve stimulation and sacral nerve stimulation are safe, effective neuromodulation therapies for overactive bladder. In this economic model percutaneous tibial nerve stimulation had substantially lower cost. An additional 1% of patients would remain on therapy at 2 years if sacral nerve stimulation were used rather than percutaneous tibial nerve stimulation but the average cost per additional patient would be more than $500,000.

Clinical and economic impact of TENS in patients with chronic low back pain: analysis of a nationwide database.

This study evaluated patients who were given transcutaneous electrical nerve stimulation (TENS) compared with a matched group without TENS prior to intervention and at 1-year follow-up. Patients who were treated with TENS had significantly fewer hospital and clinic visits, used less diagnostic imaging (31 vs 46 events per 100 patients), had fewer physical therapy visits (94 vs 107), and required less back surgery (7.5 vs 9.2 surgeries) than patients receiving other treatment modalities. Total annual costs for chronic low back pain patients without neurological involvement were lower in TENS patients ($17,957 vs $17,986 for non-TENS), even when the cost of the device was taken into account.

Posterior tibial nerve stimulation for fecal incontinence: where are we?

Neurostimulation remains the mainstay of treatment for patients with faecal incontinence who fails to respond to available conservative measures. Sacral nerve stimulation (SNS) is the main form of neurostimulation that is in use today. Posterior tibial nerve stimulation (PTNS)--both the percutaneous and the transcutaneous routes--remains a relatively new entry in neurostimulation. Though in its infancy, PTNS holds promise to be an effective, patient friendly, safe and cheap treatment. However, presently PTNS only appears to have a minor role with SNS having the limelight in treating patients with faecal incontinence. This seems to have arisen as the strong, uniform and evidence based data on SNS remains to have been unchallenged yet by the weak, disjointed and unsupported evidence for both percutaneous and transcutaneous PTNS. The use of PTNS is slowly gaining acceptance. However, several questions remain unanswered in the delivery of PTNS. These have raised dilemmas which as long as they remain unsolved can considerably weaken the argument that PTNS could offer a viable alternative to SNS. This paper reviews available information on PTNS and focuses on these dilemmas in the light of existing evidence.