Abstract
Arab Journal of Urology (2013) 11, 131–135 Arab Journal of Urology (Official Journal of the Arab Association of Urology) www.sciencedirect.com URODYNAMICS/FEMALE UROLOGY ORIGINAL ARTICLE Posterior tibial nerve stimulation as treatment for the overactive bladder Hammouda Sherif , Osama Abdelwahab Urology Department, Faculty of Medicine, Benha University, Egypt Received 23 January 2013, Received in revised form 21 April 2013, Accepted 25 April 2013 Available online 28 May 2013 KEYWORDS Abstract Objective: To evaluate the efficacy of posterior tibial nerve stimulation (PTNS) as a treatment for the overactive bladder (OAB) resistant to medical treat- Neuromodulation; ment. Overactive bladder; Patients and methods: The study included 60 patients, comprising 55 women Posterior tibial nerve (92%) and five men (8%) with a mean (SD) age of 41.4 (10.8) years, who presented stimulation to the Urology Department of Benha University Hospital from June 2010 to Octo- ber 2012. All patients were assessed initially by taking a history, a physical examina- ABBREVIATIONS tion, urine analysis, routine laboratory investigations, and a urodynamic evaluation DO, detrusor overac- in the form of flowmetry, cystometry, and a pressure-flow study in some cases. A tivity; voiding diary (daytime and night-time frequency, voiding volume, and leakage epi- OAB, overactive blad- sodes) was completed by all patients, and all underwent 12 sessions of PTNS using a der; personal computer-based system, and were reassessed after the sixth session, at the PTN(S), posterior end of the course, and at 3 and 6 months after the last session, using the same tibial nerve (stimula- methods as in the baseline visit. tion); Results: There was a statistically significant improvement in all the variables RCT, randomised assessed. No infection or failure of the PTNS mechanism was detected while using Corresponding author. Address: 10 Elashraf Street, Benha Elgdeeda, Benha 11513, Egypt. Mobile: +20 12 22904225; fax: +20 13 3220100. E-mail address: hammoda_elsherif@yahoo.com (H. Sherif). Peer review under responsibility of Arab Association of Urology. Production and hosting by Elsevier 2090-598X ª 2013 Production and hosting by Elsevier B.V. on behalf of Arab Association of Urology. http://dx.doi.org/10.1016/j.aju.2013.04.007 132 Sherif, Abdelwahab controlled trial; the technique, but there were rare instances of minor bleeding and a temporary TENS, transcutaneous painful feeling at the insertion site. neuromodulation Conclusion: PTNS is safe, and gives statistically significant improvements in the stimulation patient’s assessment of OAB symptoms. ª 2013 Production and hosting by Elsevier B.V. on behalf of Arab Association of Urology. Introduction University Hospital from June 2010 to October 2012. Informed written consent was obtained from all patients after the study protocol was approved by the Research An overactive bladder (OAB) includes urgency, frequent Ethics Committee, Faculty of Medicine, Benha Univer- voiding, nocturia and urge incontinence [1]. The symp- sity. The inclusion criteria for patients with symptoms of toms of an OAB often remain a therapeutic problem, OAB were; age P18 years, with no previous history of despite the optimal use of conservative treatment meth- continence surgery, or history of current bladder malig- ods, including drug therapy, behavioural therapy, pelvic nancy, and who had failed medical therapy for floor exercises and biofeedback [2]. Anticholinergic ther- P3 months with different types of anticholinergic apy is the first therapeutic line for the OAB, but it is lim- agents, either as a single drug or a combination. The ited by its side-effects or if the therapeutic goal is not exclusion criteria included; pregnant women, or plan- attained. In that situation neuromodulation is an effec- ning to become pregnant during the course of treatment, tive alternative treatment and its efficacy has been well patients with pacemakers or implantable defibrillators, established [3]. uncorrectable coagulopathies, patients with nerve dam- For thousands of years acupuncture has played a key age that might affect either the PTN or pelvic floor func- role in the traditional Chinese medicine. This technique tion, or a current UTI. All patients were assessed has been used in the treatment of lower urinary tract dys- initially by taking a history, a physical examination, ur- functions such as enuresis, incontinence, frequency, ur- ine analysis, routine laboratory investigations, and a gency, dysuria and retention of urine, by acting on the urodynamic evaluation in the form of flowmetry, cys- so-called S6 region located in the posterior border of tometry, and a pressure-flow study in some cases. A 1- the tibia, 5 cm above the tibial malleolus [4]. day voiding diary (daytime frequency, daytime voiding Knowledge of the afferent nerves going from the pos- volume, daytime leakage episodes, night-time frequency, terior tibial nerve (PTN) to the sacral centre of micturi- night-time voiding volume, night-time leakage episodes) tion facilitated the invention of percutaneous PTN was completed by all patients. A frequency/volume stimulation (PTNS) for managing the symptoms of an chart, recording symptoms of leakage episodes per day OAB [5]. Inhibition of detrusor activity (DO) by periph- and night, was used to evaluate the patients before eral neuromodulation of the PTN was first described by and after PTNS. McGuire et al. [6] and recent authors [7–9] confirmed a 60–80% positive response rate after 10–12 weekly treat- PTNS ments with PTNS. The precise mode of action of neuromodulation is un- The technique used consisted of inserting a 0.22-mm known. Its effects can be explained by the modulation of needle 5 cm above the medial tibial malleolus, approx- reflex pathways at the spinal cord level [10]. Paradoxi- imated as three finger breadths. The needle was con- cally, neuromodulation also works in patients with uri- nected to an electric generator producing external nary retention even if there is no anatomical pulses of 0–10 mA, which increased progressively until obstruction. It was postulated that neuromodulation the response was achieved in the form of flexor muscle interferes with the increased afferent activity arising from contraction of the first toe, fanning of all toes, or tin- the urethral sphincter, restoring the sensation of bladder gling sensation in the sole. The voltage remained at fullness and reducing the inhibition of the detrusor mus- one point below the stimulus that generated the muscu- cle contraction [11]. Thus, the aim of the present study lar contraction. was to evaluate the efficacy of PTNS as a treatment for Patients had to experience a tolerable but not pain- OAB that was resistant to medical treatment. ful sensation. If there was no response or there was pain at the insertion site, the stimulation device was Patients and methods switched off and the needle was repositioned. The treatment was repeated weekly for a 30-min period This study was a case series evaluating the efficacy of for 12 weeks. PTNS in management of OAB, and included 60 patients All the patients had 12 sessions of PTNS using the (55 women and five men, mean age 41.4 years, SD 10.8) Urgent system (Uroplasty, Inc., Minnetonka, MN, who presented to the Urology Department of Benha Posterior tibial nerve stimulation as treatment for the overactive bladder 133 USA), and were re-evaluated after the sixth session, at ly, at 6 months after the intervention, 12 (25%) of the the end of the course, and at 3 and 6 months after the patients with DO became normal, while those patients last session, using the same methods as used for the with no DO remained the same. baseline visit. There was no infection or failure of the PTNS mech- Categorical data are presented as the number and anism detected when using the technique, but there was percentage, while quantitative data were expressed as minor bleeding (five cases) and a temporary painful feel- the mean (SD). A paired t-test, McNemar’s test and ing at the insertion site (10 cases), classified as grade I Friedman’s test were used to assess significant differ- according to the modified Clavien system [12]. ences, with P < 0.05 taken to indicate statistical significance. Discussion Results OAB is a common condition in adults, with an effect on their physical, psychological and social well-being. There was a statistically significant difference Moreover, it is an important economic burden to the (P < 0.001) when analysing both the daytime and health services [13]. The PTN is a mixed nerve contain- night-time voiding frequency between before and after ing sensory and motor fibres. The correct placement of six and 12 sessions of PTNS, the changes in voiding vol- the needle electrode induces a motor and sensory re- ume before and after PTNS, and in leakage episodes sponse. Centrally the PTN projects to the sacral spinal (day and night time, (P < 0.001). cord in the same area where the bladder projection is lo- Comparing the results at baseline, the last session of cated. The sacral micturition centre and the nucleus of PTNS, and 3 and 6 months after the last session showed Onuf are most probably the areas where the therapeutic that the mean frequency per day and night at 3 and effect of neuromodulation of the bladder, by PTNS, 6 months slightly increased from that at the last session takes place [9]. of treatment, but remained lower than at baseline. The From our results, the current study showed clinically mean voiding volume per day and night also decreased significant improvements in all measured values. Van- slightly from the value after the last treatment, but re- doninck et al. [9] reported a subjective response in mained higher than at the baseline. Although the mean 64% and an objective response in 57% of their patients number of leakage episodes per day and night increased (defined as P50% reduction in urinary leakage episodes slightly from that after the last treatment, it remained per 24 h). Ruiz et al. [4] reported statistically significant lower than at baseline. All these differences were statis- improvements in daytime frequency, daytime voiding tically significant (P < 0.001; Table 1). volume, and night-time frequency in patients using The study group included 48 patients with DO (80%) PTNS. Of 26 women with frequency or urgency, 12% and 12 without DO (20%). After 6 weeks of treatment, rated the results as excellent, 65% as favourable, 15% 12 (25%) patients who had DO became normal, while as fair and 8% considered there was no difference. In those with no DO remained unchanged. Moreover, after another study, PTNS produced a statistically significant 12 weeks of treatment, half of the patients with DO be- improvement in LUTS, especially daytime and night- came normal but all patients with no DO remained un- time voiding frequency, volume and leakage episodes changed. At 3 months later there was no change in these [8]. Govier et al. [7] showed a 25% reduction in mean values from those measured after the last session. Final- daytime voids, a 21% reduction in mean night-time Table 1 The changes from the baseline values after 12 sessions, and at 3 and 6 months after the last session. Variable Mean (SD) Before After 12 sessions 3 months 6 months * * * Frequency/day 10.8 (0.99) 5.0 (3.60) 6.2 (3.01) , 6.8 (2.90) , , * * * Voiding volume/day (mL) 124 (22.6) 220 (60.5) 194 (50.8) , 196 (55.8) , * * * Leaking episode/day 3.7 (2.3) 1.6 (1.2) 1.8 (1.4) , 1.8 (1.6) , * * * Frequency/night 7.0 (1.3) 2.8 (2.1) 3.6 (2.2) , 3.6 (2.2) , * * * Voiding volume/night (mL) 144 (41.1) 220 (60.5) 190 (49.4) , 196 (55.8) , * * * Leaking episode/night 2.7 (1.7) 1.0 (0.92) 1.2 (0.95) , 1.4 (0.97) , , Urodynamic * * Maximum urinary flow rate (mL/s) 20.52 (2.6) 18.84 (4.1) 18.49 (1.8) 20.23 (2.6) Residual urine volume (mL) 17.85 (4.2) 39.54 (36.3) 25.35 (3.4) 20.11 (3.2) * * * Voided urine volume (mL) 152.7 (39.7) 260.3 (26.1) 255.2 (22.2) 250.1 (22.4) * * Cystometric capacity (mL) 282.2 (20.11) 380.6 (13.97) 375.5 (18.12) 320.3 (19.60) Significant vs. before intervention. Significant vs. after 12 sessions. Significant vs. after 3 months, by a paired t-test. 134 Sherif, Abdelwahab voids, and a 35% improvement in urge incontinence. it was reported that continuous therapy is necessary in Van der Pal et al. [14] reported a subjective response patients with OAB that is treated successfully by PTNS, of 55% (defined as a patient requesting continuous and the efficacy of PTNS can be reproduced successfully chronic treatment to maintain the response) and an in formerly treated patients [14]. objective response of 37% (defined as a decrease in Stoller afferent nerve stimulation has a short-term po- symptoms of >50%). Also, PTNS had a subjective effi- sitive effect in patients with resistant OAB, but it was cacy of 64% and an objective efficacy of 46–54% in a also established that the efficacy was maintained at non-neurogenic population with complaints of OAB 1 year in only 23% of subjects [24]. However, Geirsson [15]. MacDiarmid et al. [3] reported on 33 patients et al. [25] reported that PTNS or traditional acupuncture who responded to an initial 12 sessions of PTNS and produced no difference in voiding frequency, or mean who were offered additional treatment sessions at vary- and maximum voided volume. Also, Fjorback et al. ing intervals for a further 9 months; 94% of patients [26] noted that PTNS had no effect or failed to suppress considered themselves to be cured or improved at detrusor contractions in patients with neurological DO. 6 months, and 96% at 12 months. Safety of PTNS Arrabal-Polo et al. [16] reported a statistically sig- nificant improvement in diurnal frequency, urgency No infections or failures of the PTNS mechanism and urge incontinence. Furthermore, Peters et al. were detected in the present study, although there [17], in a randomised controlled trial (RCT) of 100 pa- were rare cases of minor bleeding and a temporary tients, compared PTNS with medication; 55% of pa- painful feeling at the insertion site. Most studies re- tients in the medication group and 80% in the PTNS ported that there were no serious adverse events asso- group considered themselves to be cured or improved. ciated with PTNS for OAB. In the RCT [17] In another RCT including 220 patients, comparing comparing PTNS with anticholinergic medication, in PTNS with a sham treatment, 21% of those in the the PTNS group there was one report of a worsening sham group and 55% in the PTNS group had a mod- of incontinence, and reports of haematuria, headache, erate or marked improvement in overall bladder symp- inability to tolerate stimulation, generalised swelling, toms at 13 weeks [18]. Also, Klinger et al. [19] used intermittent foot/toe pain, leg cramps, and a vasova- this technique in 15 patients who had a urodynamic gal response to needle placement. Constipation and evaluation, and reported an improvement in bladder dry mouth were reported less frequently in the PTNS instability. Urodynamic evidence of bladder instability group than in the medication group. Also, in the was eliminated in 11 of them after the treatment. Re- other RCT [18] of 220 patients comparing PTNS with cently, Peters et al. [20], using PTNS, reported that sham treatment, there were some adverse symptoms, the improvements in urge incontinence, frequency, i.e. bleeding at the needle site (3%), ankle bruising moderate-to-severe urgency episodes and night-time (1%), discomfort at the needle site (2%) and tingling voids, from voiding diaries at 6, 12, 18 and 24 months, in the leg (1%), but no adverse events reported in were statistically significant compared to baseline (be- the sham group. Throbbing pain at the needle site, fore the initial 12 weekly treatments). stomach discomfort and foot pain were also reported Janssen et al. [21] used the Urgent-SQ system, an previously [7]. implant that is surgically placed near the PTN and acti- Finally, from the previous discussion and according vated by an external pulse generator, allowing for ‘on- to the other reports, we suggest that PTNS, which is demand’ PTNS, with no need for needle insertion. After minimally invasive and easily applied, is associated with 9 years of clinical experience they reported that implant- an improvement in OAB symptoms and with negligible driven PTNS with the Urgent-SQ is a safe therapy for side-effects. However, maintenance therapy should be OAB. Recently, Barroso et al. [22] reported a study on considered as the next step in future research [27–29]. 22 consecutive patients treated by PTNS and 37 by In conclusion, PTNS is safe, and is associated with transcutaneous neuromodulation stimulation; there statistically significant improvements in patient-assessed was no significant difference between these treatments OAB symptoms. Although initial studies showed prom- in the variables assessed. ise, a more comprehensive evaluation of PTNS is needed to support its universal use for treating the OAB. Durability of PTNS Conflict of interest Levin et al. [23] reviewed reports on PTNS for treating idiopathic OAB in women, published in English from None. January 2000 to August 2010, and identified using the Medline/PubMed, Cochrane and Embase databases. Source of funding They found success rates of 54–93% and limited high- quality data on PTNS for OAB in women. Furthermore, There was no funding or any disclosure to companies. Posterior tibial nerve stimulation as treatment for the overactive bladder 135 efficacy in the treatment of overactive bladder refractory to Acknowledgements anticholinergics by posterior tibial nerve stimulation. Korean J Urol 2012;53:483–6. 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Journal
Arab Journal of Urology
– Taylor & Francis
Published: Jun 1, 2013
Keywords: Neuromodulation; Overactive bladder; Posterior tibial nerve stimulation; DO, detrusor overactivity; OAB, overactive bladder; PTN(S), posterior tibial nerve (stimulation); RCT, randomised controlled trial; TENS, transcutaneous neuromodulation stimulation
