Tibial Nerve Stimulation
Abstract
Purpose: Transcutaneous Posterior Tibial Nerve Stimulation (TPTNS) using adhesive skin electrodes is not commonly used due to its low efficacy. Our objective was to verify whether the combination of TPTNS with low dose Trospium chloride in the treatment of females with overactive bladder (OAB) would be more effective than TPTNS alone after failure of behavioral therapy. Materials and Methods: We randomized 30 women with OAB, into two groups, 15 patients each: Group I received 30 minutes TPTNS, three times a week; Group II received TPTNS three times a week, plus Trospium chloride (20 mg once daily) for eight weeks. Patients were evaluated using Overactive Bladder Symptom Score questionnaire (OABSS), Impact Questionnaire-short form 7 …show more content…
(IIQ-7), 3 day voiding diary and urodynamics at weeks 0 and 8.
Results: After treatment both groups improved regarding all the parameters. OABSS was reduced significantly after treatment in both groups (P < 0.001) however group II showed more significant improvement. Before treatment, IIQ-7 score showed that none of the patients had good QoL. After treatment, 6 (40%) and 14 (93.3%) had good quality of life in Group I and Group II respectively. Voiding diary showed a significant decrease in frequency after treatment in group I and II (p = 0.003 and p = 0.001) respectively. The decrease was more significant in group II. In Cystometry bladder volume at first sensation showed a significant delay in group II (p = 0.001)
Conclusions: TPTNS combined with low dose Trospium chloride proved to be more effective than TPTNS alone in the treatment of OAB in females.
Introduction:
Overactive bladder (OAB) is defined as urinary urgency, usually with urinary frequency and nocturia, with or without urgency urinary incontinence.
(1)Antimuscarinic drugs have shown efficacy in the range of 70-75%.(2) A patient with refractory OAB is the one who failed several drug therapy for at least 4-6 weeks.(2)Side effects of antimuscarinic drugs include dry mouth, pruritus, headache, blurred vision, constipation, erythema, urine retention and fatigue. More than 70% of patients do not continue therapy beyond 9 months(3).
Electrical stimulation is one of the third line treatments in patients with refractory OAB.
In a short term study, posterior tibial nerve stimulation (PTNS) was found to have comparable effects to antimuscarinics with a better side effect profile.(4) PTNS has been used as a chronic treatment to improve OAB, with a success rate between 60 and 80%, while transcutaneous posterior tibial nerve stimulation (TPTNS) has a success rate of 48-68%(5).
PTNS requires placement of a fine-needle electrode into the inner aspect of theankle. This low-risk procedure has, however, common side effects, such as minor bleeding, mild pain, or skin inflammation at the treatment site(6). However, TPTNSis especially interesting because it might reproduce the effectiveness of PTNS while minimizing risk of infection, pain and bleeding beside being cost effective and suitable for adults and children.(7–10)Studies have demonstrated the potential efficacy of combination treatments(11)which led to the aim of this study,verifying whether the combination of TPTNS with low dose Trospium chloride in the treatment of females with idiopathic OAB would be more effective than TPTNS alone after failure of behavioral therapy.
Patients and …show more content…
methods:
We performed a prospective observational study of female patients with persistent OAB symptoms after failed first-line behavioral therapy from November 2014 to November 2015 at Alexandria University Hospital. Urological evaluation, 72 hours voiding diary, and urodynamic evaluation were done. We excluded patients with urinary tract infection, bladder outlet obstruction, neurological diseases, gynecological problems, pregnancy, electronic implants (pacemakers) and patients subject to seizures.
A written consent was obtained from patients. A Urostim 2 device and electrodes (Schwa-Medico, Rouffach, France) were used. Adhesive surface electrodes were applied, one above and behind the medial malleolus and the other 10 cm cephalad. Bipolar stimulation was set to a frequency of 10Hz, pulse duration of 250 microseconds and amplitude adjusted below the patient’s discomfort threshold. The protocol consisted of 3 stimulation weekly sessions, 30-minutes duration each. Group B received 20 mg oral daily dose of Trospium chloride in addition for eight weeks. Choosing Trospium chloride was due to being a large molecule quaternary amine with minimal central nervous system penetration and decreasing the dose to half to help decrease side effects.(12)
Standardized questionnaires at baseline and after 8weeks of treatment: the
Overactive Bladder Symptom Score (OABSS), Incontinence Impact Questionnaire-short form (IIQ-7) were used. Success was defined as an improvement in the scores and associated willingness of the patient to continue treatment. OABSS includes 3 categories (score < 5 = mild, 6-11 = moderate, > 12
= severe symptoms)(13), and the IIQ-7 includes 3 categories (score < 50% = good,
50-70% = moderate, and > 70 = poor QoL).(14)
Statistical analyses were performed using SPSS software version 20.For normally distributed data, comparison between two groups were done using independent t-test, paired t-test was used to analyze two paired data. For abnormally distributed data, comparison between two groups was done using Mann Whitney test. Wilcoxon signed ranks test was used to compare between pre- and post-treatment data. Significance of the obtained results was judged at the 5% level. McNemar test and test of marginal homogeneity were used to assess improvement.
Results
The mean patients age was 48 ±16.42 years for group I and 48.13 ±10.80 years for group II with no significant difference. OABSS was reduced significantly after treatment in both groups (P < 0.001) and the decrease was more in group II significantly (P = 0.024) (Table 1). Before treatment severe OAB symptoms were encountered in 26 patients (12 in group I and 14 in group II). After treatment only 4 patients had severe symptoms, all in group I (table 2). Before treatment there was no significant difference between both groups regarding the IIQ-7 score (P = 0.768). The mean values of the score decreased significantly after treatment in group I and II (p = 0.002 and p = 0.001) respectively. Patients in group II had more significant decrease in comparison with group I (p= 0.001) (Table 3).
The IIQ-7 score before treatment showed no patient with score < 50 (good QoL). After treatment 20 patients (6 in group I and 14 in group II) had score < 50. The IIQ-7 score in group I was downgraded in 6 patients to good QoLthe other hand, 14 patients in group II were downgraded to good QoL category. The change was significant for both groups (p=0.005 and p=0.001) respectively (Table 4).
Pre-treatment frequency was not significantly different in both groups (p = 0.679).
Voiding diary showed a reduction of frequency in group I (10.6 ± 2.32 Vs 13.13 ± 1.64) than in group II (8.6 ± 0.83 Vs 12.87 ± 1.85). This frequency decreased significantly after treatment in group I and II (p = 0.003 and p = 0.001) respectively. The decrease was more significant in group II (p = 0.006) (Table 5).
The mean voided volume in voiding diary increased significantly from 110.4 ± 14.92 to 138 ± 37.79 in group I, while the increase was more prominent in group II (178.6 ± 25.91 Vs 106.15 ± 13.12). The increase in voided volume was significant in both groups, but the increase was more significant in group II (p=0.005) (Table 6).
In cystometry, bladder volume at first sensation showed a significant delay in group II (p = 0.001) (Table 7). The pre-treatment cystometric capacity was almost similar in both groups (p = 0.339). After treatment, this volume increased significantly in both groups (p = 0.026 & p = 0.001) respectively. Group II had a significantly larger capacity than group I (p = 0.034) (Table 8).
Discussion:
Neuromodulation is considered a third line treatment of OAB.(15)PTNS is not used as a first line treatment due to its high cost and it is reserved for those who have OAB refractory to antimuscarinics.(16)Tibial nerve stimulation is effective, durable and minimally invasive. Some authors stated that it should be offered early in the course of OAB treatment.(17) We used TPTNS to evaluate its actual success rate as a primary treatment in OAB. Adding TENS to drug treatment is an attractive approach to improve the results and possibly allow lowering the dependence on pharmaceutical therapy alone, limiting side effects and positively impacting QoL. Anticholinergics can work synergistically with TENS due to different mechanisms of action.(18)
Pharmacological treatment with Trospium Chloride blocks muscarinic receptors that are responsible for vesical contractions.
TENS inhibits the detrusor by central reflex. Since the success rate of TPTNS is lower than the PTNS in the literature, we combined low dose anticholinergic (20 mg Trospium chloride) with it to enhance its success rate. Our aim was to save the patients from side effects of full dose anticholinergics. Trospium chloride is considered as one of the agents with fewer side effects.(19) Our patients did not report any side effects related to the small dose of the drug.
Investigators found that subjective improvement in symptoms and QoL scores is more important than the objective improvement.(20,21) According to another study PTNS subjects achieved statistically significant improvement in bladder symptoms with 54.5% reporting moderately or markedly improved responses from baseline Vs 20.9% of sham subjects.(20) In the present study both OABSS and IIQ-7 scores showed a significant improvement in both groups of patients but more in combination group.
In the present work, the voiding diary showed a more significant reduction of frequency in group I. Govier et al studied 53 patients, the reduction in the number of daytime urination was 25% and improvement of quality of life
was
21%.(6) In our study the mean voided volume in voiding diary increased category. Onsignificantly in both groups but was more prominent in group II. Other studies reported an increase in the voided volume after treatment.(20,22) Peters et al stated that, the voided volume increased from 150 ml to 186 ml.(22)
The volume at first sensation in the cystometry did not change significantly in group A, while a significant increase occurred in group II. Furthermore, group II had a larger cytometric capacity than group A. This could be due to synergistic effect of anticholinergic drug. The cystometric capacity increased significantly after treatment in both groups. Klinger et al reported an increase from 197 ml to
252 ml.(23) Ammi et al mentioned that the cystometric capacity is predictive for success.(21) Multimodal therapy by using anticholinergic drugs with PTNS improved the success without any added side effects. Karademir et al added 5 mg Oxybutinin to PTNS, and the success rate jumped from 61.6% to 83.2%.(24)
Conclusion:
TPTNS is well tolerated and effective especially when combined with low dose Trospium chloride. It improves the results without any added side effects. This way of treatment could be used after failure of behavioral therapy in females with idiopathic OAB. Nevertheless, studies with longer follow-up are still required.
Purpose: Transcutaneous Posterior Tibial Nerve Stimulation (TPTNS) using adhesive skin electrodes is not commonly used due to its low efficacy. Our objective was to verify whether the combination of TPTNS with low dose Trospium chloride in the treatment of females with overactive bladder (OAB) would be more effective than TPTNS alone after failure of behavioral therapy. Materials and Methods: We randomized 30 women with OAB, into two groups, 15 patients each: Group I received 30 minutes TPTNS, three times a week; Group II received TPTNS three times a week, plus Trospium chloride (20 mg once daily) for eight weeks. Patients were evaluated using Overactive Bladder Symptom Score questionnaire (OABSS), Impact Questionnaire-short form 7 …show more content…
(IIQ-7), 3 day voiding diary and urodynamics at weeks 0 and 8.
Results: After treatment both groups improved regarding all the parameters. OABSS was reduced significantly after treatment in both groups (P < 0.001) however group II showed more significant improvement. Before treatment, IIQ-7 score showed that none of the patients had good QoL. After treatment, 6 (40%) and 14 (93.3%) had good quality of life in Group I and Group II respectively. Voiding diary showed a significant decrease in frequency after treatment in group I and II (p = 0.003 and p = 0.001) respectively. The decrease was more significant in group II. In Cystometry bladder volume at first sensation showed a significant delay in group II (p = 0.001)
Conclusions: TPTNS combined with low dose Trospium chloride proved to be more effective than TPTNS alone in the treatment of OAB in females.
Introduction:
Overactive bladder (OAB) is defined as urinary urgency, usually with urinary frequency and nocturia, with or without urgency urinary incontinence.
(1)Antimuscarinic drugs have shown efficacy in the range of 70-75%.(2) A patient with refractory OAB is the one who failed several drug therapy for at least 4-6 weeks.(2)Side effects of antimuscarinic drugs include dry mouth, pruritus, headache, blurred vision, constipation, erythema, urine retention and fatigue. More than 70% of patients do not continue therapy beyond 9 months(3).
Electrical stimulation is one of the third line treatments in patients with refractory OAB.
In a short term study, posterior tibial nerve stimulation (PTNS) was found to have comparable effects to antimuscarinics with a better side effect profile.(4) PTNS has been used as a chronic treatment to improve OAB, with a success rate between 60 and 80%, while transcutaneous posterior tibial nerve stimulation (TPTNS) has a success rate of 48-68%(5).
PTNS requires placement of a fine-needle electrode into the inner aspect of theankle. This low-risk procedure has, however, common side effects, such as minor bleeding, mild pain, or skin inflammation at the treatment site(6). However, TPTNSis especially interesting because it might reproduce the effectiveness of PTNS while minimizing risk of infection, pain and bleeding beside being cost effective and suitable for adults and children.(7–10)Studies have demonstrated the potential efficacy of combination treatments(11)which led to the aim of this study,verifying whether the combination of TPTNS with low dose Trospium chloride in the treatment of females with idiopathic OAB would be more effective than TPTNS alone after failure of behavioral therapy.
Patients and …show more content…
methods:
We performed a prospective observational study of female patients with persistent OAB symptoms after failed first-line behavioral therapy from November 2014 to November 2015 at Alexandria University Hospital. Urological evaluation, 72 hours voiding diary, and urodynamic evaluation were done. We excluded patients with urinary tract infection, bladder outlet obstruction, neurological diseases, gynecological problems, pregnancy, electronic implants (pacemakers) and patients subject to seizures.
A written consent was obtained from patients. A Urostim 2 device and electrodes (Schwa-Medico, Rouffach, France) were used. Adhesive surface electrodes were applied, one above and behind the medial malleolus and the other 10 cm cephalad. Bipolar stimulation was set to a frequency of 10Hz, pulse duration of 250 microseconds and amplitude adjusted below the patient’s discomfort threshold. The protocol consisted of 3 stimulation weekly sessions, 30-minutes duration each. Group B received 20 mg oral daily dose of Trospium chloride in addition for eight weeks. Choosing Trospium chloride was due to being a large molecule quaternary amine with minimal central nervous system penetration and decreasing the dose to half to help decrease side effects.(12)
Standardized questionnaires at baseline and after 8weeks of treatment: the
Overactive Bladder Symptom Score (OABSS), Incontinence Impact Questionnaire-short form (IIQ-7) were used. Success was defined as an improvement in the scores and associated willingness of the patient to continue treatment. OABSS includes 3 categories (score < 5 = mild, 6-11 = moderate, > 12
= severe symptoms)(13), and the IIQ-7 includes 3 categories (score < 50% = good,
50-70% = moderate, and > 70 = poor QoL).(14)
Statistical analyses were performed using SPSS software version 20.For normally distributed data, comparison between two groups were done using independent t-test, paired t-test was used to analyze two paired data. For abnormally distributed data, comparison between two groups was done using Mann Whitney test. Wilcoxon signed ranks test was used to compare between pre- and post-treatment data. Significance of the obtained results was judged at the 5% level. McNemar test and test of marginal homogeneity were used to assess improvement.
Results
The mean patients age was 48 ±16.42 years for group I and 48.13 ±10.80 years for group II with no significant difference. OABSS was reduced significantly after treatment in both groups (P < 0.001) and the decrease was more in group II significantly (P = 0.024) (Table 1). Before treatment severe OAB symptoms were encountered in 26 patients (12 in group I and 14 in group II). After treatment only 4 patients had severe symptoms, all in group I (table 2). Before treatment there was no significant difference between both groups regarding the IIQ-7 score (P = 0.768). The mean values of the score decreased significantly after treatment in group I and II (p = 0.002 and p = 0.001) respectively. Patients in group II had more significant decrease in comparison with group I (p= 0.001) (Table 3).
The IIQ-7 score before treatment showed no patient with score < 50 (good QoL). After treatment 20 patients (6 in group I and 14 in group II) had score < 50. The IIQ-7 score in group I was downgraded in 6 patients to good QoLthe other hand, 14 patients in group II were downgraded to good QoL category. The change was significant for both groups (p=0.005 and p=0.001) respectively (Table 4).
Pre-treatment frequency was not significantly different in both groups (p = 0.679).
Voiding diary showed a reduction of frequency in group I (10.6 ± 2.32 Vs 13.13 ± 1.64) than in group II (8.6 ± 0.83 Vs 12.87 ± 1.85). This frequency decreased significantly after treatment in group I and II (p = 0.003 and p = 0.001) respectively. The decrease was more significant in group II (p = 0.006) (Table 5).
The mean voided volume in voiding diary increased significantly from 110.4 ± 14.92 to 138 ± 37.79 in group I, while the increase was more prominent in group II (178.6 ± 25.91 Vs 106.15 ± 13.12). The increase in voided volume was significant in both groups, but the increase was more significant in group II (p=0.005) (Table 6).
In cystometry, bladder volume at first sensation showed a significant delay in group II (p = 0.001) (Table 7). The pre-treatment cystometric capacity was almost similar in both groups (p = 0.339). After treatment, this volume increased significantly in both groups (p = 0.026 & p = 0.001) respectively. Group II had a significantly larger capacity than group I (p = 0.034) (Table 8).
Discussion:
Neuromodulation is considered a third line treatment of OAB.(15)PTNS is not used as a first line treatment due to its high cost and it is reserved for those who have OAB refractory to antimuscarinics.(16)Tibial nerve stimulation is effective, durable and minimally invasive. Some authors stated that it should be offered early in the course of OAB treatment.(17) We used TPTNS to evaluate its actual success rate as a primary treatment in OAB. Adding TENS to drug treatment is an attractive approach to improve the results and possibly allow lowering the dependence on pharmaceutical therapy alone, limiting side effects and positively impacting QoL. Anticholinergics can work synergistically with TENS due to different mechanisms of action.(18)
Pharmacological treatment with Trospium Chloride blocks muscarinic receptors that are responsible for vesical contractions.
TENS inhibits the detrusor by central reflex. Since the success rate of TPTNS is lower than the PTNS in the literature, we combined low dose anticholinergic (20 mg Trospium chloride) with it to enhance its success rate. Our aim was to save the patients from side effects of full dose anticholinergics. Trospium chloride is considered as one of the agents with fewer side effects.(19) Our patients did not report any side effects related to the small dose of the drug.
Investigators found that subjective improvement in symptoms and QoL scores is more important than the objective improvement.(20,21) According to another study PTNS subjects achieved statistically significant improvement in bladder symptoms with 54.5% reporting moderately or markedly improved responses from baseline Vs 20.9% of sham subjects.(20) In the present study both OABSS and IIQ-7 scores showed a significant improvement in both groups of patients but more in combination group.
In the present work, the voiding diary showed a more significant reduction of frequency in group I. Govier et al studied 53 patients, the reduction in the number of daytime urination was 25% and improvement of quality of life
was
21%.(6) In our study the mean voided volume in voiding diary increased category. Onsignificantly in both groups but was more prominent in group II. Other studies reported an increase in the voided volume after treatment.(20,22) Peters et al stated that, the voided volume increased from 150 ml to 186 ml.(22)
The volume at first sensation in the cystometry did not change significantly in group A, while a significant increase occurred in group II. Furthermore, group II had a larger cytometric capacity than group A. This could be due to synergistic effect of anticholinergic drug. The cystometric capacity increased significantly after treatment in both groups. Klinger et al reported an increase from 197 ml to
252 ml.(23) Ammi et al mentioned that the cystometric capacity is predictive for success.(21) Multimodal therapy by using anticholinergic drugs with PTNS improved the success without any added side effects. Karademir et al added 5 mg Oxybutinin to PTNS, and the success rate jumped from 61.6% to 83.2%.(24)
Conclusion:
TPTNS is well tolerated and effective especially when combined with low dose Trospium chloride. It improves the results without any added side effects. This way of treatment could be used after failure of behavioral therapy in females with idiopathic OAB. Nevertheless, studies with longer follow-up are still required.