|Year : 2020 | Volume
| Issue : 3 | Page : 427-432
Posterior tibial nerve stimulation vs trospium chloride in treatment of overactive bladder in elderly women
Islam A Elshora, Amany A Soliman, Sayeda I Ali
Department of Urology, Al Azhar Faculty of Medicine, Cairo, Egypt
|Date of Submission||07-Jun-2020|
|Date of Decision||22-Jun-2020|
|Date of Acceptance||23-Jun-2020|
|Date of Web Publication||2-Oct-2020|
MD Amany A Soliman
Department of Urology, Al Azhar Faculty of Medicine, Cairo, 19333
Source of Support: None, Conflict of Interest: None
Objective This study aimed to assess the outcome of posterior tibial nerve (PTN) stimulation vs trospium chloride in the treatment of overactive bladder syndrome (OAB) in elderly women regarding safety and efficacy.
Patients and methods A prospective randomized study was done on 30 postmenopausal women presented with OAB symptoms (wet or dry) in Al-Zahraa University Hospital from March 2019 to March 2020. Patients were classified into two groups. Group Ι included 15 patients who received trospium chloride. Group ΙΙ included 15 patients who were managed by percutaneous posterior tibial nerve stimulation (PTNS). The authors compared the patients in both groups for OAB symptoms (urgency, frequency, nocturia, and urge urinary incontinence) at 4, 8, and 12 weeks, and for urodynamic parameters at the beginning and the end of treatment.
Results There was a statistically significant improvement regarding OAB symptoms and urodynamic parameters at the end of the treatment, with no significant difference between both groups. However, the adverse effects were observed mainly with trospium chloride group (dry mouth, constipation, and headache), which were not detected in the PTNS group.
Conclusion The authors concluded that trospium chloride and PTN stimulation had the same effect in the treatment of OAB symptoms, and the two lines of treatment are effective and can be used safely in patients with OAB syndrome. However, PTNS is safe, and associated with significant improvement of OAB symptoms, with no significant adverse effect in comparison with trospium chloride, which led to discontinuation of treatment. However, initial studies showed promise. A more comprehensive evaluation of PTNS is needed to support its universal use for the treatment of OAB syndrome.
Keywords: overactive bladder, posterior tibial nerve stimulation, trospium chloride
|How to cite this article:|
Elshora IA, Soliman AA, Ali SI. Posterior tibial nerve stimulation vs trospium chloride in treatment of overactive bladder in elderly women. Sci J Al-Azhar Med Fac Girls 2020;4:427-32
|How to cite this URL:|
Elshora IA, Soliman AA, Ali SI. Posterior tibial nerve stimulation vs trospium chloride in treatment of overactive bladder in elderly women. Sci J Al-Azhar Med Fac Girls [serial online] 2020 [cited 2020 Oct 26];4:427-32. Available from: http://www.sjamf.eg.net/text.asp?2020/4/3/427/296952
| Introduction|| |
Overactive bladder syndrome (OAB) was defined by the International Continence Society as ‘urgency with or without urge incontinence, usually with frequency and nocturia in the absence of urinary infection or another identifiable disease’ .
The incidence of this syndrome in adults varies between 12 and 17% and increases with age. In Europe, the prevalence ranges from 12 to 22%, in the USA is around 16%, and in Spain, it is 21% . OAB affects the patient’s quality of life, mainly when the patients present with symptoms of bladder filling, such as micturition urgency and its associated urge incontinence. The conventional first-line treatment for OAB is behavioral therapy and anticholinergics drugs. The medications that are approved in the USA to treat OAB include oxybutynin, tolterodine, solifenacin, darifenacin, trospium chloride, and fesoterodine.
Oxybutynin was the first medication used in the treatment of OAB and is still the most studied anticholinergic medication for OAB. However, a high incidence of adverse effects, such as dry mouth, constipation, blurred vision, and cognitive impairment associated with immediate-release oxybutynin led to the development of newer anticholinergic medication with the same effectiveness and improved tolerability . These newer agents are typified by their affinity for a particular muscarinic receptor subtype, their ability to cross the blood–brain barrier, or their unique metabolism and excretion. Trospium chloride, which was approved for the treatment of OAB, markedly improves the OAB symptoms and urodynamic parameters with fewer adverse effects (anticholinergics and central nervous system adverse effects) .
Although anticholinergic medication is the first-line treatment for patients with OAB symptoms, a significant percentage of patients do not respond to this treatment owing either to lack of adherence or lack of efficacy or tolerability . So, alternative lines of treating can be used . For thousands of years, acupuncture has a role in the traditional Chinese medicine, which was used in the treatment of lower urinary tract (LUT) dysfunctions such as enuresis, incontinence, frequency, dysuria, and retention of urine that act on the S6 region located in the posterior border of the tibia, 5 cm above the tibial malleolus . Information on the afferent nerves arising from the posterior tibial nerve (PTN) to the sacral center of micturition has facilitated the evaluation of percutaneous posterior tibial nerve stimulation (PTNS) for treatment of OAB symptoms .
Inhibition of detrusor overactivity (DO) by peripheral neuromodulation of the PTN was first described by McGuire . There was a 60–80% response rate after 10–12 weekly treatments with PTNS .
| Patients and methods|| |
A prospective intervention therapeutic clinical trial study was conducted on 30 postmenopausal female patients who had OABs [urinary urgency, frequency, nocturia, and/or urge urinary incontinence (UUI)] with no prior treatment with anticholinergic drugs or PTNS. Patients were recruited from the Outpatient Urology Clinics at Al-Zahraa University Hospital from March 2019 to March 2020. Patients are randomly classified into two groups. Group Ι included 15 patients who received trospium hydrochloride (Trospamexin 20 mg tablet). Group ΙΙ include 15 patients who underwent PTNS. All patients met the inclusion criteria and were willing to participate in the study. Patients with a history of pelvic surgery, patients with neurological deficit, patients with peripheral neuropathy that may cause neurogenic bladder, patients who received anticholinergic medication, pregnancy or suspicion of pregnancy, patients with cardiac pacemaker, and patients with genitourinary infection were excluded from the study. Approval of the Ethical Committee of Al-Zahraa University Authority and written informed consent from all patients were obtained. A detailed history was taken about the complaint of the patient regarding duration of the symptoms, the severity of frequency, nocturia, urgency, urinary incontinence, and any associated symptoms such as dysuria, hematuria, or stress urinary incontinence. All patients underwent neurological and urological examination, urine analysis, and urine culture and sensitivity to exclude cystitis, which may cause DO. The also underwent abdominopelvic ultrasound to evaluate the urinary tract and measure post-voiding residual urine. Moreover, urodynamic study (Ellipse ANDROMEDA Medical Systems, Taufkirchen, Germany) (filling and voiding cystometric study) was performed after appropriate antimicrobial therapy when infection was diagnosed by urine culture, to the evaluated volume at first desire to void, maximal detrusor pressure, bladder capacity, and compliance during filling cystometry. We compared the patients in both groups for OAB symptoms (urgency, frequency, nocturia, and urge urinary incontinence) at 4, 8, 12 weeks, urodynamic parameters at the beginning and the end of treatment, and for present or absent of adverse effects.
Patients in group I received trospium hydrochloride for twelve weeks at a dose of 40 mg/day, 20 mg in the mornings and 20 mg in the evenings.
Patients in group II underwent PTNS for 12 weeks, 1–3 times a week, and each session lasted for 30 min using the Urgent PC Neuromodulation System which is a combination of reusable Urgent PC stimulator and disposable Lead Set. PTNS was done in a supine position with the medial malleolus pointing upward. A 34-G stainless steel needle is inserted three fingerbreadths (5 cm) above the medial malleolus, between the posterior margin of the tibia and soleus muscle. The aim is to place the tip of the needle close to the PTN without actually touching it. The insertion depth is about 2–4 cm with angulations of 60–90°. A stick electrode is placed on the ipsilateral extremity near the arch of the foot. The needle and the electrode are then connected to a low-voltage (9 V) Urgent PC stimulator with an adjustable pulse intensity of 0–9 mA, a fixed pulse width of 200 μs, and a pulse rate of 20 Hz. Stimulation of the PTN has an effect on both efferent and afferent nerve fibers. Flexion of the great toe, or fanning, is a result of an efferent effect. The sensory afferent effect is a radiation tickling sensation of the foot sole. During the initial test stimulation, the amplitude is slowly and increased gradually until the large toe starts to curl, or toes start to fan. Needle repositioning or reinsertion at the ipsilateral or contralateral ankle was done when the patient complained of discomfort at the needle site. Once the optimal position is assured, stimulation is applied at an intensity level well tolerated by the patient and can be increased or decreased during the treatment.
Data were analyzed by Microsoft Office 2010 (excel) and Statistical Package for the Social Sciences version 20. P value more than 0.05 is considered nonsignificant. P value less than or equal to 0.05 is considered significant. P value less than or equal to 0.01 is considered highly significant.
| Results|| |
This prospective randomized study was conducted on 30 postmenopausal patients referred to the outpatient clinic of Al-Zahraa University Hospital with OABs (urgency, frequency, nocturia, and/or UUI). In this study, we compared the effect of trospium chloride and PTNS on patients with OAB regarding symptoms and urodynamic parameters.
There were no statistically significant differences between the two groups regarding age, BMI, type of overactivity (dry and wet), and duration of symptoms (P=0.473, 0.522, 0.487, and 0.545, respectively) ([Table 1]).
There was a significant improvement in symptoms of OAB after treatment with trospium chloride (P=0.042, 0.051, 0.052, and 0.052 for frequency, urgency, nocturia, and UUI, respectively) ([Table 2]).
|Table 2 Comparison between symptoms of overactive bladder syndrome before and after treatment with trospium chloride (group I)|
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There was a significant gradually improvement in symptoms of OAB after treatment with posterior tibial nerve stimulation till the end of study in group II (P=0.051, 0.051, 0.052, and 0.051 for frequency, urgency, nocturia, and UUI, respectively) ([Table 3]).
|Table 3 Comparison between symptoms of overactive bladder syndrome before and after treatment with percutaneous posterior tibial nerve stimulation (group II)|
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Urodynamic findings of group I showed statistically significant differences between pre- and post-treatment parameters.
There was an increase in volume at first desire with decrease in maximum detrusor pressure and increased cystometric capacity of the bladder [P=0.002, 0.032, and 0.001 for first desire,maximum detrusor pressure (MDP), and capacity, respectively] ([Table 4]).
|Table 4 Comparison between urodynamic findings before and after treatment with trospium chloride (group I)|
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Regarding group II, there was also a statistically significant difference between pre- and posttreatment parameters of urodynamic findings.
There was an increase in volume at first desire with decrease in maximum detrusor pressure and increased cystometric capacity of the bladder (P=0.001, 0.031, 0.000 for 1st desire, MDP, and capacity, respectively), as shown in [Table 5].
|Table 5 Comparison between urodynamic findings before and after treatment with percutaneous posterior tibial nerve stimulation (group II)|
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There were no statistically significant differences between symptoms of OAB in both groups at the end of our study (P=0.538, 0.632, 0.433, and 0.834 for frequency, urgency, nocturia, and UUI, respectively), as shown in [Table 6].
|Table 6 Symptoms of overactive bladder syndrome in the two groups at the end of study|
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There were no statistically significant differences between the parameters of urodynamics in two groups at the end of our study, as shown in [Table 7].
|Table 7 Comparison between the results of urodynamic parameters in the two groups at the end of the study|
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Regarding complications, in group I, some patients complained of dry mouth, constipation, and headache, but in group II, these complications were absent except for minimal bleeding and discomfort at the site of puncture, as shown in [Figure 1].
|Figure 1 Soliman AA. Posterior tibial nerve stimulation vs trospium chloride in treatment of overactive bladder in elderly women. Sci J Al Azhar Med Fac Girls YEAR;VOL;PG_start-PG_END.|
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| Discussion|| |
OAB syndrome is a common condition with an effect on physical, psychological, and social well-being. Moreover, it is an important economic burden to health services . The main treatment goal of OAB is to inhibit DO and thus to increase functional bladder capacity .
Our study was done to evaluate the effect of trospium chloride and electrical stimulation of a PTN in patients with OAB syndrome as related to symptoms and urodynamic parameters and showed significant improvements in both groups, with no significant differences between them.
Trospium chloride has three chemical and pharmacokinetic properties unique among anticholinergics agents: it is a positively charged quaternary ammonium compound with minimal central nervous system penetration; it is not metabolized by the cytochrome P450 system, resulting in a lower tendency for drug interactions; and it is excreted mainly unchanged in the urine as the active parent compound, providing local activity to achieve early onset of clinical effect and prolonged efficacy .
Our study revealed significant improvement of subjective and objective response regarding OAB symptoms (P=0.042) in group 1, in which patients were treated by trospium chloride. Our results agreed with a study conducted on 37 patients with observed declines in voiding parameters and urgency severity following the termination of treatment in the trospium hydrochloride group .
Regarding urodynamic parameters, there was a significant statistical increase in volume at first desire to micturate, decrease in maximal detrusor pressure, and increased in cystometric capacity in patients treated with trospium chloride (P=0.002, 0.031, and 0.001 for first desire, MDP, and capacity, respectively). In a 12-week, randomized, placebo-controlled clinical study in patients with OAB syndrome, trospium chloride 20 mg twice daily was more effective than placebo in decreasing the number of micturition per 24 h and the number of urge incontinence episodes per week, and increasing the volume of urine voided per micturition, which agree with our results .
Another study showed significant improvement in urodynamic parameters of patients with OAB syndrome after the treatment, but the cognitive functions did not change. The analysis of hierarchical and simultaneous regressions made it possible to establish that the predictor variables significantly influencing medication adherence of elderly women with OAB to trospium chloride treatment are executive function and working memory composite .
PTN stimulation is an alternative technique for the treatment of OAB syndrome, which is effective with no adverse effects of the anticholinergic medication. Despite medical treatment being the first line for the management of OAB, the adherence to medication is difficult owing to its adverse effects. PTNS is simple, minimally invasive, and easy to be applied, and well tolerated by patients.
The PTN is a mixed nerve containing sensory and motor fibers. The correct adjustment of the needle electrode produces a motor and sensory response. Centrally the PTN projects to the sacral spinal cord in the same area where the bladder projection is located. The sacral micturition center and the Onuf nucleus are most probably the areas where the therapeutic effect of neuromodulation of the bladder by PTN stimulation occurred .
Our study showed clinically significant improvements in all measured values in patients treated by PTNS, regarding frequency, urgency, nocturia, and UUI (P=0.051). In comparison, Vandoninck et al.  reported a subjective response in 64% and an objective response in 57% of their patients (defined as ≥50% reduction in urinary leakage episodes per 24 h) . Another study reported statistically significant improvements in daytime frequency, daytime voiding volume, and night-time frequency in patients treated by PTN stimulation, which was done on 26 women with frequency or urgency. Overall, 12% rated the results as excellent, 65% as favorable, 15% as fair, and 8% considered there was no difference .Finally, PTN stimulation and trospium hydrochloride were effective similarly in patients with OAB syndrome, and thus the continuation of these two treatments is important because the discontinuation of these treatments would cause a relapse of most of the symptoms of OAB syndrome. So, further studies are needed to compare the effects as well as the superiority of one treatment over the other in long-term use.
| Conclusion|| |
We concluded that trospium chloride and PTN stimulation had the same effect in the treatment of OAB symptoms and the two lines of treatment are effective and can be used safely in patients with OAB syndrome. However, PTNS is safe and is associated with significant improvement of OAB symptoms, with no significant adverse effect in comparison with trospium chloride, which led to discontinuation of treatment. However, initial studies have shown promise, and a more comprehensive evaluation of PTN stimulation is needed to support its universal use for the treatment of OAB syndrome.
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Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7]