Beac IntelliSTIM Perineal Incontinence Electrostimulator BE-28UG

The BECA 28UG perineal electrostimulator is a therapeutic unit for the treatment of incontinence, by means of perineal electrostimulation, for professional or personal use.

Intellistim 28UG perineal electrostimulation by BEAC, using vaginal or anal probes, is the treatment of choice in many cases of urinary incontinence.

The possibility of integrating professional treatment with home sessions is often decisive for therapeutic success.

The IntelliSTIM UG unit, although equipped with the sophisticated features and functional flexibility required by professional use, is also easy to use directly, by the patient.

- Large LCD display
- Simple and intuitive operation
- 4 free programs
- 11 selectable programs, suitable for different incontinence treatments.
- IntelliSTIM function with automatic interactive adjustment of time parameters
- Display of all parameters and possibility of modification during the session
- 2 waveforms can be selected for use with ring or rod probes.

The device is able to perform, by purchasing the alettrodes, tibial stimulation for the treatment of pelvic problems.

Non-invasive Transcutaneous Electrical Stimulation in the Treatment of Overactive Bladder

Abstract

We reviewed the literature on transcutaneous electrical nerve stimulation (TENS) used as therapy for overactive bladder symptoms (OAB), with a particular focus on: stimulation site, stimuli parameters, neural structures thought to be targeted, and clinical and urodynamic outcomes achieved. Most studies have used sacral or tibial nerve stimulation. The literature suggests that while TENS therapy may have neuromodulatory effects, the patient is unlikely to benefit significantly from a single application of TENS, and in fact clear benefits from acute studies have not been reported. In long-term studies there were differences in descriptions of stimulation intensity, therapy strategy and electrode placement, as well as in the various symptoms and pathology of the patients. In addition, most of the studies were uncontrolled and therefore did not evaluate the placebo effect. Little is known about the basic mechanism by which these therapies work and therefore exactly which structures need to be stimulated, and with what parameters. There is promising evidence for the efficacy of a transcutaneous stimulation approach, but appropriate standardization of stimulation criteria and outcome measures will be needed to define the best way to manage this therapy and document its efficacy.

1. Introduction

Overactive bladder syndrome (OAB) symptoms is a well-recognized set of symptoms that patient experience during the phase of the cycle of urination. It is characterized by urgency (a sudden urge to urinate that is difficult to postpone) which, in almost all patients, is accompanied by an increase in frequency and nocturia and, particularly in female patients, by urge incontinence [1] . About one-third of female patients are severely disturbed by urinary incontinence [2] .

Electrical stimulation has been used for several decades in the treatment of various lower urinary tract dysfunctions. The Finetech-Bridley sacral stimulator established anterior root [3] , an implanted electrical sacral roots (S ₂ -S ₄ ) stimulator to aid bladder emptying, formed a precursor to today's widespread sacral neuromodulation techniques [4]  and [5 ] . I S ₂ -S ₄ Nerve roots supply the motor power principle to the bladder. In particular, the S ₃ root mainly innervates the detrusor muscle and is the main target of sacral neuromodulation.

Another important and well-established site of stimulation is that of the posterior tibial nerve (PTN). The PTN is a mixed nerve containing L ₅ -S ₃ fibers, again coming from the same spinal segments as the parasympathetic innervations to the bladder (S ₂ -S ₄ ). The Afferent Nerve Stimulator Stoller (SANS) was introduced, to stimulate PTN using a 34-gauge electrode inserted in the same place and used in electro acupuncture (the so-called SP6 point), with a surface electrode placed behind the medial malleolus [ 6] . Currently a commercial device (Urgent-PC, Uroplasty, Inc., Minnetonka, USA) uses this technique. Usually 12 sessions of the posterior percutaneous tibial nerve stimulation (PTNS), at weekly intervals, are used and a large randomized placebo-controlled trial showed significant improvement in overall OAB symptoms (60/110) compared to shams (23/110) [7] . It has been shown that PTNS responders can continue to benefit from therapy for more than 12 months [8] . The exact mechanism of PTNS remains unclear multidisciplinary studies and further studies are needed to clarify this.

For the purposes of this review we are going to consider non-invasive techniques only, defined as "a procedure that does not involve the introduction of an instrument into the body". In addition, we also define transcutaneous electrical nerve stimulation (TENS) as a technique in which electrical stimuli are passed through intact skin.

The main reason to focus on this mode is that it has a number of practical benefits in its delivery. The method is completely non-invasive, with surface electrodes attached to a battery operated on a low-cost stimulator and applied to an appropriate site in the body. Stimulators are easy to use with non-expensive, usually hydrogel-based, electrode and battery based that are the only cost of ongoing treatment. TENS treatment itself should not require regular visits of patients to clinics and is usually self-administered at home, which is convenient for the patient. In general there are little to no side effects by the dozens, although sometimes redness or irritation of the skin can occur around the electrodes which resolves once the stimulation session is over. TENS has also been used for several decades for pain control. The use of TENS in the treatment of OAB and lower urinary tract disease is less well established.

Other minimally invasive electrical stimulation techniques such as: plugs, anal vaginal stimulation [9]  and  [10] ; percutaneous stimulation (needle is inserted near a targeted nerve); or implanted stimulation devices are beyond the scope of this review [4]  and  [5] . In particular, the thorns are often rejected by the patient due to embarrassment and a sense of impure liness [11] .

The dorsal genital nerve was used as another site of stimulation [10] using surface electrodes to provide stimuli. However, because this review focuses on techniques that are convenient for patients, we have not examined these studies in detail.

2. Methods

We searched the PubMed electronic database from the beginning until December 2013. The search terms used were "urge incontinence", "urgency", "overactive bladder", "urinary incontinence" or "detrusor instability" in combination with "electrical stimulation", "tens", "tens", "nerve stimulation", "neuromodulation surface", "non-invasive stimulation", "test" or "study". In addition, we followed up on citations from primary references to relevant articles that the database could not locate. The exclusion criteria were: studies that were not in English; faecal incontinence treatment studies; those involving children, those studying animal models; those involving percutaneous electrical stimulation, anal stimulation, vaginal/penile stimulation or implanted devices or those that did not focus primarily on storage symptoms. A flowchart of the selection process is shown in Fig. 1.

Figure 1. 

Flowchart of the paper sorting process.

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3. Results

Primary research identified 410 items. Using the defined exclusion criteria we reviewed 16 articles in detail. We have not specifically reviewed studies with a higher concentration on interstitial cystitis or incapacitating dysfunction although these are mentioned, if any.

3.1. sacral stimulation

In 1996 Hasan et al. [12] S Respect ₃ neuromodulation using implanted devices with TENS applied to the perianal region (S ₂ -S ₃ dermatomes). Improvement in more than 50% of idiopathic detrusor patients suggested the potential of using TENS at a sacral site.

In a study by Walsh et al. [13] 1 week from continuous stimulation for 12 hours a day at S ₃ Dermatomes greatly improved both frequency and nocturia. However, only 3 to 32 patients continued with therapy, and only on an intermittent basis, during up to 6 months of follow-up. The authors did not assess whether patients found with TENS for day 12 was uncomfortable and potentially led to discontinuation of therapy.

Following this study, a urodynamically estimated group of 33 patients suffering from detrusor overactivity and symptoms of OAB reported similar effects for self-administered stimulation over the sacral locus twice daily compared to oxybutynin in a 14-week crossover study (6 w stimulation +2 washout w +6 w stimulation) [14] . The stimulation group also reported far fewer side effects in a comparison of oxybutynin. The authors did not specifically document a certain degree of difficulty in applying stimulation in 30% of patients. This may reflect the inconvenience of placing electrodes on S ₂ -S ₃ dermatomes or the length of the daily treatment session (up to 6 h).

A heterogeneous group of neurogenic patients with urinary symptoms were studied in a non-randomized trial using a TENS machine with electrodes placed over the natal fissure twice daily in a home setting [15] . Nineteen of 44 patients decided to keep the machine after this trial, consistent with the reported beneficial effect treatment size.

Another small study of 18 patients (7 neurogenic bladder, 5 OAB, 6 nocturia) reported an improvement in 10/18 after 1 month of stimulation on the posterior sacral foramen [11] . The authors suggested that this type of therapy causes less discomfort than vaginal spine or anal stimulation. However, in contradiction to this statement, they reported that in some cases, the intensity was not set to a high enough level to produce significant effects in all patients.

3.2. Posterior tibial nerve stimulation (PTNS)

McGuire et al. [16] Peripheral electrical stimulation is used first to stimulate the PTN. In this initial study an anodal electrode was placed on the common peroneal nerve or PTN and a cathode electrode was placed over the contralateral equivalent site. They reported positive results in 8/11 detrusor hyperactivity patients who became dry after treatment, and in seven patients with neurological disease (multiple sclerosis, spinal cord injury) of whom five became dry or improved. Following this, the SANS and subsequently the Urgent PC device established a substantial evidence base using the percutaneous approach to stimulate PTN, although a different location from McGuire et al. was used. Further studies of either percutaneous or transcutaneous posterior tibial nerve stimulation (TPTNS) have used electrodes placed on the same area as the SANS (Fig. 2) [6] . So TPTNS could be a plausible and potentially attractive treatment option based on the available evidence for its efficacy in percutaneous form.

Figure 2. 

Location of electrodes for transcutaneous posterior tibial nerve stimulation (TPTNS). The stimulation can be delivered using a conventional transcutaneous electrical nerve stimulation (TENS) machine.

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The personal efficacy of TPTNS and oxybutynin versus control was studied in 28 women with OAB [17] . TPTNS has been described as improving subjective symptoms without adverse events, but more robust assessment tools and careful documentation of the etiopathology of the patients studied would be needed to draw more detailed conclusions.

Significant improvement in older women with urge urinary incontinence was reported after 12 weeks (once weekly) of stimulation in combination with Kegel exercise and bladder formation [18] . However, this effect was not superior to patients in a group receiving no stimulus.

In a self-administered TPTNS non-randomized trial 83% of multiple sclerosis (MS) patients reported clinical improvement in urgency [19] . This study also confirmed a good patient acceptance of the therapy in their family environment.

In a placebo-controlled study, 37 women with symptoms of idiopathic OAB were randomized to either a treatment or sham group with electrodes placed in the same place for both groups [20] . Urinary frequency significantly improved, both in the treatment group ( p  = 0.002) and in the sham group ( p  = 0.025). A statistically significant difference between the groups was not reached, a possible confounding factor being the unequal basal frequency urination (13,88 Vs. 11.35 per day).

3.3. Other Electrical Stimulation Sites

One of the first techniques for treating poor urinary tract storage stimulated suprapubic region in patients with painful bladder syndrome [21]  and  [22] . This method has been used to relieve abdominal pain, similar to the principle of TENS when used for pain relief supposedly. Frequency Subsequently these patients also experienced reduced urinary [22] . Two subsequent studies documented an improvement in urodynamic parameters in patients with detrusor hyperactivity (DO), sensory urgency, or neurogenic problems. However, based on the literature, the efficacy of stimulation of a suprapubic site in patients with OAB symptoms is not demonstrated [23]  and  [24] .

Another reported approach used stimulation of the thigh muscle in patients with spinal cord injuries to relieve spasticity. In some of these cases, this has led to improvements in urge incontinence [25] and an increase in maximum cystometry capacity (MCC) and reduced maximum detrusor pressure (MDP) [26]  and  [27] . In addition to this, 6/19 patients reported clinical improvement in urinary incontinence and the frequency extends for 3 months after treatment [26] .

Based on this, at best limited evidence for stimulation at other sites, the most logical approach to be used in transcutaneous electrical stimulation techniques appears to be a sacral stimulus or PTNS as they are directly or indirectly addressed, the S ₃ spinal cord root.

3.4. Are acute stimulation effects of clinical significance?

An obvious approach to answer this question would be to evaluate the efficacy of electrical stimulation in suppressing detrusor hyperactivity (DO), chosen because it presents in many patients with OAB symptoms [28] . This led the researchers to investigate the acute effects of electrical stimulation during a urodynamics study.

One hundred and forty-six patients with idiopathic detrusor instability (IDI), sensory urgency, or DO secondary to neurogenic diseases showed improvements in MCC ( p  = 0.0009) compared to controls (without stimulation) when stimulation was applied over the course of the S ₃ Dermatomes [ 29] . Similarly Hasan et al. [12] stimulation of the same sham site and control groups. However, the comparison of suprapubic, sacral, and sham stimulation from Bower et al. [23] have not clearly demonstrated these immediate effects on MCC. The authors concluded that the improvement observed in the first void craving (FDV) in patients may not be functionally important, although a significant reduction in maximum detrusor pressure may suggest potential efficacy in DO. Another approach used conditional stimulation to suppress bladder contractions in 12 MS patients with detrusor neurogenic hyperactivity (NDO) at a sacred site [30] and in eight MS patients at the PTN [31] using a needle electrode. Unfortunately, none of these patients had a positive response to dorsal penile stimulation in which 10/12 patients were able to suppress the contraction of the detrusor [30] . The dorsal nerve of the penis is a division of the pudendal nerve, and similar effects of electrical stimulation have been shown when stimulating the pudendal nerve in both other studies in humans [32]  and  [33] and in animal cat models [34]  and  [35] . This nerve is a deep nerve in the pelvic region. Although it has been suggested that it could be targeted using surface electrodes and a specific stimulation waveform[34]  and  [35] We were able to demonstrate the benefits of this waveform over a conventional pacing waveform [36] . So it would seem that this nerve can only be targeted with implanted electrodes, needle electrodes or in the current state.

Similarly inconsistent effects apply for acute TPTNS studies, although Amarenco et al. [37] reported positive results in half of the neurological disease of the patients studied (MS, SCI, Parkinson's disease). These patients showed a 50% improvement in volume at the first detrusor contraction and/or MCC of more than 50% of baseline. A previous urodynamic study showed no significant differences in any of the urodynamic parameters in 36 patients with detrusor hyperactivity [12] . This different result could perhaps be due to different pathologies observed in patients.

Neither approach to seeking acute effects, either at a stimulant site, has clearly and firmly demonstrated efficacy. However, the balance of literature indicates that patients may benefit from neuromodulation effects that could result from repeated stimulation sessions, rather than a single application. In addition, de Seze et al. [19] concluded that the treatment may also be effective in patients who did not respond to an initial acute TTNS applied during urodynamic testing.

4. Discussion

4.1. What stimulation parameters?

The literature on the stimulation parameters used is summarized in Table 1, Table 2 and Table 3. The position of the electrodes and the range of stimulus parameters are likely to be critical factors in all forms of stimulation. Relevant stimulus parameters include pulse width; pulse repetition rate; burst length (if applicable) and intensity of the stimulus (preferably referred to as current as voltage stimulation coupled with uncertain impedance electrode-tissue interface leads to uncertainty regarding the strength of the stimulus provided). The technical description of the stimuli used in some studies does not give all these details.

Table 1.

Literature review the clinical and urodynamic effects of TENS during long-term application.

DH, detrusor hyperreflexia; IC, interstitial cystitis; IDI, idiopathic detrusor instability; IDO, idiopathic detrusor hyperactivity; IVD, irritating dysfunction emptying; MCC, maximum cystometry capacity; MHU, Mesure du Handicap urinaire; MS, multiple sclerosis; OAB, overactive bladder; PTN, posterior tibial nerve; SCI, spinal cord injuries; SU, sensory urgency; UUI, urinary urge incontinence.

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Table 2.

Literature review the acute urodynamic effects of TENS.

DH, detrusor hyperreflexia; DI, detrusor instability; DPN, dorsal penis/clitoral nerve; FDV, first desire to urinate; FIDC, first involuntary contraction of the detrusor muscle; IDI, idiopathic detrusor instability; MCC, maximum cystometry capacity; MS, multiple sclerosis; PD, Parkinson's disease; PTN, posterior tibial nerve; SCI, spinal cord injuries; SU, sensory urgency.

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Table 3.

Summary of studies reviewed according to their type and site of stimulation.

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To achieve sacral stimulation Yokozuka et al. [11] Patients tasked with placing surface electrodes on the posterior sacral foramen and to increase the stimulation intensity until an anal contraction could be felt. They hypothesized that, in cases where there was no improvement, electrodes were not placed in the correct position or the intensity was not high enough due to associated discomfort. There is support for Takahashi and Tanaka [38] in which slight changes in the position of the electrodes produced noticeable apparent changes in the urethral pressure response [11] . Sacral stimulation studies reported to date usually have electrodes placed in sacral holes or on the buttocks above the S ₂ and S ₃dermatomes. The precise placement of electrodes on sacred sites varies between studies, presumably because the location of sacral dermatomes is uncertain [39]  and  [40] . The intensity of the stimulation current was usually set at a maximum dictated by the pain threshold. In other studies, patients were instructed to set an intensity that produced a tickling sensation [12] , [14]  and  [15] . Nerve trunks (roots) in these areas are located deep within the foramina and it is unlikely that these were directly stimulated at the level of the intensity of the stimulus in use. However, the cutaneous nerves in dermatomes are easy to stimulate and therefore superficial stimulation of sensory fibers, which can lead to both direct and indirect modulation of spinal cord reflex mechanisms, may explain the reported effects. In addition, the intensity that produces contraction of the anal sphincter [11] it involves the stimulation of motor nerves, thus activating different mechanisms and indeed can cause considerable discomfort to patients. Clarification of the exact site of stimulation and the required intensity should be addressed in future work. Based on the available evidence, we are not able to conclude which are the best stimulation parameters to use for sacral stimulation. The original description of PTNS by McGuire et al. [16] It was not repeated in terms of the position of the electrodes. Most studies place the electrodes near the medial malleolus, where the PTN is relatively superficial. It is unclear on which leg the electrodes need to be placed on for optimal response, and whether this is important; some authors placed electrodes on the left leg [17] , [20]  and  [37] , while others on the right leg [18] , [19]  and  [31] . It may also be more effective for placing electrodes bilaterally, although no studies have yet looked at this. In describing the current intensity setting, some of the studies presented motor responses during stimulation [17]  and  [18] . In other studies, the stimulation intensity was set to be just below the motor threshold [37] or just above the threshold of perception [19] .

The study reporting the most promising therapeutic results is that of de Seze et al. [19] , which reported successful PTNS for OAB symptoms in MS patients. Stimulation intensity in this study was set behind the threshold of perception and patients reported no motor responses following stimulation. So only sensory fibers or skin nerves overlying the PTN were likely stimulated, which suggests this may be sufficient for the treatment of OAB. If the treatment is self-administered, it is likely that the patient would prefer lower stimulation levels, which can then lead to stimulation of the cutaneous nerves alone rather than the posterior tibial nerve itself.

4.2. Sham stimulation methodology

Research of possible placebo effects is probably essential in the study of new therapies and this is particularly the case with electrical stimulation techniques because of the sensations they cause. However, because of these sensations, the production of sham electrical stimulation can be difficult. An interesting methodology for sham was carried out in a study of children with OAB, where, in one arm of the study, stimulation was applied over the scapula, where effects on lower urinary tract control would be expected to occur [41] . Similarly Hasan et al. [12] TENS applied above the T ₁₂ dermatome that acted as a placebo.

Electrical stimulation below motor threshold levels causes tingling sensations due to stimulation of the skin's sensory nerve structures. An alternative option for a sham methodology may be to gradually decrease the stimulation intensity to zero after a few seconds of use and to indicate to the subject that the sensational stimuli may fade with time. This is an approach widely used in techniques such as transcranial current stimulation [42] . In addition, the subject may adapt to such stimuli that they are not really able to recognize whether the stimulation persists or not. This habituation is likely to depend on the frequency of stimulation used, the strength of the stimuli applied and on personal subjective responses.

Another approach in placebo effect investigations could be to apply the electrodes to the same area of the skin, but without the stimulation current using stimulators modified for this purpose [43] . However, this assumes that the patient must be naïve from electrical stimulation and therefore without knowing that it causes sensation.

Leroi et al. [44] A randomized SHAM controlled trial performed in which patients were not told that they could receive the sham stimulation. Patients were randomized into active and sham stimulus groups. This methodology was approved by their local ethics committee, although the editors of the journal in which they are subsequently published strongly discourage investigators from using such methodology as they thought it might represent a violation of the Declaration of Helsinki. We think that this is a justifiable approach to overcome the technical problems of fictitious stimuli subject to it at the appropriate ethics committee approval stage. However, the benefit to the patient of such an arrangement must be considered and the offer of active treatment, after the study could address this issue.

5. Conclusion

The choice of stimulation parameters, the location of the stimulation applied, the outcome measures used, and the underlying conditions and symptoms studied are very different in the literature to date. There is little long-term follow-up data published in the literature and therefore the treatment regimen producing ongoing benefits is unclear.

The current consensus is that the most promising site of stimulation is S ₃ area of the spinal cord on the sacral region or above the posterior tibial nerve, but it is unclear which stimulus delivery approach is the most effective. Little is known about the mechanisms underlying action and that exact structures need to be stimulated.

However there is tantalizing evidence for the effectiveness of the transcutaneous stimulation approach, although further large placebo-controlled trials are required to provide a solid knowledge base. The standardization of the future process methodology is important to allow comparisons between studies and stimulation protocols.

- Power supply: 2 x 1.5 V AA alkaline batteries (LR6);
- Output: 100 mApp on 1000 Ohm load (with 200mS pulses)
- Pulse width: From 50mS to 400mS adjustable in 50mS steps
- Frequency: 1Hz to 150Hz (1-2-3-4-5-10-12-14-16-18-20-25-30-35-40-45-50-60-70-80-90-100-110-120-130-140-150).
- Waveform: Symmetrical Biphasic Pulses - Alternating Biphasic Pulses.
- Treatment timer: Continuous, 10min, 20 min, 30min, 45min, 60min, 90min.
- ACTION/PAUSE times: From 1 to 60 sec, adjustable in steps from 1 sec.
- RAMP time: 0 to 5 sec, adjustable in 1 sec steps.
- Dimensions: 138mm x 6 8mm x 28mm.
- Weight: 160 g. batteries included.
- Temperature of use and storage: from +5 to +35 °C.
- Relative humidity of use and storage: from 20% to 80%.

- Intellistim BE-28UG device
- 2 stylus batteries
- connection cables
- user manual in Italian
- Travel case

The probes are to be purchased separately.