Aging, neurologic diseases, and diabetes are a few risk factors that may lead to underactive bladder (UAB) syndrome. Despite all of the serious consequences of UAB, current solutions, the most common being ureteric catheterization, are all accompanied by serious shortcomings. The necessity of multiple catheterizations per day for a physically able patient not only reduces the quality of life with constant discomfort and pain but also can end up causing serious complications. Here, we present a bistable actuator to empty the bladder by incorporating shape memory alloy components integrated on flexible polyvinyl chloride sheets. The introduction of two compression and restoration phases for the actuator allows for repeated actuation for a more complete voiding of the bladder. The proposed actuator exhibits one of the highest reported voiding percentages of up to 78% of the bladder volume in an anesthetized rat after only 20 s of actuation. This amount of voiding is comparable to the common catheterization method, and its one time implantation onto the bladder rectifies the drawbacks of multiple catheterizations per day. Furthermore, the scaling of the device for animal models larger than rats can be easily achieved by adjusting the number of nitinol springs. For neurogenic UAB patients with degraded nerve function as well as degenerated detrusor muscle, we integrate a flexible triboelectric nanogenerator sensor with the actuator to detect the fullness of the bladder. The sensitivity of this sensor to the filling status of the bladder shows its capability for defining a self-control system in the future that would allow autonomous micturition.

Underactive bladder or detrusor underactivity (DU) is defined as a reduction of contraction strength or duration of the bladder wall. Despite the serious healthcare implications of DU, there are limited solutions for affected individuals. A flexible 3D printed implantable device driven by shape memory alloys (SMA) actuators is presented here for the first time to physically contract the bladder to restore voluntary control of the bladder for individuals suffering from DU. This approach is used initially in benchtop experiments with a rubber balloon acting as a model for the rat bladder to verify its potential for voiding, and that the operating temperatures are safe for the eventual implantation of the device in a rat. The device is then implanted and tested on an anesthetized rat, and a voiding volume of more than 8% is successfully achieved for the SMA‐based device without any surgical intervention or drug injection to relax the external sphincter.

The disruption of coordination between smooth muscle contraction in the bladder and the relaxation of the external urethral sphincter (EUS) striated muscle is a common issue in dysfunctional bladders. It is a significant challenge to overcome for neuromodulation approaches to restore bladder control. Bladder-sphincter dyssynergia leads to undesirably high bladder pressures, and poor voiding outcomes, which can pose life-threatening secondary complications. Mixed pelvic nerves are potential peripheral targets for stimulation to treat dysfunctional bladders, but typical electrical stimulation of pelvic nerves activates both the parasympathetic efferent pathway to excite the bladder, as well as the sensory afferent pathway that causes unwanted sphincter contractions. Thus, a novel pelvic nerve stimulation paradigm is required. In anesthetized female rats, we combined a low frequency (10 Hz) stimulation to evoke bladder contraction, and a more proximal 20 kHz stimulation of the pelvic nerve to block afferent activation, in order to produce micturition with reduced bladder-sphincter dyssynergia. Increasing the phase width of low frequency stimulation from 150 to 300 µs alone was able to improve voiding outcome significantly. However, low frequency stimulation of pelvic nerves alone evoked short latency (19.9-20.5 ms) dyssynergic EUS responses, which were abolished with a non-reversible proximal central pelvic nerve cut. We demonstrated that a proximal 20 kHz stimulation of pelvic nerves generated brief onset effects at lower current amplitudes, and was able to either partially or fully block the short latency EUS responses depending on the ratio of the blocking to stimulation current. Our results indicate that ratios >10 increased the efficacy of blocking EUS contractions. Importantly, we also demonstrated for the first time that this combined low and high frequency stimulation approach produced graded control of the bladder, while reversibly blocking afferent signals that elicited dyssynergic EUS contractions, thus improving voiding by 40.5 ± 12.3%. Our findings support advancing pelvic nerves as a suitable neuromodulation target for treating bladder dysfunction, and demonstrate the feasibility of an alternative method to nonreversible nerve transection and sub-optimal intermittent stimulation methods to reduce dyssynergia.

for such transformation. [3] Voluntary repeatable shape transformation, material biocompatibility, and small weight of NiTi shape memory alloy (SMA) actuators make them suitable for medical applications. [4][5][6][7][8][9][10][11][12] Usage of NiTi SMA actuators for muscular contraction, [8] artificial anal sphincter, [7] urethral valve, [13] myocardium, [8] drug delivery system, [3] and most recently, voiding of a bladder, [14] has been reported.The previous SMA-based actuator for voiding of a bladder consisted of a flexible vest that covered the bladder surface and physically contracted it upon the actuation of assembled SMA wires. [14] Since a fixed length was considered for SMA wires in this design, the device could be used for only one bladder size that was matched with the total inner diameter of actuator. The proposed design in our study has a more conformable vest that can be fitted for a wider range of bladder sizes in rats with similar body weight, and can substantially improve the voiding volume and energy consumption of the device.The previous SMA-based actuator was proposed for assisting the detrusor muscle in myogenic underactive bladder (UAB) patient with detrusor muscle contractility disorder but intact nerves. [14] Our study broadens the application of the actuating device also to neurogenic UAB patients suffering from both damaged detrusor muscle and nervous system; these patients are not able to rely on the natural nerve pathways to realize The use of shape memory alloy (SMA) actuators to restore voiding of bladder for myogenic under active bladder (UAB) patients is proposed recently. Even though previous work show the unique capability of this technology for bladder voiding, the low voiding volume and high energy consumption of the device limit the advancement of this technique. This study proposes a novel approach using an interlaced configuration to overcome these limitations. In this device, SMA actuators are threaded through rigid anchor points of the flexible vest. The novel anchorage of SMA actuators provides more conformability for the vest and lower energy consumption for the device, while the new interlaced configuration enhances the voiding volume. The device is tested initially on a rubber model for the bladder, then it is implanted in an anesthetized rat, and a voiding volume of more than 20% at 4 V is successfully achieved. A commercial force sensor is integrated with the device to make it suitable for neurogenic UAB patients. The sensor provides a feedback control signal to the patient to initiate the actuation of the device upon fullness of bladder. The overall system is a promising advance over the state-of-the-art providing bladder voiding in UAB patients.

ObjectivesThe bladder becomes retentive during the early phase of spinal cord injury, and requires proper bladder management to prevent damage to the lower urinary tract and kidney. We investigated the effects of on-demand pelvic nerve stimulation on the areflexive bladder during the earliest phase of complete spinal cord injury in rats and the use of pelvic nerve signals as a proxy to estimate intravesical pressure for closed-loop applications. Materials and MethodsIn order to stimulate the pelvic nerves in female Sprague-Dawley rats with complete spinal cord transection (T7 level), a flexible electrode was implanted unilaterally on pelvic nerve, and electrical stimulation was provided by a custom-built nerve stimulator. Stimulationevoked voiding was monitored in the awake state while size, capacity and spontaneous contractions of the bladder were analysed under anaesthesia. Separately, recordings of the pelvic nerve signals, external urethral sphincter activity and intravesical pressure were performed in animals with intact and transected spinal cord under anaesthesia. ResultsSuccessful pelvic nerve stimulation enabled more frequent voiding, reduced overdistension of bladder, and preserved non-voiding spontaneous bladder contractions.Typical bladder management protocol for SCI rats (manual expression every 8 -12 hours) resulted in more severe bladder overdistention. Signal processing of the recorded extraneural pelvic nerve signals successfully reconstructed changes in intravesical pressure, demonstrating their use in estimating the fullness and contractions of the bladder. ConclusionsThe preliminary results suggest that pelvic nerve stimulators can serve as an alternative method for frequent emptying of the areflexive bladder. Simultaneous recording of the same pelvic nerve will be useful for development of a closed-loop neuroprosthesis.