Nickel-sized implant may relieve urge incontinence in OAB
A nickel-sized implantable neuromodulation device that stimulates the tibial nerve can help reduce symptoms of urgency urinary incontinence (UUI) associated with overactive bladder (OAB) syndrome in patients who are refractory to OAB medications, a pilot study shows.
“The device can be implanted during an office-based procedure under local anaesthesia. After activation, subsequent stimulation does not require multiple office visits, or externally applied apparatus — in contrast to other investigational tibial nerve stimulators,” the researchers pointed out, highlighting that the technology is minimally invasive.
In the prospective, multisite, single-arm, open-label feasibility study, 46 participants (mean age 63.4 years, 98 percent female) with refractory UUI had the neuromodulation device implanted over the tibial nerve in their lower legs. The device was activated after 4 weeks and the participants were followed up at 3 and 6 months after device activation. [J Urol 2018;doi:10.1016/j.juro.2018.10.017]
After 3 months of treatment, the device led to significantly reduced episodes of UUI compared with baseline (median, 1.7 vs 4.2 episodes/day; p=0.001), which corresponds to a median reduction of 71 percent. The benefit was sustained at 1.5 episodes/day at 6 months.
Also, majority (69.6 percent) of the participants had ≥50 percent reduction in UUI episodes at 3 months, thus meeting the prespecified definition for responder. A ≥75 percent reduction in UUI was observed in 41.3 percent of patients and 21.7 percent were dry with no UUI episodes at 3 months.
“[The] investigational device was safe and resulted in a dramatic reduction in episodes of UUI for 70 percent of participants after 3 months … with a response that was durable to at least 6 months,” observed the researchers.
At 6 months, 67.4 percent of the participants continued to meet the criteria for responder, and 23.9 percent had complete resolution of UUI.
Consistent with the objective findings, patient-reported outcomes also improved during the follow-up visits at 3 and 6 months vs baseline, as indicated on the Incontinence Quality of Life instrument (I-QOL; 71.3 and 67.4 vs 45.4). “This change from baseline in the I-QOL was nearly three times the minimally important difference for this measure,” according to the researchers.
“[There were no significant safety concerns … [and] all related adverse events [AEs] were resolved,” they reported.
Serious AEs occurred in three participants, with one of them being cellulitis secondary to wound care, which resolved with intravenous antibiotics. The other two involved a case related to condition already present at baseline and a pneumonia case which was considered unrelated to the device. “No patient required revision or removal of the device due to discomfort, pain, or infection at the implant or incision site.”
As the study population was small with no control group, the researchers suggested that future studies involving a larger population may help shed light on the factors associated with responders. They also planned to extend follow-up of patients out to 12 months to confirm the durability of response to treatment.