Aortic balloon occlusion in distal zone 3 reduces blood loss from obstetric hemorrhage in placenta accreta spectrum.

BACKGROUND: Peripartum hemorrhage is a significant cause of maternal death. We developed a standardized, multidisciplinary cesarean hysterectomy protocol for placenta accreta spectrum (PAS) using prophylactic resuscitative endovascular balloon occlusion of the aorta (REBOA). We initially placed the balloon in proximal zone 3, below the renal arteries. An internal review revealed more bleeding than expected, and we subsequently changed our protocol to occlude the origin of the inferior mesenteric artery (distal zone 3), to decrease blood flow through collateral circulation. We hypothesized that distal zone 3 occlusion would reduce blood loss and transfusion volume and may permit a longer duration of occlusion compared with proximal zone 3 occlusion without increasing ischemic complications. METHODS: We conducted a single-center retrospective cohort study of patients with suspected PAS who underwent REBOA-assisted cesarean hysterectomy from December 2018 to March 2022. Medical records of all patients with PAS were reviewed. Data were extracted from hospital admission through 3 months postpartum. RESULTS: Forty-four patients met the inclusion criteria. Nine never had the balloon inflated. Eighteen patients had placement in proximal zone 3, whereas twenty-six patients had placement in distal zone 3. Background and clinical characteristics were similar in both groups. Placental pathology was obtained in every case. After adjusting for relevant risk factors, multivariate analysis revealed that distal occlusion was associated with a 45.9% (95% confidence interval, 23.8-61.6%) decrease in estimated blood loss, 41.5% (13.7-60.4%) decrease in red blood cell transfusion volume, and 44.9% (13.5-64.9%) reduction in total transfusion volume. There were no vascular access or resuscitative endovascular balloon occlusion of the aorta-related complications in either group. CONCLUSION: This study highlights the safety of prophylactic REBOA in planned cesarean hysterectomy for PAS and provides a rationale for distal zone 3 positioning to reduce blood loss. Resuscitative endovascular balloon occlusion of the aorta should be considered at other institutions with placenta accreta programs, especially in patients with extensive collateral flow. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level IV.

Long-term durability of percutaneous tibial nerve stimulation for the treatment of overactive bladder.

PURPOSE: The Overactive Bladder Innovative Therapy Trial during phase 1 was a randomized trial demonstrating comparable effectiveness of percutaneous tibial nerve stimulation and extended-release tolterodine during 12 weeks of therapy for frequency, nocturia, urgency, voided volume and urge incontinence episodes. In this second phase of the Overactive Bladder Innovative Therapy Trial we assessed the sustained therapeutic efficacy of percutaneous tibial nerve stimulation in subjects with overactive bladder during 1 year. MATERIALS AND METHODS: After 12 weeks subjects randomized to weekly percutaneous tibial nerve stimulation with Urgent((R)) PC were offered an additional 9 months of treatment with assessments at 6 and 12 months from baseline. Outcome measures included voiding diary data, overactive bladder questionnaires, global response assessments and safety assessments. RESULTS: A total of 33 percutaneous tibial nerve stimulation responders continued therapy with 32 and 25 subjects completing 6 and 12 months of therapy, respectively. Subjects received a mean of 12.1 treatments during an average of 263 days, with a mean of 21 days (median 17) between treatments. Subject global response assessments showed sustained improvement from 12 weeks at 6 and 12 months, with 94% and 96% of responders, respectively. At 12 months mean improvements from baseline included a frequency of 2.8 voids daily (p <0.001), urge incontinence of 1.6 episodes daily (p <0.001), nocturia with 0.8 voids (p <0.05) and a voided volume of 39 cc (p <0.05). Overactive bladder questionnaire symptom severity was significantly improved from 12 weeks to 12 months (p <0.01) as well as from 6 to 12 months (p <0.01). No serious adverse events occurred. CONCLUSIONS: Statistically significant overactive bladder symptom improvement achieved with 12 weekly percutaneous tibial nerve stimulation treatments demonstrates excellent durability through 12 months. The durability of response demonstrates the effectiveness of percutaneous tibial nerve stimulation as a viable, long-term therapy for overactive bladder.

Randomized trial of percutaneous tibial nerve stimulation versus extended-release tolterodine: results from the overactive bladder innovative therapy trial.

PURPOSE: The Overactive Bladder Innovative Therapy trial was a randomized, multicenter, controlled study that compared the effectiveness of percutaneous tibial nerve stimulation to extended-release tolterodine. The reduction in overactive bladder symptoms along with global response assessments was evaluated. MATERIALS AND METHODS: A total of 100 adults with urinary frequency were randomized 1:1 to 12 weeks of treatment with weekly percutaneous tibial nerve stimulation or to 4 mg daily extended-release tolterodine. Voiding diaries and an overactive bladder questionnaire were completed at baseline and at the end of therapy to compare 24-hour voiding frequency, urinary urge incontinence episodes, voids causing waking, volume voided, urgency episodes and quality of life indices. Global response assessments were completed by subjects and investigators after 12 weeks of therapy. RESULTS: The global response assessment demonstrated that subject assessment of overactive bladder symptoms compared to baseline was statistically significant in the percutaneous tibial nerve stimulation arm with 79.5% reporting cure or improvement compared to 54.8% of subjects on tolterodine (p = 0.01). Assessments by investigators were similar but did not reach statistical significance (p = 0.05). After 12 weeks of therapy objective measures improved similarly in both groups for reductions in urinary frequency, urge urinary incontinence episodes, urge severity and nighttime voids, as well as for improvement in voided volume. There were no serious adverse events or device malfunctions. CONCLUSIONS: This multicenter, randomized trial demonstrates that percutaneous tibial nerve stimulation is safe with statistically significant improvements in patient assessment of overactive bladder symptoms, and with objective effectiveness comparable to that of pharmacotherapy. Percutaneous tibial nerve stimulation may be considered a clinically significant alternative therapy for overactive bladder.