Department of Obstetrics and Gynecology, Baylor Scott & White Health, 2401 South 31st Street, Temple, TX, 76508, USA.
Department of Obstetrics and Gynecology, Mount Auburn Hospital, Cambridge, and the Department of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, and the Department of Obstetrics, Gynecology, and Reproductive Biology, Harvard Medical School, Boston, MA, USA.
Int Urogynecol J. 2021 Jan;32(1):149-157. doi: 10.1007/s00192-020-04392-4. Epub 2020 Jun 25.
To evaluate if age and comorbidities are associated with progression from trial phase to implantation of an implantable pulse generator in women with overactive bladder.
This multisite retrospective cohort included women with overactive bladder with or without urinary incontinence who had a trial phase for sacral neuromodulation. The primary outcome was progression to implantation. A sub-analysis of implanted patients was performed for the outcome of additional therapies or "implant only" for the duration of follow-up. Multivariate logistic regression models including potential predictors of implantation and post-implantation addition of therapies were performed.
At six academic institutions, 91% (785/864) of patients progressed to implantation. Post-implantation success was achieved by 69% (536/782) of patients at median follow-up of 2 (range 0.3 to 15) years. Odds of implantation [OR 0.73 (CI 0.61, 0.88)] and post-implantation success [OR 0.78 (CI 0.98, 0.97)] were lower with increasing decades of age. Medical comorbidities evaluated did not affect implantation rates or post-implant success.
Most women have successful sacral neuromodulation trials despite older age and comorbidities. Higher decade of age has a negative effect on odds of implantation and is associated with addition of therapies post-implantation. Comorbidities assessed in this study did not affect implantation or addition of therapies post-implantation. Most women add therapies to improve efficacy post-implantation, and explantation rates are low.
评估年龄和合并症是否与膀胱过度活动症女性从试验阶段到植入可植入脉冲发生器的进展相关。
这项多中心回顾性队列研究纳入了有或无尿失禁的膀胱过度活动症女性，她们进行了骶神经调节的试验阶段。主要结局是进展到植入。对植入患者进行了亚分析，以评估在随访期间的附加治疗或“仅植入”的结果。进行了多变量逻辑回归模型分析，包括植入的潜在预测因素和植入后的附加治疗。
在 6 家学术机构中，91%（785/864）的患者进展到植入。在中位随访 2 年（范围 0.3 至 15 年）时，69%（536/782）的患者达到了植入后的成功。植入的可能性[OR 0.73（CI 0.61, 0.88)]和植入后的成功[OR 0.78（CI 0.98, 0.97)]随着年龄的增加而降低。评估的合并症并没有影响植入率或植入后的成功率。
尽管年龄较大和合并症较多，但大多数女性的骶神经调节试验都取得了成功。更高的十年年龄对植入的可能性有负面影响，并与植入后的治疗增加有关。本研究评估的合并症并没有影响植入或植入后的治疗增加。大多数女性会增加治疗以提高植入后的疗效，并且取出率较低。
