PDF(Pubmed)
Abstract：
BACKGROUND: Bladder dysfunction, notably urinary retention, emerges as a significant complication for cervical cancer patients following radical hysterectomy, predominantly due to nerve damage, severely impacting their postoperative quality of life. The challenges to recovery include insufficient pelvic floor muscle training and the negative effects of prolonged postoperative indwelling urinary catheters. Intermittent catheterization represents the gold standard for neurogenic bladder management, facilitating bladder training, which is an important behavioral therapy aiming to enhance bladder function through the training of the external urethral sphincter and promoting the recovery of the micturition reflex. Nevertheless, gaps remain in current research regarding optimal timing for intermittent catheterization and the evaluation of subjective symptoms of bladder dysfunction.
METHODS: Cervical cancer patients undergoing laparoscopic radical hysterectomy will be recruited to this randomized controlled trial. Participants will be randomly assigned to either early postoperative catheter removal combined with intermittent catheterization group or a control group receiving standard care with indwelling urinary catheters. All these patients will be followed for 3 months after surgery. The study\'s primary endpoint is the comparison of bladder function recovery rates (defined as achieving a Bladder Function Recovery Grade of II or higher) 2 weeks post-surgery. Secondary endpoints include the incidence of urinary tract infections, and changes in urodynamic parameters, and Mesure Du Handicap Urinaire scores within 1 month postoperatively. All analysis will adhere to the intention-to-treat principle.
CONCLUSIONS: The findings from this trial are expected to refine clinical management strategies for enhancing postoperative recovery among cervical cancer patients undergoing radical hysterectomy. By providing robust evidence, this study aims to support patients and their families in informed decision-making regarding postoperative bladder management, potentially reducing the incidence of urinary complications and improving overall quality of life post-surgery.
BACKGROUND: ChiCTR2200064041, registered on 24th September, 2022.
METHODS: Cervical cancer patients undergoing laparoscopic radical hysterectomy will be recruited to this randomized controlled trial. Participants will be randomly assigned to either early postoperative catheter removal combined with intermittent catheterization group or a control group receiving standard care with indwelling urinary catheters. All these patients will be followed for 3 months after surgery. The study\'s primary endpoint is the comparison of bladder function recovery rates (defined as achieving a Bladder Function Recovery Grade of II or higher) 2 weeks post-surgery. Secondary endpoints include the incidence of urinary tract infections, and changes in urodynamic parameters, and Mesure Du Handicap Urinaire scores within 1 month postoperatively. All analysis will adhere to the intention-to-treat principle.
CONCLUSIONS: The findings from this trial are expected to refine clinical management strategies for enhancing postoperative recovery among cervical cancer patients undergoing radical hysterectomy. By providing robust evidence, this study aims to support patients and their families in informed decision-making regarding postoperative bladder management, potentially reducing the incidence of urinary complications and improving overall quality of life post-surgery.
BACKGROUND: ChiCTR2200064041, registered on 24th September, 2022.
摘要：
背景：膀胱功能障碍，尤其是尿潴留，作为宫颈癌患者根治性子宫切除术后的重要并发症，主要是因为神经损伤,严重影响其术后生活质量。康复的挑战包括盆底肌肉训练不足以及术后留置导尿管的负面影响。间歇性导尿是神经源性膀胱管理的黄金标准，促进膀胱训练，这是一种重要的行为疗法，旨在通过训练尿道外括约肌增强膀胱功能，促进排尿反射的恢复。然而，目前关于间歇性导尿的最佳时机和膀胱功能障碍主观症状评估的研究仍存在空白.
方法：本随机对照试验将招募接受腹腔镜根治性子宫切除术的宫颈癌患者。参与者将被随机分配到术后早期导管拔除联合间歇性导管插入组或接受标准护理并留置导尿管的对照组。所有这些患者将在手术后随访3个月。该研究的主要终点是术后2周膀胱功能恢复率的比较（定义为达到膀胱功能恢复II级或更高）。次要终点包括尿路感染的发生率，和尿动力学参数的变化，术后1个月内的MesureDuHandicapUrinaire评分。所有分析都将坚持意向治疗原则。
结论：本试验的结果有望改善宫颈癌根治术患者的临床管理策略，以提高术后恢复。通过提供有力的证据,这项研究旨在支持患者及其家属在术后膀胱管理方面的知情决策，有可能降低泌尿系并发症的发生率，提高术后整体生活质量。
背景：ChiCTR2200064041，9月24日注册，2022年。
方法：本随机对照试验将招募接受腹腔镜根治性子宫切除术的宫颈癌患者。参与者将被随机分配到术后早期导管拔除联合间歇性导管插入组或接受标准护理并留置导尿管的对照组。所有这些患者将在手术后随访3个月。该研究的主要终点是术后2周膀胱功能恢复率的比较（定义为达到膀胱功能恢复II级或更高）。次要终点包括尿路感染的发生率，和尿动力学参数的变化，术后1个月内的MesureDuHandicapUrinaire评分。所有分析都将坚持意向治疗原则。
结论：本试验的结果有望改善宫颈癌根治术患者的临床管理策略，以提高术后恢复。通过提供有力的证据,这项研究旨在支持患者及其家属在术后膀胱管理方面的知情决策，有可能降低泌尿系并发症的发生率，提高术后整体生活质量。
背景：ChiCTR2200064041，9月24日注册，2022年。
