Transcutaneous Electrical Nerve Stimulation in Nerve-Sparing Radical Hysterectomy: Effects on Bladder Management and Quality of Life in Cervical Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Incidence of urinary retention after catheter removal
研究概览
简要总结
To evaluate the effects of transcutaneous electrical nerve stimulation (TENS) on bladder management, pelvic floor muscle strength, and quality of life (QoL) in patients undergoing nerve-sparing radical hysterectomy (NSRH) for cervical cancer. A total of 78 NSRH patients during May 2023-May 2024 were divided into conventional catheter management (control group, n = 39) and conventional management + TENS (intervention group, n = 39). Outcomes including urinary retention incidence, postvoid residual urine volume (PVR), catheter indwelling duration, intervention compliance, pelvic floor muscle strength grading, voiding function parameters [first desire to void (FD), bladder compliance (BC), maximum cystometric capacity (MCC)], QoL scores (EORTC QLQ-C30: functional, symptom, and global health domains), and safety were assessed. The intervention group demonstrated significantly lower urinary retention incidence, reduced PVR, and shorter catheter duration versus controls (all P < 0.05). Both groups maintained > 90% intervention compliance (P > 0.05). Post-intervention voiding parameters (FD, BC, MCC) improved more significantly in the intervention group (all P < 0.05), with superior pelvic floor muscle strength grading (P < 0.001). QoL assessment revealed lower functional domain scores and higher symptom/global health scores in the intervention group (all P < 0.001). Safety analysis showed only mild dermal reactions in the intervention group, without significant between-group difference in complication rates (P > 0.05). TENS significantly improves bladder function, pelvic floor muscle strength, and QoL in post-NSRH patients with a favorable safety profile, demonstrating substantial clinical value.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histopathologically confirmed cervical cancer (FIGO stage IB1-IIA2).
- •Scheduled for or completed nerve-sparing radical hysterectomy (NSRH) with pelvic lymphadenectomy.
- •Successful indwelling urinary catheter placement within 24 hours postoperatively.
- •Age 18-70 years.
- •Willing to comply with TENS intervention and follow-up assessments.
排除标准
- •Pre-existing neurogenic bladder or urinary tract infection (UTI).
- •Severe cardiopulmonary, hepatic, or renal dysfunction.
- •Hematologic disorders or systemic infections.
- •Contraindications to electrical stimulation (e.g., pacemaker, skin lesions at electrode sites).
- •Inability to provide informed consent or complete study procedures.
研究组 & 干预措施
Standard Bladder Management
Control group receiving conventional postoperative bladder care without TENS
TENS with Standard Management
Experimental group receiving standard care plus TENS therapy
-Real-time electrode adjustment based on feedback Administered using MMK520i device (Degas Intelliance)
干预措施: Transcutaneous Electrical Nerve Stimulation (TENS) (Device)
结局指标
主要结局
Incidence of urinary retention after catheter removal
时间窗: Within 7 days post-catheter removal (typically postoperative days 14-21).
Proportion of patients with postvoid residual urine volume (PVR) \>100 mL following initial catheter removal, assessed via bladder ultrasound.
次要结局
- Postvoid residual urine volume (PVR)(Measured immediately after catheter removal and at 1-month follow-up.)
- Catheter indwelling duration(Up to 30 days postoperatively.)
- Pelvic floor muscle strength grading(At 1-month post-intervention.)
- Voiding function parameters (FD, BC, MCC)(Pre-intervention and 1-month post-intervention.)
- Quality of Life (EORTC QLQ-C30 scores)(Pre-intervention and 1-month post-intervention.)
研究者
Weiye Yin
Principal Investigator
Fudan University