Transcutaneous Electrical Nerve Stimulation in Nerve-Sparing Radical Hysterectomy: Effects on Bladder Management and Quality of Life in Cervical Cancer

Not Applicable

Completed

• Conditions: Cervical Cancer; Postoperative Bladder Dysfunction; Urinary Retention; Pelvic Floor Muscle Weakness; Lower Urinary Tract Symptoms; Recovery of Bladder Function; Improvement in Pelvic Floor Muscle Strength; Enhancement of Quality of Life

• Registration Number: NCT07070687
• Lead Sponsor: Fudan University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-05
• Study Start: 2023-05-02
• Primary Completion: 2024-05-03
• Study Completion: 2024-05-22
• Study First Submitted: 2025-07-09
• Study First Submitted QC: 2025-07-09
• Last Update Submitted: 2025-07-09
• Study First Posted: 2025-07-17
• Last Update Posted: 2025-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 78

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of urinary retention after catheter removal	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.

Secondary Outcome Measures

Name	Time	Method
Postvoid residual urine volume (PVR)	Measured immediately after catheter removal and at 1-month follow-up.	Quantification of residual urine volume (mL) via bladder ultrasound after voiding.
Catheter indwelling duration	Up to 30 days postoperatively.	Total days from surgery to permanent catheter removal.
Pelvic floor muscle strength grading	At 1-month post-intervention.	Assessed via vaginal examination using a 6-point scale (Grades 0-V).
Voiding function parameters (FD, BC, MCC)	Pre-intervention and 1-month post-intervention.	* First desire to void (FD): Volume (mL) at initial urge.; * Bladder compliance (BC): Δvolume/Δpressure (mL/cmH₂O).; * Maximum cystometric capacity (MCC): Volume (mL) at strong urge.
Quality of Life (EORTC QLQ-C30 scores)	Pre-intervention and 1-month post-intervention.	Standardized scores for functional, symptom, and global health domains.

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China