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

Fudan University

Status: Completed

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

Treatments: Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Study type: Interventional

Funder types: Other

Identifiers

NCT07070687

2207256-18

Details and patient eligibility

About

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.

Enrollment: 78 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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78 participants in 2 patient groups

Standard Bladder Management

No Intervention group

Description:

Control group receiving conventional postoperative bladder care without TENS

TENS with Standard Management

Experimental group

Description:

Experimental group receiving standard care plus TENS therapy -Real-time electrode adjustment based on feedback Administered using MMK520i device (Degas Intelliance)

Treatment:

Device: Transcutaneous Electrical Nerve Stimulation (TENS)