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

NCT ID: NCT07070687

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-02
• Study Completion Date: 2024-05-22

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard Bladder Management

Control group receiving conventional postoperative bladder care without TENS

Group Type: NO_INTERVENTION

No interventions assigned to this group

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)

Group Type: EXPERIMENTAL

Transcutaneous Electrical Nerve Stimulation (TENS)

Intervention Type: DEVICE

Low-frequency electrical stimulation (800Hz) applied at CV2/S3 regions twice daily for 7 days using MMK520i device

Interventions

Transcutaneous Electrical Nerve Stimulation (TENS)

Low-frequency electrical stimulation (800Hz) applied at CV2/S3 regions twice daily for 7 days using MMK520i device

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Weiye Yin

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fudan University Shanghai Cancer Center

Shanghai, , China

Countries

China

Other Identifiers

2207256-18

Identifier Type: -

Identifier Source: org_study_id