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

NCT07070687 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2025-07-17

No results posted yet for this study

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

Interventions

DEVICE

Transcutaneous Electrical Nerve Stimulation (TENS)

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

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-02
Primary Completion
2024-05-03
Completion
2024-05-22

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07070687 on ClinicalTrials.gov