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Completed

NCT Number: NCT07070687

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcutaneous Electrical Nerve Stimulation (TENS)

Device

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

Primary outcomes

  1. Incidence of urinary retention after catheter removal

    Time frame: 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 outcomes

  1. Postvoid residual urine volume (PVR)

    Time frame: Measured immediately after catheter removal and at 1-month follow-up.

    Quantification of residual urine volume (mL) via bladder ultrasound after voiding.

  2. Catheter indwelling duration

    Time frame: Up to 30 days postoperatively.

    Total days from surgery to permanent catheter removal.

  3. Pelvic floor muscle strength grading

    Time frame: At 1-month post-intervention.

    Assessed via vaginal examination using a 6-point scale (Grades 0-V).

  4. Voiding function parameters (FD, BC, MCC)

    Time frame: 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.
  5. Quality of Life (EORTC QLQ-C30 scores)

    Time frame: Pre-intervention and 1-month post-intervention.

    Standardized scores for functional, symptom, and global health domains.

Other outcomes

  1. Safety and adverse events

    Time frame: Throughout the intervention period (7 days) and 1-month follow-up.

    Incidence of complications (UTI, urolithiasis, pain) and TENS-related reactions (erythema, paresthesia).

  2. Intervention compliance

    Time frame: During the 7-day intervention period.

    Proportion of participants completing the full TENS protocol (≥90% sessions).

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 17, 2025
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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