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NCT07070687Completed

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

Source: ClinicalTrials.gov · Last updated 17 Jul 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
78 (actual)
First submitted
9 Jul 2025
Start date
2 May 2023
Primary completion date
3 May 2024
Lead sponsor
Fudan University
NCT number
NCT07070687

What you commit to

  • Study type: Interventional
  • Participants enrolled: 78
  • From 2 May 2023 to the primary completion date, 3 May 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Pre-existing neurogenic bladder or urinary tract infection (UTI).
  • Hematologic disorders or systemic infections.

Other

  • Severe cardiopulmonary, hepatic, or renal dysfunction.
  • Contraindications to electrical stimulation (e.g., pacemaker, skin lesions at electrode sites).
  • Inability to provide informed consent or complete study procedures.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fudan University Shanghai Cancer Center
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.