Clinical trial · Interventional
Transcutaneous Electrical Nerve Stimulation in Nerve-Sparing Radical Hysterectomy: Effects on Bladder Management and Quality of Life in Cervical Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Enhancement of Quality of Life | — | UNRESOLVED | — |
| Improvement in Pelvic Floor Muscle Strength | — | UNRESOLVED | — |
| Lower Urinary Tract Symptoms | — | UNRESOLVED | — |
| Pelvic Floor Muscle Weakness | — | UNRESOLVED | — |
| Postoperative Bladder Dysfunction | — | UNRESOLVED | — |
| Recovery of Bladder Function | — | UNRESOLVED | — |
| Urinary Retention | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Transcutaneous Electrical Nerve Stimulation (TENS) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Standard Bladder Management
- description
- Control group receiving conventional postoperative bladder care without TENS
- type
- EXPERIMENTAL
- label
- TENS with Standard Management
- description
- Experimental group receiving standard care plus TENS therapy -Real-time electrode adjustment based on feedback Administered using MMK520i device (Degas Intelliance)
- interventionNames
- Device: Transcutaneous Electrical Nerve Stimulation (TENS)
Primary outcomes (1)
- measure
- Incidence of urinary retention after catheter removal
- timeFrame
- Within 7 days post-catheter removal (typically postoperative days 14-21).
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available