Cervical Cancer, Enhancement of Quality of Life, Improvement in Pelvic Floor Muscle Strength, Lower Urinary Tract Symptoms, Pelvic Floor Muscle Weakness, Postoperative Bladder Dysfunction, Recovery of Bladder Function, Urinary Retention
Conditions
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.
Interventions
DEVICETranscutaneous Electrical Nerve Stimulation (TENS)
Low-frequency electrical stimulation (800Hz) applied at CV2/S3 regions twice daily for 7 days using MMK520i device
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of urinary retention after catheter removal | 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
| Measure | Time frame | Description |
|---|---|---|
| Postvoid residual urine volume (PVR) | Measured immediately after catheter removal and at 1-month follow-up. | Quantification of residual urine volume (mL) via bladder ultrasound after voiding. |
| Catheter indwelling duration | Up to 30 days postoperatively. | Total days from surgery to permanent catheter removal. |
| Pelvic floor muscle strength grading | At 1-month post-intervention. | Assessed via vaginal examination using a 6-point scale (Grades 0-V). |
| Voiding function parameters (FD, BC, MCC) | 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. |
| Quality of Life (EORTC QLQ-C30 scores) | Pre-intervention and 1-month post-intervention. | Standardized scores for functional, symptom, and global health domains. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety and adverse events | Throughout the intervention period (7 days) and 1-month follow-up. | Incidence of complications (UTI, urolithiasis, pain) and TENS-related reactions (erythema, paresthesia). |
| Intervention compliance | During the 7-day intervention period. | Proportion of participants completing the full TENS protocol (≥90% sessions). |
Countries
China
Outcome results
None listed