Fudan University Shanghai Cancer Center
Shanghai, 200032, China
NCT Number: NCT07070687
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.
Looking for future studies?
Notify Me18 year–70 year
Female
Interventional
Not applicable
Shanghai, 200032, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Low-frequency electrical stimulation (800Hz) applied at CV2/S3 regions twice daily for 7 days using MMK520i device
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.
Time frame: Measured immediately after catheter removal and at 1-month follow-up.
Quantification of residual urine volume (mL) via bladder ultrasound after voiding.
Time frame: Up to 30 days postoperatively.
Total days from surgery to permanent catheter removal.
Time frame: At 1-month post-intervention.
Assessed via vaginal examination using a 6-point scale (Grades 0-V).
Time frame: Pre-intervention and 1-month post-intervention.
Time frame: Pre-intervention and 1-month post-intervention.
Standardized scores for functional, symptom, and global health domains.
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).
Time frame: During the 7-day intervention period.
Proportion of participants completing the full TENS protocol (≥90% sessions).
Fudan University
Other
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.
Published trials that share one or more normalized conditions with this study.
NCT03020238
Cervical Cancer, Female Urogenital Diseases
View Trial DetailsNCT07521163
Adherence Interventions, Behavior
Van, Turkey (Türkiye)
View Trial DetailsNCT07398313
Cervical Adenocarcinoma, Cervical Cancer
Chennai, Tamil Nadu, India
View Trial DetailsNCT04927494
Cervical Cancer, Female Urogenital Diseases
Lexington, Kentucky, United States
View Trial Details