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

NCT07070687 | Completed

• 1 other identifier: 2207256-18
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer; Postoperative Bladder Dysfunction; Urinary Retention; Pelvic Floor Muscle Weakness; Lower Urinary Tract Symptoms; Recovery of Bladder Function; Improvement in Pelvic Floor Muscle Strength; Enhancement of Quality of Life

Outcome Measures

Primary Outcomes (1)

• Incidence of urinary retention after catheter removal

  Proportion of patients with postvoid residual urine volume (PVR) \>100 mL following initial catheter removal, assessed via bladder ultrasound.

  Within 7 days post-catheter removal (typically postoperative days 14-21).

Secondary Outcomes (5)

• Postvoid residual urine volume (PVR)

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

• Catheter indwelling duration

  Up to 30 days postoperatively.

• Pelvic floor muscle strength grading

  At 1-month post-intervention.

• Voiding function parameters (FD, BC, MCC)

  Pre-intervention and 1-month post-intervention.

• Quality of Life (EORTC QLQ-C30 scores)

  Pre-intervention and 1-month post-intervention.

Other Outcomes (2)

• Safety and adverse events

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

• Intervention compliance

  During the 7-day intervention period.

Study Arms (2)

Standard Bladder Management

NO INTERVENTION

Control group receiving conventional postoperative bladder care without TENS

TENS with Standard Management

EXPERIMENTAL

Experimental group receiving standard care plus TENS therapy -Real-time electrode adjustment based on feedback Administered using MMK520i device (Degas Intelliance)

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Interventions

Transcutaneous Electrical Nerve Stimulation (TENS) DEVICE

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

TENS with Standard Management

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Urinary Retention; Lower Urinary Tract Symptoms

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Urination Disorders; Urologic Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 17, 2025
• Study Start: May 2, 2023
• Primary Completion: May 3, 2024
• Study Completion: May 22, 2024
• Last Updated: July 17, 2025

Record last verified: 2023-05

Locations

CN (1)