Cervical CancerNCT07070687
Transcutaneous Electrical Nerve Stimulation in Nerve-Sparing Radical Hysterectomy: Effects on Bladder Management and Quality of Life in Cervical Cancer
A study testing Transcutaneous Electrical Nerve Stimulation (TENS) in people with Cervical Cancer and Postoperative Bladder Dysfunction, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Cervical Cancer, Postoperative Bladder Dysfunction, Urinary Retention
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation (TENS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 2 May 2023to 22 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Transcutaneous Electrical Nerve Stimulation (TENS)
- Medical subject headings
- Uterine Cervical Neoplasms, Urinary Retention, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Nerve Stimulation (TENS)Device
Low-frequency electrical stimulation (800Hz) applied at CV2/S3 regions twice daily for 7 days using MMK520i device
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: Transcutaneous Electrical Nerve Stimulation (TENS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 7 days post-catheter removal (typically postoperative days 14-21).
Secondary outcomes (5)
Postvoid residual urine volume (PVR)
Quantification of residual urine volume (mL) via bladder ultrasound after voiding.
Measured: Measured immediately after catheter removal and at 1-month follow-up.
Catheter indwelling duration
Total days from surgery to permanent catheter removal.
Measured: Up to 30 days postoperatively.
Pelvic floor muscle strength grading
Assessed via vaginal examination using a 6-point scale (Grades 0-V).
Measured: At 1-month post-intervention.
Voiding function parameters (FD, BC, MCC)
- 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.
Measured: Pre-intervention and 1-month post-intervention.
Quality of Life (EORTC QLQ-C30 scores)
Standardized scores for functional, symptom, and global health domains.
Measured: Pre-intervention and 1-month post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start2 May 2023
- Primary completion3 May 2024
- Study completion22 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weiye Yin, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07070687
- Sponsor's protocol ID
- 2207256-18
- Status last verified
- May 2023
- First submitted
- 9 Jul 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electrical Nerve Stimulation in Nerve-Sparing Radical Hysterectomy: Effects on Bladder Management and Quality of Life in Cervical Cancer
- ClinicalTrials.gov ID
- NCT07070687
- Acronym / sponsor ID
- 2207256-18
- Conditions
- Cervical Cancer, Postoperative Bladder Dysfunction, Urinary Retention, Pelvic Floor Muscle Weakness, Lower Urinary Tract Symptoms, Recovery of Bladder Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 2 May 2023 (actual)
- Primary completion
- 3 May 2024 (actual)
- Study completion
- 22 May 2024 (actual)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Bladder Management | No intervention | –Control group receiving conventional postoperative bladder care without TENS |
| TENS with Standard Management | Experimental | Device: Transcutaneous Electrical Nerve Stimulation (TENS)Experimental group receiving standard care plus TENS therapy -Real-time electrode adjustment based on feedback Administered using MMK520i device (Degas Intelliance) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Electrical Nerve Stimulation (TENS)Low-frequency electrical stimulation (800Hz) applied at CV2/S3 regions twice daily for 7 days using MMK520i device | Device | TENS with Standard Management |
Primary outcome
Incidence of urinary retention after catheter removal
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.
5 secondary outcomes
Postvoid residual urine volume (PVR)
Time frame: Measured immediately after catheter removal and at 1-month follow-up.
Catheter indwelling duration
Time frame: Up to 30 days postoperatively.
Pelvic floor muscle strength grading
Time frame: At 1-month post-intervention.
Voiding function parameters (FD, BC, MCC)
Time frame: Pre-intervention and 1-month post-intervention.
Quality of Life (EORTC QLQ-C30 scores)
Time frame: Pre-intervention and 1-month post-intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Nerve Stimulation (TENS) in people with Cervical Cancer and Postoperative Bladder Dysfunction, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of urinary retention after catheter removal (time frame: Within 7 days post-catheter removal (typically postoperative days 14-21).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.