Stress Urinary IncontinenceNCT05773716
Electroacupuncture and Pelvic Floor Muscle Training for Male Stress Urinary Incontinence
A study testing Pelvic floor muscle training and Electroacupuncture in people with Stress Urinary Incontinence, run by RenJi Hospital at 1 site in China.
Trial summary
The goal of this clinical study is to compare the effects of combined electroacupuncture with pelvic floor muscle training (PFMT) versus PFMT alone in the treatment of involuntary urine leakage following prostate removal procedure due to prostate cancer. Read more about this study
- Who is it for?
- Ages 45 to 80 years, men only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Pelvic floor muscle training and Electroacupuncture
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 30 Apr 2025
- 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 45 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients present stress urinary incontinence 6 weeks after radical prostatectomy
- Aged between 45-80 years
- With an urine leakage amount over 1g measured by the one-hour pad test
- Participate voluntarily with signed the informed consent
Who cannot join
- The existence of stress urinary incontinence symptoms before the surgery
- Urine leakage due to urgency incontinence, voiding dysfunction, nocturnal enuresis and fistula
- Known history of radiation therapy to the pelvic region
- Evidence of tumor recurrence or metastasis
- Those who have already underwent treatment for stress urinary incontinence
- Patients with hemorrhagic disease or hemorrhagic tendency
Show all 10Show fewer
- The presence of ulcer, abscess and skin infection at locations of target acupoints
- With histories of cardiac pacemaker, intravascular stent and metal allergy
- With poor health conditions due to coexisting of acute comorbidities of the heart, brain, lung and kidney
- Those who refuse to sign the informed consent and unable to comply with the study protocol
Trial locations and contacts
1 site in 1 country.
China1 site
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200127
About this study
Official title: The Effects of Combination Therapy With Electroacupuncture and Pelvic Floor Muscle Training on Stress Urinary Incontinence Following Radical Prostatectomy: A Randomized Controlled Trial
The goal of this clinical study is to compare the effects of combined electroacupuncture with pelvic floor muscle training (PFMT) versus PFMT alone in the treatment of involuntary urine leakage following prostate removal procedure due to prostate cancer. The main goal is to determine that whether adding electroacupuncture to PFMT provides extra benefits in relieving urinary leakage and improves patients' quality of life. All participants will be required to perform daily PFMT for 6 weeks using uniformed standards. During the meantime, those assigned to the experimental group will additionally receive electroacupuncture three times per week for 6 weeks, while those in control group will receive sham treatment with same duration. Researchers will compare the urine leakage severity between the two groups to see if adding electroacupuncture can facilitate the recovery of symptom.
Read the detailed description
This randomized controlled trial will recruit patients presenting stress urinary incontinence 6 weeks after radical prostatectomy, with the aim to determine whether adding electroacupuncture therapy to pelvic floor muscle training (PFMT) provides extra benefits in relieving stress urinary incontinence following radical prostatectomy. Followed by signing the informed consent and baseline assessments, participants with be randomly allocated to either PFMT plus electroacupuncture arm or PFMT plus sham electroacupuncture arm in a 1:1 ratio.
Pelvic floor muscle training will be conducted daily using a consistent approach. In short, before training, the patients are required to empty the bladder and relax the whole body in a sitting or lying position. The contraction of the pelvic floor muscles is maintained for 2-6 seconds, followed by a relaxation for 2-6 seconds. This process is repeated 10 times per session, three sessions per day (in the morning, afternoon and evening), and performed daily for 6 continuous weeks.
Electroacupuncture will be performed at bilateral Zhongliao, Huiyang, Zhongji, Guanyuan and Dahe, three treatment sessions per week for 6 consecutive weeks. For sham electroacupuncture, The same acupoints will be punctured as that in treatment group, except the use of blunt-tipped needles (identical in appearance compared with normal needles) to puncture through the fixed pad and to reach the skin surface. In both groups, the needles will be clamped by electrodes which are connected to a pulse generator (Huatuo SDZ- EA, Suzhou, China). In consistency with our previous settings, continuous wave with frequency of 50Hz will be used. The current intensity is gradually increased ranging from 1mA to 5mA, according to the patient's tolerance.
Patients will be appraised at baseline, 3, 6, 10 and 18 weeks after the initiation of treatments to determine the changes of incontinence symptom, quality of life and pelvic structures. The primary outcome is the change of urine leakage amount during a 1-hour pad test at 6-week timepoint. The secondary outcomes include parameters derived from the International Consultation on Incontinence Modular Questionnaire - urinary incontinence short form, mean 24-hour pad use, pelvic magnetic resonance imaging (except for those with contraindications, such as metallic implants or psychological disorders), and the documentation of adverse events.
The statistical analysis of the baseline and outcomes at each timepoint is based on the intention-to-treat population. In addition, the data analysis of the primary outcome is also based on the per-protocol population as a supportive analysis. Quantitative variables will be compared using either independent t-tests or Mann-Whitney U-tests based on their normality. The statistical significance between nominal variables will be detected using Pearson's chi-squared tests or Fisher's exact tests. Statistical analysis will be performed using both SPSS software and R package, and the level of significance will be set at <0.05.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Pelvic floor muscle training, Electroacupuncture, Sham electroacupuncture
- Keywords
- Incontinence, Radical prostatectomy, Men, Pelvic floor muscle training, Acupuncture, Bladder diary, Pad test
- Medical subject headings
- Urinary Incontinence, Stress, Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor muscle trainingBehavioural
Participants will receive daily pelvic floor muscle training for 6 consecutive weeks. In specific, they will be instructed to perform 3 training sessions (morning, afternoon and evening) per day with an emptied bladder in a relaxed state. During each session, 10 muscle stretches are required with each contraction duration of 2~6-second and a 2~6-second relaxation following each one.
ElectroacupunctureOther
Participants will also receive electroacupuncture at bilateral Zhongliao (BL33), Huiyang (BL35), Zhongji (CV3), Guanyuan (CV4) and Dahe (KI12). During each therapy session, the electroacupuncture stimulation of acupoints in the abdomen and sacral regions will last for 30 minutes in total (15 minutes for each region) with a continuous wave of 50 Hz and a current intensity of 1 to 5 mA (preferably with the skin around the acupoints shivering mildly without pain). Participants will receive 3 treatment sessions per week (ideally every other day) for 6 consecutive weeks, 18 sessions in total.
Sham electroacupunctureOther
Sham electroacupuncture will be carried out with pragmatic placebo needles on the same acupoints in the experimental group. Procedures, electrode placements, and other treatment settings will also stay the same but with no electrical stimulation output.
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture plus pelvic floor muscle training | Experimental | Participants in this arm will receive pelvic floor muscle training using unified standards, and electroacupuncture therapy for 6 weeks. Receives: Behavioral: Pelvic floor muscle training; Other: Electroacupuncture |
| Sham electroacupuncture plus pelvic floor muscle training | Sham comparator | Participants in this arm will receive pelvic floor muscle training using the same approach as that in experimental group, and sham electroacupuncture for 6 weeks. Receives: Behavioral: Pelvic floor muscle training; Other: Sham electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of urine leakage amount at 6 weeks
The 1-hour pad test will be applied to quantitatively measure the changes of the urine leakage severity. In specific, patients will be asked to wear pre-weighed pads and drink 500 ml of sodium-free liquid in <15 minutes. After rest, they are instructed to exercise for 30 minutes, including: walking, climbing up and down one flight of stairs, standing-up from sitting (10 times), coughing vigorously (10 times), running on the spot for 1 minute, bending to pick up an object from the floor (5 times) and washing hands for 1 minute in running water. Before and after the test, the weight of the pad is measured with a high-precision balance in order to determine the amount of leakage. For this test, an increase of 1 to 10 g represents mild incontinence, 11 to 50 g represents moderate incontinence, and >50 g represents severe incontinence.
Measured: measured at baseline and 6 weeks after treatment
Secondary outcomes (14)
One-hour pad test at 3, 10, 18 weeks
For the 1-hour pad test, patients will be asked to wear pre-weighed pads and drink 500 ml of sodium-free liquid in <15 minutes. After rest, they are instructed to exercise for 30 minutes, including: walking, climbing up and down one flight of stairs, standing-up from sitting (10 times), coughing vigorously (10 times), running on the spot for 1 minute, bending to pick up an object from the floor (5 times) and washing hands for 1 minute in running water. Before and after the test, the weight of the pad is measured with a high-precision balance in order to determine the amount of leakage. For this test, an increase of 1 to 10 g represents mild incontinence, 11 to 50 g represents moderate incontinence, and >50 g represents severe incontinence.
Measured: measured at 3, 10 and 18 weeks after treatment
The status of 24-hour pad use
The 24-hour pad use will be recorded as the average daily pad number in three continuous days
Measured: measured at baseline, 6 and 18 weeks after treatment
Urinary incontinence questionnaires
The patient-reported continence status will be evaluated by the International Consultation on Incontinence Modular Questionnaire - urinary incontinence short form (ICIQ-UI-SF). The total score will be calculated based on three questions, namely the frequency of leakage (scores from 0 to 5 points), the amount of leakage (scores 0, 2, 4 or 6 points) and the impact of leakage (scores from 0 to 10 points).
Measured: measured at baseline, 3, 6, 10 and 18 weeks after treatment
Pelvic Magnetic resonance imaging
The pelvic magnetic resonance imaging (MRI) will be performed with a 1.5-T scanner with the patients in a supine position. The imaging protocol included a transversal T1-weighted 2D gradient echo sequence. High-spatial-resolution T2-weighted TSE sequences will be obtained in the axial, coronal and sagittal orientation. Several parameters will be measured, including membranous urethral length (mm), urethral wall thickness (mm), levator ani muscle thickness (mm), obturator internus muscle thickness (mm) etc. Besides, the position of the bladder neck, the shape of the bladder and the presence of a dilated posterior urethra will also be recorded. The MRI can be waived if contraindications are noted, such as metallic implants or psychological disorders.
Measured: measured at baseline, 6 and 18 (optional) weeks after treatment
Adverse events
Although electroacupuncture is well-known as a minimally invasive therapy which can be carried out in the clinic, the adverse events will be carefully documented by the researchers base on the patients' subjective report.
Measured: measured at 3, 6, 10 and 18 weeks after treatment
Data of birth
The date of birth will be recorded as year/month/date.
Measured: documented at baseline
Height
The height will be measured in meters.
Measured: documented at baseline
Weight
The weight will be measured in kilograms.
Measured: documented at baseline
Body mass index (BMI)
The BMI is calculated as weight (kg) / height (m^2)
Measured: documented at baseline
Comorbidites
The comorbidities, such as hypertension, diabetes and stroke etc., will be recorded by patient-self report.
Measured: documented at baseline
The duration after radical prostatectomy
The duration is calculated as the days between the date of recruitment and the date of radical prostatectomy.
Measured: documented at baseline
The TNM tumor staging
The TNM tumor staging is recorded according to the pathology report after radical prostatectomy.
Measured: documented at baseline
The radical prostatectomy technique
Whether the neurovasulcar preservation technique and lymph node dissection was performed is achieved according to the surgery record.
Measured: documented at baseline
The presence of positive surgical margin
This is recorded according to the pathology report after radical prostatectomy.
Measured: documented at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start1 Apr 2023
- Primary completion1 Dec 2024
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Longhua Hospital
- Responsible party
- Principal investigator, Qi-Xiang Song, RenJi Hospital
- Investigators
- Wei Xue, MD, Study chair, Department of Urology, Ren Ji Hospital, Shanghai Jiao Tong University School of MedicineYuelai Chen, MD, Study chair, Longhua Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05773716
- Sponsor's protocol ID
- ST2023
- Status last verified
- Jul 2025
- First submitted
- 19 Jan 2023
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD will be made available to other researchers upon reasonable request after the publication of this trial.
Publications
Tang K, Su T, Fu L, Chen Z, Liu G, Hou W, Ming S, Song Q, Feng S, Liu X, Wang R, Liu B, Chen Y. Effect of Electroacupuncture Added to Pelvic Floor Muscle Training in Women with Stress Urinary Incontinence: A Randomized Clinical Trial. Eur Urol Focus. 2023 Mar;9(2):352-360. doi: 10.1016/j.euf.2022.10.005. Epub 2022 Oct 26.
PubMed 36420937Liu Z, Liu Y, Xu H, He L, Chen Y, Fu L, Li N, Lu Y, Su T, Sun J, Wang J, Yue Z, Zhang W, Zhao J, Zhou Z, Wu J, Zhou K, Ai Y, Zhou J, Pang R, Wang Y, Qin Z, Yan S, Li H, Luo L, Liu B. Effect of Electroacupuncture on Urinary Leakage Among Women With Stress Urinary Incontinence: A Randomized Clinical Trial. JAMA. 2017 Jun 27;317(24):2493-2501. doi: 10.1001/jama.2017.7220.
PubMed 28655016Su T, Zhou J, Liu Z, Chen Y, Zhang W, Chu H, Luo Q, Lu J, An J, Liu B. The efficacy of electroacupuncture for the treatment of simple female stress urinary incontinence - comparison with pelvic floor muscle training: study protocol for a multicenter randomized controlled trial. Trials. 2015 Feb 8;16:45. doi: 10.1186/s13063-015-0560-1.
PubMed 25887231Geraerts I, Van Poppel H, Devoogdt N, Joniau S, Van Cleynenbreugel B, De Groef A, Van Kampen M. Influence of preoperative and postoperative pelvic floor muscle training (PFMT) compared with postoperative PFMT on urinary incontinence after radical prostatectomy: a randomized controlled trial. Eur Urol. 2013 Nov;64(5):766-72. doi: 10.1016/j.eururo.2013.01.013. Epub 2013 Jan 21.
PubMed 23357349Ribeiro LH, Prota C, Gomes CM, de Bessa J Jr, Boldarine MP, Dall'Oglio MF, Bruschini H, Srougi M. Long-term effect of early postoperative pelvic floor biofeedback on continence in men undergoing radical prostatectomy: a prospective, randomized, controlled trial. J Urol. 2010 Sep;184(3):1034-9. doi: 10.1016/j.juro.2010.05.040.
PubMed 20643454Bi X, Chen Y, Wu R, Gao W, Fan Q, Wang S, Pan J, Xue W, Song QX, Tang K. The effects of combination therapy with electroacupuncture and pelvic floor muscle exercise on stress urinary incontinence following radical prostatectomy: the protocol for a randomized controlled trial. Front Surg. 2025 Dec 16;12:1490210. doi: 10.3389/fsurg.2025.1490210. eCollection 2025.
PubMed 41477477
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Combination Therapy With Electroacupuncture and Pelvic Floor Muscle Training on Stress Urinary Incontinence Following Radical Prostatectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05773716
- Acronym / sponsor ID
- ST2023
- Conditions
- Stress Urinary Incontinence
- Keywords
- Incontinence, Radical prostatectomy, Men, Pelvic floor muscle training, Acupuncture, Bladder diary, Pad test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Longhua Hospital
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 17 Mar 2023 (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.
The goal of this clinical study is to compare the effects of combined electroacupuncture with pelvic floor muscle training (PFMT) versus PFMT alone in the treatment of involuntary urine leakage following prostate removal procedure due to prostate cancer. The main goal is to determine that whether adding electroacupuncture to PFMT provides extra benefits in relieving urinary leakage and improves patients' quality of life. All participants will be required to perform daily PFMT for 6 weeks using uniformed standards. During the meantime, those assigned to the experimental group will additionally receive electroacupuncture three times per week for 6 weeks, while those in control group will receive sham treatment with same duration. Researchers will compare the urine leakage severity between the two groups to see if adding electroacupuncture can facilitate the recovery of symptom.
Detailed description
This randomized controlled trial will recruit patients presenting stress urinary incontinence 6 weeks after radical prostatectomy, with the aim to determine whether adding electroacupuncture therapy to pelvic floor muscle training (PFMT) provides extra benefits in relieving stress urinary incontinence following radical prostatectomy. Followed by signing the informed consent and baseline assessments, participants with be randomly allocated to either PFMT plus electroacupuncture arm or PFMT plus sham electroacupuncture arm in a 1:1 ratio.
Pelvic floor muscle training will be conducted daily using a consistent approach. In short, before training, the patients are required to empty the bladder and relax the whole body in a sitting or lying position. The contraction of the pelvic floor muscles is maintained for 2-6 seconds, followed by a relaxation for 2-6 seconds. This process is repeated 10 times per session, three sessions per day (in the morning, afternoon and evening), and performed daily for 6 continuous weeks.
Electroacupuncture will be performed at bilateral Zhongliao, Huiyang, Zhongji, Guanyuan and Dahe, three treatment sessions per week for 6 consecutive weeks. For sham electroacupuncture, The same acupoints will be punctured as that in treatment group, except the use of blunt-tipped needles (identical in appearance compared with normal needles) to puncture through the fixed pad and to reach the skin surface. In both groups, the needles will be clamped by electrodes which are connected to a pulse generator (Huatuo SDZ- EA, Suzhou, China). In consistency with our previous settings, continuous wave with frequency of 50Hz will be used. The current intensity is gradually increased ranging from 1mA to 5mA, according to the patient's tolerance.
Patients will be appraised at baseline, 3, 6, 10 and 18 weeks after the initiation of treatments to determine the changes of incontinence symptom, quality of life and pelvic structures. The primary outcome is the change of urine leakage amount during a 1-hour pad test at 6-week timepoint. The secondary outcomes include parameters derived from the International Consultation on Incontinence Modular Questionnaire - urinary incontinence short form, mean 24-hour pad use, pelvic magnetic resonance imaging (except for those with contraindications, such as metallic implants or psychological disorders), and the documentation of adverse events.
The statistical analysis of the baseline and outcomes at each timepoint is based on the intention-to-treat population. In addition, the data analysis of the primary outcome is also based on the per-protocol population as a supportive analysis. Quantitative variables will be compared using either independent t-tests or Mann-Whitney U-tests based on their normality. The statistical significance between nominal variables will be detected using Pearson's chi-squared tests or Fisher's exact tests. Statistical analysis will be performed using both SPSS software and R package, and the level of significance will be set at <0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture plus pelvic floor muscle training | Experimental | Behavioral: Pelvic floor muscle training, Other: ElectroacupunctureParticipants in this arm will receive pelvic floor muscle training using unified standards, and electroacupuncture therapy for 6 weeks. |
| Sham electroacupuncture plus pelvic floor muscle training | Sham comparator | Behavioral: Pelvic floor muscle training, Other: Sham electroacupunctureParticipants in this arm will receive pelvic floor muscle training using the same approach as that in experimental group, and sham electroacupuncture for 6 weeks. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients present stress urinary incontinence 6 weeks after radical prostatectomy
- Aged between 45-80 years
- With an urine leakage amount over 1g measured by the one-hour pad test
- Participate voluntarily with signed the informed consent
Key exclusion criteria (10 listed)
- The existence of stress urinary incontinence symptoms before the surgery
- Urine leakage due to urgency incontinence, voiding dysfunction, nocturnal enuresis and fistula
- Known history of radiation therapy to the pelvic region
- Evidence of tumor recurrence or metastasis
- Those who have already underwent treatment for stress urinary incontinence
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 |
|---|---|---|
| Pelvic floor muscle trainingParticipants will receive daily pelvic floor muscle training for 6 consecutive weeks. In specific, they will be instructed to perform 3 training sessions (morning, afternoon and evening) per day with an emptied bladder in a relaxed state. During each session, 10 muscle stretches are required with each contraction duration of 2~6-second and a 2~6-second relaxation following each one. | Behavioural | Electroacupuncture plus pelvic floor muscle training, Sham electroacupuncture plus pelvic floor muscle training |
| ElectroacupunctureParticipants will also receive electroacupuncture at bilateral Zhongliao (BL33), Huiyang (BL35), Zhongji (CV3), Guanyuan (CV4) and Dahe (KI12). During each therapy session, the electroacupuncture stimulation of acupoints in the abdomen and sacral regions will last for 30 minutes in total (15 minutes for each region) with a continuous wave of 50 Hz and a current intensity of 1 to 5 mA (preferably with the skin around the acupoints shivering mildly without pain). Participants will receive 3 treatment sessions per week (ideally every other day) for 6 consecutive weeks, 18 sessions in total. | Other | Electroacupuncture plus pelvic floor muscle training |
| Sham electroacupunctureSham electroacupuncture will be carried out with pragmatic placebo needles on the same acupoints in the experimental group. Procedures, electrode placements, and other treatment settings will also stay the same but with no electrical stimulation output. | Other | Sham electroacupuncture plus pelvic floor muscle training |
Primary outcome
The change of urine leakage amount at 6 weeks
Time frame: measured at baseline and 6 weeks after treatment
The 1-hour pad test will be applied to quantitatively measure the changes of the urine leakage severity. In specific, patients will be asked to wear pre-weighed pads and drink 500 ml of sodium-free liquid in <15 minutes. After rest, they are instructed to exercise for 30 minutes, including: walking, climbing up and down one flight of stairs, standing-up from sitting (10 times), coughing vigorously (10 times), running on the spot for 1 minute, bending to pick up an object from the floor (5 times) and washing hands for 1 minute in running water. Before and after the test, the weight of the pad is measured with a high-precision balance in order to determine the amount of leakage. For this test, an increase of 1 to 10 g represents mild incontinence, 11 to 50 g represents moderate incontinence, and >50 g represents severe incontinence.
14 secondary outcomes
One-hour pad test at 3, 10, 18 weeks
Time frame: measured at 3, 10 and 18 weeks after treatment
The status of 24-hour pad use
Time frame: measured at baseline, 6 and 18 weeks after treatment
Urinary incontinence questionnaires
Time frame: measured at baseline, 3, 6, 10 and 18 weeks after treatment
Pelvic Magnetic resonance imaging
Time frame: measured at baseline, 6 and 18 (optional) weeks after treatment
Adverse events
Time frame: measured at 3, 6, 10 and 18 weeks after treatment
Data of birth
Time frame: documented at baseline
Height
Time frame: documented at baseline
Weight
Time frame: documented at baseline
Body mass index (BMI)
Time frame: documented at baseline
Comorbidites
Time frame: documented at baseline
The duration after radical prostatectomy
Time frame: documented at baseline
The TNM tumor staging
Time frame: documented at baseline
The radical prostatectomy technique
Time frame: documented at baseline
The presence of positive surgical margin
Time frame: documented at baseline
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 24 Jul 2025.
- Background: PubMed 36420937Tang K, Su T, Fu L, Chen Z, Liu G, Hou W, Ming S, Song Q, Feng S, Liu X, Wang R, Liu B, Chen Y. Effect of Electroacupuncture Added to Pelvic Floor Muscle Training in Women with Stress Urinary Incontinence: A Randomized Clinical Trial. Eur Urol Focus. 2023 Mar;9(2):352-360. doi: 10.1016/j.euf.2022.10.005. Epub 2022 Oct 26.
- Background: PubMed 28655016Liu Z, Liu Y, Xu H, He L, Chen Y, Fu L, Li N, Lu Y, Su T, Sun J, Wang J, Yue Z, Zhang W, Zhao J, Zhou Z, Wu J, Zhou K, Ai Y, Zhou J, Pang R, Wang Y, Qin Z, Yan S, Li H, Luo L, Liu B. Effect of Electroacupuncture on Urinary Leakage Among Women With Stress Urinary Incontinence: A Randomized Clinical Trial. JAMA. 2017 Jun 27;317(24):2493-2501. doi: 10.1001/jama.2017.7220.
- Background: PubMed 25887231Su T, Zhou J, Liu Z, Chen Y, Zhang W, Chu H, Luo Q, Lu J, An J, Liu B. The efficacy of electroacupuncture for the treatment of simple female stress urinary incontinence - comparison with pelvic floor muscle training: study protocol for a multicenter randomized controlled trial. Trials. 2015 Feb 8;16:45. doi: 10.1186/s13063-015-0560-1.
- Background: PubMed 23357349Geraerts I, Van Poppel H, Devoogdt N, Joniau S, Van Cleynenbreugel B, De Groef A, Van Kampen M. Influence of preoperative and postoperative pelvic floor muscle training (PFMT) compared with postoperative PFMT on urinary incontinence after radical prostatectomy: a randomized controlled trial. Eur Urol. 2013 Nov;64(5):766-72. doi: 10.1016/j.eururo.2013.01.013. Epub 2013 Jan 21.
- Background: PubMed 20643454Ribeiro LH, Prota C, Gomes CM, de Bessa J Jr, Boldarine MP, Dall'Oglio MF, Bruschini H, Srougi M. Long-term effect of early postoperative pelvic floor biofeedback on continence in men undergoing radical prostatectomy: a prospective, randomized, controlled trial. J Urol. 2010 Sep;184(3):1034-9. doi: 10.1016/j.juro.2010.05.040.
- Derived from this study: PubMed 41477477Bi X, Chen Y, Wu R, Gao W, Fan Q, Wang S, Pan J, Xue W, Song QX, Tang K. The effects of combination therapy with electroacupuncture and pelvic floor muscle exercise on stress urinary incontinence following radical prostatectomy: the protocol for a randomized controlled trial. Front Surg. 2025 Dec 16;12:1490210. doi: 10.3389/fsurg.2025.1490210. eCollection 2025.
- Individual participant dataSharing planned: Yes. The IPD will be made available to other researchers upon reasonable request after the publication of this trial.
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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.
Wei Xue, MD study chair
Department of Urology, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
Yuelai Chen, MD study chair
Longhua Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor muscle training and Electroacupuncture in people with Stress Urinary Incontinence, run by RenJi Hospital 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 4 inclusion and 10 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 24 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. Some participants in this study may receive a placebo. 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?
The change of urine leakage amount at 6 weeks (time frame: measured at baseline and 6 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05773716, which also lists 6 linked publications.
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 24 Jul 2025.