Electroacupuncture and Pelvic Floor Muscle Training for Male Stress Urinary Incontinence

NCT ID: NCT05773716

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2025-04-30

Brief 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. 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.

Conditions

Stress Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Electroacupuncture plus pelvic floor muscle training

Participants in this arm will receive pelvic floor muscle training using unified standards, and electroacupuncture therapy for 6 weeks.

Group Type: EXPERIMENTAL

Pelvic floor muscle training

Intervention Type: BEHAVIORAL

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.

Electroacupuncture

Intervention Type: OTHER

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 electroacupuncture plus pelvic floor muscle training

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.

Group Type: SHAM_COMPARATOR

Pelvic floor muscle training

Intervention Type: BEHAVIORAL

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.

Sham electroacupuncture

Intervention Type: OTHER

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.

Interventions

Pelvic floor muscle training

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.

Intervention Type: BEHAVIORAL

Electroacupuncture

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.

Intervention Type: OTHER

Sham electroacupuncture

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Longhua Hospital

OTHER

Sponsor Role: collaborator

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Qi-Xiang Song

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wei Xue, MD

Role: STUDY_CHAIR

Department of Urology, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine

Yuelai Chen, MD

Role: STUDY_CHAIR

Shanghai University of Traditional Chinese Medicine

Locations

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, , China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 36420937 (View on PubMed)

Liu 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.

Reference Type: BACKGROUND

PMID: 28655016 (View on PubMed)

Su 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.

Reference Type: BACKGROUND

PMID: 25887231 (View on PubMed)

Geraerts 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.

Reference Type: BACKGROUND

PMID: 23357349 (View on PubMed)

Ribeiro 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.

Reference Type: BACKGROUND

PMID: 20643454 (View on PubMed)

Other Identifiers

ST2023

Identifier Type: -

Identifier Source: org_study_id