Electroacupuncture and Pelvic Floor Muscle Training for Male Stress Urinary Incontinence

NCT05773716 | Completed

• 1 other identifier: ST2023
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Urinary Incontinence

Keywords

Incontinence; Radical prostatectomy; Men; Pelvic floor muscle training; Acupuncture; Bladder diary; Pad test

Outcome Measures

Primary Outcomes (1)

• 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 at baseline and 6 weeks after treatment

Secondary Outcomes (14)

• One-hour pad test at 3, 10, 18 weeks

  measured at 3, 10 and 18 weeks after treatment

• The status of 24-hour pad use

  measured at baseline, 6 and 18 weeks after treatment

• Urinary incontinence questionnaires

  measured at baseline, 3, 6, 10 and 18 weeks after treatment

• Pelvic Magnetic resonance imaging

  measured at baseline, 6 and 18 (optional) weeks after treatment

• Adverse events

  measured at 3, 6, 10 and 18 weeks after treatment

Study Arms (2)

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.

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.

Behavioral: Pelvic floor muscle training; Other: Sham electroacupuncture

Interventions

Pelvic floor muscle training 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 plus pelvic floor muscle training; Sham electroacupuncture plus pelvic floor muscle training

Electroacupuncture 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.

Electroacupuncture plus pelvic floor muscle training

Sham electroacupuncture 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.

Sham electroacupuncture plus pelvic floor muscle training

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RenJi Hospital: lead
• Longhua Hospital: collaborator

Study Sites (1)

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, 200127, China

Location

Related Publications (6)

• 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.

  PMID: 36420937 BACKGROUND

• 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.

  PMID: 28655016 BACKGROUND

• 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.

  PMID: 25887231 BACKGROUND

• 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.

  PMID: 23357349 BACKGROUND

• 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.

  PMID: 20643454 BACKGROUND

• Bi 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.

  PMID: 41477477 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress; Multiple Endocrine Neoplasia Type 1

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Wei Xue, MD

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

  STUDY CHAIR

• Yuelai Chen, MD

  Shanghai University of Traditional Chinese Medicine

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: January 19, 2023
• First Posted: March 17, 2023
• Study Start: April 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: April 30, 2025
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The study protocol will be ready to share upon reasonable request after the publication of study.

Locations

CN (1)