Electroacupuncture and Pelvic Floor Muscle Training for Male Stress Urinary Incontinence (NCT05773716) | Clinical Trial Compass
CompletedNot Applicable
Electroacupuncture and Pelvic Floor Muscle Training for Male Stress Urinary Incontinence
China120 participantsStarted 2023-04-01
Plain-language 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.
Who can participate
Age range
45 Years – 80 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The change of urine leakage amount at 6 weeks
Timeframe: measured at baseline and 6 weeks after treatment