Combining electroacupuncture with pelvic floor muscle training for men with urinary incontinence after prostate surgery
The Effects of Combination Therapy With Electroacupuncture and Pelvic Floor Muscle Training on Stress Urinary Incontinence Following Radical Prostatectomy: A Randomized Controlled Trial
This study is testing if combining electroacupuncture with pelvic floor muscle training can help men who have urinary incontinence after prostate surgery feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 45 Years to 80 Years |
| Sex | Male |
| Sponsor | RenJi Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT05773716 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of combining electroacupuncture with pelvic floor muscle training (PFMT) in treating stress urinary incontinence in men who have undergone radical prostatectomy. Participants will be randomly assigned to either the experimental group receiving both PFMT and electroacupuncture or a control group receiving PFMT with sham electroacupuncture. The study will assess the severity of urine leakage and overall quality of life improvements over a 6-week period. All participants will perform daily PFMT while those in the experimental group will receive electroacupuncture three times a week.
Who should consider this trial
Good fit: Ideal candidates are men aged 45-80 who experience stress urinary incontinence at least 6 weeks after radical prostatectomy.
Not a fit: Patients who had urinary incontinence symptoms prior to surgery or have other types of incontinence will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve urinary control and quality of life for men recovering from prostate surgery.
How similar studies have performed: Previous studies have shown promising results with electroacupuncture and PFMT for urinary incontinence, suggesting potential for success in this combined approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai
- Renji Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Qi-Xiang Song, MD, PhD
- Email: rex_song918@qq.com
- Phone: +8615021223013
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.