Clinical trial NCT05773716: Electroacupuncture and Pelvic Floor Muscle Training for Male Stress Urinary Incontinence
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: Incontinence
Radical prostatectomy
Men
Pelvic floor muscle training
Acupuncture
Bladder diary
Pad test
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Longhua Hospital
First posted: 2023-03-17
Enrollment: 80
Sex: MALE
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 question it aims to answer is that whether adding electroacupuncture to PFMT provides extra benefits in relieve 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.

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

Primary outcomes:
measure: The change of urine leakage amount at 6 weeks
timeFrame: measured at baseline and 6 weeks after treatment
Secondary outcomes:
measure: One-hour pad test at 3, 10, 18 weeks
timeFrame: measured at 3, 10 and 18 weeks after treatment
measure: The status of 24-hour pad use
timeFrame: measured at baseline, 6 and 18 weeks after treatment
measure: Urinary incontinence questionnaires
timeFrame: measured at baseline, 3, 6, 10 and 18 weeks after treatment
measure: Pelvic Magnetic resonance imaging
timeFrame: measured at baseline, 6 and 18 (optional) weeks after treatment
measure: Adverse events
timeFrame: measured at 3, 6, 10 and 18 weeks after treatment
measure: Data of birth
timeFrame: documented at baseline
measure: Height
timeFrame: documented at baseline
measure: Weight
timeFrame: documented at baseline
measure: Body mass index (BMI)
timeFrame: documented at baseline
measure: Comorbidites
timeFrame: documented at baseline
measure: The duration after radical prostatectomy
timeFrame: documented at baseline
measure: The TNM tumor staging
timeFrame: documented at baseline
measure: The radical prostatectomy technique
timeFrame: documented at baseline
measure: The presence of positive surgical margin
timeFrame: documented at baseline
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiao Tong University School of Medicine
Study officials:
affiliation: Department of Urology, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
name: Wei Xue, MD
role: STUDY_CHAIR
affiliation: Shanghai University of Traditional Chinese Medicine
name: Yuelai Chen, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.