Electroacupuncture and Pelvic Floor Muscle Training for Male Stress Urinary Incontinence

Study Overview
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Brief Summary
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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
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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. Electroacupuncture will be performed at bilateral Zhongliao, Huiyang, Zhongji, Guanyuan and Dahe, three treatment sessions per week for 6 consecutive weeks. For sham electroacupuncture, a pragmatic placebo needle on sham acupoints will be applied with no electricity output. 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, three-day bladder diary, pelvic ultrasound, magnetic resonance imaging, 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.

Official Title
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The Effects of Combination Therapy With Electroacupuncture and Pelvic Floor Muscle Training on Stress Urinary Incontinence Following Radical Prostatectomy: A Randomized Controlled Trial

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Behavioral: Pelvic floor muscle training
* Other: Electroacupuncture
* Other: Sham electroacupuncture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electroacupuncture plus pelvic floor muscle training<br>Participants in this arm will receive pelvic floor muscle training using unified standards, and electroacupuncture therapy for 6 weeks. | Behavioral: Pelvic floor muscle training<br>* 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.<br>Other: Electroacupuncture<br>* 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.<br>|
| Sham Comparator: Sham electroacupuncture plus pelvic floor muscle training<br>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<br>* 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.<br>Other: Sham electroacupuncture<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| One-hour pad test at 3, 10, 18 weeks | For the 1-hour pad test, 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 3, 10 and 18 weeks after treatment | 
| Three-day bladder diary | The bladder voiding and storage function will be recorded for 3 consecutive days using the validated International Consultation on Incontinence Modular Questionnaire - bladder diary. From each diary, mean voided volume, maximum voided volume, 24-hour frequency, nocturnal frequency, 24-hour urine volume, nocturnal urine volume, and urine leakage episodes will be calculated. | measured at baseline, 6 and 18 weeks after treatment | 
| Urinary incontinence questionnaires | The patient-reported continence status will be evaluated by the International Consultation on Incontinence Modular Questionnaire - urinary incontinence short form (ICIQ-UI-SF). The total score will be calculated based on three questions, namely the frequency of leakage (scores from 0 to 5 points), the amount of leakage (scores 0, 2, 4 or 6 points) and the impact of leakage (scores from 0 to 10 points). | measured at baseline, 3, 6, 10 and 18 weeks after treatment | 
| Pelvic ultrasound | A pelvic ultrasound will be performed using a trans-perineal approach during both static state and Valsalva maneuver to record parameters, including the urethral rotation angle, urethral -vesical junction, ano-rectal junction, and the formation of funneled bladder neck etc. | measured at baseline, and at 3 weeks during active electroacupuncture treatment | 
| Magnetic resonance imaging assessment | The magnetic resonance imaging will be performed with a 1.5-T scanner with the patients in a supine position. The imaging protocol included a transversal T1-weighted 2D gradient echo sequence. High-spatial-resolution T2-weighted TSE sequences will be obtained in the axial, coronal and sagittal orientation. Several parameters will be measured, including membranous urethral length, urethral wall thickness, levator ani muscle thickness, obturator internus muscle thickness etc. Besides, the position of the bladder neck, the shape of the bladder and the presence of a dilated posterior urethra will also be recorded. | measured at baseline, 6 and 18 (optional) weeks after treatment | 
| Adverse events | Although electroacupuncture is well-known as a minimally invasive therapy which can be carried out in the clinic, the adverse events will be carefully documented by the researchers base on the patients' subjective report. | measured at 3, 6, 10 and 18 weeks after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Incontinence, Radical prostatectomy, Men, Pelvic floor muscle training, Acupuncture, Bladder diary, Pad test