The Effects of Combination Therapy With Electroacupuncture and Pelvic Floor Muscle Training on Stress Urinary Incontinence Following Radical Prostatectomy: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- RenJi Hospital
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- The change of urine leakage amount at 6 weeks
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 45 Years to 80 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Electroacupuncture plus pelvic floor muscle training
Participants in this arm will receive pelvic floor muscle training using unified standards, and electroacupuncture therapy for 6 weeks.
Intervention: Pelvic floor muscle training (Behavioral)
Electroacupuncture plus pelvic floor muscle training
Participants in this arm will receive pelvic floor muscle training using unified standards, and electroacupuncture therapy for 6 weeks.
Intervention: Electroacupuncture (Other)
Sham electroacupuncture plus pelvic floor muscle training
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.
Intervention: Pelvic floor muscle training (Behavioral)
Sham electroacupuncture plus pelvic floor muscle training
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.
Intervention: Sham electroacupuncture (Other)
Outcomes
Primary Outcomes
The change of urine leakage amount at 6 weeks
Time Frame: measured at baseline and 6 weeks after treatment
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.
Secondary Outcomes
- The radical prostatectomy technique(documented at baseline)
- One-hour pad test at 3, 10, 18 weeks(measured at 3, 10 and 18 weeks after treatment)
- Height(documented at baseline)
- Adverse events(measured at 3, 6, 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)
- Weight(documented at baseline)
- Body mass index (BMI)(documented at baseline)
- The duration after radical prostatectomy(documented at baseline)
- Pelvic Magnetic resonance imaging(measured at baseline, 6 and 18 (optional) weeks after treatment)
- The TNM tumor staging(documented at baseline)
- Data of birth(documented at baseline)
- Comorbidites(documented at baseline)
- The presence of positive surgical margin(documented at baseline)
Investigators
Qi-Xiang Song
Principal Investigator
RenJi Hospital