A Prospective Evaluation of Early Acupuncture for Immediate Continence Enhancement After Prostatectomy
Phase: NA
Conditions: Prostate Cancer, Urinary Incontinence
Sponsor: Bin Xu

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Research Project Design Document
Project Name: A Prospective Evaluation of Early Acupuncture for Immediate Continence
Enhancement after Prostatectomy
Department: Department of Urology
Institution Address/Postal Code: 87 Dingjiaqiao, Gulou District, Nanjing,
Jiangsu Province, 210009
Principal Investigator: Bin Xu
Telephone/Email: +86 18012949196
Supervising Department: Zhongda Hospital, Southeast University
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Version Date: Aug 25, 2025

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1. Rationale
Prostate cancer (PCa) has become a major threat to male urogenital health. The
global cancer statistics report published by the WHO's International Agency for
Research on Cancer (IARC) showed 1.5 million new cases of prostate cancer
worldwide in 2022, accounting for 7.3% of all malignant tumors and ranking second
only to lung cancer in male morbidity. The incidence of prostate cancer shows
significant geographical and ethnic differences. Historically, Asia has had a lower
incidence rate compared to regions like Europe, America, Australia, and New
Zealand. However, with an aging population, changes in lifestyle, and the
popularization of screening methods such as prostate-specific antigen (PSA) testing,
the incidence of prostate cancer in China is also showing a year-on-year upward
trend. This growth has positioned China among the world leaders in both absolute
numbers of new prostate cancer cases and deaths, signaling that prostate cancer has
transformed from a relatively rare tumor into a major public health issue threatening
the health of Chinese men [1].
Radical Prostatectomy (RP) is the standard method for treating localized prostate
cancer, effectively removing tumor tissue and extending patient survival. However,
this life-saving surgery also brings almost inevitable functional sequelae.
Postoperative urinary incontinence, especially the immediate continence issue after
catheter removal, severely impacts patients' quality of life. Studies show that some
patients face immediate urine leakage or control difficulties after catheter removal,
with an incidence rate between 5%-48% [2]. One study accurately quantified the
amount of urine leakage using the 24-hour pad test, finding that in the first week
after catheter removal, the average daily urine leakage could be as high as 408.0 mL
[3]. This level is sufficient to cause severe social embarrassment and psychological
distress, urgently requiring effective interventions.
Currently, the treatment for post-RP urinary incontinence mainly relies on
conservative therapies such as Pelvic Floor Muscle Training (PFMT). However, these
measures are usually initiated after catheter removal and cannot meet the need for
immediate continence upon removal. Furthermore, the efficacy of PFMT requires
long-term adherence, patient compliance is generally poor, and most importantly,
the timing of the intervention is delayed. Traditional surgical interventions, such as
the implantation of an artificial urinary sphincter (AUS) or male sling surgery, can
improve symptoms but carry risks like infection and mechanical failure, and not all
patients are suitable for such invasive treatments [2]. In terms of drug therapy, the
several classes of drugs currently under investigation (including anticholinergics,
PDE5 inhibitors, duloxetine, etc.) still lack evidence and remain controversial [4], and
cannot be used as standard therapy for post-RP urinary incontinence patients. There
is currently a lack of effective and widely recognized solutions for immediate
continence intervention after catheter removal.

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Against the backdrop of existing treatments failing to meet clinical needs, this study
proposes early postoperative acupuncture as an innovative and scientifically rational
intervention strategy. Acupuncture is not merely an "alternative therapy" but an
effective "non-invasive peripheral neuromodulation technique" confirmed by
modern medical research. Its theoretical basis for improving immediate
postoperative continence is built on solid neurophysiological foundations and
evidence from previous clinical studies. The core pathology of post-RP urinary
incontinence is neuromuscular dysfunction. Acupuncture therapy, by stimulating
specific acupoints on the body surface, can activate corresponding neural pathways,
thereby modulating the function of the bladder and urinary sphincter. Its possible
mechanisms of action include: Direct sacral neuromodulation (The deep anatomical
location of the Baliao (BL31-BL34) acupoints corresponds precisely to the sacral
foramina, and needle stimulation can directly act on the sacral nerve roots. This is
mechanistically similar to Sacral Neuromodulation (SNS) therapy, which is already
widely used clinically [5].) and Activation of the pudendal nerve-sphincter pathway
(Stimulating sacral acupoints like Baliao can activate the afferent and efferent fibers
of the pudendal nerve, enhancing the tension and closure function of the external
urinary sphincter, thereby increasing urethral resistance and preventing involuntary
urine leakage [6]).
Multiple studies have already shown that acupuncture has a certain effect in
alleviating postoperative urinary incontinence. For example, in a study conducted by
Yang Hao et al. [7], a clear conclusion was drawn by comparing the effects of
"pudendal nerve electroacupuncture stimulation" versus "pelvic floor biofeedback
electrical stimulation" in treating 81 patients with post-prostatectomy urinary
incontinence. The study found that electroacupuncture therapy not only took effect
faster (improvement at 4 weeks vs. 8 weeks for the control group) but also had a
significantly higher total effective rate at 12 weeks (73.17% vs. 37.50%). Furthermore,
the electroacupuncture group outperformed the control group on all quality of life
and functional scores, and its efficacy remained stable during a follow-up period of
up to 6 months, demonstrating good long-term effects. However, most existing
research focuses on the treatment of long-term postoperative urinary incontinence,
with few studies addressing the improvement of immediate continence after
catheter removal.
Therefore, the core innovation of this study lies in the "timing" of the acupuncture
treatment, specifically early acupuncture therapy. To be precise, we will perform
acupuncture treatment during the postoperative window before catheter removal
(while the bladder is in a "resting" state with continuous drainage via the catheter).
The core hypothesis is: By applying neuromodulatory stimulation in advance, the
urinary control system can be "pre-activated" and "functionally reorganized" before
it faces the actual challenge (i.e., bladder filling and urination after removal). This
may be achieved through the following pathways: Re-establishing neural
connections (Activating and "awakening" neural pathways temporarily suppressed

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by surgical trauma.), Enhancing baseline sphincter tone (Preemptively increasing the
resting tension of the external urinary sphincter through pudendal nerve
stimulation.), Stabilizing detrusor function (Inhibiting potential, uncoordinated
detrusor contractions to prepare for stable bladder filling.), and Reducing local
inflammatory response (Acupuncture has a recognized anti-inflammatory effect,
which can help reduce surgical site edema and nerve irritation, creating a more
favorable local microenvironment for functional recovery.) This "pre-emptive"
intervention aims to adjust the patient's neuromuscular system to a better state of
readiness, enabling it to more effectively cope with the pressure of bladder filling at
the moment of catheter removal, thereby achieving a smoother transition in urinary
control function and shortening or even avoiding a severe immediate incontinence
period.
In summary, the early acupuncture intervention protocol proposed in this study not
only possesses a solid neurophysiological basis and ample supporting evidence but
also represents a shift in clinical thinking from "passive treatment" to "active
prevention." By implementing non-invasive neuromodulation at a critical time
window, it is expected to fill a huge gap in current clinical practice and provide a safe,
effective, and economical new pathway for improving the immediate postoperative
quality of life for prostate cancer patients. The specific objective is: To systematically
evaluate the efficacy of early acupuncture treatment by comparing the treatment
group (early acupuncture + standard care) versus the control group (no acupuncture
+ standard care) in terms of urine leakage volume, proportion of complete
continence, pad usage, and patient satisfaction within 24 hours after catheter
removal.
References:
[1]
Ferlay J, Ervik M, Lam F, Laversanne M, Colombet M, Mery L, Piñeros M, Znaor A, Soerjomataram I, Bray F (2024). Global
Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on Cancer.
[2]
Sandhu JS, Breyer B, Comiter C, Eastham JA, Gomez C, Kirages DJ, et al. Incontinence after Prostate Treatment: AUA/SUFU
Guideline. Journal of Urology [Internet]. 2019 Aug 1 [cited 2025 Jul 12];202(2):369–78.
[3]
Sathianathen NJ, Johnson L, Bolton D, Lawrentschuk NL. An objective measurement of urinary continence recovery with pelvic
floor physiotherapy following robotic assisted radical prostatectomy. Transl Androl Urol. 2017 Jul;6(Suppl 2):S59-S63.
[4]
Castellan P, Ferretti S, Litterio G, Marchioni M, Schips L. Management of Urinary Incontinence Following Radical Prostatectomy:
Challenges and Solutions. Ther Clin Risk Manag. 2023 Jan 15;19:43-56. doi: 10.2147/TCRM.S283305.
[5]
Paik SH, Han SR, Kwon OJ, Ahn YM, Lee BC, Ahn SY. Acupuncture for the treatment of urinary incontinence: A review of
randomized controlled trials. Exp Ther Med. 2013 Sep;6(3):773-780. doi: 10.3892/etm.2013.1210IF: 2.3 Q3 . Epub 2013 Jul 9.
[6]
Yang M, Zhu L, Yao H, Chen Y, Liu Z. Effects of electroacupuncture on chronic urinary retention after pelvic or lumbosacral
tumor resection surgeries: a retrospective cohort study. Transl Androl Urol. 2024 Mar 31;13(3):397-405. doi: 10.21037/tau-23-468.
Epub 2024 Mar 14.
[7]
杨浩,吕婷婷,吕笑,等.阴部神经电针刺激疗法治疗前列腺根治术后尿失禁的疗效观察[J].中华男科学杂
志,2002,26(12):1119-1123.DOI:10.13263/j.cnki.nja.2020.12.011
Study Rationale and Significance

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This study focuses on the impact of early postoperative acupuncture intervention on
immediate urinary continence after catheter removal, filling a gap in existing
research. Early postoperative intervention may accelerate the recovery of urinary
control function by stimulating relevant nerves and muscles, reducing the risk of
immediate urine leakage after removal. If the study yields positive results, early
electroacupuncture treatment can provide patients with a non-invasive and safe
treatment option, significantly improving postoperative quality of life and reducing
the use of pads and the associated psychological burden.
Our team expects to conduct a prospective randomized controlled study (a
collaboration between the Department of Urology at Zhongda Hospital, Southeast
University; the Department of Urology at Nanjing Lishui People's Hospital; and the
Department of Urology at Wuxi Xishan People's Hospital). Information on patients
receiving treatment will be obtained from the electronic medical record (EMR)
systems of Zhongda Hospital, Nanjing Lishui People's Hospital, and Wuxi Xishan
People's Hospital. Patients meeting the inclusion and exclusion criteria will be
screened and subsequently receive electroacupuncture treatment postoperatively.
By following up with these patients and comparing them with postoperative patients
receiving placebo electroacupuncture, we will study the impact on patient prognosis.
II. Study Content
1. Study Objectives
To evaluate the effect of early electroacupuncture intervention on immediate urinary
continence after prostatectomy in a prospective study.
2. Study Content
(1) Selection of Study Sites: This study will be conducted at the Department of
Urology, Zhongda Hospital, Southeast University; the Department of Urology,
Nanjing Lishui People's Hospital; and the Department of Urology, Wuxi Xishan
People's Hospital.
(2) Selection of Study Subjects: Information on patients receiving acupuncture
treatment and control group patients will be obtained from the multi-center EMR
systems. Patients meeting the inclusion/exclusion criteria will be screened. Using
block randomization, they will be allocated 1:1 into either the treatment group or the
control group and receive either acupuncture treatment or sham acupuncture treatment
for inclusion in the clinical study.
Number of subjects to be enrolled at each center:

Department of Urology, Zhongda Hospital, Southeast University: 84 cases

Department of Urology, Nanjing Lishui People's Hospital: 30 cases

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
Department of Urology, Wuxi Xishan People's Hospital: 30 cases
Sample Size: This study is a prospective, multi-center, randomized,
placebo-controlled clinical trial designed to assess the efficacy of early
electroacupuncture intervention in improving immediate urinary continence after
radical prostatectomy (RP). The Primary Endpoint has been determined as the urine
leakage volume (in grams) measured by the 1-hour pad test administered immediately
after catheter removal (within the first 1 hour post-removal). This calculation is based
on a test comparing two independent sample means. The required parameters include
the expected mean difference between groups (effect size, δ), the within-group
standard deviation (σ), the Type I error probability (α), and the Type II error
probability (β). We set the two-sided significance level α = 0.05, statistical power
(1−β) = 0.80, and a 1:1 allocation ratio for the two groups (treatment vs. sham
acupuncture).
In the absence of a perfectly matched study focusing on post-RP males, comparing
electroacupuncture versus sham acupuncture, and using the 1-hour pad test (grams) as
the primary endpoint, we have, after rigorous screening, selected a high-quality,
large-scale (N=504), multi-center randomized controlled trial published by Liu et al.
in the Journal of the American Medical Association (JAMA) in 2017 as the primary
basis for parameter estimation. That study's methodological design
(electroacupuncture vs. sham acupuncture) and primary outcome measure (1-hour pad
test leakage volume) are highly consistent with our study, representing the best
available evidence. Although its study population was women with stress urinary
incontinence, we consider its reported effect size and variability data to be the most
reasonable reference for this calculation, given the cross-gender commonality of the
core physiological mechanism (sacral neuromodulation via electroacupuncture) for
regulating urinary control.
Based on the results from Liu et al.'s study:

Expected Effect Size (δ): The electroacupuncture group showed 7.4 grams
more reduction in 1-hour pad test leakage compared to the sham acupuncture
group. We use this as the expected mean difference between groups.

Within-group Standard Deviation (σ): Based on the reported 95%
confidence interval of the effect size, we extrapolated the pooled standard
deviation for the "change value" in leakage volume (before and after
intervention) to be approximately 14.9 grams.
Based on the parameters above, using the sample size formula for comparing two
independent means: n = [(Zα/2 + Zβ)² × 2σ²] / δ²
The calculation shows that to achieve 80% power, each group requires at least 64
subjects.

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Considering the short intervention cycle and clear follow-up nodes of this study, we
estimate a dropout or withdrawal rate of approximately 10%. To compensate for this
potential sample loss, the adjusted number of recruits needed per group is 64 / (1 −
0.10) ≈71.11. Rounding up, we determine that each group needs to recruit 72
subjects.
In summary, this study plans to enroll a total of 144 subjects (72 in the treatment
group, 72 in the control group). This sample size is sufficient to statistically and
effectively test the core hypothesis of this study and is feasible within the multi-center
collaborative framework. An interim analysis will assess whether the sample size
needs adjustment based on actual enrollment and data variability.
Reference: Liu Z, Liu Y, Xu H, et al. Effect of Electroacupuncture on Urinary
Leakage Among Women With Stress Urinary Incontinence: A Randomized Clinical
Trial. JAMA. 2017;317(24):2493–2501. doi:10.1001/jama.2017.7220
(3) Study Period 2025.08.01——2027.08.01
Study Subject Sampling and Allocation Method
This study will employ a prospective, multi-center, randomized controlled trial
design. All patients undergoing radical prostatectomy during the study period who
meet all inclusion criteria, do not meet any exclusion criteria, and voluntarily sign the
informed consent form will be enrolled consecutively. To ensure the scientific rigor
of the allocation process, subject allocation will utilize a centralized, stratified block
randomization method. We will use participating hospitals as the stratification factor,
generating independent random sequences for each center to eliminate potential
inter-institutional bias. Within each stratum, we will use mixed block sizes (sizes 4
and 6) for random allocation to maintain a close dynamic balance between the
treatment and control groups at all stages of the study. To achieve allocation
concealment, the random sequences will be generated by an independent
statistician (not involved in clinical work) and deployed within a secure central
randomization system. On-site researchers will only be able to obtain the patient's
group assignment through the system after the patient is formally enrolled, thereby
preventing selection bias. This study plans to randomly allocate a total of 144
subjects to the treatment group and the control group in a 1:1 ratio.
Informed Consent of Study Subjects
Signing of the informed consent form.
Outcome Measures

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Follow-up on patient's urinary continence at 1 week, 4 weeks, 8 weeks, 12 weeks,
and 24 weeks after catheter removal (half-year follow-up).
1. Primary Endpoint: Urine leakage volume (grams) measured by the first
1-hour pad test during the follow-up at 1 week post-catheter removal.
2. 1-hour Pad Test Results: Conducted at the 4-week and 24-week follow-ups.
3. ICIQ-SF Questionnaire Score: At 1, 4, 8, 12, and 24 weeks post-removal to
evaluate incontinence symptoms and their impact on quality of life. The
proportion of completely continent patients (zero leakage) will directly
quantify immediate continence.
4. Self-Rating Anxiety Scale (SAS) Score: To assess the potential improvement
in patients' psychological state due to the acupuncture intervention.
5. Voiding Diary and IPSS: Patients will maintain a voiding diary and complete
the International Prostate Symptom Score (IPSS) questionnaire at each
follow-up node to assess nocturia and provide a comprehensive evaluation of
urinary function.
(7) Treatment Methods
All patients will have their urinary catheter removed on postoperative day 14
(POD14). The early electroacupuncture intervention (including real
electroacupuncture and sham electroacupuncture) will be initiated on postoperative
day 7 (POD 7), with subsequent sessions on POD 9 and POD 11, for a total of 3
sessions.
Treatment Group: Receive electroacupuncture at acupoints including Shenshu
(BL23), Pangguangshu (BL28), and Baliao (BL31-34), 30 minutes each time. A
continuous wave of 2Hz will be used initially, with the intensity gradually increased
to a level that is comfortable for the patient. The current intensity will be 1-5mA and
can be gradually increased to the maximum tolerable level for the patient.
Control Group: Will use non-invasive sham acupuncture needles: validated blunt-tip,
non-penetrating needles (such as Park or Streitberger needles). When pressure is
applied, the needle tip retracts into the handle, giving the patient a sensation of
pressure on the skin, but it does not puncture the skin. The procedure will be
performed at non-acupoints (points 1-2 cm away from the real acupoints but not on
the same meridian). The electroacupuncture device clips will also be attached to the
sham needle handles, and the device will be turned on (emitting the same sound or
light indicators), but no electrical current will be delivered. This ensures the entire
treatment scenario is visually and auditorily identical to the real treatment group.
To ensure all subjects receive consistent standard postoperative rehabilitation
guidance and to control for potential confounding variables, all successfully enrolled

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patients (regardless of group) will receive standardized Pelvic Floor Muscle Training
(PFMT) health education on POD 7 (the same day as the first intervention).
3. Research Methods
Research Design
This trial will adopt a randomized controlled prospective study design.
Inclusion and Exclusion Criteria
Subject Inclusion Criteria are as follows:
1. Patients who have undergone radical prostatectomy with a clear pathological
diagnosis of prostate cancer.
2. One week post-RP.
3. Karnofsky Performance Status (KPS) score $\ge$ 60 or ECOG score 0-1.
4. Age between 50 and 85 years.
5. Signed informed consent.
Subject Exclusion Criteria are as follows:
1. Pathology report shows positive surgical margins.
2. Has undergone treatment for postoperative urinary incontinence, such as
cystostomy, urinary sphincter reconstruction, or urethral sling surgery.
3. Currently receiving or has received treatments with similar principles to
acupuncture (e.g., electroacupuncture, moxibustion, warm needling) within
the past six months.
4. Patients with urinary tract infections (excluding asymptomatic lower urinary
tract infections).
5. Known severe cardiac diseases, such as severe arrhythmia, severe cardiac
insufficiency, acute myocarditis, constrictive pericarditis, cardiac tamponade,
or severe valvular disease.
6. Known liver damage or potential severe liver disease (ALT or AST > 10 times
normal).
7. Known severe renal impairment (eGFR < 25 mL/min/1.73m²) , or
planning/undergoing dialysis, or acute contrast-induced nephropathy at
screening.
8. Known severe primary diseases in other vital organs or the hematopoietic
system.
9. Known coagulation dysfunction (with typical clinical diagnosis or definitive
laboratory test results).
10. Patients with psychiatric disorders or cognitive impairment; severe
depression, alcohol dependence, or history of drug abuse.

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11. Existing urinary incontinence due to other reasons.
12. Patients deemed unsuitable for the study by the investigator, or those with a
high probability of dropping out, such as frequent changes in work
environment leading to difficulty in follow-up.
13. Life expectancy $\le$ 6 months, as judged by the investigator.
14. Currently participating in other clinical trials.
(3) Enrollment and Treatment Protocol
Information on patients who have undergone radical prostatectomy will be obtained
from the EMR systems of Zhongda Hospital, Nanjing Lishui People's Hospital, and
Wuxi Xishan People's Hospital. After screening patients who meet the
inclusion/exclusion criteria and signing the informed consent form , patients will be
allocated into groups using a centralized, stratified block randomization method
24and receive either acupuncture treatment or sham acupuncture treatment.
Trial Treatment Protocol: All patients will have their urinary catheter removed on
postoperative day 14 (POD 14). The early acupuncture intervention (including real
and sham acupuncture) will be initiated on postoperative day 7 (POD 7), with
subsequent sessions on POD 9 and POD 11, for a total of 3 sessions.
Treatment Group: Receive electroacupuncture at acupoints including Shenshu
(BL23), Pangguangshu (BL28), and Baliao (BL31-34), 30 minutes each time. A
continuous wave of 2Hz will be used initially, with the intensity gradually increased
to a level that is comfortable for the patient. The current intensity will be 1-5mA and
can be gradually increased to the maximum tolerable level for the patient.
Control Group: Will use non-invasive sham acupuncture needles: validated blunt-tip,
non-penetrating needles. When pressure is applied, the needle tip retracts into the
handle, giving the patient a sensation of pressure on the skin, but it does not
puncture the skin. The procedure will be performed at non-acupoints (points 1-2 cm
away from the real acupoints but not on the same meridian). The
electroacupuncture device clips will also be attached to the sham needle handles,
and the device will be turned on (emitting the same sound or light indicators), but no
electrical current will be delivered. This ensures the entire treatment scenario is
visually and auditorily identical to the real treatment group.
To ensure all subjects receive consistent standard postoperative rehabilitation
guidance and to control for potential confounding variables, all successfully enrolled
patients (regardless of group) will receive standardized Pelvic Floor Muscle Training
(PFMT) health education on POD 7 (the same day as the first intervention).
Efficacy Evaluation

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1. Primary Endpoint: Urine leakage volume (grams) measured by the first
1-hour pad test during the follow-up at 1 week post-catheter removal.
2. 1-hour Pad Test Results: Conducted at the 4-week and 24-week follow-ups.
3. ICIQ-SF Questionnaire Score: At 1, 4, 8, 12, and 24 weeks post-removal to
evaluate incontinence symptoms and their impact on quality of life. The
proportion of completely continent patients (zero leakage) will directly
quantify immediate continence.
4. Self-Rating Anxiety Scale (SAS) Score: To assess the potential improvement
in patients' psychological state due to the acupuncture intervention.
5. Voiding Diary and IPSS: Patients will maintain a voiding diary and complete
the International Prostate Symptom Score (IPSS) questionnaire at each
follow-up node to assess nocturia and provide a comprehensive evaluation of
urinary function.
(4) Statistical Analysis
Statistical analysis will be performed by professional statisticians from the Clinical
Evaluation and Analysis Center of Zhongda Hospital, Southeast University, using SPSS
Statistics (V.26.0). All analyses will follow the Intention-to-Treat (ITT) principle. Data
normality will be assessed using the Shapiro-Wilk test. Imbalances in baseline
demographic and clinical characteristics will be adjusted using Analysis of Covariance
(ANCOVA). Normally distributed continuous variables will be expressed as mean ±
standard deviation; non-normally distributed continuous variables and ordinal
variables will be expressed as median (interquartile range); categorical variables will
be expressed as counts and percentages. Missing data for primary and secondary
endpoints will be handled using multiple imputation, and the primary analysis will be
based on the imputed dataset. A series of sensitivity analyses will be conducted to
assess the robustness of the study conclusions to different methods of handling
missing data. After catheter removal (during the 4-week follow-up), the type of
urinary incontinence will be classified through clinical assessment (e.g., medical
history, cough stress test). An analysis will then be performed to determine if there
are differences in the efficacy of early acupuncture intervention in the subgroup of
patients "diagnosed with pure stress urinary incontinence" versus other subgroups,
such as "mixed urinary incontinence".
Feasibility Analysis
Theoretical Feasibility
The theoretical feasibility of this study is established on a solid foundation of modern
neurophysiology and existing clinical evidence. The core pathology of post-Radical
Prostatectomy (RP) urinary incontinence is neuromuscular dysfunction. The early
acupuncture proposed in this protocol is not a traditional alternative therapy but
rather an evidence-based "non-invasive peripheral neuromodulation technique".

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Its scientific basis lies in the stimulation of specific sacral acupoints, such as Baliao
(BL31-34), which can directly act on the deep anatomical sacral nerve roots. This
mechanism is highly similar to the clinically widespread Sacral Neuromodulation
(SNS) therapy, providing strong theoretical support for the intervention's
effectiveness. This neuromodulation can activate the pudendal nerve-sphincter
pathway, enhancing the tension and closure function of the external urinary
sphincter, thereby improving urinary control. Although existing research has
primarily focused on long-term postoperative incontinence, clinical trials have
already demonstrated that electroacupuncture is fast-acting, effective, and provides
stable improvement for post-RP urinary incontinence. This serves as direct
supporting evidence that acupuncture can effectively intervene in this functional
disorder. The core innovation and theoretical confidence of this study stem from
advancing the intervention timing—intervening during the "window period" before
catheter removal and the subsequent functional challenge. Our core hypothesis is:
by applying neuromodulatory stimulation in advance, we can "pre-activate" and
"functionally reorganize" the neural pathways temporarily suppressed by surgical
trauma. This adjusts the patient's neuromuscular system to a better state of
readiness, achieving a paradigm shift from "passive treatment" to "active
prevention," and hopefully allowing for a smoother functional transition after
catheter removal.
Clinical Operational Feasibility
This study is designed as a multi-center, prospective, randomized controlled trial,
planned to be conducted at Zhongda Hospital, Southeast University, and other
medical institutions. Relying on the mature urological diagnosis and treatment
platforms and prostate cancer patient databases at each center ensures the
feasibility of patient recruitment. Participant information can be screened through
electronic medical record systems. The inclusion criteria are clear and the exclusion
criteria are strict, facilitating the rapid identification of the target population. The
study expects to recruit 144 patients, 72 in each group; this sample size is calculated
based on existing research data and is statistically reasonable.
The acupuncture intervention will be performed by qualified acupuncturists using
standardized acupoints (e.g., Shenshu (BL23), Pangguangshu (BL28), Baliao (BL31-34),
etc.). The procedure is simple and safe. The intervention is scheduled for one week
post-prostatectomy, three times a week, 30 minutes per session. This is compatible
with routine postoperative care and does not add burden to the patient. The
assessment within 24 hours after catheter removal (e.g., pad test, proportion of
complete continence) will be completed using standardized tools, making the
outcome measurement objective and easy to implement. The follow-up plan (1 week
post-removal and beyond) will be completed via telephone or outpatient visits,
combined with the International Consultation on Incontinence Questionnaire-Short
Form (ICIQ-SF), making data collection efficient and controllable.

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Furthermore, each center is equipped with complete infrastructure, including sterile
needles, treatment rooms, and data management systems, ensuring the smooth
conduct of the trial. The research team consists of urologists, acupuncturists, and
statisticians who have received standardized training, ensuring operational
consistency and data quality. All participants will sign an informed consent form, and
legal and ethical risks are manageable. In summary, this study is highly feasible at the
clinical operational level and is capable of effectively advancing the trial process and
obtaining reliable results.
6. Innovative Aspects of the Project
Currently, research on the impact of early acupuncture intervention on immediate
urinary continence after catheter removal in post-RP patients is a blank slate. This
study aims to fill this research gap by evaluating the effect of early postoperative
acupuncture treatment on patients' immediate continence ability through a
prospective controlled study. The specific objective is: To systematically evaluate the
efficacy of early acupuncture intervention by comparing the intervention group
(early acupuncture + standard care) versus the control group (sham acupuncture +
standard care) in terms of urine leakage volume, proportion of complete continence,
pad usage, and patient satisfaction within 24 hours after catheter removal. If the
study results confirm the expectations, it will provide a new, non-invasive
intervention for clinical practice, significantly improving the quality of patient's
postoperative recovery and reducing the burden on the healthcare system. This
study will directly address the core issue of generally low-quality evidence in this
field by employing a gold-standard research design. It focuses on the POD 7-14
window, an intervention period not yet systematically studied, to explore the impact
of early acupuncture intervention on immediate continence upon catheter removal.
It is expected to provide high-level evidence for improving the early postoperative
quality of life for prostate cancer patients. Furthermore, this study will promote the
integration of traditional Chinese medicine with modern medicine, providing new
therapeutic ideas and practical evidence for post-prostatectomy rehabilitation
globally.
Expected Research Outcomes
This study anticipates that early acupuncture intervention will significantly improve
immediate urinary continence in post-RP patients after catheter removal. This is
expected to manifest as reduced urine leakage volume, an increased proportion of
complete continence, decreased pad usage, and enhanced patient satisfaction. If the
study results confirm these expectations, it will provide a new, non-invasive
intervention for clinical practice, significantly improving the quality of patients'
postoperative recovery and reducing the burden on the healthcare system. This
study will directly address the core issue of generally low-quality evidence in this

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field by employing a gold-standard research design, focusing on the POD 7-14
window—a period not yet systematically studied—to explore the impact of early
acupuncture intervention on immediate continence upon catheter removal. It is
expected to provide high-level evidence for improving the early postoperative
quality of life for prostate cancer patients. Furthermore, this study will promote the
integration of traditional Chinese medicine with modern medicine, providing new
therapeutic ideas and practical evidence for post-prostatectomy urinary
incontinence rehabilitation globally.
Work Basis and Conditions
Research Work Accumulation Related to This Project
The Department of Urology at Zhongda Hospital, Southeast University, has
established a relatively complete clinical database for urogenital malignant tumors.
The department regularly performs radical prostatectomy surgeries and
communicates well with patients regarding informed consent. Our team has
completed the relevant literature search and has already constructed a knowledge
framework regarding post-prostatectomy urinary incontinence symptoms and
acupuncture treatment.
Within the team, the project leader, Chief Physician Xu Bin, is a senior expert in the
field of urology with long-term dedication to the clinical diagnosis, treatment, and
research of prostate cancer. He possesses extensive experience in radical
prostatectomy (RP) and can provide authoritative control over the research direction,
patient screening, and surgical quality from the clinical source. Core members,
including Deputy Chief Physician, and Attending Physicians not only focus on
post-prostatectomy functional rehabilitation but also actively explore and research
the mechanisms and clinical effects of acupuncture therapy on improving urinary
dysfunction. They have accumulated a considerable theoretical foundation and
preliminary research experience. To further ensure the professionalism of the
protocol's execution, we are also in close collaboration with Attending Physician
from our hospital's Acupuncture Department, who is responsible for the final
supervision and guidance of the standardized operation of the acupuncture and
sham acupuncture protocols. This project boasts an outstanding team with a
comprehensive professional knowledge structure and deep interdisciplinary research
backgrounds, providing a solid foundation for the smooth implementation of the
research.
To further verify the feasibility of the research protocol and obtain preliminary data
support, we conducted a small-sample preliminary experiment. To date, the team
has completed the collection of follow-up data for 15 patients, all of whom were
treated with robot-assisted laparoscopic radical prostatectomy by the same surgical
team. We divided them into an acupuncture group (n=7) and a control group (n=8)

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and conducted a preliminary analysis of the International Consultation on
Incontinence Questionnaire-Short Form (ICI-Q-SF) scores for both groups. The data
was statistically processed using the Mann-Whitney U test, with the null hypothesis
(H0) being "there is no difference in ICI-Q-SF scores between the acupuncture group
and the control group." The result showed P<0.05, indicating a statistically significant
difference between the two groups' scores. The positive results of this preliminary
experiment not only verify the feasibility of the research's technical route but also
provide initial indications of the potential value of acupuncture therapy in improving
post-prostatectomy urinary incontinence, laying a solid data foundation for the
comprehensive and in-depth development of this project.
Budget
Funding for this research project comes from the 2025 Zhongda Hospital, Southeast
University, internal funding for new technologies and new projects: "Clinical
Application of Acupuncture to Improve Immediate Urinary Continence After Radical
Prostatectomy," Project No. CZXM-GSP-YW-202535.
The approximate project budget is as follows: Consumables for pad tests: 1000 RMB
Purchase of 4 new electroacupuncture devices: 2400 RMB Acupuncture treatment
consumables and sham (placebo) acupuncture needle purchase costs: 500 RMB
Printing costs for informed consent forms and various questionnaires: 500 RMB
Ethics review fee: 500 RMB Total: 4900 RMB