Development of an evidence-based auriculotherapy program for urinary incontinence in men after radical prostatectomy

Abstract

Objective

This study aims to develop an evidence-based auriculotherapy program for reducing urinary incontinence in men after radical prostatectomy.

Methods

The Medical Research Council Framework for Developing and Evaluating Complex Interventions was used to guide the intervention development process, which consisted of four stages: (1) establishing the research team; (2) identifying existing evidence; (3) identifying relevant theories; and (4) refining and modeling the program via an expert panel.

Results

An initial auriculotherapy program was developed based on available evidence from three practice standards, eight books, nine reviews, and two clinical trials. The Delphi study confirmed excellent consensus, with all items scoring ≥ 3.5 and a coefficient of variation < 0.25. The final auriculotherapy program comprises true-auriculotherapy and sham-auriculotherapy, each including six key components: (1) auricular acupoints, (2) auricular acupoints location, (3) auriculotherapy modality, (4) auricular sticking techniques, (5) auricular acupressure techniques, and (6) auriculotherapy dosage.

Conclusions

This study develops an evidence-based and theory-driven auriculotherapy for postprostatectomy incontinence management, which will be further implemented in clinical settings to confirm its effectiveness. The methodology described in this study may provide implications for future studies to develop complex interventions in the field of alternative therapies.

Trial registration

ChiCTR2300071700.

Introduction

Globally, prostate cancer is among the most commonly diagnosed cancers in men, accounting for 14.1% of all male malignancies, second only to lung cancer (14.3%).¹ Although the 5-year relative survival rate for men with prostate cancer is reported to be 97% and tends to increase, many cancer-related symptoms and treatment-related complications still distress men.² Urinary incontinence (UI) is the most frequently reported urinary complication following radical prostatectomy, which often occurs at catheter removal and is more significant during the first six months.³ The prevalence of UI varies widely due to differences in population characteristics, definitions of continence, and surgical techniques, with reported incidence rates ranging from 2% to 57%.⁴ According to a patient-centered analysis of men undergoing radical prostatectomy, frequent and ill-timed UI could negatively impact men’s daily living activity, mood, social life, and erectile dysfunction, which contribute to poor quality of life.^5,6

Based on current evidence,^3,7 surgical interventions are curative treatments for men with UI, such as artificial urinary sphincter and male sling. However, surgical interventions are usually considered only after the failure of conservative treatments due to their invasive nature and multiple complications. The American Urological Association guideline recommends that men who remain incontinent at one year or have severe UI at 6 months after radical prostatectomy should undergo surgical interventions (e.g., artificial urinary sphincter).³ Pharmacological therapy for relieving male UI mainly includes antimuscarinic agents, mirabegron, duloxetine, and desmopressin, which are recommended by the European Association of Urology guidelines.⁸ However, all of them have potential side effects, such as constipation, blurred vision, fatigue, and cognitive dysfunction.⁸ Therefore, nonsurgical and nonpharmacological interventions have been regarded as the first-line treatments to improve UI management for men after radical prostatectomy.^3,8,9

To identify the existing evidence on nonsurgical and nonpharmacological interventions for male UI, our research team conducted a scoping review.¹⁰ The findings showed that pure pelvic floor muscle training, Pilates, Yoga, whole body vibration, diaphragm/abdominal muscle training, micturition interruption exercise, acupuncture, and auriculotherapy demonstrated positive effects on UI management.¹⁰ However, as the most widely used technique to manage UI in clinical practice, pelvic floor muscle training and its simplified version of micturition interruption exercise often received poor compliance.¹¹ Other interventions such as Pilates, Yoga, and whole body vibration require expensive specific equipment as well as professional training, which adds additional time, energy, and financial burden. Thus, preferable nonpharmacological interventions for UI management which are relatively risk-free, easy to learn, and less time-consuming remain to be explored.

Auriculotherapy is a traditional Chinese medicine (TCM) technique that modulates physiological functions or alleviates pathological conditions by stimulating specific auricular acupoints on the auricle.¹² As a safe, convenient, and low-cost approach, auriculotherapy has proven effective in managing various health issues, such as constipation, nausea, and vomiting.^13,14 An integrative review¹⁵ revealed that auriculotherapy could alleviate lower urinary tract symptoms in adults and the elderly whether it was applied in conjunction with other complementary therapies or not. Thus, auriculotherapy may have the potential to reduce UI. Our meta-analysis¹⁶ also demonstrated that auriculotherapy was useful for relieving UI symptoms. However, auriculotherapy varied greatly in terms of auricular acupoints selection, intervention modality, intensity, and duration.¹⁶ Therefore, this study aimed to develop an evidence-based auriculotherapy program for UI after radical prostatectomy.

Methods

This study was guided by the Medical Research Council (MRC) framework, a widely used method for developing and evaluating complex interventions.^17,18 Following the MRC framework, the auriculotherapy program was developed through four stages: (1) establishing the research team; (2) identifying existing evidence; (3) identifying relevant theories; and (4) refining and modeling the program via an expert panel. Fig. 1 shows the study designs for the auriculotherapy program development. To enhance transparency and consistency, the findings were reported using the Guidance for Reporting Intervention Development Studies in Health Research (GUIDED) checklist, and the intervention was described using the Template for Intervention Description and Replication (TIDieR) checklist.^19,20

Fig. 1.

Study designs for auriculotherapy program development. UI, urinary incontinence; TCM, traditional Chinese medicine.

Establishing the research team

The MRC framework emphasizes the importance of involving all relevant stakeholders, including those who will deliver, use, and benefit from the intervention.²¹ Given that professional knowledge and skills related to acupuncture, urology, nursing, and other disciplines are required for developing the auriculotherapy program for UI, stakeholders from these disciplines were invited to join our research team based on existing resources.

Identifying existing evidence

The MRC framework highlights the necessity of existing evidence for developing appropriate interventions.¹⁸ To comprehensively gather existing evidence, various literature retrieval methods were implemented combining database searches and visits to the official websites of relevant academic organizations. A literature search was conducted through nine databases including PubMed, EBSCO, EMBASE, Scopus, ScienceDirect, Cochrane Library, CNKI, Wanfang Database, and Chongqing VIP using “auricular point sticking/ear acupressure/auricular-plaster therapy/auricular acupressure/auricular pressure/auriculotherapy” as search terms. Additionally, the official websites of the World Federation of Acupuncture Societies, the China National Standards Administration, and the Chinese Nursing Association were searched to obtain practice standards or guidelines related to auriculotherapy.

Identifying relevant theories

The MRC framework recommends using and adapting current theories to develop interventions.²¹ Considering auriculotherapy was a widely-used TCM technique, the manual retrieval of ancient or modern books in TCM was extremely crucial as a great deal of theories were recorded in them. Therefore, books on auriculotherapy were manually searched through the university library.

Refining and modeling the program via an expert panel

Based on the findings from the first three stages, the initial draft of the auriculotherapy program was constructed. The Delphi technique was employed to gather expert opinions via questionnaires, thereby avoiding mutual interference and minimizing potential conflicts.²² Experts were selected based on the following criteria: (1) engaging in urology, TCM, acupuncture, or auriculotherapy with corresponding health professional certification; (2) holding a bachelor’s degree or higher; and (3) having over 10 years of clinical or research experience in TCM, acupuncture or urology. Experts were recruited through convenience sampling from relevant departments in hospitals or universities, and research team members were excluded from the expert panel to ensure objectivity. Before the formal expert consultation, the research team developed a questionnaire comprising three sections: (1) a description of the study aims and background, along with instructions for completing the questionnaire; (2) a form for collecting experts’ demographic information, familiarity with the research subject, and judgments on the questionnaire; and (3) the content of the auriculotherapy program. Experts were asked to rate the importance of each item in the auriculotherapy program using a 5-point Likert scale, where 1 indicated “very unimportant” and 5 indicated “very important”.

Results

Establishing the research team

A multidisciplinary research team was established, comprising a nursing professor specializing in nursing management, a chief nurse with clinical expertise, a urology doctor experienced in radical prostatectomy, and three graduate students trained in systematic evidence-based medicine. The team’s primary responsibilities included: (1) conducting a literature review; (2) developing the initial auriculotherapy program; (3) selecting experts through e-mailing; (4) creating and distributing questionnaires for expert consultation; and (5) collecting expert data and opinions. Through literature searches and group discussions, the team confirmed the research aims, identified the relevant clinical context, and defined the target population. In our clinical context, oral education on pelvic floor muscle exercises was the most common method for managing UI after radical prostatectomy, but patient compliance was poor due to lack of supervision. Six patients with UI after radical prostatectomy expressed a preference for nonpharmacological and nonsurgical interventions, specifically TCM techniques like auriculotherapy to manage UI. The target population for the auriculotherapy program was defined as patients who had undergone radical prostatectomy and were diagnosed with UI post-prostatectomy.

Identifying existing evidence

Through a comprehensive search, we identified and included three practice standards,23, 24, 25 eight books,26, 27, 28, 29, 30, 31, 32, 33 nine reviews,^10,16,34, 35, 36, 37, 38, 39, 40 and two clinical trials.^41,42 These evidences provided support for the identification of appropriate auricular acupoints, locating methods, auriculotherapy modality, auricular sticking and acupressure techniques, and intervention dosages, which were the core components of the auriculotherapy program, as detailed below.

Identifying appropriate auricular acupoints and locating methods

Following the principle of “selecting acupoints based on the corresponding parts, relevant Zang-Fu organs and meridians, and its function”, the main auricular acupoints were kidneys (relevant organs), bladder (corresponding parts), urethra (corresponding parts), and central rim (acupoints function). Adjunct auricular acupoints were lungs (relevant organs), spleen (relevant organs), subcortex, sympathetic nerves, and Shenmen (Fig. 2).^27,30 The main auricular acupoints were standardized for all patients, while adjunct auricular acupoints were adjusted according to individual patient conditions and different types of UI (Table 1), including kidney qi deficiency, lung and spleen qi deficiency, and kidney yin deficiency.³⁰ Auricular acupoints were located using observation and palpation along with standard auricular maps, models, and detectors. Observation is a safe and effective method for recognizing auricular acupoints with positive responses, which are frequently reflected in the shape and color changes of the auricle, such as pigmentation, depression, and nodules.^26,29 Palpation is another approach to identify the most sensitive auricular acupoints by using a probing pen or stick.^26,29 Identical auricular acupoints selection and locating methods were employed for both the true-auriculotherapy and sham-auriculotherapy.

Fig. 2.

Selection for appropriate auricular acupoints.

Table 1.

Clinical manifestations and corresponding auricular acupoints selection of different UI types.

Types	Symptoms	Auricular acupoints
Kidney qi deficiency	Fatigue, fear of cold, weakness in Fig. and physique, dizziness and lumbago, loss control of urine, cold limbs, weakness of the lower limbs, pale tongue with white coating, deep and thready pulse	Kidney (CO10), Bladder (CO9), Urethra (HX3), Central Rim (AT2,3,4i)
Lung and spleen qi deficiency	Urine leakage, polyuria or incontinence of urine when coughing or laughing, occasional cramping of the abdomen, pale tongue with white coating, weak pulse	Kidney (CO10), Bladder (CO9), Urethra (HX3), Central Rim (AT2,3,4i), Lung (CO14), Spleen (CO13)
Kidney yin deficiency	Urine leakage when coughing, frequent nocturia, dizziness, soreness and weakness of the waist and knees, dysphoria with feverish sensation in chest, palms, and soles, irritability, red tongue with thin coating, thready and rapid pulse	Kidney (CO10), Bladder (CO9), Urethra (HX3), Central Rim (AT2,3,4i), Subcortex (AT4), Sympathetic Nerve (AH6a), Shenmen (TF4)

UI, urinary incontinence.

Identifying appropriate auriculotherapy modality

Ear acupuncture, ear bloodletting, ear electroacupuncture, ear plaster, and ear massage are the six main auriculotherapy modalities.^24,26, 27, 28, 29, 30, 31, 32, 33 Given the invasiveness and physician dependency of the first four methods, this study adopted ear plaster and ear massage due to their safety, convenience, and accessibility. Nurses with qualified training could administer ear plaster and ear massage independently. The most common material used for ear plaster is Vaccaria seeds (“wang bu liu xing zi”) regarding its appropriate size, smooth surface, hard density, and no side effects.³² Moreover, to minimize the adverse events of auriculotherapy, hyposensitive tape was utilized to reduce local skin reactions like redness, itch, and eruptions.^38,39 In the true-auriculotherapy, ear plaster, and ear massage were applied using the Vaccaria seeds’ auricular patches, with continuous and regular acupressure. In contrast, the sham-auriculotherapy applied ear plaster using the Vaccaria seeds’ auricular patches without acupressure to achieve minimal therapeutic effects.35, 36, 37

Identifying appropriate auricular sticking and acupressure techniques

To standardize ear plaster operations and ensure consistent intervention delivery, auricular sticking techniques (Fig. 3) were developed based on eight books.26, 27, 28, 29, 30, 31, 32, 33 Techniques frequently mentioned in these books, such as whole auricle massage (n ​= ​8), helix massage (n ​= ​8), and earlobe massage (n ​= ​6) were adopted in this study. Auricular acupressure techniques were designed to achieve adequate and consistent auricular stimulation. Given that UI was a deficiency syndrome in TCM, point-pressing (pressing auricular acupoints one at a time with fingertip) or gentle massage (pressing auricular acupoints gently with finger pulp and rotating the seeds clockwise) were adopted, which were frequently applied to treat deficiency syndrome.^30,31 The intensity of acupressure should induce the Deqi sensation, a local sensation of warmness, swelling, pain, or congestion, typically sustained for 1–2 minutes, with adjustments based on patient tolerance.26, 27, 28, 29, 30, 31, 32, 33 Patient adherence was monitored via an auricular acupressure diary to ensure acupressure was performed at least three times daily. In the true-auriculotherapy, “trilogy of auriculotherapy” was implemented: massaging the auricular acupoints, locating the corresponding auricular points, and planting seeds into these acupoints.⁴¹ In contrast, sham-auriculotherapy omitted ear massage and excluded auricular acupressure techniques to restrict the specific therapeutic effects.

Fig. 3.

Flow chart of the auricular sticking techniques.

Identifying appropriate auriculotherapy dosage

Auriculotherapy dosage comprises frequency, session, and total intervention duration. Auricular acupressure was recommended three times daily (morning, afternoon, and before bed), with additional acupressure allowed if urinary control was compromised.^16,26, 27, 28, 29, 30, 31, 32, 33 Auricular patches were retained for 3–7 days in winter and 1–3 days in summer according to practice standards.²⁵ Considering that UI frequently occurs in the early stages following radical prostatectomy, particularly within the first three months.^3,10 The total intervention duration was set for 12 weeks. Additionally, given that patients are required to have urinary catheters removed at approximately two weeks postsurgery, and blood PSA levels are assessed approximately four weeks postsurgery in an outpatient setting, the auriculotherapy program will be implemented at three days, one week, two weeks, and four weeks after radical prostatectomy, with follow-up continuing until 12 weeks. Identical sessions and total duration were adopted for both true-auriculotherapy and sham-auriculotherapy. Additionally, the frequency of auricular acupressure was not applicable in sham-auriculotherapy due to the absence of acupressure.

Identifying relevant theories

Through a comprehensive search, we identified Zang-Fu organs and meridians theory, holographic biology, and neural theory as the most frequently used theories for auriculotherapy. Zang-Fu organs and meridians theory emphasizes that the auricle is the gathering part of various pulses, the heart of the kidney, and the cardinal of Shaoyang; stimulation of auricular acupoints can regulate the function and balance the yin-yang of visceral organs.²⁶ Holographic biology believes that the entire organism can be found in any comparatively independent portion. For example, the human auricle resembles the early human embryo, which is known as the “inverted fetus”. Therefore, the corresponding section of the auricle will respond appropriately when the body is ill. Similarly, the function of homologous human organs can be altered by stimulating target auricular regions.^26,29,32,33 Neural theory demonstrates the distribution and innervation of nerves in the ear, which includes the great auricle nerve, minor occipital nerve, auriculotemporal nerve, facial nerve, glossopharyngeal nerve, vagus nerve, and sympathetic nerves. These nerves serve as critical pathways connecting the auricle to visceral organs. By stimulating the nerves on the auricle, auriculotherapy exerts a dual-regulatory effect, correcting bodily imbalances to achieve therapeutic outcomes.^26,29

Refining and modeling the intervention via an expert panel

Expert panel

A total of 21 experts met the criteria and were invited by the research team, of which 19 experts completed the questionnaire. The response rate was 90.5%, over the minimum of 70% recommended in the literature, which indicated the experts were highly motivated.²² The expert panel comprised ten TCM physicians or nurses, six urology physicians or nurses, and three acupuncturists from four provinces in China: Zhejiang, Anhui, Beijing, and Jilin. The demographic information of experts is detailed in Supplementary Table S1. To involve the authoritative experts related to the topic area as much as possible, the authority coefficient (Cr) was applied, which referred to the mean of the judgment coefficient (Ca) and familiarity coefficient (Cs). In this study, the Ca was 0.94, the Cs was 0.85, and the Cr was 0.895, over the threshold of 70% suggested in the literature, which was considered acceptable.⁴³

The definition of consensus is usually determined before the Delphi, which is mostly measured via percent agreement or units of central tendency.⁴⁴ A systematic review revealed that 75% was the median threshold to define consensus,⁴⁵ so the 75% percent agreement was applied to define consensus, which was calculated as the number of experts who selected “important” or “very important” divided by the total number of experts. In the first round of consultation, all expects had a score of 5 or 4 for all items, which reached a consensus. Thus, the research team decided to end the consultation after a full discussion. The mean, standard deviation (SD), and coefficient of variation (CV) were used as descriptive data. The CV reflects whether there are large differences in expert opinions, which is the SD divided by the mean of each item. The smaller the value is, the more the expert opinions tend to be consistent. The criteria for retaining the items were set for a mean value ​≥ ​3.5 points, and a CV ​< ​0.25.⁴⁶ Detailed information was presented in Supplementary Table S2.

Results of the modeling process

Although the initial auriculotherapy program was excellently agreed upon by the 19 experts, several modifications were recommended: (1) intensity of auriculotherapy: two experts believed that there is a difference between the Deqi of acupuncture and auricular acupressure, and the clinical manifestations were commonly seen as heat, swelling, pain, or local congestion for the latter; (2) auricular acupoints selection: one expert suggested acupoints selection should in accordance with the different types of UI in TCM, and the number of auricular acupoints was often set for three to five acupoints. Another expert wondered whether selecting the target acupoints based on the positive reaction of auricular acupoints; (3) auriculotherapy dosage: two experts recommended acupressure of the articular acupoints 1–2 min each time, which was more common in our clinical settings; (4) sham-auriculotherapy modality: an expert questioned whether to consider choosing different materials to reduce the stimulation of acupoints.

Based on the existing evidence and the specific clinical context, we have given full consideration to the experts’ suggestions. An online meeting was subsequently held by the research team to discuss the implementation and modify the draft. The specific adjustments were as follows: (1) auricular acupoints selection: corresponding auricular acupoints were selected according to the different types of UI proposed by Wang and Zhong,³⁰ which was not mentioned in the initial auriculotherapy program; (2) auricular acupressure techniques: the definition of Deqi was revised according to experts’ suggestions, and the time of each acupoints acupressure was adjusted from 2 to 5 minutes (the most common acupoints acupressure time summarized by a systematic review¹⁶) to 1–2 minutes to enhance clinical applicability. The final true-auriculotherapy and sham-auriculotherapy, along with supporting justifications and evidence sources, are summarized in Table 2 and Table 3.

Table 2.

Contents of the true-auriculotherapy with relevant justifications and evidence.

Item	Contents	Justifications	Evidence sources
Auricular acupoints	Main acupoints: Kidney (CO10), Bladder (CO9), Urethra (HX3), Central Rim (AT2,3,4i) Adjunct acupoints: Lung (CO14), Spleen (CO13), Subcortex (AT4), Sympathetic Nerve (AH6a), Shenmen (TF4)	(1)Lungs, spleen, kidneys, and bladders are essential to fluid metabolism, and their dysfunction could cause UI (2)Subcortical, sympathetic, and Shenmen may enhance the signaling pathways and increase the cerebral cortex's conditioned excitability to the bladder (3)Dialectical treatment: Different acupoints formulas were selected according to the type of UI	(1)The principle of acupoints selection: acupoints were selected according to the corresponding parts, Zang-Fu dialectics and meridian theory, as well as the theory of Western medicine, acupoints function, and clinical experience (2)Huang, P87, P20527 (3)Wang and Zhong, P95-9630
Auricular acupoints location	(1)Observation by using the standard auricular map and model (2)Palpation by using the auricular detector	Pathological changes of different diseases can cause positive reactions of corresponding auricular points, such as morphological alterations, decreased pain thresholds, and electrical resistance changes	(1)Cheng and Zhou26 (2)Auriculotherapy practice standards23,24
Auriculotherapy modality	(1)Ear plaster and ear massage (2)The Vaccaria seeds' auricular patches with regular and consistent acupressure	(1)Ear-plaster and ear massage are superior to invasive auriculotherapy modalities (such as acupuncture and bloodletting) in terms of convenience and safety (2)Vaccaria seeds: The most common material used for ear plaster because of its appropriate size, smooth surface, hard density, and no side effect	(1)Huang, P10227 (2)Shan, P6432 (3)Auriculotherapy practice standard24
Auricular sticking techniques	(1)This item was applied to intervention providers (2)The “trilogy of auriculotherapy”: auricular massage, auricular acupoints positioning, and auricular acupoints sticking	(1)Auricular massage before compression can trigger a stress response, wake up the brain, activate the whole body function, and enhance the efficacy (2)Auricular massage was convenient, safe, and effective	(1)Wang and Zhu, P92-9429 (2)Feng et al., P45-4633 (3)Shan, P71-7232 (4)Wang and Zhong, P43-4430 (5)Clinical trial41
Auricular acupressure techniques	(1)This item was applied to the patients (2)Point-pressing (pressing auricular acupoints one at a time with fingertip) OR gentle massage (pressing auricular acupoints gently with finger pulp and rotating the seeds clockwise) were adopted (3)Intensity or time of each pressing: achievement of Deqi sensation, generally 1–2 min, appropriate adjustment can be made according to the patient's tolerance	(1)Point-pressing and gentle massage were suitable for deficiency syndrome (2)Deqi: a TCM term used to express the satisfactory treatment effect, and the Deqi of auricular acupoint was frequently manifested in warmness, swelling, pain, or congestion	(1)Shan, P64-6632 (2)Guan et al., P114-11831 (3)Systematic review16
Auriculotherapy dosage	(1)3 to 4 times a day, acupressure was recommended in the morning, afternoon, and before bed. Additional acupressure was suggested while losing control of urine (2)3–7 days per session in winter, and 1–3 days per session in summer (3)Binaural simultaneity (4)Last for 12 weeks	(1)The most common auriculotherapy dosage used in clinical studies (2)Acupressure seeds are routinely stored for 2–4 days, or up to 7 days if properly protected (3)The nature of the progression of UI after prostate surgery	(1)Huang, P10227 (2)Guan et al., P113-11831 (3)Auriculotherapy practice standard25 (4)Systematic review10

UI, urinary incontinence; TCM, traditional Chinese medicine.

Table 3.

Contents of the sham-auriculotherapy with relevant justifications and evidence.

Item	Contents	Justifications	Evidence sources
Auricular acupoints	Main acupoints: Kidney (CO10), Bladder (CO9), Urethra (HX3), Central Rim (AT2,3,4i) Adjunct acupoints: Lung (CO14), Spleen (CO13), Subcortex (AT4), Sympathetic Nerve (AH6a), Shenmen (TF4)	(1) Three types of sham acupoints: non-meridian non-acupoints, irrelevant meridian acupoints, and target auricular acupoints (2) The ear size is small, the auricular acupoints can be recognized more, and it is difficult to locate the non-auricular points (3) There is no guarantee that other irrelevant meridian acupoints have no effect on improving UI	Systematic reviews35, 36, 37
Auricular acupoints location	(1) Observation by using the standard auricular map and model (2) Palpation by using the auricular detector	To achieve a blind design of participants	Auriculotherapy practice standards23,24
Auriculotherapy modality	(1) Ear plaster (2) Vaccaria seeds auricular patches with no acupressure	To reduce stimulation to certain auricular acupoints and minimize potential curative effects	Systematic review36
Auricular sticking techniques	(1) This item was applied to intervention providers (2) The traditional auricular sticking techniques: auricular acupoint positioning and auricular acupoint sticking (3) Auricular application only fixed tightly, and was advised to avoid causing Deqi sensation	To minimize the specific treatment effects produced by acupoint stimulation	Systematic review36
Auricular acupressure techniques	Not applicable	To minimize the specific treatment effects produced by acupoint stimulation	Systematic review36
Auriculotherapy dosage	3–7 days per session in winter and 1–3 days per session in summer, total lasted 12 weeks	To achieve a blind design of participants	(1) Systematic review36 (2) Auriculotherapy practice standard25

UI, urinary incontinence.

Discussion

This study described the development process of an evidence-based, theory-based, and personalized auriculotherapy program in a combination of TCM and Western medicine context for men with UI after radical prostatectomy. Following the guidance of the MRC framework, the auriculotherapy program was meticulously designed to integrate local contextual factors, stakeholder perspectives, existing evidence, and available theories. The use of the GUIDE checklist and TIDieR checklist (Supplementary Table S3) ensured the transparency and rigor in reporting the intervention development process and guaranteed the reproducibility of our program. This study provides reliable methodological experience for future researchers to develop a complex intervention in the field of alternative therapies, especially the TCM techniques.

This study innovatively designed a personalized and tailored auricular formula based on the TCM dialectical treatment principle and relevant Western medical theories. The selection of auricular acupoints is central to the auriculotherapy program, and appropriate auricular acupoints are crucial for achieving optimal therapeutic effects.26, 27, 28, 29, 30, 31, 32, 33 From a TCM perspective, kidneys govern water metabolism, particularly urine production, and excretion, while the bladder, as the “organ of body fluid”, is responsible for urine storage and discharge. Dysfunction of the kidneys and bladder could disrupt liquid metabolism, leading to loss of control over kidney qi and bladder function, and ultimately causing UI. The primary mechanisms of UI occurrence might contribute to kidney Yang deficiency and bladder dysfunction.³⁰ Considering the above factors, kidneys (CO₁₀) and bladder (CO₉) were selected as the main auricular acupoints, aligning with findings from a systematic review⁴⁰ that identified these as the most commonly used auricular acupoints for UI treatment. From a Western medicine perspective, UI following radical prostatectomy is primarily associated with urethral sphincter deficiency, detrusor muscle dysfunction, and bladder dysfunction.⁹ Given the urethra’s critical role in urinary control, urethra (HX₃) was also selected as the main auricular acupoint. Central rim (AT_2,3,4,i), also called pituitary acupoints, was also selected as the main acupoint due to its traditional use in TCM for treating UI.⁴² The lungs (CO14) and spleen (CO13), while closely related to water metabolism including urine production and metabolism, are more commonly used to treat diseases related to respiratory and digestive functions.26, 27, 28, 29, 30, 31, 32, 33 These acupoints were regarded as adjunct auricular acupoints to be used selectively based on patient-specific conditions. The subcortex (AT₄), sympathetic nerve (AH_6a), and Shenmen (TF₄) were selected for their ability to enhance neural signaling pathways and improve cortical conditioning excitability from the bladder.³⁰ However, due to their broader indications, these acupoints were also classified as adjunct auricular acupoints. By stimulating these auricular acupoints consistently and regularly, UI symptoms might be alleviated through mechanisms such as improved blood flow, meridian dredging, yin-yang balance, and regulation of zang-fu organ function.^26,29 Unlike the previous auriculotherapy program for chemotherapy-induced nausea and vomiting developed by Tan et al.,⁴⁷ which utilized a standardized auricular formula for all patients, our study designs a targeted auricular formula tailored to address distinct clinical manifestations of UI, including kidney qi deficiency, lung and spleen qi deficiency, and kidney yin deficiency. This individualized strategy aligns with the contemporary patient-centered treatment paradigm, emphasizing precision and personalization in therapeutic interventions.

This study designed the sham-auriculotherapy for UI after radical prostatectomy, which provided robust methodological support for distinguishing and clarifying the therapeutic effect and placebo effect of auriculotherapy. Previous studies indicate that the total effects generated by acupuncture or acupressure comprise specific therapeutic effects, nonspecific psychological effects, and nonspecific psychological (placebo) effects related to the patient’s belief that the treatment is effective.^35,37 Considering that sham-auriculotherapy may have some therapeutic or placebo effects, future clinical trials should compare it with other conservative treatments like pelvic floor muscle training. A comparison of the UI outcome effect sizes and other outcome effect sizes (e.g., endocrine symptoms) between the sham-auriculotherapy group and the conservative treatment group can identify the size of the placebo effects and nonspecific physiological effects produced by sham-auriculotherapy. Inappropriate sham acupoint stimulation design may produce unnecessarily specific effects, potentially overestimating the placebo effects of sham interventions.³⁵ This study employed three systematic reviews that summarized the placebo designs of acupuncture, acupressure, and ear acupressure in randomized controlled trials to determine the most appropriate sham acupoint stimulation design. Three types of sham acupoints are commonly used to minimize specific therapeutic effects: non-meridian non-acupoints, irrelevant meridian acupoints, and the same acupoints as the true group with inadequate or no stimulation. Non-meridian non-acupoints are usually selected at 3–5 mm beside the original acupoint or between the two meridians and are the most common acupoints used in sham acupuncture interventions.^37,48 However, according to the theory of acupoints and modern research, acupoints may be a composite system of three-dimensional space structure and body function, rather than being completely equivalent to a line or a point on the body surface.⁴⁹ The size of the spatial structure of acupoints may have changed along with changes in bodily function, so it cannot be proven that the acupoints located next to the meridian point were the non-acupoints.⁴⁹ Moreover, the distribution of acupoints in the external ear is so dense that cannot be located accurately. Therefore, non-meridian non-acupoints are not suitable for the design of sham-auriculotherapy in clinical trials because of their ambiguous definitions, uncertain effects, and challenging positioning operations. Irrelevant meridian acupoints are acupoints with no or little curative effect on the targeted disease or symptoms. However, according to the “holism concept” in TCM and the interaction between acupoints, stimulation of any meridian acupoint could produce certain curative effects by regulating the nervous, immune, and endocrine systems, and the potential therapeutic effect of these acupoints on targeted disease or symptoms cannot be completely avoided.⁵⁰ Considering all the above concerns, the same auricular acupoints used in true-auriculotherapy were adopted in sham-auriculotherapy. Notably, although sham interventions are methodologically necessary for blinding and placebo control, they may raise ethical questions regarding the temporary withholding of true treatments. To ensure equity and benefit to the participants as much as possible, participants in the sham-auriculotherapy group and other conservative treatment groups should offer free access to true-auriculotherapy after trial completion.

The rigor and theoretical foundation of the developed auriculotherapy program were enhanced by synthesizing existing evidence and relevant auriculotherapy theories. Through a comprehensive, extensive, and multi-channel evidence retrieval, three practice standards,23, 24, 25 eight books,26, 27, 28, 29, 30, 31, 32, 33 nine reviews,^10,16,34, 35, 36, 37, 38, 39, 40 and two clinical trials^41,42 were eventually included. Three practical standards provide strong support for the naming, location, and operation process of auricular points. The eight books contributed a wealth of theoretical and practical experience to the construction of the entire auriculotherapy program and understanding of the therapeutic mechanism of auriculotherapy. Three of the reviews were conducted by the research team prior to this study. One scoping review¹⁰ focused on summarizing the characteristics of non-surgical and non-pharmacological interventions for UI following radical prostatectomy, offering guidance for intervention duration. One meta-analysis¹⁶ examined the effectiveness and characteristics of auriculotherapy for UI, providing valuable suggestions for the selection of auricular acupoints, modality, and techniques design. One systematic review³⁴ summarized the barriers and facilitators for patients’ acceptance and adherence to auriculotherapy, which played a key role in the application of the developed auriculotherapy program in clinical practice. The remaining reviews and clinical trials also provide insightful opinions on the design of the sham-auriculotherapy and the auricular acupoints selection and techniques for true-auriculotherapy. Furthermore, the most frequently used theories related to auriculotherapy, namely the Zang-Fu organs and meridians theory and holographic biology, were adopted to locate and select the appropriate auricular acupoints. Given that the potential mechanism of UI after radical prostatectomy may be due to surgical damage to nerves related to the micturition reflex (e.g., pudendal nerve, pelvic nerve),⁵¹ the nerve theory was utilized to understand how auriculotherapy influences UI. These theories provide a robust foundation for understanding the mechanisms of auriculotherapy in managing UI and developing the auriculotherapy program.

The Delphi technique results demonstrated that the auriculotherapy program exhibited excellent content validity, which indicated the final auriculotherapy program was acceptable and feasible in the local context. While three rounds were proved to achieve sufficient stability in the responses and were the most common number of rounds for expert consultations,⁵² our study achieved consensus in the first round, thus only one round was conducted. This study emphasized that the number of rounds of Delphi rounds was not fixed; rather, it can be stopped as long as consensus is reached. Notably, although experts proposed considering alternative materials to reduce auricular acupoint stimulation for sham-auriculotherapy, our study still utilized Vaccaria seeds auricular patches. The reason is that Vaccaria seeds auricular patches are the most widely used auricular point stickers in clinical research and the most common products that have corresponding medical equipment production licenses for sale on the current market, which can guarantee the safety of patients.

Limitations

We recognize several limitations in this study. First, although we tried our best to identify the available evidence associated with auriculotherapy, some evidence might have been missed. Second, we did not conduct a quality assessment of the included evidence, it was hoped that future researchers may consider the quality of evidence while developing TCM-related interventions. Third, this study focused on the development process of the auriculotherapy program, with limited exploration of their application in clinical practice. Therefore, it is necessary to test its effectiveness in future clinical trials.

Conclusions

To the best of our knowledge, this is the first auriculotherapy program for postprostatectomy incontinence to be developed following the guidance of the MRC framework, which might offer health care professionals a risk-free, convenient, and low-cost approach to manage UI in men following radical prostatectomy. The MRC framework is confirmed to be a valuable tool to develop a complex intervention in the field of alternative therapies particularly for TCM techniques. The auriculotherapy program is evidence-based and theory-driven, as it was developed based on a series of reviews, practice standards, and relevant theories. The clinical effect of this program will be further examined in future randomized controlled trials.

CRediT authorship contribution statement

Ying Zhang: Conceptualization, Methodology, Writing – original draft. Keping Zhu: Methodology, Resources, Data Curation. Siyuan Wu: Methodology, Resources, Data Curation. Fuchao Xie: Methodology, Writing – Review & Editing. Wenbo Qiao: Methodology. Yaqin Li: Methodology. Kun Li: Methodology. Wei Wang: Supervision, Writing – Review & Editing. All authors read and approved the manuscript.

Ethics statement

This study was approved by the Clinical Research Ethics Committee of the First Affiliated Hospital, College of Medicine, Zhejiang University (Approval No. 2023-0362) and was conducted in accordance with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. All participants provided written informed consent.

Data availability statement

The authors confirm that the data supporting the findings of this study are available within the article and its supplementary materials.

Declaration of generative AI and AI-assisted technologies in the writing process

No AI tools/services were used during the preparation of this work.

Funding

This work was supported by the “Double First-Class” Construction Specialized Discipline Project at Zhejiang University (Grant No. HL202402). It was also funded by the Scientific Research Project of the National Traditional Chinese Medicine Examination (Grant No. TB2024002). The funders had no role in considering the study design or in the collection, analysis, interpretation of data, writing of the report, or decision to submit the article for publication.

Declaration of competing interest

The authors declare no conflict of interest.

Appendix A. Supplementary data

The following is the Supplementary data to this article.