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Abstract
Introduction Overactive bladder (OAB) affects approximately 500 million people worldwide, with a higher prevalence in women than in men, significantly impacting the quality of life of female patients. Treatment options for OAB are currently limited. Previous research has proposed that electroacupuncture could be a viable treatment for OAB in women, but there is a lack of high-quality clinical evidence. This study aims to evaluate the effectiveness of electroacupuncture as a safe and efficient non-pharmacological treatment for female OAB by comparing it with solifenacin succinate.
Methods and analysis This study is a multicentre, single-blind, double-dummy randomised controlled non-inferiority clinical trial involving 204 eligible female participants with OAB. Participants will be randomly assigned in a 1:1 ratio to either the electroacupuncture group (receiving electroacupuncture and placebo) or the solifenacin succinate group (receiving sham electroacupuncture and solifenacin succinate). Each participant will undergo 12 sessions of electroacupuncture (or sham electroacupuncture) treatment and solifenacin succinate (or placebo) treatment over a 4-week period. The primary outcome measure will be the percentage change in the number of micturition episodes every 24 hours at week 4 compared with baseline. Secondary outcomes will include a percentage reduction in the number of micturition episodes every 24 hours at 2th, 8th and 16th weeks of the trial, Overactive Bladder Symptom Score, number of urinary incontinence and urgency episodes every 24 hours based on a 3-day voiding diary, OAB Questionnaire, Generalised Anxiety Disorder Scale-7, King’s Health Questionnaire and Participant Self-evaluation of Therapeutic Effects. Adverse events will be monitored throughout the study. Efficacy analyses will be conducted on both the intention-to-treat population and the per-protocol set population.
Ethics and dissemination Ethical approval has been obtained from the Medical Ethics Committee of Longhua Hospital Shanghai University of Traditional Chinese Medicine (approval number: 2022LCSY097). Each participant will sign a written informed consent before randomisation. The results of this study will be published in a peer-reviewed journal.
Trial registration number NCT05798403.
- Bladder disorders
- Neuro-urology
- COMPLEMENTARY MEDICINE
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STRENGTHS AND LIMITATIONS OF THIS STUDY
This study is a multicentre, single-blind, double-dummy randomised controlled non-inferiority clinical trial that will be conducted in three medical centres.
This study is the first non-inferiority Randomised Controlled Trial (RCT) to compare electroacupuncture with solifenacin succinate for overactive bladder using a dual simulation approach.
The acupuncturists will not be blinded due to the specific nature of acupuncture manipulation.
The study does not include long-term efficacy observation.
Introduction
Overactive bladder (OAB) is characterised by urgency, with or without urge incontinence, along with frequent urination and nocturia in the absence of proven infection or other identifiable pathology.1 Epidemiological researche has shown that approximately 500 million people worldwide are affected by OAB,2 3 with a higher prevalence in women compared with men.4 The incidence of OAB tends to rise with age and the onset of menopause,5 6 with approximately 30% of women over 65 years of age affected. Despite this, only 19.7% of those with OAB reported consulting healthcare professionals for their symptoms while 50.7% expressed a willingness to seek medical advice but did not follow through.7 8 Moreover, OAB significantly impacts patients’ quality of life and contributes to increased financial burdens.9–11 The aetiology of OAB, which remains unclear, is commonly believed to be closely related to detrusor overactivity, allergic bladder sensory function, abnormal urethra and pelvic floor muscle function, abnormal neurotransmission and abnormal mental behaviour. Some researchers suggest that the underlying mechanism of OAB is also associated with changes in the central nervous system governing bladder function.12–17 The American Urological Association (AUA）emphasises that the purpose of treating OAB is symptom reduction.18 Currently, main treatments for OAB encompass behavioural therapy, pharmacological treatments like antimuscarinic agents, β3 adrenoceptor agonist, calcium channel blockers and so on.19–22 Additionally, sacral neuromodulation, botulinum toxin injections, multicomponent intervention and surgery are also methods to treat OAB.23–26 Meanwhile, in recent years, videourodynamic study has played a role in diagnosing OAB and guiding treatment.27 However, pharmacological treatment remains the usual method of clinical treatment. Solifenacin succinate, a competitive muscarinic receptor antagonist, has shown efficacy in improving maximum cystometric capacity and reducing detrusor pressure of OAB patients to alleviate symptoms.28 29 However, solifenacin succinate is associated with side effects like blurred consciousness, dry mouth and constipation,30 limiting its widespread clinical use. While other treatments have shown some effectiveness, they also have corresponding clinical limitations.31–33 Therefore, the comprehensive consideration of OAB treatment in clinical practice is essential, prompting active exploration of other effective treatment methods to alleviate patients’ suffering.
Electroacupuncture can effectively improve the clinical symptoms of OAB.34 Our previous clinical studies on the treatment of OAB with electroacupuncture have also provided preliminary evidence of the effectiveness of electroacupuncture.35 Moreover, one of our previous studies suggested that a combination of alternating abdominal and sacral acupuncture points has a relative advantage in the treatment of OAB,36 which is a potential optimisation plan to improve clinical efficacy. As for the comparison between electroacupuncture and medication for the treatment of OAB in women, the results are inconclusive based on the limited research evidence. The aim of the study is to investigate the effectiveness and safety of electroacupuncture compared with solifenacin succinate. Our hypothesis is that electroacupuncture is not inferior to solifenacin succinate in reducing the percentage reduction in the number of micturition episodes every 24 hours at week 4 after the treatment.
Methods
Study design
This study is a multicentre, single-blind, double-dummy randomised controlled non-inferiority clinical trial that will be conducted at three centres, including Longhua Hospital of Shanghai University of Chinese Medicine, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine and Tongji Hospital of Tongji University. A total of 204 patients will be recruited and assigned to either electroacupuncture or solifenacin succinate in a 1:1 ratio. The treatment will last for 4 weeks in both groups, followed by a 12-week follow-up. A flow chart of the trial procedures is illustrated in figure 1. Table 1 provides a schematic diagram showing the time schedule of enrolment, interventions, assessments and visits for participants. Any modifications to the research programme will be documented with dates and details in each section.
Schedule of enrolment, interventions and assessments
Trial flow chart. GAD-7, Generalised Anxiety Disorder Scale-7; KHQ, King’s Health Questionnaire; OAB-q: Overactive Bladder Questionnaire; OABSS: Overactive Bladder Symptom Score.
Participants
Participants will be recruited by means of an announcement and a poster on the hospital’s official online information platform. Interested individuals can contact researchers for an initial screening via the provided telephone number. Those meeting the inclusion criteria will then undergo a face-to-face interview with an independent researcher and a baseline assessment. Following this, eligible participants will be randomly assigned to either the electroacupuncture group or the solifenacin succinate group by a specialist researcher. They will be fully informed about the study’s potential benefits and risks before signing an informed consent form, which can be found in online supplemental material. Participants will have the option to withdraw from the study at any point.
Supplemental material
Inclusion criteria
The eligibility criteria that participants meet for the trial are as follows: (1) Meet the AUA diagnostic criteria for adult OAB disorder (non-neurogenic)18 and the Chinese Urological Association’s Guidelines for the Diagnosis and Treatment of Urological Diseases in China (2014 edition) for OAB.37 (2) Female patients aged 18–75 years. (3) Duration of illness with OAB ≥3 months. (4) 3≤Overactive Bladder Symptom Score (OABSS)≤11.38 (5) No abnormality in routine urine tests. (6) Patients had never received acupuncture treatment. (7) No mental or intellectual abnormalities, able to understand the provisions of the scales and complete the assessment. (8) Consent to participate in this study and sign a written informed consent.
Exclusion criteria
Those who meet any of the following criteria are excluded: (1) Combination of more serious heart, liver, kidney and other serious diseases or patients with severe liver or kidney insufficiency. (2) Patients with pelvic organ prolapse ≥II degree, urinary system surgery history or pelvic floor surgery history. (3) Patients with other diseases presenting with OAB symptoms (such as clinically significant bladder outlet obstruction with a maximum flow rate <10 mL/s and patients with a postvoid residual volume of more than 100 mL).39 (4) Those with urinary diseases (such as calculi and tuberculosis of the bladder), malignant tumours and neurological disorders. (5) Patients who are pregnant or breast feeding. (6) Patients using medication that may affect bladder function 1 month prior to enrolment or have received behavioural therapy for OAB 3 months prior to enrolment, etc. (7) Patients with pacemakers. (8) Patients with blood diseases, diabetes mellitus or mental diseases. (9) Infections, ulcers, abscesses and skin infections at needling sites; metal allergy or extreme needle phobia. (10) Participation in other clinical medical trial studies over the last month.
Randomisation, allocation concealment and blinding
The random allocation scheme for this study will be created by the Clinical Research Centre of Longhua Hospital, Shanghai University of Traditional Chinese Medicine using the ‘Proc plan’ function of SAS V.9.4 statistical analysis software. The randomisation scheme will use stratified block randomisation with centres as a stratification factor, competing for group inclusion. When blocks are depleted, centres will notify the data management centre for replenishment. Independent investigators will place treatment allocation codes in consecutively numbered, opaque envelopes. Envelopes will be chosen by the researcher based on the patient visit sequence. The participant will be informed that their chances of being placed in either the electroacupuncture or solifenacin succinate group are equal. Neither participants nor researchers will know the grouping in advance. All researchers will undergo standardised training sessions before the study implementation, and departmental separation will be strictly maintained to ensure study reliability.
This study will use the single-blind approach. During the study, except for acupuncturists, other people involved in the trial, including participants, study supervisors, efficacy evaluators, data analysts, prescription drug prescribers and statistical analysts, will all be blinded to patients group assignment. Patients will be scheduled for appointments and treated in separate rooms to prevent contact and communication. Blind evaluation method will be used to evaluate and record each observation index by the evaluator who does not know the group assignment. Data will be summarised by a third-party blind statistical analysis to ensure the authenticity and reliability of the research results.
Intervention
The study duration for each participant is 18 weeks. Participants will receive either 12 electroacupuncture treatments (30 min three times per week) or solifenacin succinate treatment (5 mg per day for four consecutive weeks) over a 4-week period. The follow-up period will be weeks 4 and 12 post-treatments (equivalent to weeks 8 and 16 of the full trial period). Additionally, participants will be required to maintain a voiding diary for three consecutive days during weeks 0, 2, 4, 8 and 16.
Electroacupuncture group (electroacupuncture and placebo)
Participants in the electroacupuncture group will receive acupuncture treatment at the following acupoints, including Shenshu (BL23), Ciliao (BL32), Zhonglvshu (BL29), Huiyang (BL35), Weizhong (BL40), Zhongji (CV3), Dahe (KI12), Shuidao (ST28) and Sanyinjiao (SP6) (figure 2). The treatment will be administered bilaterally for all acupoints except CV3. (Acupoint location: refer to The Location of Acupoints: State Standard of the People’s Republic of China (GB/T 12346-2021)). An electrical stimulator (SDZ-V EA instrument, Hwato, Suzhou, China) is applied to ipsilateral BL32 and BL35 (KI12 and ST28) with continuous waves of 30 Hz and currents of 1.0–5.0 mA. It should be noted that CV3, KI12, ST28, SP6 are used as the group A acupoints and BL23, BL32, BL29, BL35, BL40 as the group B acupoints. The patient will receive treatment with group A acupoints during the first session, followed by group B acupoints in the second session and then alternating between group A and B acupoints in subsequent sessions. The acupuncture technique for each point is described in table 2. During needle insertion, all needles will be manipulated through lifting, twirling and thrusting to reach de qi, a sensation commonly associated with acupuncture characterised by swelling, soreness, numbness and heaviness, believed to have a significant role in the curative impact of acupuncture. In the study, sterile acupuncture needles will be used, which are from Suzhou Medical Supplies Factory Co.’s Hwato (size 0.25×40 mm and 0.30×75 mm). Patients in the electroacupuncture group will also receive placebo medication in the form of oral Solifenacin succinate placebo (Wuhan Humanwell Likang Pharmaceutical). This placebo is composed of lactose (100 mesh), corn starch, hydroxypropylmethylcellulose (E-5), magnesium stearate and Obaday @ film-coated premix 03F12967-CN. The placebo will be taken at a dosage of 5 mg (one tablet) once a day for four consecutive weeks. It is important to note that the appearance, specifications and packaging of the placebo are identical to Solifenacin Succinate. During the study, patients will also be asked to record details of medication duration, withdrawal time and drug reaction.
The locations and manipulations of acupoints in the intervention group
Location of acupoints. BL23: Shenshu, BL32: Ciliao, BL29: Zhonglvshu, BL35: Huiyang, BL40: Weizhong, CV3: Zhongji, K112: Dahe, ST28: Shuidao, SP6: Sanyinjiao.
Solifenacin succinate group (solifenacin succinate and sham electroacupuncture)
Participants in the solifenacin succinate group will orally take 5 mg (one tablet) of solifenacin succinate (Wuhan Humanwell Likang Pharmaceuticals) for four consecutive weeks. Additionally, they will receive sham electroacupuncture using a sham acupuncture device (patent number: ZL 2023 2 0605629.3) on sham points. The acupuncture points are the same as the electroacupuncture group but without the insertion of needles. The procedures, electrode positions and other treatment settings are the same as the electroacupuncture group, without the skin penetration, power output or needle manipulation of the de qi. Any changes in dosage, discontinuation or side effects will be clearly recorded in the case report form.
Outcomes
Primary outcome
The primary outcome is the percentage change in the number of micturition episodes every 24 hours at week 4 compared with baseline. It is measured by a 3-day voiding diary.
Secondary outcome
The secondary outcomes include the following seven items: (1) The percentage change in the number of micturition episodes every 24 hours at 2th, 8th and 16th weeks of the trail. (2) The mean changes of OABSS. It will be evaluated at weeks 2, 4, 8 and 16. (3) The number of urinary incontinence and urgency every 24 hours based on a 3-day voiding diary. It will be evaluated at baseline and weeks 2, 4, 8 and 16. (4) OAB questionnaire: It will be evaluated at baseline and week 4. (5) Generalised Anxiety Disorder-7 (GAD-7): It will be evaluated at baseline and week 4. (6) King’s Health Questionnaire: It will be evaluated at baseline and week 4. (7) Participant self-evaluation of therapeutic effects: It will be evaluated using a 4-point scale, which is level 0 (not at all helpful), level 1 (a little helpful), level 2 (moderately helpful) and level 3 (very helpful). It will be evaluated at weeks 2, 4, 8 and 16.
Adverse events
All adverse events (AEs) related to electroacupuncture and medication will be recorded in detail during the course of this study. AEs associated with electroacupuncture include needle breakage, prolonged pain lasting more than 2 hours postneedling, local haematoma, bleeding, infection, as well as other discomforts such as fatigue, palpitations, dizziness, headache and insomnia following needling. What’s more, adverse drug reactions including dry mouth, constipation, nausea, abdominal pain, indigestion, etc will be recorded on an ‘adverse event form’ for further investigation by the investigator to determine the extent and causes of these events. The percentage of AEs (%) during the trial will be used to calculate the incidence of AEs. In addition, if any serious AEs occurred, the treatment would be terminated and a final decision would be made on whether to continue with the study.
Blinding assessment
After the last treatment, three options will be offered by an independent assessor in an interrogative manner: electroacupuncture, sham electroacupuncture and uncertainty. The patients’ answers will be statistically analysed to assess the success of the blinded implementation.
Data collection, management and monitoring
Data management for this study will adhere to the predefined time, content and methodology outlined in the data management plan. Prior to commencing the study, all participants will undergo standardised training to ensure uniform understanding and knowledge among researchers. Licensed acupuncturists with at least 5 years of clinical experience in the study. These acupuncturists will receive standardised training in acupuncture point positioning, acupuncture technique standards and the use of sham electrodes.
Additionally, each study centre will appoint a trial drug manager who will dispense drugs in accordance with the subjects’ visit order and drug codes, recording this information on the Clinical Trial Drug Use Record Form. Investigators will document the amount of trial drugs dispensed, taken and returned by each subject at every visit. Furthermore, a quality control group will be established within the study team to conduct regular and random inspections and verify data from participating study centres.
Statistical methods
Sample size
The sample size in this study was determined based on the percentage change in the number of micturition episodes every 24 hours at week 4 compared with baseline. According to the previous studies,40 41 in the solifenacin succinate group, the mean number of micturition episodes every 24 hours before treatment was 11.5. The mean reduction in the number of micturition episodes every 24 hours at week 4 after treatment was 2.21, and the SD was 2.45. This corresponded to a 19.2% reduction in the number of micturition episodes. In the placebo group, the mean number of micturition episodes every 24 hours before treatment was 11.1, and the mean reduction in the number of micturition episodes every 24 hours at week 4 after treatment was 1.03, resulting in a 9% reduction. The non-inferiority margin for the two groups was determined to be 2% by experts. Based on the preliminary trial, it was estimated that the mean reduction number of micturition episodes every 24 hours at week 4 in the electroacupuncture group after treatment was 3.00, and the SD was 2.45. This translates to a 26.1% reduction in micturition episodes. The percentage decrease in micturition episodes every 24 hours at week 4 between the electroacupuncture and solifenacin succinate groups was found to be 6.9%, calculated using an equal SD of 0.2 as per literature findings. A 1:1 ratio was conducted between the two groups with a one-sided alpha of 0.025 and a power of 80% (β=0.2). According to PASS V.15.0 software, each group will require 81 cases, with an additional 20% for potential dropouts, resulting in a final sample size of 102 cases per group and a minimum total of 204 subjects.
Statistical analysis
Data collection and entry will be performed by specially trained clinical staff. Outcomes efficacy analyses will be analysed in both intention-to-treat (ITT) and per-protocol set (PPS) populations. Missing values for patients in each group will be filled based on the last observation. Based on the FAS, the linear mixed model will be used to analyse the differences between the groups, and the research centre will be used as a random effect to correct the baseline for the mean number of micturition episodes every 24 hours. PPS will be used as sensitivity analyses also. Safety analyses were conducted on ITT population, which included all participants randomly assigned to receive at least one study treatment. A 95% CI for the difference between the treatment group and the control group at week 4 will be calculated. If the lower limit of the 95% CI is above −2%, at the α level of 0.05, it indicates that the treatment group is non-inferior to the control group. SAS V.9.4 software will be used for statistical analysis by independent statisticians who are unaware of the group assignment. Continuous variables will be presented as mean±SD or median (IQR) while categorical variables will be displayed as frequency (constitutive ratio). The significance level will be established at 5% (p<0.05) with a 95% CI.
Patient and public involvement
Patients or the general public are not involved in the design, implementation, reporting or dissemination of the research plan.
Trial status
The trial is currently in the recruitment stage, with the first patient being recruited on 7 July 2023. It is anticipated that the trial will be completed by 31 March 2025.
Ethics and dissemination
The trial has been authorised by the Longhua Hospital Shanghai University of Traditional Chinese Medicine’s Medical Ethics Committee (Ethical approval number: 2022LCSY097). Before taking part in the trial, all patients will have to complete a written consent form. The study’s results will be reported at academic conferences and in peer-reviewed publications. All participants’ personal data will be anonymised before the findings are published in order to prevent the identification of specific patients.
Discussion
It is commonly believed that women are more likely to suffer from OAB than men, although the exact causes remain unclear.3 The substantial annual healthcare costs associated with OAB patients impose a significant financial strain on the healthcare system.42 While antimuscarinic agents are the recommended treatment for OAB,18 43 concerns about potential side effects, AEs and poor medication adherence persist.44–46 Treatment guidelines for OAB aim to optimise symptom management and quality of life while minimising AEs and patient burden.17 18 Fortunately, there is a growing interest in non-pharmacological therapies in clinical practice. Previous studies on acupuncture have limitations such as small sample sizes, single study centres and wide variation in the selection of acupoints and methods of manipulation.47 48 In addition, a systematic evaluation and meta-analysis of acupuncture for OAB in adults have not shown significant differences in effectiveness compared with traditional drugs.49 Therefore, further high-quality studies are warranted.
In order to be able to provide a more reliable clinical basis for the electroacupuncture treatment of OAB, several improvements have been implemented in the study design. First, to our knowledge, this will be the first non-inferiority Randomised Controlled Trial (RCT) to evaluate electroacupuncture versus solifenacin succinate for OAB using a dual simulation approach. The electroacupuncture group will receive electroacupuncture and a placebo while the solifenacin succinate group will receive pharmacological treatment and sham electroacupuncture. This trial design ensures uniformity in medication, frequency and doses for both groups. Moreover, for the electroacupuncture treatment, the selected acupuncture points, the form of treatment, the frequency and duration of treatment are also uniform, which can fully ensure that the subjects will be blinded to the implementation of the method. Second, to assess the effectiveness of blinding, an evaluation test will be conducted at the final session to confirm the success of blinding implementation. Third, electroacupuncture, a treatment method combining electrical stimulation with hand acupuncture, was used in this study to provide a dual stimulation effect. This approach aims to leverage the de qi sensation generated by hand acupuncture and continuous electrical stimulation. Previous study has shown that the continuous wave of electroacupuncture at 30 Hz exhibits a notable efficacy in enhancing the clinical urinary status and quality of life in patients with OAB.35 Fourth, a key focus of this study was the assessment of the percentage change in the number of micturition episodes every 24 hours at week 4 compared with baseline, serving as the primary outcome measure. The number of micturition episodes is an important assessment of OAB and can be reliably measured by a voiding diary. The study concluded that the number of micturition episodes can be used as a measure of response to treatment.18 Meanwhile, the study also converted the change in the number of micturition episodes into a percentage for statistical observation, so that the improvement in the patient’s symptoms could be more visually assessed. If the therapeutic effect of electroacupuncture improving the patients’ urinary symptoms is not inferior to solifenacin succinate within 4 weeks, then electroacupuncture treatment will sufficiently build the patients' confidence in follow-up treatment, reduce the use of medication, improve the patients’ life quality and compensate for the lack of other treatment methods. Fifth, an important aspect of acupuncture’s clinical effectiveness lies in the strategic combination of acupuncture points. Typically, acupuncture points that exert a notable impact on the internal organs are situated near the respective organs. From a modern neuroanatomical standpoint, these acupuncture points with the most pronounced effect on internal organ function often coincide with local nerve segments that innervate the same organs. The selected acupoints used in our clinical practice exhibit these defining features. The two groups of acupoints of the study have these characteristics. Finally, acupuncture, a non-pharmacological therapy aligned with the social-psycho-biomedical model of modern medicine, offers a holistic regulation of the organism and can enhance the emotional well-being of patients. Research indicates that patients with OAB often experience mood disorders such as anxiety and depression.8 Furthermore, there seems to be a correlation between improvements in mood and reductions in clinical symptoms. Therefore, the secondary observations will incorporate the GAD-7 scale to evaluate changes in patients’ mood and further confirm the impact of electroacupuncture on the emotional state of individuals with OAB.
Nonetheless, there are several limitations to this study. First of all, the clinical observation of acupuncture treatment was limited to a short period of 4 weeks. Additionally, follow-up observations were only conducted at weeks 4 and 12 post-treatment, failing to capture the long-term efficacy of electroacupuncture for OAB. Finally, the acupuncturists will not be blinded due to the specific nature of acupuncture manipulation. However, these shortcomings may be further improved in future clinical trials.
In summary, it is essential to conduct a high-quality clinical study of electroacupuncture in the treatment of OAB. We hope that the results of this study will provide high-quality clinical evidence for the treatment of OAB with electroacupuncture.
Ethics statements
Patient consent for publication
Acknowledgments
The authors would like to express their sincere gratitude to Ming Yang and Shunxian Zhang from the Clinical Research Centre of Longhua Hospital Shanghai University of Traditional Chinese Medicine, as well as to all researchers at the three central hospitals for their valuable advice and dedication. They also extend their thanks to all the patients who participated in the study, and to the medical workers who contributed but are not specifically mentioned in the article.
References
Supplementary materials
Supplementary Data
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Footnotes
BC and PY are joint first authors.
Contributors BC and PY contributed equally to this article as co-first authors. PY and Y-LC contributed to the conception of the study. The manuscript was drafted by BC and PY. WH, QF and JL are responsible for the electroacupuncture treatment in the trial. JH, SM and STC participated in the trial communication and monitoring. YH, LL and XL are responsible for data collection. All authors participated in the reading, discussion and revision of the manuscript and all approved of the protocol for publication. PY is responsible for the overall content as guarantor.
Funding This work was supported by the Shanghai Shenkang Hospital Development Centre Joint Research Project on Emerging Frontier Technologies (SHDC12022103), the Chinese Medicine Inheritance Ancient Literature and Special Techniques Special Project 2022 (GZY-KJS-2022-038), the Shanghai 3-year Action Plan of Accelerating The Inheritance and Development of TCM—The Construction of TCM Specialty Alliance in East China Region and at The Municipal Level—The TCM Pelvic Floor Disease Rehabilitation Specialty Alliance Project (ZY (2021-2023)-0302), the Shanghai Shenkang Hospital Development Centre Medical Enterprise Integration Innovation Synergy Special Project (SHDC2022CRT003), the Shanghai Shenkang Hospital Development Centre demonstration research ward construction project (SHDC2022CRW006) and Shanghai Famous Old Chinese Medicine Experts Academic Experience Research Studio Construction Project (SHGZS-202232).
Disclaimer The funding body has no role in the study design, data collection, data analysis, interpretation of results, writing of the manuscript, or submission of the report for publication.
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.