Effect of electro-acupuncture on postpartum urinary retention —— A protocol for multicenter, randomized and placebo-controlled trial

doi:10.21203/rs.3.rs-4968359/v1

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Study protocol

Effect of electro-acupuncture on postpartum urinary retention —— A protocol for multicenter, randomized and placebo-controlled trial

https://doi.org/10.21203/rs.3.rs-4968359/v1

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Background

Postpartum urinary retention (PUR) is one of the serious and common clinical complications after delivery. Although urinary catheterization can provide temporary relief from voiding disorders, it may cause discomfort, pain, and even urethral injury to the mother, thereby increasing the risk of urinary system infection. Acupuncture was shown it has unique advantages in relieving the clinical symptoms of PUR, promoting bladder recovery. However, there is not sufficient high-quality evidence to strongly support the effectiveness of electroacupuncture in the prevention and treatment of PUR. Therefore, we have designed a multi-center, large-sample, randomized controlled clinical trial to assess the impact of electroacupuncture intervention on the incidence of PUR and the recovery of bladder function.

Methods

This is a multicenter, randomized, parallel-group clinical trial conducted in China to investigate the impact of electroacupuncture intervention on the incidence of PUR. Patient screening and enrollment will take place at four hospitals in China: the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin Central Hospital of Gynecology Obstetrics, Tianjin Shuige Hospital and Second People's Hospital of Fengrun District, Tangshan City. Patients will be randomly assigned to either the electroacupuncture group or the sham acupuncture group, with 330 patients in each group. Each acupuncture treatment will comprise three 30-minute sessions over 2 days (the first hour, the first day, and the second day after delivery). The primary outcome measure is the incidence of PUR. Adverse events will be recorded, and their impact will be analyzed at the end of the trial.

Discussion

This study will provide high-quality evidence support for the effectiveness of electroacupuncture in preventing and treating PUR, and provide scientific basis for the application of non-drug therapy in postpartum rehabilitation.

Trial registration

ClinicalTrials.gov: ChiCTR2300078039.Registered on 27 November 2023.

Postpartum urinary retention

Electroacupuncture

Controlled clinical trial

Postpartum urinary retention (PUR) is a serious and common clinical complication after delivery [1], mainly manifested as voiding disorders or incomplete bladder emptying. Based on its different clinical manifestations, PUR can be classified into overt, covert, and persistent PUR. Overt PUR refers to the inability to void 6 or more hours after vaginal delivery or removal of catheter after cesarean section. Covert PUR is defined as post-void volume (PVR) of >150ml measured by ultrasound or catheterization after spontaneous urination. Persistent PUR is urinary retention lasting beyond 3 days postpartum and requires indwelling catheter or intermittent self-catheterization [2, 3].

Based on differences in diagnostic criteria, measurement methods, and timing, the incidence of PUR varies from 1.5–45% [4]. However, covert PUR is somewhat concealed, making clinical screening and management more challenging, and it is more prone to delayed diagnosis and misdiagnosis. Although some studies have shown that covert PUR can normalize within a few days, even a single over-distension of the bladder can cause long-term urination disturbance, affecting the long-term function of the bladder, leading to recurrent urinary tract infections, and even renal failure [5]. Additionally, PUR can affect uterine involution, resulting in increased postpartum bleeding, which imposes a heavy psychological burden on the parturients and seriously impacts their physical and mental recovery, as well as their quality of life and long-term health [4]. Therefore, early diagnosis and prevention of PUR are of great significance for the physical and mental well-being of parturients.

The clinical treatment of PUR mainly involves urethral catheterization, drug therapy, physical therapy, and pelvic floor muscle functional exercises[6]. While urinary catheterization can temporarily alleviate the clinical symptoms of voiding disorders, it does not offer a complete cure. Additionally, this procedure can cause maternal discomfort, pain, and anxiety, and even urethral injury, increasing the risk of urinary system infections [7, 8]. Studies have shown that urinary tract infections caused by urinary catheter account for approximately 60–80% of patients with urinary tract infections, and long-term indwelling urinary catheters can weaken bladder autonomic function, which is not conducive to recovery [8]. Drug therapy, such as tamsulosin, neostigmine, and bethanechol, mainly acts on bladder and sympathetic nervous system receptors, and its impact on improving post-void residual bladder volume is unclear. Additionally, these drugs have side effects such as tachycardia, diarrhea, and vomiting, and it is unknown whether they are secreted in human milk, thus safety considerations for maternal breastfeeding are lacking [2]. Conventional non-invasive methods, such as functional exercises and acupoint hot compresses, are easy to accept but have limited efficacy for patients with severe PUR or complications, and the long-term effect is unclear [8]. Therefore, it is urgent to find a safe, effective, less side effect-prone, and long-term curative approach for the prevention and treatment of PUR.

Currently, acupuncture has been widely utilized in 196 countries and regions, and has been widely recognized by the international community. In recent years, numerous clinical studies have confirmed the significant effect of acupuncture on functional diseases, leading to its inclusion in numerous international clinical practice guidelines[9]. It has been found that acupuncture has demonstrated unique advantages in improving the clinical symptoms of patients with urinary retention, promoting bladder recovery, reducing long-term complications. Additionally, it has a profound impact on improving postpartum uterine contraction pain, postpartum hemorrhage, and other symptoms, enhancing the quality of parturient life [10]. Nevertheless, there is a lack of multi-center, large-sample, and scientifically designed randomized controlled studies worldwide that support the effectiveness of acupuncture in the prevention and treatment of PUR. Furthermore, the existing clinical studies on acupuncture for treating PUR overlook the early identification and diagnosis of covert PUR, posing a potential threat to the long-term health of parturients[11].

Study design

This is a multicenter, randomized, parallel-group clinical trial conducted in China to investigate the impact of electroacupuncture intervention on the incidence of PUR. The study protocol is to prefer the Consolidated Standards of Reporting Trials (CONSORT) guidelines[12] and the Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA)[13], as well as with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)[14]statement The study will commence following ethics approval and registration protocol. Patient screening and inclusion will start in August 2024. It has been registered at Chinese Clinical Trials Registry (ChiCTR2300078039). Figure1 is the study flow chart and Table 1 shows the schedule of enrolment, interventions and assessments.

Table 1. the Schedule of Enrolment, Interventions and Assessments.Interventions and Assessments.

Participants

Recruitment and withdrawal

Patient screening and recruitment will take place at four hospitals in China: the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin Central Hospital of Gynecology Obstetrics, Tianjin Shuige Hospital and Second People's Hospital of Fengrun District, Tangshan City. The target enrollment is set at 660 patients. Obstetricians responsible for identifying eligible patients will be briefed about the study, and these patients will then be given the option to decide whether they want to participate. After signing the informed consent form, patients will be randomly assigned to either the electro-acupuncture group or the sham acupuncture group, with 330 patients allocated to each group. It is important to emphasize that patients have the right to withdraw from the study at any stage.

Inclusion criteria

Patients meeting the following additional inclusion criteria may be included:

1. Primiparous women aged 20 to 45 years with singleton pregnancies planning for vaginal delivery.

2. Delivery at a gestational age of 37 to 42 weeks.

3. Being clearly conscious and cooperative.

4. Signing the informed consent.

Exclusion criteria:

Patients meeting any of the following conditions will be excluded:

1. Termination of pregnancy due to fetal malformation or stillbirth.

2. Severe central nervous system diseases, internal and surgical diseases, mental and psychological diseases, urogenital-related diseases, infectious diseases, and long-term drug treatment.

3. Severe coagulation disorders and a tendency towards spontaneous bleeding.

4. Skin damage at the acupuncture site.

5. Refusal to follow-up.

6. Refusal to sign the informed consent form.

Drop-out and discontinuation criteria:

One of the following conditions occurs during the study, who will be included in the full analysis set in principle, but not in accordance with the per-protocol set for analysis, and acupuncture patients will be included in the safety analysis.

1. Rescue measures are implemented due to postpartum hemorrhage, eclampsia, or other obstetric conditions;

2. Conversion from vaginal delivery to cesarean section

3. Infection is diagnosed during delivery;

4. An indwelling catheter is used and diuretics are administered due to other diseases within 6 hours after delivery;

5. A degree III laceration above the perineal fissure is diagnosed;

6. Due to other postpartum reasons, the number of treatment sessions received by patients is less than 3 times, which affects the analysis and judgment of the results;

7. The researchers can terminate the patients from the study at any stage if any events occur that may affect the safety of patients in the study.

Randomization and blinding

This study will use the network-based clinical trial public management platform (ResMan, http://www.medresman.org.cn/login.aspx) to implement centralized randomization.Randomization will be conducted at each sub-center by block randomization (with a block size of 4). Once patients have signed the informed consent form and completed all necessary baseline assessments, researchers will retrieve the corresponding blind envelope, input the number on the envelope into the ResMan database, and select the corresponding patients' treatment plan. Both patients and researchers will be blinded to the group allocation. However, acupuncturists will be aware of the group allocation for the purposes of acupuncture operation.

After the final acupuncture treatment, all patients will be asked, "Do you believe that acupuncture has penetrated the skin?" The response will be categorized into three options:

Acupuncture penetrated the skin;
Acupuncture did not penetrate the skin;
I don't know.

This will be taken into consideration to evaluate the success of blinding.

Interventions

Each acupuncture treatment modality will involve three sessions, each lasting 30 minutes, administered over two consecutive days (first hour, first day, second day after delivery). The selection of acupuncture points is based on traditional Chinese medicine theory, evidence-based clinical research, and our accumulated clinical experience. The treatment protocol adheres to CONSORT and STRICTA recommendations, providing comprehensive details on the treatment, including the number of needles used, session frequency, and treatment duration. Only licensed acupuncturists holding a master's degree and possessing more than two years of acupuncture experience will conduct the treatment. Prior to the study commencement, all acupuncturists at each sub-center will receive instruction in the theory of postpartum urinary retention and standardized operating procedures.

Electro-acupuncture group

The selected acupoints will include Baihui (GV20), Zhongji (CV3), and Guanyuan (CV4), adhering strictly to the National Acupoint Standard of the People’s Republic of China in 2021 (GB/T 12346-2021). Detailed positioning is illustrated in Table 2 and Figure 2. Patients will be positioned supine during the procedure. Adhesive pads will be applied to the skin over the acupoints, followed by the insertion of single-use acupuncture needles (0.25 * 40 mm, Hwato, Suzhou, China) through the adhesive pads.

The sequence and technique of acupuncture are as follows: initially, acupuncture at Baihui (GV20) will be performed with a depth of 10-15mm and an angle parallel to the scalp. Subsequently, a small amplitude and high-frequency twisting method will be applied, with the needle twirling in the range of 90°-180° at a frequency of 100 to 120 times per minute for 1 minute. Following this, Zhongji (CV3) and Guanyuan (CV4) will be obliquely punctured at a depth of 10-20mm and at a 45° angle to the abdomen. The same small amplitude and high-frequency twisting method will be employed for 1 minute. Acupuncturists will manually stimulate the needles to achieve de qi, and then paired electrodes from an electroacupuncture (EA) apparatus (SDZ-ⅡB, Suzhou Medical Appliance, Suzhou, Jiangsu, China) will be attached to the needle handles at CV3 and CV4. The wave will be set continuously at 2 Hz, with the intensity adjusted to the maximum tolerated by the patients. The needles will be retained for 30 minutes. The specific operation and electrode connection are depicted in Figure 2.

Table2. Locations and needling methods of acupoints for electro-acupuncture group

Acupoint	Location	Needling method
Baihui (GV20)	On the head, 5 inches above the center of the front hairline.	depth of 10-15mm and an angle parallel to the scalp, then adopt the method of small amplitude and high frequency twisting(the range of twirling of the needle was 90°- 180°, and the frequency was 100 to 120 times a minute) for 1 min.
Zhongji (CV3)	In the lower abdomen, 4 cun below the umbilicus, on the anterior median line.	obliquely acupunctured 10-20mm and at a 45° angle to the abdomen.
Guanyuan (CV4)	In the lower abdomen, 3 cun below the umbilicus, on the anterior median line.	obliquely acupunctured 10-20mm and at a 45° angle to the abdomen.

Sham acupuncture group

Patients in the sham acupuncture group will undergo non-insertive acupuncture treatment following the same procedure as the electro-acupuncture group. However, the treatment will be applied to non-acupoints (sham-Baihui, sham-Zhongji, sham-Guanyuan) using sham needles with a blunt tip (0.25 × 40 mm, Hwato, Suzhou, China). The sham needles will not penetrate the skin, and the procedure will not aim to elicit the "De Qi" sensation. An EA apparatus will be attached to the needle handles at sham-Zhongji and sham-Guanyuan, but no electricity output will be applied. The needles will be retained for 30 minutes. Specific positioning and operation details are outlined in Table 3 and Figure 2.

Table3. Locations and needling methods of non-acupoints for Sham group

Acupoint	Location	Needling method
Sham-Baihui	2 cun lateral from GV20	Sham needles will not penetrate the skin
Sham-Zhongji	6 cun lateral from CV4(left)	Sham needles will not penetrate the skin
Sham-Guanyuan	6 cun lateral from CV4(right)	Sham needles will not penetrate the skin

Outcome measurements

At the baseline, clinical and sociodemographic data will be collected from all patients, encompassing:

1.Basic Information:

Age;
Gestational age at delivery;
Height;
Weight (Predelivery);
Body Mass Index (Predelivery);
Conception mode.

2. Management of the Delivery Process:

Duration of labor;
Use of epidural anesthesia;
Incidence of episiotomy and perineal lacerations;
Instances of vacuum-assisted and instrumental delivery;
Process of placental delivery;
Administration of uterine contractile drugs.

3. Newborn Condition:

Weight;
Length;
Apgar score.

Primary outcome

The primary outcome is the PUR incidence.

The PVR of the bladder will be measured using an Ultrasonic Bladder Scanner (BVI-9400 BladderScan®, Verathon Medical Europe, Ijsselstein, The Netherlands) at specific time points: the first urination after delivery, 6 hours after delivery, the initial urination on the first day, and the second day following acupuncture. The recorded PVR of the bladder and whether catheterization was required will be documented. The specific measurement times are illustrated in Figure 3.

Secondary outcome

The time of first urination, the amount of urination and the feeling of unobstructed urination.

1.Recording Time from Delivery Completion to First Urination:

The elapsed time from the conclusion of delivery to the initiation of the first urination will be recorded, measured in minutes ("min").

2.Recording Volume of First Post-Delivery Urination:

After urination in a urinal, the volume of urine will be measured using a cup, expressed in milliliters ("mL").

3.Assessment of Unobstructed Feeling During First Urination:

The unobstructed sensation during the initial urination will be evaluated using the Traditional Chinese Medicine Syndrome Quantification Scale, where:

0 points: Unable to urinate;
2 points: Dribbling out urine, with a sense of difficulty;
4 points: Urination is acceptable, with a residual feeling;
6 points: Very smooth, without any residual sensation.

Effective rate of urination

The classification of the first urination volume is as follows:

A volume greater than 500 ml is considered significant;
A volume ranging from 100 to 500 ml is deemed effective;
A volume less than 100 ml is categorized as invalid.

The effective rate of urination is calculated using the formula: Effective rate of urination=(number of significant cases + number of effective cases)/total cases × 100%.

Postpartum uterine contraction pain

The Visual Analogue Scale (VAS) will be employed to assess postpartum uterine contraction pain. The visual scale spans 10 centimeters, ranging from 0 to 10, where "0" represents a painless state, and "10" signifies the most unbearable pain. Scores will be assigned at specific time points, including six hours after delivery, two hours after acupuncture on the first day, and two hours after acupuncture on the second day.

Cumulative amount of 24 hours postpartum bleeding

The volume of vaginal bleeding within the first 24 hours after delivery will be documented using postpartum measuring pads. These pads will be changed regularly every 2-4 hours, and upon replacement, they will be weighed and measured, with the unit of measurement being milliliters ("mL").

Postpartum depression and anxiety

The Edinburgh Postpartum Depression Scale (EPDS) will be employed to assess depressive symptoms. The scale comprises 10 items, which will be administered after the final acupuncture session and again 6-8 weeks after delivery. Each item is graded on a four-point scale (0 to 3 points). A cumulative total score of ≥13 points indicates a diagnosis of postpartum depression.

Safety assessment

Common adverse reactions associated with acupuncture include incidents such as broken needles, localized hematoma, bleeding, infection, and localized severe sharp pain. Post-delivery, common adverse reactions encompass late postpartum hemorrhage, postpartum infection, and constipation. Any adverse events (AEs) occurring during the study period will be thoroughly assessed, treated, and documented in the case report form (CRF).

Follow-up

Follow-up 1—6-8 weeks after delivery

Patients will undergo follow-up through outpatient visits. Urination sensations will be assessed using the Traditional Chinese Medicine Syndrome Quantification Scale, where:

0 points: Unable to urinate;
2 points: Dribbling out urine, with a sense of difficulty;
4 points: Urination is acceptable, with a residual feeling;
6 points: Very smooth, without any residual sensation.

Follow-up 2—One year after delivery

Patients will be followed up via telephone. The assessment will include monitoring symptoms related to urination, defecation, and pelvic organ prolapse. Additionally, the Pelvic Floor Dysfunction Questionnaire (PFDI-20) will be administered.

Data management and monitoring

CRFs will be developed to record and store individual patient data. To streamline data management and process monitoring, an electronic CRF based on the ResMan network system will be employed for data management. After researchers input the data and address any inquiries to guarantee accuracy, database locking will be conducted by data administrators. Both hardcopy files and electronic documents will be archived for a minimum of 5 years post-publication. In the event that readers or reviewers have queries, they can contact the corresponding author to access the original data. Moreover, an independent Data and Safety Monitoring Board (DSMB in Table4) will be established to review and interpret the data generated during the study. The primary objective is to safeguard patient safety and maintain data integrity throughout the research. The DSMB will offer recommendations on research design, data quality, and analysis, thereby ensuring the protection of subjects involved in the study.

Table4. Data and Safety Monitoring Board (DSMB)

Member name	Affiliation	Roles and responsibilities
Linling Wu	First Teaching Hospital of Tianjin University of TCM	Review the protocol with respect to ethical and safety standards. Review the progress of the trial.
Ning Xue	First Teaching Hospital of Tianjin University of TCM	Monitor the safety of the trials. Review and interpret the data generated from the study.
Zhimei Zhao	First Teaching Hospital of Tianjin University of TCM	Adjudicate adverse events.

Quality control

To ensure the trials' quality, standardized training will be provided to all acupuncturists, obstetricians, evaluators, and statisticians before the official launch of the clinical trial. The training will encompass research goals and content, patient recruitment, treatment procedures, patient communication skills, and outcome evaluation, aiming to maintain consistency across various patients and researchers. This approach ensures the feasibility and safety of the clinical research. Throughout the clinical trial, independent monitors will regularly visit each center to verify strict adherence to the research plan. They will also scrutinize the original data to ensure the CRFs are accurate, complete, and correct.

Sample size

This study adopts a superiority design. Based on the research findings, the incidence of overt Postpartum Urinary Retention in the intervention group is projected at 4.0%, while in the control group, it is estimated to be 9.0% [4]. Assuming a 1:1 ratio between the intervention and control groups, and utilizing a superiority test with a significance level (α) of 0.05, a power (1-β) of 80%, and accounting for a potential dropout rate of 10%, the study is planned to enroll 660 patients, evenly distributed with 330 in each group. The calculation formula is as follows:

Statistical analysis

Demographic characteristics, general situations, and baseline conditions of the two groups will be compared and analyzed. For measurement data, an independent samples t-test or Wilcoxon rank-sum test will be employed, while χ2 test or Fisher test will be used for categorical data.

The incidence of PUR will be accurately assessed using Fisher's exact test, and the relative risk (RR) along with the corresponding 95% confidence interval will be calculated. For other ordinal data, the Wilcoxon rank-sum test will be applied, while clinical counting data will undergo testing through the χ2 test. Postpartum depression and anxiety will be compared using Fisher's exact test, and the RR along with the corresponding 95% confidence interval will be computed. Subject blinding effectiveness will be analyzed using the Bang Blinding Index and James Blinding Index. All statistical tests will be two-sided, and a P value less than 0.05 will be considered statistically significant for the tested differences.

For exploratory subgroup analysis, participants will be stratified into different subgroups based on age (< 40 years, ≥ 40 years), BMI (< 25kg/m2, ≥ 25kg/m2), duration of labor (< 700min, ≥ 700min), epidural anesthesia (with or without), vaginal midwifery techniques (forceps midwifery, fetal head attraction midwifery, fetal head rotation, perineotomy), gestational age (> 280 days, ≤ 280 days), and newborn birth weight (< 4000g, ≥ 4000g). The incidence difference between the two groups will be compared within each subgroup using the same statistical methods as mentioned above. Due to the exploratory nature of this analysis, no adjustments for multiple testing will be made at this stage.

GraphPad Prism 8 will be used for all statistical analysis.

Urination is a complex process involving the coordinated efforts of the cerebral cortex, spinal cord micturition center, peripheral nervous system, and muscle system[7]. Disruptions to the muscle or nerve functions controlling urination during childbirth can impact normal micturition function, resulting in PUR [15]. Acupuncture emerges as a promising intervention for PUR, showcasing advantages in the regulation of neurotransmitters and objective improvement in urodynamic studies[16, 17]. Relevant research has confirmed that acupuncture can inhibit neuronal apoptosis, promote the synthesis and secretion of neurotrophic factors, repair damaged nerves, and thereby improve bladder function[18–20]. Animal studies have demonstrated that electroacupuncture can stimulate afferent and efferent nerves in the rat's pelvic cavity, promote detrusor muscle contraction, and improve voiding function [21].

In this project, acupuncture is applied at three points: Baihui, Guanyuan, and Zhongji. Modern anatomical studies have revealed that the paracentral lobule of the cerebral cortex serves as the higher center for urination, controlling the relaxation and contraction of the bladder sphincter muscle. Its surface projection corresponds to the vertex midline where the Baihui point is located [22]. Therefore, acupuncture at the Baihui point stimulates information transmission to the central nervous system. The central "commands" are then transmitted via efferent nerves to the innervated muscle groups, eliciting movements of the pelvic floor muscles and sphincter muscles to restore their physiological functions. According to modern theories of acupuncture, the therapeutic scope of an acupuncture point is closely related to the innervation area of its associated nerve segments. The urination activity of the bladder is controlled by the lower urination center in the lumbosacral region, with the parasympathetic nerves and sympathetic nerves originating from spinal segments S2-4 and T11-L2, respectively, innervating the bladder detrusor muscle and internal sphincter muscle. Zhongji and Guanyuan, located in the lower abdomen and in close proximity, both receive innervation from spinal segments T12-L4. Acupuncture at these two points can enhance the conduction of neural impulses, excite paralyzed nerve fibers, and thereby restore the function of the bladder sphincter muscle[23, 24].Therefore, acupuncture has the effects of promoting spontaneous urination, reducing residual urine volume, alleviating urinary retention symptoms, and preventing long-term bladder dysfunction. Additionally, acupuncture is known for its capacity to modulate pain thresholds, alleviate depression, and effectively enhance patients' quality of life. Its convenient and safe application makes it a clinically accessible and widely applicable intervention [25, 26]

Nevertheless, there is a scarcity of clinical research on acupuncture as a treatment for PUR both domestically and internationally. A clinical study indicates that acupuncture exhibits the potential to ameliorate urinary retention symptoms, serving as an alternative to urethral catheterization. This approach may contribute to a decreased risk of urinary tract infection and spare individuals the uncomfortable and painful process associated with indwelling catheters, making it a preferable non-invasive option for postpartum individuals experiencing PUR [11]. However, the study cited faces limitations such as a small sample size and the absence of random grouping, resulting in a low level of evidence. Urgent challenges persist in existing clinical research on acupuncture for PUR, including: 1. Lack of clarity in PUR diagnosis, with many studies focusing predominantly on overt PUR while overlooking the diagnosis and treatment of covert PUR, thereby posing potential risks to both short-term and long-term bladder function. The current evidence level for acupuncture treatment of PUR is suboptimal, and a dearth of multi-center, large-sample, randomized controlled clinical trials hampers the availability of high-quality data to support its efficacy.

To address the existing challenges in current clinical research, we have formulated a comprehensive strategy involving a multi-center, large-sample, randomized controlled clinical trial. This trial aims to assess the impact of electroacupuncture intervention on both the incidence of PUR and the recovery of bladder function. Our investigation will encompass the three distinct categories of PUR, namely overt, covert, and persistent types. Additionally, we will explore the influence of electroacupuncture on common postpartum conditions such as uterine contraction pain, postpartum bleeding, depression, and anxiety. A critical aspect of the study involves long-term observations through follow-up, where we will scrutinize the enduring effects of acupuncture on urination and pelvic floor function in postpartum individuals.

However, certain limitations are acknowledged in our study design. The nature of acupuncture treatment poses challenges to achieving practitioner blinding. Simultaneously, the administration of sham acupuncture may induce psychological effects on patients. The standardization of acupuncture points, applied uniformly across all subjects without syndrome differentiation, is another study limitation. Furthermore, a potential challenge lies in determining the willingness of postpartum patients to continue acupuncture treatment until the study's conclusion and to actively cooperate with the follow-up process.

We anticipate that the outcomes of this study will furnish high-quality evidence supporting the efficacy of electroacupuncture in both preventing and treating PUR. Furthermore, these findings are expected to establish a solid scientific foundation for the application of non-drug therapies in postpartum rehabilitation.

Participants have not yet been recruited at the time of manuscript submission. Participant recruitment is expected to start in 1 August 2024, and is expected to end in 1 August 2026.

PUR Postpartum urinary retention

PVR Post-void volume

EA Electroacupuncture

VAS Visual Analogue Scale

EPDS Edinburgh Postpartum Depression Scale

AEs Adverse events

CRF Case report form

PFDI-20 Pelvic Floor Dysfunction Questionnaire

DSMB Data and Safety Monitoring Board

RR Relative risk

Ethics approval and consent to participate

This trial will be conducted under the requirements of the Declaration of Helsinki. It has been registered with the Chinese Clinical Trial Registry under the registration number ChiCTR2300078039. It is also listed in the Trials Register and has received approval from the Institutional Review Board of the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine (TYLL2023[Z]027). The trial's results will be disseminated through peer-reviewed publications and conference abstracts. All participants will provide voluntary written informed consent after fully discussing potential benefits and risks before participating.

Consent for publication

Not applicable.

Availability of data and materials

All data produced in the present work are contained in the manuscript.

Competing interests

The authors declare no competing interests.

Funding

This work is supported by the Inheritance and Innovation of Traditional Chinese Medicine "100 Million" Talent Project (Qihuang Project) Youth Qihuang.

Authors' contributions

ZD,YZ and HC contributed equally to this work. ZD and YZ conceived the study. HC, XZ , FY and LD provided practical suggestions on the design of the study during its development. BW completed the tables and figures. XT and YC drafted the manuscript and all the authors approved the final manuscript.

Acknowledgements

We would like to thank the sub-center hospitals for their trust, support, and assistance with subject recruitment and management. We also extend our gratitude to all the researchers who have participated and will continue to participate in this study.

Author details

¹Reproductive Medicine Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin, China

² School of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China

³Obstetrics Department, Tianjin Central Hospital of Gynecology Obstetrics, Tianjin, China

⁴Second People's Hospital of Fengrun District, Tangshan City, Tangshan, Hebei, China.

⁵Acupuncture Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin, China.

⁶Tianjin Central Hospital of Gynecology Obstetrics, Tianjin, China

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No competing interests reported.

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Effect of electro-acupuncture on postpartum urinary retention —— A protocol for multicenter, randomized and placebo-controlled trial

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