Improvement of Urinary Retention Symptoms With Electroacupuncture Therapy

January 12, 2024 updated by: dr. Ayu Permata Sari, Indonesia University

Improvement of Urinary Retention Symptoms After Vaginal Delivery With Electroacupuncture Therapy

Postpartum urinary retention (PPUR) can occur in women who deliver vaginally. The incidence of this occurrence varies from 1.7 - 17.9%, this different variation due to different definitions of PPUR and the methods used to measure it. There are 2 categories of RUPP, namely covert and overt, in overt PPUR the prevalence ranges from 0.3 to 4.7%, while covert PPUR can reach up to 45%. In Indonesia alone, the incidence of PPUR is around 14.8%3, where vaginal PPUR is around 70% more higher than sectio caesarean patients. A study conducted at the RSCM in 2009 by Yustini, et al stated that the incidence of PPUR was 9-14%, and if the delivery was using forceps it would increase to 38%. Other studies conducted by Suskhan at the RSCM in 2015, it was stated that the incidence of urinary retention was 13.6% of 500 research subjects. Another study conducted by Chen, et al in 2020 in China, stated that the most common cause of urinary retention in hospitals was surgery. gynecological cases, which is 69% while for obstetric cases by 18.6% where the main cause of this retention is due to vaginal delivery. The high number of PPUR can increase the incidence of postpartum hemorrhage, urinary tract infections, mental fatigue during the puerperium and result in delays in breastfeeding. Bladder catheterization which is one of the treatments for PPUR is also closely related to the risk the occurrence of morbidity and complications, where 17.5% of urinary tract infections are infections obtained from hospitals or HAIs (Healthcare Associated Infections) and 80% of these infections are caused by the installation of urethral catheters, especially the installation of urethral catheters in the ER which is carried out without clear indications such as described in a study conducted by Gokula et al in Michigan in 2007.

According to Sudhakaran, symptomatic RUPP (overt) is defined as the absence of a spontaneous voiding process or the inability to urinate since 6 hours after vaginal delivery or 6 hours after catheter removal after caesarean section. Asymptomatic (covert) PPUR is defined as a post-void residual volume (PVRV) 200 ml after the first spontaneous urination as measured by ultrasound or catheter, which indicates incomplete voiding.6 Asymptomatic PPUR may occur due to reduced sensation and contractility that occurs as a result of trauma from the innervation to the bladder. Symptoms of this RUPP according to Suskhan are unexplained urination, prolonged urination, more frequent urination, inability to urinate, feeling of full bladder and abdominal distension. The presence of the above symptoms will cause the bladder to enlarge during a physical examination of the abdomen.

Acupuncture as a non-medical therapy has been widely used both in China and in other countries, especially to treat pain and neurological disorders. Urination is a neural reflex activity. Acupuncture points that correspond to the innervation of the bladder can stimulate conduction of parasympathetic nerve impulses, resulting in bladder detrusor contraction, increased intravesical pressure and relaxation of the internal sphincter. Thus, acupuncture can regulate bladder function in the process of urination.

Based on the study of Zhao, et al, it was stated that electroacupuncture can stimulate afferent and efferent nerves in the pelvic cavity of rats, increase detrusor contraction and encourage urination. Other studies have shown that electroacupuncture can also reduce the myoelectric activity of abnormal contraction of the external urethral sphincter during urination, reduce resistance during urination, improve coordination between the bladder detrusor and urethral sphincter and reduce residual urine volume. As for the side effects caused by acupuncture based on a systematic study conducted almost none.

Based on the description above, acupuncture can be considered as a supportive therapy that can overcome the problem of PPUR with minimal side effects to prevent worsening of the condition. In this study, researchers wanted to determine the effectiveness of acupuncture interventions using electroacupuncture modalities to accelerate urination after delivery and reduce residual urine volume in patients after vaginal delivery with electroacupuncture intervention for 30 minutes / session, 2 sessions in 1 x 24 hours.

Study Overview

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • DKI Jakarta
      • Jakarta, DKI Jakarta, Indonesia, 14220
        • Koja Regional Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • subject who had urinary retention 6 hours after vaginal delivery and the residual urine volume 500 - 1000 mL
  • female 20 - 40 years old
  • pregnancy > 34 weeks and baby's weight > 2000 gr
  • agree to participate in this study and sign the inform consent

Exclusion Criteria:

  • patient who had emergency situation, such as bleeding or unstable hemodynamic
  • using pace maker
  • had cardiac arrhythmia
  • patient had disease that make them using the catheter (such as chronic kidney disease)
  • allergy to stainless steel
  • scar in the acupuncture point locations
  • using prothesis
  • had intrathecal labour analgesia (ILA)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: True electroacupuncture group
the investigators use stainless steel acupuncture needle, disposable : Huanqiu® 0.25 x 0.40 mm Electroacupuncture device : Hwato-SDZ V®, continuous wave, 2 Hz, for 30 minutes
the investigators use stainless steel acupuncture needle, disposable : Huanqiu® 0.25 x 0.40 mm Electroacupuncture device : Hwato-SDZ V®, continuous wave, 2 Hz, for 30 minutes
Sham Comparator: sham electroacupuncture group

the investigators use the same device like true electroacupuncture group, but the acupuncture needle not puncture on the skin and only attached.

electroacupuncture device, with no electrical stimulation

the investigators use the same device like true electroacupuncture group, but the acupuncture needle not puncture on the skin and only attached.

electroacupuncture device, with no electrical stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
residual urine volume after electroacupuncture therapy and catheter removal
Time Frame: 6 hours
after 24 hours using catheter, it will be remove. 6 hours after catheter removal, the investigators will check how much the residual urine volume in the bladder
6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
first time micturation
Time Frame: 6 hours
after 24 hours using catheter, it will be remove. anytime after the removal if participants going to first micturition, the investigators will collect the data
6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Actual)

December 2, 2022

Study Completion (Actual)

December 29, 2022

Study Registration Dates

First Submitted

August 28, 2022

First Submitted That Met QC Criteria

September 1, 2022

First Posted (Actual)

September 2, 2022

Study Record Updates

Last Update Posted (Estimated)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 12, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe