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CompletedNCT05526651Updated Jan 17, 2024

Improvement of Urinary Retention Symptoms With Electroacupuncture Therapy

An interventional study of true electroacupuncture and sham electroacupuncture in Urinary Retention, sponsored by Indonesia University. Completed at 1 site in Indonesia. Open to female participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-17.

Sponsored by Indonesia University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Urinary Retention

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Keywords

  • Urinary Retention
  • Postpartum urinary retention
  • electroacupuncture
  • vaginal delivery
  • acupuncture
03

In context

Urinary Retention

235 studies on the registry are indexed under Urinary Retention; 39 are open to participants now.

This study's enrollment of 60 is below the median of 95 across 185 interventional studies indexed under Urinary Retention.

Browse Urinary Retention studies →

Lead sponsor

Indonesia University is the lead sponsor of 448 studies on the registry; 56 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • 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

    Other: true electroacupuncture

  • 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

    Other: sham electroacupuncture

Interventions

  • Othertrue electroacupuncture

    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

  • Othersham electroacupuncture

    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

06

What researchers measure

Primary outcomes

  1. residual urine volume after electroacupuncture therapy and catheter removal

    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

    Time frame: 6 hours

Secondary outcomes

  1. first time micturation

    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

    Time frame: 6 hours

07

Study locations

1 site
  • Koja Regional Hospital
    Jakarta, DKI Jakarta 14220, Indonesia
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05526651
Lead sponsor
Indonesia University
Responsible party
dr. Ayu Permata Sari (Medical doctor, student of medical acupuncture specialist program, Indonesia University) — Principal investigator
First posted
Sep 2, 2022
Start date
Sep 1, 2022
Primary completion
Dec 2, 2022
Completion
Dec 29, 2022
Last update
Jan 17, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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