Urinary RetentionNCT05526651
Improvement of Urinary Retention Symptoms With Electroacupuncture Therapy
A study testing true electroacupuncture in people with Urinary Retention, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Retention
- What is being tested?
- true electroacupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Sep 2022to 29 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Urinary Retention
- Being tested
- true electroacupuncture, sham electroacupuncture
- Keywords
- Urinary Retention, Postpartum urinary retention, electroacupuncture, vaginal delivery, acupuncture
- Medical subject headings
- Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
true electroacupunctureOther
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 electroacupunctureOther
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
| Study group | Role | What they receive |
|---|---|---|
| True electroacupuncture group | Experimental | 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 Receives: Other: true electroacupuncture |
| sham electroacupuncture group | Sham comparator | 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 Receives: Other: sham electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start1 Sep 2022
- Primary completion2 Dec 2022
- Study completion29 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary RetentionStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study divided into 2 arms, true electroacupuncture group and sham electroacupuncture group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. Ayu Permata Sari, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05526651
- Sponsor's protocol ID
- 22-08-0889
- Status last verified
- Jan 2024
- First submitted
- 28 Aug 2022
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Urinary Retention Symptoms After Vaginal Delivery With Electroacupuncture Therapy
- ClinicalTrials.gov ID
- NCT05526651
- Acronym / sponsor ID
- 22-08-0889
- Conditions
- Urinary Retention
- Keywords
- Urinary Retention, Postpartum urinary retention, electroacupuncture, vaginal delivery, acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 2 Dec 2022 (actual)
- Study completion
- 29 Dec 2022 (actual)
- First posted
- 2 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Study divided into 2 arms, true electroacupuncture group and sham electroacupuncture group
| Arm | Type | Receives |
|---|---|---|
| True electroacupuncture group | Experimental | Other: true electroacupuncturethe 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 electroacupuncture group | Sham comparator | Other: sham electroacupuncturethe 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 |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| true electroacupuncturethe 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 group |
| sham electroacupuncturethe 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 group |
Primary outcome
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
1 secondary outcome
first time micturation
Time frame: 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Individual participant dataSharing planned: Undecided
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Postpartum Urinary Retention
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Pelvic Health Electrically Evoked Recording (PEER) 2 Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing true electroacupuncture in people with Urinary Retention, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
residual urine volume after electroacupuncture therapy and catheter removal (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.