Urinary RetentionNCT02731417
Acupuncture Treatment for Post-partum Urinary Retention
A study testing acupuncture and Foley catheter in people with Urinary Retention, run by Rambam Health Care Campus.
Trial summary
There are no set national guidelines for the management of postpartum bladder. There is little evidence on the management of postpartum urinary retention and many hospitals have implemented their own postpartum bladder care protocols. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Retention
- What is being tested?
- acupuncture and Foley catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Apr 2018
- 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with postpartum urinary retention with either difficulty having voluntary micturition or a post-void residual (PVR) urine volume greater than 100 ml. confirmed by ultrasonography.
Who cannot join
- Patients with dermatitis over the acupuncture points,
- active urinary tract infection, prior use of anti-cholinergic drugs, cholinergic drugs, and alpha blockers.
About this study
There are no set national guidelines for the management of postpartum bladder. There is little evidence on the management of postpartum urinary retention and many hospitals have implemented their own postpartum bladder care protocols.
Acupuncture has been implemented as an alternative course of treatment for urinary retention with reports of spontaneous restoring of micturition in all of the patients. The investigators aimed at examining if acupuncture is a useful tool to treat postpartum urinary retention.
Read the detailed description
Urinary retention is a common and frustrating complication in women during the immediate postpartum period. Physiologic changes in the bladder that occur during pregnancy predispose patients to develop symptomatic retention of urine during the first hours to days after delivery.
Postpartum urinary retention has a reported incidence ranging from 1.7 to 17.9 percent. Up to 5% of these women may have significant and longer lasting dysfunction, which if not recognised in the early peripartum period, may lead to bladder distension and overflow incontinence with significant long-term bladder dysfunction. Factors associated with postpartum urinary retention include: (1)Nulliparous women. (2) Prolonged labour, especially a prolonged second stage. (3)Assisted/instrumental delivery. (4)Perineal injury. (5)Caesarean section. (6)Regional analgesia.
Treatment begins with supportive measures to enhance the likelihood of micturition, such as ambulation, privacy, and a warm bath. If these measures are not successful, catheterization is usually performed.
There are no set national guidelines for the management of postpartum bladder care as yet. There is little evidence on the management of postpartum urinary retention and many hospitals have implemented their own postpartum bladder care protocols.
Acupuncture has been implemented as an alternative course of treatment for urinary retention in several chinese medical centers over the years with reports of spontaneous restoring of micturition in all of the patients.
A prospective study including all patients with postpartum urinary retention meeting the study criteria will be recruited. All patients will be required to give their informed consent. All patients will undergo a pre-treatment and post-treatment ultrasound recording the residual urine volume.
After the pre-treatment ultrasound acupuncture will be performed according to the following: 1) The points Sanyinjiao (SP 6) and Zusanli (ST 36) on the right side will be punctured 1/5-2 cm deep and moderate stimulation will be applied. 2) The needles will be retained for 30 minutes after achieving Qi and will be manipulated once every 3-5 minutes. After 30 minutes of acupuncture treatment, the patient will have an opportunity to void. If the patient is successful in voiding a post-treatment ultrasound recording the residual urine volume will be performed. If the post-void residual (PVR) urine volume is less than 100 ml acupuncture treatment will be considered a success. If the patient is not successful at voiding during the hour after acupuncture treatment, a post-treatment ultrasound recording the residual urine volume will be performed. If the post-void residual (PVR) urine volume is greater than 100 ml, acupuncture treatment will be considered a failure and the patient will be catheterized.
- Conditions
- Urinary Retention
- Being tested
- acupuncture, Foley catheter
- Medical subject headings
- Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureOther
Acupuncture for women with post partum urinary retention
Foley catheterDevice
Foley catheter insertion for women with post partum urinary retention.
| Study group | Role | What they receive |
|---|---|---|
| Urinary retention-group 1 | Experimental | For women with post partum urinary retention designated for experimental treatment. Receives: Other: acupuncture |
| Urinary retention-group 2 | Active comparator | For women with post partum urinary retention designated for current departmental protocol treatment. Receives: Device: Foley catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
urine residual volume following acupuncture
If micturition is achieved within one hour of acupuncture - residual urine volume in bladder is measured by ultrasound (ml).
Measured: one hour following acupuncture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2018 (estimated)
- Study completionApr 2018 (estimated)
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.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, wamir, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02731417
- Sponsor's protocol ID
- 0590-15
- Status last verified
- Apr 2016
- First submitted
- 6 Mar 2016
- Last updated
- 7 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture Treatment for Post-partum Urinary Retention
- ClinicalTrials.gov ID
- NCT02731417
- Acronym / sponsor ID
- 0590-15
- Conditions
- Urinary Retention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 7 Apr 2016 (estimated)
- 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.
There are no set national guidelines for the management of postpartum bladder. There is little evidence on the management of postpartum urinary retention and many hospitals have implemented their own postpartum bladder care protocols.
Acupuncture has been implemented as an alternative course of treatment for urinary retention with reports of spontaneous restoring of micturition in all of the patients. The investigators aimed at examining if acupuncture is a useful tool to treat postpartum urinary retention.
Detailed description
Urinary retention is a common and frustrating complication in women during the immediate postpartum period. Physiologic changes in the bladder that occur during pregnancy predispose patients to develop symptomatic retention of urine during the first hours to days after delivery.
Postpartum urinary retention has a reported incidence ranging from 1.7 to 17.9 percent. Up to 5% of these women may have significant and longer lasting dysfunction, which if not recognised in the early peripartum period, may lead to bladder distension and overflow incontinence with significant long-term bladder dysfunction. Factors associated with postpartum urinary retention include: (1)Nulliparous women. (2) Prolonged labour, especially a prolonged second stage. (3)Assisted/instrumental delivery. (4)Perineal injury. (5)Caesarean section. (6)Regional analgesia.
Treatment begins with supportive measures to enhance the likelihood of micturition, such as ambulation, privacy, and a warm bath. If these measures are not successful, catheterization is usually performed.
There are no set national guidelines for the management of postpartum bladder care as yet. There is little evidence on the management of postpartum urinary retention and many hospitals have implemented their own postpartum bladder care protocols.
Acupuncture has been implemented as an alternative course of treatment for urinary retention in several chinese medical centers over the years with reports of spontaneous restoring of micturition in all of the patients.
A prospective study including all patients with postpartum urinary retention meeting the study criteria will be recruited. All patients will be required to give their informed consent. All patients will undergo a pre-treatment and post-treatment ultrasound recording the residual urine volume.
After the pre-treatment ultrasound acupuncture will be performed according to the following: 1) The points Sanyinjiao (SP 6) and Zusanli (ST 36) on the right side will be punctured 1/5-2 cm deep and moderate stimulation will be applied. 2) The needles will be retained for 30 minutes after achieving Qi and will be manipulated once every 3-5 minutes. After 30 minutes of acupuncture treatment, the patient will have an opportunity to void. If the patient is successful in voiding a post-treatment ultrasound recording the residual urine volume will be performed. If the post-void residual (PVR) urine volume is less than 100 ml acupuncture treatment will be considered a success. If the patient is not successful at voiding during the hour after acupuncture treatment, a post-treatment ultrasound recording the residual urine volume will be performed. If the post-void residual (PVR) urine volume is greater than 100 ml, acupuncture treatment will be considered a failure and the patient will be catheterized.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urinary retention-group 1 | Experimental | Other: acupunctureFor women with post partum urinary retention designated for experimental treatment. |
| Urinary retention-group 2 | Active comparator | Device: Foley catheterFor women with post partum urinary retention designated for current departmental protocol treatment. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with postpartum urinary retention with either difficulty having voluntary micturition or a post-void residual (PVR) urine volume greater than 100 ml. confirmed by ultrasonography.
Key exclusion criteria (2 listed)
- Patients with dermatitis over the acupuncture points,
- active urinary tract infection, prior use of anti-cholinergic drugs, cholinergic drugs, and alpha blockers.
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 |
|---|---|---|
| acupunctureAcupuncture for women with post partum urinary retention | Other | Urinary retention-group 1 |
| Foley catheterFoley catheter insertion for women with post partum urinary retention. | Device | Urinary retention-group 2 |
Primary outcome
urine residual volume following acupuncture
Time frame: one hour following acupuncture
If micturition is achieved within one hour of acupuncture - residual urine volume in bladder is measured by ultrasound (ml).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2016.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture and Foley catheter in people with Urinary Retention, run by Rambam Health Care Campus.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 7 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
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?
urine residual volume following acupuncture (time frame: one hour following acupuncture). 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 7 Apr 2016.