Acupuncture Treatment for Post-partum Urinary Retention
Primary Purpose
Urinary Retention
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
acupuncture
Foley catheter
Sponsored by
About this trial
This is an interventional supportive care trial for Urinary Retention
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients with dermatitis over the acupuncture points,
- active urinary tract infection, prior use of anti-cholinergic drugs, cholinergic drugs, and alpha blockers.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Urinary retention-group 1
Urinary retention-group 2
Arm Description
For women with post partum urinary retention designated for experimental treatment.
For women with post partum urinary retention designated for current departmental protocol treatment.
Outcomes
Primary Outcome Measures
urine residual volume following acupuncture
If micturition is achieved within one hour of acupuncture - residual urine volume in bladder is measured by ultrasound (ml).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02731417
Brief Title
Acupuncture Treatment for Post-partum Urinary Retention
Official Title
Acupuncture Treatment for Post-partum Urinary Retention
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
April 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rambam Health Care Campus
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Retention
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Urinary retention-group 1
Arm Type
Experimental
Arm Description
For women with post partum urinary retention designated for experimental treatment.
Arm Title
Urinary retention-group 2
Arm Type
Active Comparator
Arm Description
For women with post partum urinary retention designated for current departmental protocol treatment.
Intervention Type
Other
Intervention Name(s)
acupuncture
Intervention Description
Acupuncture for women with post partum urinary retention
Intervention Type
Device
Intervention Name(s)
Foley catheter
Intervention Description
Foley catheter insertion for women with post partum urinary retention.
Primary Outcome Measure Information:
Title
urine residual volume following acupuncture
Description
If micturition is achieved within one hour of acupuncture - residual urine volume in bladder is measured by ultrasound (ml).
Time Frame
one hour following acupuncture
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Patients with dermatitis over the acupuncture points,
active urinary tract infection, prior use of anti-cholinergic drugs, cholinergic drugs, and alpha blockers.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Acupuncture Treatment for Post-partum Urinary Retention
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