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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
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Urinary Retention

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

    First Posted
    March 6, 2016
    Last Updated
    April 6, 2016
    Sponsor
    Rambam Health Care Campus
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    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

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    Acupuncture Treatment for Post-partum Urinary Retention

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