Clinical trial NCT02731417: Acupuncture Treatment for Post-partum Urinary Retention
Official title: Acupuncture Treatment for Post-partum Urinary Retention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Retention
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2016-04-07
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: urine residual volume following acupuncture
timeFrame: one hour following acupuncture
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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