Acupuncture Treatment for Post-partum Urinary Retention

Urinary Retention Clinical Trial

Official title:

Acupuncture Treatment for Post-partum Urinary Retention

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02731417
• Other study ID #: 0590-15
• Status: Not yet recruiting
• Phase: N/A
• First received: March 6, 2016
• Last updated: April 6, 2016
• Start date: April 2016
• Est. completion date: April 2018

Study information

• Verified date: April 2016
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Urinary Retention

Intervention

Other:
• acupuncture
Acupuncture for women with post partum urinary retention

Device:
• Foley catheter
Foley catheter insertion for women with post partum urinary retention.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	urine residual volume following acupuncture	If micturition is achieved within one hour of acupuncture - residual urine volume in bladder is measured by ultrasound (ml).	one hour following acupuncture	No