NCT02731417

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2016

Completed
26 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 7, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

April 7, 2016

Status Verified

April 1, 2016

Enrollment Period

2 years

First QC Date

March 6, 2016

Last Update Submit

April 6, 2016

Conditions

Urinary Retention

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Urinary retention-group 1

EXPERIMENTAL

For women with post partum urinary retention designated for experimental treatment.

Other: acupuncture

Urinary retention-group 2

ACTIVE COMPARATOR

For women with post partum urinary retention designated for current departmental protocol treatment.

Device: Foley catheter

Interventions

acupunctureOTHER

Acupuncture for women with post partum urinary retention

Urinary retention-group 1
Foley catheterDEVICE

Foley catheter insertion for women with post partum urinary retention.

Urinary retention-group 2

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with dermatitis over the acupuncture points,
  • active urinary tract infection, prior use of anti-cholinergic drugs, cholinergic drugs, and alpha blockers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urinary Retention

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

March 6, 2016

First Posted

April 7, 2016

Study Start

April 1, 2016

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

April 7, 2016

Record last verified: 2016-04