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Clinical Trials/NCT06354244
NCT06354244RecruitingNot Applicable

Effects of Electroacupuncture of Different Treatment Frequency in Chronic Urinary Retention Caused by Lower Motor Neuron Lesions: a Prospective Cohort Study

Guang'anmen Hospital of China Academy of Chinese Medical Sciences1 site in 1 country100 target enrollmentStarted: April 4, 2024Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
100
Locations
1
Primary Endpoint
The response rate.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The aim of this study is to compare the effects of electroacupuncture of different frequency in patients with chronic urinary retention caused by lower motor neuron lesions

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Diagnosed with urinary retention caused by lower motor neuron lesions (e.g., sacral plexus, cauda equina, or sacral cord lesions).
  • •18 years or older.
  • •Baseline post void residuals (PVR) ≥150 mL.
  • •The course of urinary retention ≥1 month.
  • •Having normal bladder sensation.
  • •Using clean intermittent catheterization (CIC), indwelling catheterization (IC), manual assisted voiding including putting pressure on abdomen, or cystostomy catheterization.
  • •Signed informed consent and voluntary participation in the study.

Exclusion Criteria

  • •Having a lower urinary tract obstruction, such as bladder neck contracture, urethral stricture, prostatic hyperplasia, or large urinary stones that can cause obstruction.
  • •Having any type of malignant tumors not removed.
  • •Having severe systemic disorders not controlled.
  • •Having implanted electrodes of cardiac pacemaker, pudendal nerve stimulation, bladder stimulation, or SNM.
  • •Pregnancy or lactation.
  • •Eletroacupuncture treatment duration < 2 weeks.

Outcomes

Primary Outcomes

The response rate.

Time Frame: Week 12.

Responders are defined as patients whose post void residuals (PVR) reduced by 50% or more from baseline.

Secondary Outcomes

  • The response rate.(Week 4, Week 8 and Week 24.)
  • The change in the proportion of patients reporting severe urinating difficulty from baseline.(Week 4, Week 8,Week 12 and Week 24.)
  • The change in the proportion of patients having stool retention from baseline.(Week 4, Week 8,Week 12 and Week 24.)
  • The change in the proportion of patients requiring catheterization from baseline.(Week 4, Week 8,Week 12 and Week 24.)
  • The proportion of patients reporting much better or moderately better regarding the Patient Global Impression of Improvement (PGI-I).(Week 4, Week 8,Week 12 and Week 24.)
  • The change in post void residuals (PVR) from baseline.(Week 4, Week 8,Week 12 and Week 24.)
  • The proportion of patients having recurrent symptomatic UTI, hydroureter, or hydronephrosis.(Week 4, Week 8,Week 12 and Week 24.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Liu Zhishun

Principal Investigator

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study Sites (1)

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