Clinical trial NCT06354244: Electroacupuncture of Different Treatment Frequency in Chronic Urinary Retention Caused by Lower Motor Neuron Lesions
Official title: Effects of Electroacupuncture of Different Treatment Frequency in Chronic Urinary Retention Caused by Lower Motor Neuron Lesions: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urinary Retention
Lower Motor Neurone Lesion
Keywords: electroacupuncture
chronic urinary retention
cohort study
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: There are a group of patients with nerve lesions presenting with chronic urinary retention, having to rely on life-long catheterization to empty the bladder. However, complications of catheterization including recurrent urinary tract infection and urethral stricture formation, negatively impact on patients' daily life and bring heavy burden on family and society, together making it a less ideal option.

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


Eligibility criteria: 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.

Primary outcomes:
measure: The response rate.
timeFrame: Week 12.
Secondary outcomes:
measure: The response rate.
timeFrame: Week 4, Week 8 and Week 24.
measure: The change in post void residuals (PVR) from baseline.
timeFrame: Week 4, Week 8,Week 12 and Week 24.
measure: The change in the proportion of patients reporting severe urinating difficulty from baseline.
timeFrame: Week 4, Week 8,Week 12 and Week 24.
measure: The change in the proportion of patients having stool retention from baseline.
timeFrame: Week 4, Week 8,Week 12 and Week 24.
measure: The change in the proportion of patients requiring catheterization from baseline.
timeFrame: Week 4, Week 8,Week 12 and Week 24.
measure: The proportion of patients reporting much better or moderately better regarding the Patient Global Impression of Improvement (PGI-I).
timeFrame: Week 4, Week 8,Week 12 and Week 24.
measure: The proportion of patients having recurrent symptomatic UTI, hydroureter, or hydronephrosis.
timeFrame: Week 4, Week 8,Week 12 and Week 24.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Study officials:
References: