Optimized Acupuncture Treatment for Female Stress Urinary Incontinence

NCT05635669 · tracked via the Priya Life Science China tracker

Sponsor

Yin Ping

Phase

Not applicable

Started

2023-01-04

Last updated

2025-05-22

Condition(s) studied

Stress Urinary Incontinence

Investigational drug(s) / intervention(s)

Sacral acupoints acupunctureAbdominal acupoints acupunctureAlternating acupoints acupuncture

Sacral acupoints acupuncture: Before treatment, the participants will be asked to go to the toilet. All treatments will be performed after skin disinfection. As acupuncture needles are inserted, all points will be lifted, twisted, and stabbed to activate the sensation of de qi. The electroacupuncture stimulation lasted for 30 minutes with a continuous wave of 50 Hz and a current intensity of 1 to 5 mA (preferably with the skin around the acupoints shivering mildly without pain). Participants will receive three treatments per week (every other day), each lasting 30 minutes, for a total of 18 sessions over the course of 6 weeks. The follow-up sessions are on week 18, 30, 42 and 54. In this group, paired electrodes from the electroacupuncture apparatus were attached transversely to the needle handles at bilateral Huiyang(BL35) and Zhongliao(BL33) .

Abdominal acupoints acupuncture: Before treatment, the participants will be asked to go to the toilet. All treatments will be performed after skin disinfection. As acupuncture needles are inserted, all points will be lifted, twisted, and stabbed to activate the sensation of de qi. The electroacupuncture stimulation lasted for 30 minutes with a continuous wave of 50 Hz and a current intensity of 1 to 5 mA (preferably with the skin around the acupoints shivering mildly without pain). Participants will receive three treatments per week (every other day), each lasting 30 minutes, for a total of 18 sessions over the course of 6 weeks. The follow-up sessions are on week 18, 30, 42 and 54. In this group, paired electrodes from the electroacupuncture apparatus were attached to the needle handles respectively at Zhongji(RN3) and one side of Dahe(KI12), as well as Guanyuan(RN4) and another side of Dahe(KI12).

Alternating acupoints acupuncture: Before treatment, the participants will be asked to go to the toilet. All treatments will be performed after skin disinfection. As acupuncture needles are inserted, all points will be lifted, twisted, and stabbed to activate the sensation of de qi. The electroacupuncture stimulation lasted for 30 minutes with a continuous wave of 50 Hz and a current intensity of 1 to 5 mA (preferably with the skin around the acupoints shivering mildly without pain). Participants will receive three treatments per week (every other day), each lasting 30 minutes, for a total of 18 sessions over the course of 6 weeks. The follow-up sessions are on week 18, 30, 42 and 54. The application of electroacupuncture is the same as Sacral group and Abdominal group.

Study summary

This multicenter randomized controlled trial is designed to explore a relatively suitable application of acupoint combinations and to provide certain clinical evidence for the optimization of acupuncture treatment of female SUI.

Eligibility

Sex

FEMALE

Min age

40 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: * Patients with mild to moderate SUI mentioned in the diagnostic criteria above; * Aged 40～75 years; * Sign the informed consent. Exclusion Criteria: * Other types of urinary incontinence (urgent, overflow or mixed). * History of urinary incontinence surgery or pelvic floor surgery; * Pelvic organ prolapse ≥ stage II; * Symptomatic urinary tract infection; * Residual urine volume \> 30 mL; * Maximum urinary flow rate \< 20ml/s. * Limitation of movement (walk and/or run and/or climb stairs); * Patients who have been using drugs that may affect bladder function or receiving SUI specialized treatment; * Severe cardiovascular, cerebral, liver, kidney and hematopoietic system disease, mental disorders, diabetes, multiple system atrophy, cauda equina neuropathy and spinal cord disease; * Pregnancy or lactation period. * With cardiac pacemaker, acupuncture phobia or metal allergies;

Primary outcome measure(s)

The change of urine leakage measured by the 1-hour pad test — Week 6
Quantity of fluid loss will be measured by 1-hour pad test, compared with the baseline (week 0).

Trial sites (1)

Facility	City	Region	Status
Longhua Hospital Shanghai University of Traditional Chinese Medicine	Shanghai	China	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05635669 on ClinicalTrials.gov ↗ ← All trials in China