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A Single-Center Clinical Trial Series on the Effectiveness and Safety of Acupuncture Robot-Assisted Human-Machine Collaborative Operation:Clinical Validation Study on Stress Urinary Incontinence

The Efficacy and Safety of Human-AcuRobot Collaborative Operation for Knee Osteoarthritis Stress Urinary Incontinence and Stroke Hemiplegia: A pilot single-centred study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001028
Enrollment
Unknown
Registered
2025-05-26
Start date
2025-06-08
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Urinary Incontinence

Interventions

Sponsors

Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosis of stress urinary incontinence (SUI) in accordance with the recommendations of the 4th International Consultation on Incontinence ICI and the standards of the International Continence Association; 2. Course of the conditions: =1 year; 3. Involuntary leakage of urine during exertion sneezing or coughing stops when stress ends; 4. Observable involuntary urine leakage associated with increased abdominal pressure or a 1-hour pad test showing a weight increase > 1 g; 5. Subjective scale of clinical symptoms (Ingelman-Sundberg grading system): mild to moderate SUI ; 6. Gender: Female; 7. Age: 40–75 years.

Exclusion criteria

Exclusion criteria: 1. Participated in other clinical trials or acupuncture treatment in the past 3 months; 2. Allergic to metals or resin materials; 3. Pregnant or breastfeeding women; 4. Other types of urinary incontinence (e.g. urge mixed overflow incontinence); 5. History of UI or pelvic surgery; 6. Pelvic organs prolapse >2nd degree; 7. Residual urinary volume (RUV) >30 mL; 8. Restrictions on walking stair climbing or running; 9. Specialized treatment for SUI in the past 3 months including SUI medications (e.g.: duloxetine) pelvic floor muscle training (PFMT) biofeedback therapy pelvic floor vaginal or anal electrical or magnetic stimulation or transcutaneous electrical nerve stimulation (TENS) of the pelvic floor or medications affecting bladder function; 10. Symptoms of urinary tract infections (e.g. frequent or intense urge to pee); 11. Severe cardiovascular cerebral liver kidney or mental illnesses diabetes multisystem atrophy cauda equina injury or spinal cord disorders.

Design outcomes

Primary

MeasureTime frame
Urine leakage amount in a 1-hour pad test;

Secondary

MeasureTime frame
Frequency of urinary incontinence episodes over 24 hours.;Incontinence Quality of Life Instrument (I-QOL) scores.;

Countries

China

Contacts

Public ContactPan Xingfang

Tianjin University of Traditional Chinese Medicine

panxingfang@163.com18649067519

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026