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A prospective randomized controlled clinical trial of transcutaneous electrical nerve stimulation combined with mirabegron in the treatment of overactive bladder

A prospective randomized controlled clinical trial of transcutaneous electrical nerve stimulation combined with mirabegron in the treatment of overactive bladder

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080528
Enrollment
Unknown
Registered
2024-01-31
Start date
2023-02-05
Completion date
Unknown
Last updated
2024-02-05

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

Conditions

overactive bladder

Interventions

TENS plus mirabegron group:TENS combined with mirabegron (Astellas) 50mg, once a day was given. Two skin-adhesive electrodes were attached to the skin according to the plan of placing the negative el
fake TENS plus mirabegron group:Mirabegron (Astellas) 50mg once daily combined with sham TENS for 30 min was given. The stimulation amplitude was set to 0 using the same TENS setup, electrode position

Sponsors

The General Hospital of Chongqing Steel Company
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Female patients, aged 18-75 years, met the diagnostic criteria of OAB in the Chinese Guidelines for the diagnosis and treatment of Urological diseases, and did not take OAB drugs, drugs affecting urination, or other treatment within 2 weeks.

Exclusion criteria

Exclusion criteria: (1) routine urine and urine culture suggesting acute and chronic urinary tract infection; (2) ultrasonography and CT suggesting urinary calculi and tumors; (3) urodynamics suggesting bladder outlet obstruction; (4) neurogenic bladder; (5) severe liver and kidney dysfunction and cardiopulmonary dysfunction; (6) mental disorders and the inability to cooperate throughout the whole course of treatment; (7) allergy or contraindication to mirabegron; and (8) pacemaker installation, pregnancy or lactation.

Design outcomes

Primary

MeasureTime frame
3 day Voiding diary;

Secondary

MeasureTime frame
Overactive Bladder Symptom Score;Overactive Bladder Questionnaire short form;treatment satisfaction-visual analogue scale;

Countries

China

Contacts

Public ContactLiang Zhao

The General Hospital of Chongqing Steel Company

doudouba2020@qq.com+86 157 2304 3086

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026