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The safety and efficacy of a micro radiofrequency therapy system in the treatment of overactive bladders: the protocol and methodology for a multi-center, controlled clinical trial

The safety and efficacy of a micro radiofrequency therapy system in the treatment of overactive bladders: the protocol and methodology for a multi-center, controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050096
Enrollment
Unknown
Registered
2021-08-16
Start date
2019-04-01
Completion date
Unknown
Last updated
2022-04-25

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

Conditions

Overactive bladder (OAB)

Interventions

experiment:uRF energy is "on"
controll:uRF energy is "off"

Sponsors

Zhejiang Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
19 Years to 72 Years

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years old; 2. Patients who meet the refractory OAB diagnostic criteria; 3. Normal upper urinary tract function, with a bladder capacity > 100ML 4. Patients who are not stable or have used OAB drugs or other therapies; 5. Voluntary participate in this test and sign written informed consent; 6. Ability to communicate well with the researchers and be willing to follow the entire test requirements.

Exclusion criteria

Exclusion criteria: 1. Pregnant and breastfeeding women; 2. Patients with secondary OAB symptoms such as urinary tract obstruction; 3. Combined with infected persons with no controlled urinary system within 1 week; 4. Kidney insufficiency and blood creatinine greater than 1.5 times the normal value; 5. Patients with surgical contraindications; 6. Any neurostimulator, pacemaker, implanted defibrillator has been implanted in the body; 7. There are malignant tumors and other serious accompanying diseases that seriously affect health; 8. Those who have received botulinum toxin treatment in nearly 12 months; 9. Those who are allergic to latex materials; 10. There are other accompanying diseases affecting the trial / surgical efficacy; 11. Those who have attended other clinical trials within 3 months before the trial; 12. Other circumstances that the researcher found not unsuitable for the study.

Design outcomes

Primary

MeasureTime frame
Treatment success rate;

Secondary

MeasureTime frame
mean volume per micturition per 24 hours;Quality of-life score;

Countries

China

Contacts

Public ContactZhihui Xu

Zhejiang Provincial People's Hospital

jhtotal@163.com+86 13757179772

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 12, 2026