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A double-blinded randomized multicentre study to investigate the effect and safe of remote programming and variable frenquency stimulation on sacral neuromodulation for overactive bladder

A double-blinded randomized multicentre study to investigate the effect and safe of remote programming and variable frenquency stimulation on sacral neuromodulation for overactive bladder

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036677
Enrollment
Unknown
Registered
2020-08-24
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-09-21

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

Conditions

Refractory overactive bladder

Interventions

Constant frequency stimulation group:Constant frequency stimulation
Variable frequency stimulation group:Variable frequency stimulation
remote programming group:remote programming
Conventional programming group:Conventional programming

Sponsors

Beijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients aged >= 18 years; 2. Patients with overactive bladder (OAB) symptoms, such as urgent urinary incontinence, frequent urination and urgency, who have been implanted with sacral nerve stimulation system; 3. The patients who agreed not to increase or decrease the drugs related to lower urinary tract symptoms and pelvic function during the trial; 4. Patients who voluntarily participate in clinical trials and can sign informed consent form; 5. Subjects who can communicate well with researchers and are willing to comply with the requirements of the whole experiment.

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating women; 2. Patients with uncontrolled urinary tract infection, urinary tract obstruction and urinary tract tumor; 3. Patients with mental disorders who cannot cooperate with doctors; 4. Patients with non urinary malignancies and other concomitant diseases that seriously affect their health; 5. Patients who have received botulinum toxin treatment in the past 12 months; 6. Patients with severe pelvic organ prolapse; 7. Patients who have participated in other clinical trials 3 months before the trial; 8. Other situations in which the researcher considers it inappropriate to participate in the study.

Design outcomes

Primary

MeasureTime frame
Therapeutic efficiency;

Secondary

MeasureTime frame
OABSS;QOL;VAS scores;satisfaction;

Countries

China

Contacts

Public ContactYaoguang Zhang

Beijing Hospital

bjyyec@126.com+86 10-85136272

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 16, 2026