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Prospective multicenter study of long-term efficacy and safety of the rechargeable sacral neuromodulation system

A Multicenter Postoperative Clinical Follow-up Study on the Long-term Efficacy and Safety of Rechargeable Implantable Sacral Nerve Stimulation Pulse Generators After Market Launch

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400084621
Enrollment
Unknown
Registered
2024-05-21
Start date
2023-03-17
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

chronic pelvic pain syndrome,Overactive Bladder

Interventions

Test Group:None

Sponsors

Beijing Tsinghua Changgung Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Age =18 years old; 2) Chronic pelvic pain (including but not limited to chronic prostatitis, chronic pelvic pain syndrome, bladder pain syndrome, perineal pain and other clinically unexplained chronic pelvic or echo pain) 3) There are symptoms of overactive bladder (such as urge incontinence, frequent urination, urgent urination, etc.); 4) Rechargeable implantable sacral nerve stimulator (Model: G134R) has been implanted; 5) Voluntarily participate in clinical research, and can sign informed consent; 6) Ability to communicate well with researchers and willingness to comply with overall research requirements.

Exclusion criteria

Exclusion criteria: 1) Pregnant and lactating women; 2) Combined with uncontrolled urinary tract infection, urinary tract obstruction, urinary tract tumor; 3) Mental illness can not cooperate with the doctor; 4) Participants who participated in other clinical trials within 3 months before the trial; 5) Other conditions in which the investigator considers it inappropriate to participate in the study.

Design outcomes

Primary

MeasureTime frame
Improvement rate of pain level ;

Secondary

MeasureTime frame
voiding diary; pain level ;the pain urgency and frequency questionnaire;visual analogue scale;quality of life;Medication related to urination dysfunction or pain treatment;

Countries

China

Contacts

Public ContactLu Guijun

Beijing Tsinghua Changgung Hospital

njja02989@btch.edu.cn+86 189 3118 5818

Outcome results

None listed

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