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Clinical study on 3D technology-assisted implantation of stimulation electrode in sacral neuromodulation

Clinical study on 3D technology-assisted implantation of stimulation electrode in sacral neuromodulation

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039471
Enrollment
Unknown
Registered
2020-10-28
Start date
2021-01-01
Completion date
Unknown
Last updated
2021-02-01

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

Conditions

sacral neuromodulation

Interventions

Group of mixed reality:holographic image
control group:X-ray localization
Group of 3D printing positioning guide plate:3D printing positioning guide plate

Sponsors

The Second Hospital of Tianjin Medical Univerity
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients with an age range of between 18 and 75 years, male or female; (2) Patients with hyperactivity of bladder, non-obstructive urinary retention, pelvic pain or painful bladder syndrome; (3) Patients volunteered to take part in this clinical trial, and signed informed consent form.

Exclusion criteria

Exclusion criteria: (1) Pregnant women; (2) Body mass index (BMI) greater than 35; (3) Without indications for the operation; (4) With serious system disease in heart, liver,etc. (5) With chronic diseases combined hypertension,diabetes,or coronary heart disease; (6) With poor compliance; (7) Evaluated as being not suitable for this clinical trial; (8) Participated in other clinical trials within a month; (9) Allergic constitution.

Design outcomes

Primary

MeasureTime frame
Times of needle puncturee;Intraoperative control test time;

Secondary

MeasureTime frame
Puncture success time;score of patient's satisfaction;Phase II conversion rate (%);

Countries

China

Contacts

Public ContactLi Wei

The Second Hospital of Tianjin Medical University

lwyx1987@163.com+86 13752528087

Outcome results

None listed

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