Skip to content

A Multicenter Randomized Controlled Trial of Intraoperative Ultrasound-Guided versus X-ray-Guided Localization during Stage 1 Sacral Neuromodulation

A Multicenter Randomized Controlled Trial of Intraoperative Ultrasound-Guided versus X-ray-Guided Localization during Stage 1 Sacral Neuromodulation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116331
Enrollment
Unknown
Registered
2026-01-08
Start date
2026-01-08
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Frequent urination, urgency, urge urinary incontinence, fecal incontinence and pelvic floor dysfunction diseases

Interventions

Group A:X-ray positioning,
Group B:Ultrasound positioning

Sponsors

Xi'an Jiaotong University Second Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Age: 18 - 75 years old, gender not restricted; 2) Confirm the diagnosis and condition. The indications for sacral nerve stimulation therapy are clear. The patient gives informed consent and undergoes the SNM surgery. 3) Voluntary participation in this clinical study. Before the start of the study, the subjects sign a written ethical and informed consent form.

Exclusion criteria

Exclusion criteria: 1) Patients with mental or cognitive impairments who cannot cooperate with SNM surgery and programming; 2) Patients who do not meet the indications for sacral nerve stimulation therapy as per the "Chinese Expert Consensus on SNM"; 3) Other situations that the researcher deems unsuitable for participation in the study, such as those who are allergic or have rejection of the implanted SNM materials.

Design outcomes

Primary

MeasureTime frame
Preoperative preparation time: The time spent on preparing surgical equipment, anesthesia methods, and routine preoperative preparations for both groups of patients at each center;Postoperative re-examination of electrode position: For both groups of patients at each center, compared with the standard sacral bone positioning reference, the measurement of the stimulation electro;Timing of localization puncture surgery: The time when both groups of patients in each center completed the determination of the S3 sacral foramen and achieved a valid response during the puncture pro;Response localization surgery time: The time for stimulating electrode insertion and release to be completed for both groups of patients in each center;

Secondary

MeasureTime frame
Patient and healthcare worker protection;

Countries

China

Contacts

Public Contactqi chen

Xi'an Jiaotong University Second Affiliated Hospital

cq168.cool@163.com+86 133 6392 0572

Outcome results

None listed

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