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Effect of photoelectric navigation technology in sacral neuromodulation (SNM) and pudendal neuromodulation (PNM) and its application in the improvement of lower urinary tract symptoms: a prospective, single-center, randomized controlled design clinical study

Assessment of the Application of Photonic Navigation Technology in Precise Puncture for Sacral Neuromodulation (SNM)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098093
Enrollment
Unknown
Registered
2025-03-03
Start date
2025-03-09
Completion date
Unknown
Last updated
2025-03-10

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

Conditions

Voiding dysfunction

Interventions

Observation group:Surgical instruments
Control group:Sacral nerve puncture with traditional X-ray fluoroscopy

Sponsors

Shanghai Pudong Gongli Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Indications recommended or expanded by the Chinese expert consensus on the clinical application of sacral neuromodulation, including refractory overactive bladder, non-obstructive urinary retention, fecal incontinence, neurogenic lower urinary tract dysfunction, interstitial cystitis, etc. (2) Patients aged 18-80 years. (3) No obvious limb, spine and pelvic deformities. (4) At the same time, the pelvic CT scan and lower abdominal MRI examination were completed to ensure that the image quality met the requirements of the navigation system. (5) Willing to participate in this study.

Exclusion criteria

Exclusion criteria: (1) Progressive neurological lesions, complete paraplegia. (2) Patients who have metal implants in their bodies and cannot undergo MRI examinations. (3) The CT and MRI images are blurry, and the image quality cannot meet the needs of reconstruction and analysis. (4) Broken and infected skin of the buttocks, which may affect postoperative recovery or increase the risk of complications. (5) Uncontrolled severe urinary tract infection: severe damage to the upper urinary tract (severe vesicoureteral reflux, severe hydronephrosis). (6) Low compliance bladder, bladder outlet obstruction, bladder contracture and other conditions that affect the effect and safety of surgery.

Design outcomes

Primary

MeasureTime frame
Puncture needle insertion attempts;Intraoperative neuromodulation test time;Threshold voltage;Phase II conversion rate;

Secondary

MeasureTime frame
Postoperative complications;

Countries

China

Contacts

Public ContactLv Jianwei

Shanghai Pudong Gongli Hospital

ljwass@126.com+86 138 1669 4688

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 6, 2026