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Overactive bladder(OAB,Urgency) was determined by International Continence Society as Urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of urinary tract infection (UTI) or other obvious pathology.The SNM treatment involves a two-stage surgical procedure performed under local anesthesia. The device include IPG (implantable programme generator) and lead. In the initial test phase, 1st stage, electrode is placed near the sacral nerve and requires a 2 weeks assessment. This allows your doctors and you to assess your initial response according to your voiding dairy and satisfaction. In 2nd stage, SNM procedure is implantation of the IPG.
X ray guidance is harmful to both patients and doctors, while ultrasound guidance is real time visual guidance ,easy to operate by doctors and a radiation free option to challenge anatomy. Urologists are skilled in both ultrasound operations and anatomy basics and dedicating to developing better guidance technique in surgery.
The study here compare the efficacy and safety of ultrasound versus X ray guidance technique in SNM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| US group | Experimental | lead implantation surgery for SNM using ultrasound guided technique |
|
| X-ray group | Sham Comparator | lead implantation surgery for SNM using X-ray guided technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ultrasound | Procedure | Lead implantation surgery for SNM using ultrasound guided technique |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Successful rate | Successful rate is the percentage of patients who experienced a successful result (≥50% improvements in baseline symptoms ) as recorded in voiding dairies. | 6 months post -IPG implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse effect | During operation, 2 weeks post-lead implantation, 3 and 6 months post -IPG implantation | |
| Guidance technique performance time | From beginning operation until successful lead placement is completed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fumin Jia, PhD | Contact | 010-59361265 | pins_medical@163.con | |
| Luming Li | Contact | 010-60736388 |
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| X-ray |
| Procedure |
Lead implantation surgery for SNM using X-ray technique |
|
| Times of X-ray radiation | During operation |
| Overactive bladder symptom score (OABSS) | pre-operation baseline, 2 weeks post-lead implantation, 3 and 6 months post -IPG implantation |
| Quality of Life (QoL) scores | pre-operation baseline, 2 weeks post-lead implantation, 3 and 6 months post -IPG implantation |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019220 | High-Energy Shock Waves |
| D014965 | X-Rays |
| ID | Term |
|---|---|
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
| D055585 | Physical Phenomena |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D011839 | Radiation, Ionizing |
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