NCT02946723

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2017

Typical duration for phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 27, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

Enrollment Period

1.5 years

First QC Date

October 25, 2016

Last Update Submit

October 25, 2016

Conditions

Refractory Overactive Bladder

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • 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

  • 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

Study Arms (2)

US group

EXPERIMENTAL

lead implantation surgery for SNM using ultrasound guided technique

Procedure: ultrasound

X-ray group

SHAM COMPARATOR

lead implantation surgery for SNM using X-ray guided technique

Procedure: X-ray

Interventions

ultrasoundPROCEDURE

Lead implantation surgery for SNM using ultrasound guided technique

US group
X-rayPROCEDURE

Lead implantation surgery for SNM using X-ray technique

X-ray group

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 16 years;
  • Subjects suitable for SNM surgery;
  • Normal upper urinary tract function;
  • Bladder volume \> 100 mL;
  • Good compliance and able to complete the follow-up assessments.

You may not qualify if:

  • Psychiatric or neurologic disabilities on neurologic evaluation such as multiple sclerosis, spinal cord injury, epilepsy, Parkinson's disease, stroke;
  • Bladder lithiasis or tumor (cystoscopy or ultrasonography);
  • Stress urinary incontinence;
  • Bladder outlet obstruction;
  • Diuresis \> 3 liters per 24 hours;
  • Negative at the test period or previous treatment with SNM;
  • Pregnancy and plan to be pregnancy in 2 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

High-Energy Shock WavesX-Rays

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical PhenomenaElectromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaRadiation, Ionizing

Central Study Contacts

Fumin Jia, PhD

CONTACT

010-59361265pins_medical@163.con

Luming Li

CONTACT

010-60736388

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2016

First Posted

October 27, 2016

Study Start

February 1, 2017

Primary Completion

August 1, 2018

Study Completion

February 1, 2019

Last Updated

October 27, 2016

Record last verified: 2016-10