Clinical Trial of Sacral Neuromodulation for Treatment of Refractory Overactive Bladder (OAB)

Refractory Overactive Bladder Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02619721
• Other study ID #: PINS-016
• Status: Active, not recruiting
• Phase: Phase 0
• First received: November 30, 2015
• Last updated: October 8, 2016
• Start date: October 2015
• Est. completion date: February 2018

Study information

• Verified date: March 2016
• Source: Beijing Pins Medical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Evaluate the long-term clinical effectiveness and safety of the PINS Sacral Neuromodulation to patients with refractory Overactive Bladder.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 7
• Est. completion date: February 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Age greater than 16 years OAB and/or OAB symptoms Refractory to standard medical therapy 100ml bladder capacity with normal upper urinary tract Good surgical candidate Able to complete study documentation and return for followup evaluation

Exclusion Criteria:

• Neurological conditions Stress urinary incontinence OAB symptoms caused by urinary tract infections

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Refractory Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Device:
• PINS SNS

Locations

Country	Name	City	State
China	Beijing Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Pins Medical Co., Ltd	Beijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in voiding frequency from baseline to the voiding frequency evaluvation period 6 month		6 month of stimulation	No