This trial is active, not recruiting.

Condition refractory overactive bladder
Treatment pins sns
Phase phase 0
Sponsor Beijing Pins Medical Co., Ltd
Collaborator Beijing Hospital
Start date October 2015
End date November 2017
Trial size 7 participants
Trial identifier NCT02619721, PINS-016


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Sacral Neuromodulation is on as soon as implantation
pins sns
(Placebo Comparator)
Sacral Neuromodulation is off after implantation
pins sns

Primary Outcomes

Changes in voiding frequency from baseline to the voiding frequency evaluvation period 6 month
time frame: 6 month of stimulation

Eligibility Criteria

Male or female participants at least 16 years old.

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

Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Beijing Pins Medical Co., Ltd.