NCT02619721

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
7

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Oct 2015

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

October 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

October 11, 2016

Status Verified

March 1, 2016

Enrollment Period

2.1 years

First QC Date

November 30, 2015

Last Update Submit

October 8, 2016

Conditions

Refractory Overactive Bladder

Keywords

PINS SNS OAB

Outcome Measures

Primary Outcomes (1)

  • Changes in voiding frequency from baseline to the voiding frequency evaluvation period 6 month

    6 month of stimulation

Study Arms (2)

Sacral Neuromodulation is on

EXPERIMENTAL

Sacral Neuromodulation is on as soon as implantation

Device: PINS SNS

Sacral Neuromodulation is off

PLACEBO COMPARATOR

Sacral Neuromodulation is off after implantation

Device: PINS SNS

Interventions

PINS SNSDEVICE
Sacral Neuromodulation is offSacral Neuromodulation is on

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Hospital

Beijing, Beijing Municipality, 100050, China

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

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

Study Design

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

Study Record Dates

First Submitted

November 30, 2015

First Posted

December 2, 2015

Study Start

October 1, 2015

Primary Completion

November 1, 2017

Study Completion

February 1, 2018

Last Updated

October 11, 2016

Record last verified: 2016-03

Locations

CN(1)