NCT03239951

Brief Summary

Subjects with AUR secondary to BPO that comply with Inclusion/Exclusion Criteria. A total of 50 eligible subjects will be recruited into the study to receive treatment with iTind system. Study duration will be 12 months post implantation, with follow-up extension of up to 3 years. Extension of follow up period will not require an additional ICF.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
terminated

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

July 25, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 4, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

February 27, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

July 22, 2020

Status Verified

July 1, 2020

Enrollment Period

1.9 years

First QC Date

July 25, 2017

Last Update Submit

July 19, 2020

Conditions

BPH

Outcome Measures

Primary Outcomes (1)

  • Ability to void without catheter

    TWOC Success Rate, defined as the proportion (%) of subjects successfully undergoing the TWOC assessment at the later of visit 3 or visit 4.

    2 weeks

Study Arms (1)

Device

EXPERIMENTAL

Temporary implant (iTind)

Device: iTind

Interventions

iTindDEVICE

temporary implant

Device

Eligibility Criteria

Age40 Years - 90 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male with AUR secondary to BPO
  • Age ≥40 years
  • Acute urinary retention with at least one failed trial without catheter (TWOC) while on alpha blocker
  • Ability to sign an informed consent form
  • Prostate volume \<80 ml
  • Life expectancy \>1 year.

You may not qualify if:

  • Suspected malignant disease of the lower urinary tract including prostate or bladder cancer
  • Chronic retention of urine with history of either retention volume greater than one liter or upper tract obstruction
  • Known neurogenic bladder
  • Immunosuppression
  • Suspected urethral strictures, bladder neck contracture, Urinary bladder stones
  • An obstructive or protruding median lobe of the prostate
  • An active symptomatic urinary tract infection
  • Enrolled in another treatment trial for any disease
  • Previous pelvic irradiation or radical pelvic surgery
  • Any previous prostate surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Firmly Park Hospital

Frimley, United Kingdom

Location

King's college

London, SE1 9RT, United Kingdom

Location

Norwich University Hospital

Norwich, United Kingdom

Location

Study Officials

  • Gordon Muir, MD

    King's College Hospital NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2017

First Posted

August 4, 2017

Study Start

February 27, 2018

Primary Completion

January 20, 2020

Study Completion

March 31, 2020

Last Updated

July 22, 2020

Record last verified: 2020-07

Locations

GB(3)