NCT04165408

Brief Summary

This trial is to assess the safety and clinical performance of Contino device is preventing Urinary Incontinence in male subjects with Sphincteric Incompetence

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
suspended

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

November 1, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 18, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

November 19, 2019

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

February 20, 2025

Status Verified

August 1, 2024

Enrollment Period

5.8 years

First QC Date

November 1, 2019

Last Update Submit

February 19, 2025

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (4)

  • To establish the safety of the Contino®

    safety is characterized by the absence of complications

    14 Months

  • To establish the clinical performance of the Contino®

    Clinical performance is characterized by the ability to stop involuntary urine flow

    14 Months

  • Change from baseline in the ICIQ-SF score

    At Visit Days 30 and 60

    14 Months

  • Change from baseline in the weight of the protective pads

    At Visit Days 30 and 60

    14 Months

Secondary Outcomes (3)

  • Level of ease of use inserting the Contino® from the Follow-up Questionnaire

    14 Months

  • Level of ease of use removing the Contino® from the Follow-up Questionnaire

    14 Months

  • Number of subjects with newly observed urinary function improvements

    14 Months

Study Arms (1)

Device Use

EXPERIMENTAL

Only one arm

Device: Contino

Interventions

ContinoDEVICE

The Contino® urethral insert is a self-administered licensed medical device, is inserted into the distal portion of the male urethra inhibiting the flow of urine. The Contino is self-inserted into the adult male urethra and is removed prior to urination. Much more than just a device, Contino® is an integrated solution that includes personalised fitting and support from incontinence specialists. It is made from highly specialised medical grade polymer, which has been extensively tested for biocompatibility.

Device Use

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male 18 years of age or older
  • Evidence of sphincteric incompetence as assessed by the Investigator
  • ECOG 0 or 1 performance status
  • Evidence of moderate to severe urinary incontinence as assessed by the Investigator, typically 2 or more protective garments or pads per day

You may not qualify if:

  • Inability to consistently insert the Contino® into his own urethra and remove it
  • Less than 2 months post radical prostatectomy for localized prostate cancer
  • History of significant incontinence that is other than stress incontinence
  • Evidence of neurogenic bladder dysfunction resulting in uncontrolled contractions
  • Untreated urethral stricture disease
  • Use of anticoagulant or antiplatelet medications excluding low-dose ASA (in the opinion of the Investigator)
  • Any cardiac condition that requires the use of pre-procedure antibiotic prophylaxis such as a mechanical valve (in the opinion of the Investigator)
  • Body Mass Index (BMI) greater than 32 kg/m2 (in the opinion of the Investigator provided the subject is able to insert \& remove the device)
  • Known immune deficiency either due to disease or medications (in the opinion of the Investigator)
  • Uncontrolled diabetes (in the opinion of the Investigator)
  • An UTI (in the opinion of the Investigator)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Fe/Male Health Centres

Oakville, Ontario, L6H 3P1, Canada

Location

Dr. Dean Elterman

Toronto, Ontario, M5G 1E2, Canada

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

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

Study Officials

  • Dean Elterman, MD

    University Urology Associates

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 1, 2019

First Posted

November 18, 2019

Study Start

November 19, 2019

Primary Completion

September 1, 2025

Study Completion

December 30, 2025

Last Updated

February 20, 2025

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)