A Multi-center, International Prospective Follow up Study

A Multi-center, International Prospective Follow up Study to Assess the Safety and Efficacy of the iTind Procedure After Three to Five Years of Follow Up

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04579913

Enrollment

Registered

2020-10-08

Start date

2020-12-21

Completion date

2021-04-22

Last updated

2021-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia (BPH)

Brief summary

The study objective is to assess the safety and efficacy of iTind three to five years following treatment.

Detailed description

This study will recruit patients who participated in the MT-03 study in the iTind arm to assess the safety and efficacy of the iTind procedure at three to five years following treatment as demonstrated by reduction of symptoms measured by IPSS and QoL and improvement of functional parameters as measured by peak urinary flow and PVR. Sexual and erectile function will also be assessed alongside the incidence of any related late occurring adverse events.

Interventions

OTHERReview of medical history, administration of questionnaires, uroflowmetry and PVR as measured by ultrasound

Administration of questionnaires to assess patient LUTS, quality of life, sexual behavior and erectile function, in addition to performing PVR and uroflow tests.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Healthy volunteers

Inclusion criteria

1. Subject signed informed consent form (ICF) 2. Subject who had participated in the MT-03 study in the iTind arm 3. Subject able to comply with the study protocol.

Exclusion criteria

1. Any anatomical or physiological condition that in the opinion of the investigator likely to impede successful completion of the study 2. Patients that are known to have had undergone an alternative surgical procedure for BPH during MT-03 study.

Design outcomes

Primary

Measure	Time frame	Description
iTind Durability	36 months post procedure	The primary endpoint of the study is time to first alternative surgical BPH intervention, defined as the time (in months) from the iTind procedure to intervention.

Secondary

Measure	Time frame	Description
iTind Efficacy	36 months post procedure	Change from baseline in IPSS
iTind Safety	36 months post procedure	Safety will be assessed by the rate of complications attributed to iTind since the last recorded follow up from MT-03 study

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026