A Multi-center, International Prospective Follow up Study

Terminated

• Conditions: Benign Prostatic Hyperplasia (BPH)
• Interventions: Other: Review of medical history, administration of questionnaires, uroflowmetry and PVR as measured by ultrasound

• Registration Number: NCT04579913
• Lead Sponsor: Medi-Tate Ltd.

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.

Study Timeline

• Study First Submitted: 2020-09-29
• Study First Submitted QC: 2020-10-04
• Study First Posted: 2020-10-08
• Study Start: 2020-12-21
• Primary Completion: 2021-03-12
• Status Verified: 2021-04
• Study Completion: 2021-04-22
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 17

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
iTind subjects	Review of medical history, administration of questionnaires, uroflowmetry and PVR as measured by ultrasound	Patient who participated previously in the MT-03 study in the iTind arm

Primary Outcome Measures

Name	Time	Method
iTind Durability	60 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 Outcome Measures

Name	Time	Method
iTind Efficacy	60 months post procedure	Change from baseline in Qmax
iTind Safety	60 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

Trial Locations

Locations (5)

Clinical Research Center of Florida; 🇺🇸 Pompano Beach, Florida, United States

Manhattan Medical research; 🇺🇸 Manhattan, New York, United States

Premier Urology Group; 🇺🇸 New York, New York, United States

Lenox Hill Hospital; 🇺🇸 New York, New York, United States

Toronto; 🇨🇦 Toronto, Ontario, Canada