A Multi-center, International Prospective Follow up Study

Medi-Tate

Status: Terminated

Conditions: Benign Prostatic Hyperplasia (BPH)

Treatments: Other: Review of medical history, administration of questionnaires, uroflowmetry and PVR as measured by ultrasound

Study type: Observational

Funder types: Industry

Identifiers

NCT04579913

MT-03A

Details and patient eligibility

About

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

Full 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.

Enrollment: 17 patients

Sex: Male

Volunteers: No 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.

Trial design

17 participants in 1 patient group

iTind subjects

Description:

Patient who participated previously in the MT-03 study in the iTind arm

Treatment:

Other: Review of medical history, administration of questionnaires, uroflowmetry and PVR as measured by ultrasound