A Multi-center, International Prospective Follow up Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-21

Study Completion Date

2021-04-22

Brief Summary

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

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Detailed Description

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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.

Conditions

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Benign Prostatic Hyperplasia (BPH)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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iTind subjects

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

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

Intervention Type OTHER

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

Interventions

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Review 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.

Intervention Type OTHER

Eligibility Criteria

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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.

Eligible Sex

MALE

Accepts Healthy Volunteers

No