Study to Assess the Efficacy, Safety and Tolerability of (iTind)

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-27

Study Completion Date

2020-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Subjects with AUR secondary to BPO that comply with Inclusion/Exclusion Criteria.

A total of 50 eligible subjects will be recruited into the study to receive treatment with iTind system.

Study duration will be 12 months post implantation, with follow-up extension of up to 3 years. Extension of follow up period will not require an additional ICF.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Assess the Efficacy of Medi-Tate iTind Device

NCT02145208

Benign Prostatic Hyperplasia (BPH)

COMPLETED NA

Post-Market Study to Assess iTind Safety in Comparison to UroLift

NCT04757116

Benign Prostatic Hyperplasia (BPH)

RECRUITING NA

Pivotal Study to Assess the Safety and Effectiveness of the iTind Device

NCT02506465

Benign Prostate Hyperplasia

COMPLETED NA

A Multi-center, International Prospective Follow up Study

NCT04579913

Benign Prostatic Hyperplasia (BPH)

TERMINATED

Implanted Nitinol Device (iTind) System in Chinese Males With Lower Urinary Tract Symptom Secondary to BPH

NCT05440981

Prostate Hyperplasia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Spontaneous acute urinary retention (AUR) is one of the most significant complications of long-term benign prostatic hyperplasia (BPH). In the past it has represented an immediate indication for surgery. Between 25% and 30% of men who underwent transurethral prostatectomy (TURP) had AUR as their main indication in older series and today most subjects failing to void after attempted catheter removal still undergo surgery. For this reason alone, AUR is an important and feared event from the viewpoint of the subject. The subject originally has inability to urinate, with increasing pain, and eventually a visit to the emergency room, catheterization, follow-up visits to the physicians, an attempt at catheter removal, and eventual recovery or surgery, which is both painful and time consuming.

After the acute period most men with AUR will be offered a 'trial without catheter' (TWOC) and about half will resume spontaneous voiding. Most men who fail a TWOC, experience a recurrent episode of AUR, or have moderate or severe lower urinary tract symptoms (LUTS) that are refractory to medical management will be considered for surgery.

In the older literature, the risk of recurrent AUR was cited as 56% to 64% within 1 week of the first episode and 76% to 83% in men with diagnosed BPH.

(http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1476058/). Additional researches show that ten percent of men in their seventies and 30% in their eighties will have AUR within the next five years.

Benign prostatic hyperplasia is the cause for the AUR in at least 65% of men presenting with AUR.

In the below study of the natural history of BPH, the risk of AUR was 1.6% at five years for men aged 40-49 years and 10% at 70-79 years.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

BPH

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Device

Temporary implant (iTind)

Group Type EXPERIMENTAL

iTind

Intervention Type DEVICE

temporary implant

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

iTind

temporary implant

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male with AUR secondary to BPO
* Age ≥40 years
* Acute urinary retention with at least one failed trial without catheter (TWOC) while on alpha blocker
* Ability to sign an informed consent form
* Prostate volume \<80 ml
* Life expectancy \>1 year.

Exclusion Criteria

* Suspected malignant disease of the lower urinary tract including prostate or bladder cancer
* Chronic retention of urine with history of either retention volume greater than one liter or upper tract obstruction
* Known neurogenic bladder
* Immunosuppression
* Suspected urethral strictures, bladder neck contracture, Urinary bladder stones
* An obstructive or protruding median lobe of the prostate
* An active symptomatic urinary tract infection
* Enrolled in another treatment trial for any disease
* Previous pelvic irradiation or radical pelvic surgery
* Any previous prostate surgery.

Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No