Clinical trial NCT05440981: Implanted Nitinol Device (iTind) System in Chinese Males With Lower Urinary Tract Symptom Secondary to BPH
Official title: The Use of Temporarily Implanted Nitinol Device (iTind) System in Chinese Male Patients With Lower Urinary Tract Symptom Secondary to Benign Prostate Enlargement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Hyperplasia
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-07-01
Enrollment: 13
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective series of consecutive cases of patients undergoing iTind for the treatment of male LUTS.

Detailed description: This is a prospective series of consecutive cases of patients undergoing iTind for the treatment of male LUTS.The procedure was carried out using perioperative antibiotic prophylaxis, according to the local culture and sensitivity profile. Patient will be discharged and readmitted 7 days for device removal under local anaesthesia transurethrally. After the device is removed and patients will be monitor for any problem in voiding or haematuria, and then discharged. Subjects will be follow-up at 3-, 6, 12- months after treatment.

Eligibility criteria: Inclusion Criteria:

* Men aged between 50 - 80 years
* Clinically indicated for surgical treatment
* Prostate volume of 25 to 75 cc

Exclusion Criteria:

* Patients with active urinary tract infection or in retention of urine
* Patients with bleeding disorder or on anti-coagulation
* Patients with bladder pathology including bladder stone and bladder cancer
* Patients with urethral stricture
* Patients with neurogenic bladder and/or sphincter abnormalities
* Patients with previous nonpharmacological prostate treatment,
* Prostate cancer
* Fail to give informed consent

Primary outcomes:
measure: Changes in International Prostate Symptom Score (IPSS) at 6 months after treatment score
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: 30-day complications after study intervention
timeFrame: at 30 days after study intervention
measure: Total score in IPSS questionnaire after study intervention
timeFrame: Baseline, 3 months, 6 months and 12 months
measure: International Prostate Symptom Score (IPSS) questionnaire QoL Score
timeFrame: Baseline, 3 months, 6 months and 12 months
measure: Overactive bladder symptom score (OABSS) questionnaire total score
timeFrame: Baseline, 3 months, 6 months and 12 months
measure: Pain Score
timeFrame: Immediately after study intervention and 1 wee after study intervention
measure: Urodynamic function assessed by uroflowmetry parameter
timeFrame: Baseline, 3 months, 6 months and 12 months
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Chi Fai NG, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kahokehr A, Gilling PJ. Landmarks in BPH--from aetiology to medical and surgical management. Nat Rev Urol. 2014 Feb;11(2):118-22. doi: 10.1038/nrurol.2013.318. Epub 2014 Jan 21.
citation: Gratzke C, Bachmann A, Descazeaud A, Drake MJ, Madersbacher S, Mamoulakis C, Oelke M, Tikkinen KAO, Gravas S. EAU Guidelines on the Assessment of Non-neurogenic Male Lower Urinary Tract Symptoms including Benign Prostatic Obstruction. Eur Urol. 2015 Jun;67(6):1099-1109. doi: 10.1016/j.eururo.2014.12.038. Epub 2015 Jan 19.
citation: Amparore D, Fiori C, Valerio M, Schulman C, Giannakis I, De Cillis S, Kadner G, Porpiglia F. 3-Year results following treatment with the second generation of the temporary implantable nitinol device in men with LUTS secondary to benign prostatic obstruction. Prostate Cancer Prostatic Dis. 2021 Jun;24(2):349-357. doi: 10.1038/s41391-020-00281-5. Epub 2020 Oct 1.
citation: Chughtai B, Elterman D, Shore N, Gittleman M, Motola J, Pike S, Hermann C, Terrens W, Kohan A, Gonzalez RR, Katz A, Schiff J, Goldfischer E, Grunberger I, Tu LM, Alshak MN, Kaminetzky J. The iTind Temporarily Implanted Nitinol Device for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Multicenter, Randomized, Controlled Trial. Urology. 2021 Jul;153:270-276. doi: 10.1016/j.urology.2020.12.022. Epub 2020 Dec 26.