nitinol and Prostatic-Hyperplasia

Office-based treatments are increasingly offered as an optional step to replace medical treatment or delay surgery for male lower urinary tract symptoms (LUTS). Nevertheless, little is known regarding the risks of retreatment.. To systematically evaluate the current evidence regarding retreatment rates after water vapor thermal therapy (WVTT), prostatic urethral lift (PUL), and temporarily implanted nitinol device (iTIND) procedures.. A literature search was conducted up to June 2022 using the PubMed/Medline, Embase, and Web of Science databases. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were followed to identify eligible studies. The primary outcomes were the rates of pharmacologic and surgical retreatment during follow-up.. A total of 36 studies including 6380 patients met our inclusion criteria. Surgical and minimally invasive retreatment rates were generally well reported in the studies included and reached up to 5% after 3 yr of follow-up for iTIND, and up to 4% for WVTT and 13% for PUL after 5 yr of follow-up. The types and rates of pharmacologic retreatment are poorly reported in the literature, with the latter reaching up to 7% after 3 yr of follow-up for iTIND, and up to 11% after 5 yr of follow-up for WVTT and PUL. The main limitations of our review are the unclear to high risk of bias in most of the studies included and the lack of long-term (>5 yr) data on retreatment risks.. Our results highlight the low retreatment rates at mid-term follow-up after office-based treatments for LUTS, supporting the development of these strategies as an intermediate step between BPH medication and conventional surgery. Pending more robust data with longer follow-up, these results should be used to improve patient information and facilitate shared decision-making.. Our review highlights the low risk of mid-term retreatment after office-based treatments for benign enlargement of the prostate that is affecting urinary function. For well-selected patients, these results support the increasing use of office-based treatment as an intermediate option before conventional surgery.

Topics: Humans; Lower Urinary Tract Symptoms; Male; Prostate; Prostatic Hyperplasia; Prostheses and Implants; Retreatment; Urethra

Minimally invasive surgical therapies for male lower urinary tract symptoms secondary to benign prostatic obstruction were developed to be safer and more tolerable than standard ablative techniques. These treatments have not been compared with each other in a randomised fashion, and for some treatments, there are no trials against a reference technique.. To compare the efficacy, safety, and tolerability of water vapour thermal therapy (WVTT), prostatic urethral lift (PUL), prostatic arterial embolisation (PAE), temporary implantable nitinol device (iTIND), transurethral microwave thermotherapy (TUMT), and transurethral resection of the prostate (TURP).. A systematic search of MEDLINE/PubMed, Embase, Cochrane Library, and grey literature for randomised controlled trials was performed. Trials meeting the selection criteria were assessed for the risk of bias using the Cochrane RoB2 tool. Treatments were compared, using a network meta-analysis, in terms of outcomes including symptom score, quality of life, maximum urinary flow rate, postvoid residual urine, International Index of Erectile Function (IIEF-5), and scales from the Male Sexual Health Questionnaire.. The search identified 63 trials. Symptoms and quality of life for PAE, PUL, and WVTT appeared similar to those for TURP, whereas TURP was found to have the most clinically significant improvement in flow rate. TUMT was less efficacious than TURP but provided similar results on quality of life. Comparisons of ejaculatory function favoured WVTT and PUL compared with TURP. The relative efficacy of iTIND was less clear because of the risk of bias in the respective trial.. PAE, PUL, and WVTT appear favourable from a risk-benefit perspective despite probably having less efficacy than TURP for objective outcomes. These findings warrant confirmation through long-term randomised controlled trials.. This paper has summarised the evidence from 63 clinical trials on minimally invasive surgical therapies for men with symptoms of an enlarged prostate, including water vapour thermal therapy (WVTT), prostatic urethral lift (PUL), prostatic arterial embolisation (PAE), temporary implantable nitinol device, and transurethral microwave thermotherapy (TUMT). Improvement in symptoms for each of PAE, PUL, TUMT, and WVTT in short-term follow-up was similar to that for the standard surgical treatment, although standard surgery appeared to provide the greatest increase in urine flow. Men who had WVTT or PUL were less likely to have problems with sexual function than those who had standard surgery.

Topics: Humans; Lower Urinary Tract Symptoms; Male; Network Meta-Analysis; Prostatic Hyperplasia; Quality of Life; Steam; Transurethral Resection of Prostate; Treatment Outcome

To evaluate the safety and efficacy of the temporarily implanted nitinol device (iTind) versus prostatic urethral lift (PUL) for minimally invasive surgical treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia in a matching-adjusted indirect comparison (MAIC).. Seven clinical trials were identified via a systematic literature review. Individual patient data from iTind trials and aggregated data from PUL trials were used in the MAIC. Safety and efficacy outcomes at 12 months post-treatment were compared between the adjusted iTind population and the pooled PUL population.. iTind patients were significantly less likely than PUL patients to experience treatment-related adverse events within 3 months (25.0% vs. 79.8%; p < 0.001), including dysuria (17.8% vs. 34.7%; p = 0.001), hematuria (12.0% vs. 25.9%; p = 0.002), and pain (9.5% vs. 18.7%; p = 0.023). Rates of treatment-related adverse events from 3 to 12 months were also significantly lower among iTind than PUL patients (2.6% vs. 24.4%; p < 0.001). iTind and PUL efficacy outcomes were statistically equivalent on changes from baseline to 12 months on the International Prostate Symptom Score, quality of life, Qmax, post-void residual volume, and the Sexual Health Inventory for Men (all p > 0.05).. This MAIC found superior safety and reduced risks of early and later treatment-related adverse events with iTind versus PUL. The 12-month efficacy was equivalent on subjective and objective urinary and sexual health metrics. This study finds that the iTind temporary device provides equivalent efficacy with lower adverse event risks versus the PUL permanent implants for patients with benign prostatic hyperplasia with lower urinary tract symptoms.

Topics: Humans; Lower Urinary Tract Symptoms; Male; Prostate; Prostatic Hyperplasia; Quality of Life; Treatment Outcome

BPH is a common disease in aging men which impacts quality of life. With advancing age expectation coupled with the rising demand for BPH therapy, new technologies have been developed that target rapid recovery and symptom relief, low complication rates, and the ability to perform the procedure in an outpatient setting with local anesthesia. MIST technologies have fostered BPH medical care with ejaculation preservation. Techniques and outcomes for BPH technologies including Aquablation, Rezūm, UroLift, iTind, Optilume BPH, XFLO, Zenflow, and Butterfly are reviewed and evaluated. Given the novelty of these technologies, long-term data are required to assess safety and efficacy.

Topics: Ablation Techniques; Alloys; Antineoplastic Agents, Phytogenic; Dilatation; Humans; Male; Minimally Invasive Surgical Procedures; Paclitaxel; Prostatic Hyperplasia; Prostheses and Implants; Robotic Surgical Procedures; Steam; Urinary Catheters

A 66-years old male patient presents with lower urinary tract symptoms, mostly due to obstructive symptoms, and an enlarged prostate with 80 cm

Topics: Aged; Alloys; Arteries; Embolization, Therapeutic; Humans; Lower Urinary Tract Symptoms; Male; Minimally Invasive Surgical Procedures; Prostate; Prostatic Hyperplasia; Steam

In the last decade, there has been a growing interest in minimally invasive treatment for benign prostatic hyperplasia (BPH) associated with lower urinary tract symptoms (LUTS). In this field, one of the options currently available is the temporary implantable nitinol device (iTIND) (Medi-Tate®; Medi-Tate Ltd., Or Akiva, Israel).. To review the recent data available in the literature regarding the role of the first-generation (TIND) and second-generation (iTIND) devices for the management of BPH with LUTS, especially focusing on follow-up of functional outcomes.. PubMed, Embase, and the Cochrane Central Register of Controlled Trials were screened for clinical trials on this topic.. Literature evidences regarding implantation of TIND and iTIND for PBH with LUTS are limited. There are only three studies available, one with a medium-term follow-up. The results of these studies suggested that both the TIND and iTIND implantations are safe, effective, and well-tolerated procedures, allowing spare ejaculation in sexually active patients.. Current evidences emphasize that the temporary implantable nitinol devices are promising alternatives to the standard minimally invasive surgical options for BPH-related LUTS. Further studies are needed to confirm the effectiveness over a long-term follow-up.

Topics: Alloys; Biocompatible Materials; Humans; Lower Urinary Tract Symptoms; Male; Minimally Invasive Surgical Procedures; Prostatic Hyperplasia; Prosthesis Implantation; Stents

The purpose of the present systematic review is to offer a narrative synthesis of the available literature regarding the role of the temporary implantable nitinol device (TIND) (Medi-Tate®; Medi-Tate Ltd., Or Akiva, Israel) for the treatment of benign prostatic hyperplasia (BPH)-related lower urinary tract symptoms (LUTS), specifically focusing on the follow-up data.. Current available evidences are limited in this topic. Sample size of patients available for analysis is small. Moreover, the duration of follow-up period is intermediate and longer follow-up is required. At the available 3 years follow-up, the TIND implantation is safe, effective, and well tolerated. The extended follow-up of the first and only available cohort of patients who underwent TIND for LUTS related to BPH corroborated previous literature findings. Further studies are required in order to assess the durability of TIND outcomes over a longer follow-up, to better define the indications of this approach, and to demonstrate the advantages of second-generation device over the first.

Topics: Alloys; Follow-Up Studies; Humans; Male; Minimally Invasive Surgical Procedures; Prostatic Hyperplasia; Prostheses and Implants

There is growing interest in minimally invasive (MI) treatment options for male lower urinary tract symptoms (LUTS). Among these options, the temporary implantable nitinol device (TIND; Medi-Tate, Or Akiva, Israel) is a novel instrument used to alleviate symptoms by creating incisions in the prostate via mechanical stress.. To review recent data for TIND as an MI procedure to improve LUTS.. Medline, PubMed, the Cochrane Database, and Embase were screened for clinical trials, randomized controlled trials, and review articles on the use of TIND in patients with male LUTS.. Preliminary data suggest that TIND is a safe and effective MI technique for patients with male LUTS. Symptom relief and increase in urinary flow after 36mo are promising. However, long-term results are needed.. Various treatment options for male patients suffering from urinary voiding symptoms are emerging. TIND, a temporary implantable nitinol device, appears to be a safe option that improves symptoms without affecting sexuality.

Topics: Alloys; Clinical Trials as Topic; Humans; Israel; Lower Urinary Tract Symptoms; Male; Minimally Invasive Surgical Procedures; Postoperative Complications; Prostate; Prostatic Hyperplasia; Prostheses and Implants; Randomized Controlled Trials as Topic; Stress, Mechanical; Urinary Retention; Urinary Tract Infections

Recently, more and more alternative therapeutic methods have been used for the treatment of benign prostatic hyperplasia (BPH). We will report on therapeutic results with a new thermosensitive stent system (Memotherm). This wire mesh stent has been designed especially for urological purposes. It is made of Nitinol, a thermoreactive material, and gains its maximum expansion force al body temperature. Due to the properties of the material the stent is flexible and can adapt to the anatomical conditions of the prostatic part of the urethra. Because of individual variations in the length of the prostatic part of the urethra, the system is available in lengths from 2 to 8 cm. The knitted structure for the first time allows atraumatic removal. Between April, 1992, and September, 1993, we treated a total of 54 BPH patients with the stent system. Mean patient age was 76.1 +/- 7.6 years (61-98). Mean prostatic volume was 51.9 +/- 25 ml (20-150), and the length of the applicated stents was 32.3 +/- 9.5 mm (20-70). Patient selection for stent treatment was carried out with regard to the preoperative risk status of this patient group. Fourteen (26%) of the patients treated were able to micturate before operation; in 40 (74%) urinary drainage was accomplished by means of an indwelling catheter. Following stent application, 53 out of 54 patients were able to micturate. With the first group (preoperative voiding ability), maximum flow had increased from 4.5 ml/s to a mean of 15.8 ml/s, while residual urine volume had decreased from 194.4 ml to 11.8 ml and the AUA 6 Symptoms Score had improved from 24 points to 3.5 points 6 months after stent application. All differences were statistically significant (P < 0.02). With the second group (no preoperative voiding ability), the AUA 6 Symptoms Score had improved from 25 points to 3.9 points (P < 0.02) 6 months after the operation, at which time the mean maximum flow rate was 14.8 ml/s and residual urine volume 14.8 ml. There was no statistically significant difference between the patients who were able and those who were unable to micturate before operation. One case of epididymitis was the only major complication observed after stent placement. Frequent urgency symptoms (30 out of 54 patients; 55.5%) subsided after a mean period of 1 week. The Memotherm stent offers an interesting therapeutic alternative for BPH risk patients.

Topics: Aged; Aged, 80 and over; Alloys; Equipment Design; Hot Temperature; Humans; Male; Middle Aged; Prostatic Hyperplasia; Stents

Topics: Aged; Erectile Dysfunction; Humans; Lower Urinary Tract Symptoms; Male; Middle Aged; Prostatic Hyperplasia; Treatment Outcome

To report the results of a multicenter, randomized, controlled trial with a temporarily implanted nitinol device (iTind; Medi-Tate Ltd, Hadera, Israel) compared to sham for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia.. Men 50 years or older were randomized 2:1 between iTind and sham procedure arms. A self-expanding, temporary nitinol device was placed for 5-7 days and an 18F Foley catheter was inserted and removed for the iTind and sham group, respectively. Patients were assessed at baseline, 1.5, 3, and 12 months postoperatively using the IPSS, peak urinary flow rate, residual urine, quality of life, and the International Index of Erectile Function. Unblinding occurred at 3 months.. A total of 175 men (mean age 61.1 ± 6.5) participated (118 iTind vs 57 sham). A total of 78.6% of patients in the iTind arm showed a reduction of ≥3 points in IPSS, vs 60% of patients in the control arm at 3 months. At 12 months, the iTind group reported a 9.25 decrease in IPSS (P< .0001), a 3.52ml/s increase in peak urinary flow rate (P < .0001) and a 1.9-point reduction in quality of life (P < .0001). Adverse events were typically mild and transient, most Clavien-Dindo grade I or II, in 38.1% of patients in the iTind arm and 17.5% in the control arm. No de novo ejaculatory or erectile dysfunction occurred.. Treatment with the second-generation iTind provided rapid and sustained improvement in lower urinary tract symptoms for the study period while preserving sexual function.

Topics: Alloys; Humans; Lower Urinary Tract Symptoms; Male; Middle Aged; Prospective Studies; Prostatic Hyperplasia; Prostheses and Implants; Single-Blind Method

Although effective for benign prostatic hyperplasia (BPH), transurethral resection of the prostate (TURP) can be associated with side effects including prolonged recovery, storage and voiding symptoms, and a risk of acute urinary retention.. To test a new minimally invasive device for the treatment of lower urinary tract symptoms (LUTS) due to BPH, involving implantation of a C-shaped nitinol ring (ClearRing) in a circular incision in the prostatic tissue using an electrocuting blade over a dilatation balloon.. This was a multicenter single-arm clinical trial involving 29 men with severe symptomatic BPH.. Implantation of a ClearRing device under regional anesthesia.. Effectiveness in alleviating LUTS was assessed in terms of International Prostate Symptom Score (IPSS) at baseline and 3, 6, and 12 mo after the procedure. To evaluate changes from baseline, a general estimating equation model was fitted to IPSS, the Quality of Life (QOL) scale, Benign Prostatic Hyperplasia Impact Index, maximum flow rate (Q. We demonstrated preliminary feasibility of the ClearRing device for minimally invasive treatment of BPH in men. Further studies are needed to confirm the safety and efficacy of this approach.. In this study we tested outcomes after implantation of a ClearRing device in patients with benign prostatic hyperplasia. We found that the device was safe and effective. However, there was a high rate of implantation failure due to malpositioning, which was significantly improved following modification of the delivery device.

Topics: Aged; Aged, 80 and over; Alloys; Humans; Lower Urinary Tract Symptoms; Male; Middle Aged; Prospective Studies; Prostatic Hyperplasia; Prostheses and Implants; Prosthesis Design; Treatment Outcome

An easily removable prostate stent would be useful in various clinical situations but is not currently available. Thus, we studied the safety, tolerability, and ease of removal of a nitinol (nickel-titanium alloy) prostate stent in 10 men with symptomatic benign prostatic hyperplasia. The circular-coil stent becomes hourglass in shape following deployment, with the narrowest diameter approximately 35F. A working hypothesis was that the temperature-sensitive shape memory of nitinol would allow for its easy removal vis-à-vis other available stents. Using several modifications of a prototype insertion device, we found that the nitinol stents were easily inserted, retained their shape during retention periods of 1 to 4 weeks, caused no gross tissue reaction, and were removed easily with gentle traction after in situ cooling with iced saline lavage. Stent migration was observed in two patients, but otherwise, the stents were well tolerated. Nitinol prostate stents appear to fulfill a theoretical promise of being biologically inert, "superelastic," and pliable when cooled, allowing for easy removal. Further clinical investigation appears warranted.

Topics: Aged; Alloys; Equipment Design; Equipment Safety; Follow-Up Studies; Humans; Male; Middle Aged; Pilot Projects; Prostatic Hyperplasia; Stents; Temperature; Treatment Outcome; Urologic Surgical Procedures

In this study our aim was to compare a first-generation intraprostatic stent (Prostakath) with a second-generation one (ProstaCoil) in patients with prostatic obstruction. The comparison was made in terms of ease of insertion, need for repositioning, migration, infection, stone formation and length of time in place. One hundred and seventeen patients with an age range of 52-94 years were included in this study. Forty-nine of the patients were treated with gold-plated stainless-steel-made stent (Prostakath) inserted under sonographic and 68 of the patients were treated with a nitinol-made stent (ProstaCoil) inserted under fluoroscopic guidance. Indications for stent insertion were similar for both groups. We found that immediate correct positioning was 83% for the Prostakath and 100% for the ProstaCoil. In 42% of the cases the Prostakath necessitated later repositioning because of partial migration and in 12% of the cases removal because of complete migration into the bladder or the anterior urethra. No migration was observed with the ProstaCoil. In 10% of these cases the Prostakath could not be inserted because of the instability of the stent. Due to its larger caliber the second-generation stent caused more transient irritative symptoms. No difference was found in stent-induced infections (10% for all stents). Encrustations were found in 40% of the patients at 1 year with the Prostakath, but in 30% with the ProstaCoil at 2 years. Maximal indwelling time was 12 months with the Prostakath and 36 months with the ProstaCoil. We conclude that the second-generation stent was more advantageous because of its larger caliber allowing catheterization and endoscopic examinations, more flexibility and much longer indwelling time.

Topics: Aged; Aged, 80 and over; Alloys; Follow-Up Studies; Humans; Male; Middle Aged; Prostatic Hyperplasia; Stainless Steel; Stents; Urinary Bladder Neck Obstruction; Urinary Catheterization

Recently, more and more alternative therapeutic methods have been used for the treatment of benign prostatic hyperplasia (BPH). We will report on therapeutic results with a new thermosensitive stent system (Memotherm). This wire mesh stent has been designed especially for urological purposes. It is made of Nitinol, a thermoreactive material, and gains its maximum expansion force al body temperature. Due to the properties of the material the stent is flexible and can adapt to the anatomical conditions of the prostatic part of the urethra. Because of individual variations in the length of the prostatic part of the urethra, the system is available in lengths from 2 to 8 cm. The knitted structure for the first time allows atraumatic removal. Between April, 1992, and September, 1993, we treated a total of 54 BPH patients with the stent system. Mean patient age was 76.1 +/- 7.6 years (61-98). Mean prostatic volume was 51.9 +/- 25 ml (20-150), and the length of the applicated stents was 32.3 +/- 9.5 mm (20-70). Patient selection for stent treatment was carried out with regard to the preoperative risk status of this patient group. Fourteen (26%) of the patients treated were able to micturate before operation; in 40 (74%) urinary drainage was accomplished by means of an indwelling catheter. Following stent application, 53 out of 54 patients were able to micturate. With the first group (preoperative voiding ability), maximum flow had increased from 4.5 ml/s to a mean of 15.8 ml/s, while residual urine volume had decreased from 194.4 ml to 11.8 ml and the AUA 6 Symptoms Score had improved from 24 points to 3.5 points 6 months after stent application. All differences were statistically significant (P < 0.02). With the second group (no preoperative voiding ability), the AUA 6 Symptoms Score had improved from 25 points to 3.9 points (P < 0.02) 6 months after the operation, at which time the mean maximum flow rate was 14.8 ml/s and residual urine volume 14.8 ml. There was no statistically significant difference between the patients who were able and those who were unable to micturate before operation. One case of epididymitis was the only major complication observed after stent placement. Frequent urgency symptoms (30 out of 54 patients; 55.5%) subsided after a mean period of 1 week. The Memotherm stent offers an interesting therapeutic alternative for BPH risk patients.

Topics: Aged; Aged, 80 and over; Alloys; Equipment Design; Hot Temperature; Humans; Male; Middle Aged; Prostatic Hyperplasia; Stents

To report the 3-year results of a prospective, single arm, multicenter, international clinical study with the second generation of the temporary implantable nitinol device (iTIND; Medi-Tate Ltd®, Israel) on men suffering lower urinary tract symptoms (LUTS) secondary to benign prostatic obstruction (BPO).. Eighty-one men with symptomatic BPO (IPSS ≥ 10, peak urinary flow <12 ml/s, and prostate volume <75 ml) were enrolled in this study between December 2014 and December 2016. Subjects were washed-out 1 month for alpha-blockers and 6 months for 5-ARIs. The implantation was performed under light sedation and the removal 5-7 days later with topical anesthesia. Perioperative results including OR-time, pain (VAS) postoperative complications (Clavien-Dindo-Grading System), functional results (Qmax, IPSS, PVR) and quality of life (QoL) were assessed at 1, 3, 6 months, 1, 2, and 3 years. Sexual and ejaculatory function were evaluated using two yes/no questions.. Thirty-six month functional results were available for 50 patients and demonstrated that iTIND efficacy remained stable through 3 years, with averages IPSS, QOL, Qmax and PVR of 8.55 + 6.38, 1.76 + 1.32, 15.2 + 6.59 ml/s and 9.38 + 17.4 ml, improved from baseline by -58.2, -55.6, +114.7, and -85.4% (all significantly different from their corresponding baseline values, p < 0.0001). Even considering the Intention to Treat analysis (ITT), the 36-month results confirmed significant improvements of the functional outcomes if compared with baselines values (all p < 0.0001). No late post-operative complications were observed between 12 and 36 months. Sexual function was stable through 3 years, with no reports of sexual or ejaculatory dysfunctions. No patients underwent alternative treatments between 24 and 36 months.. Treatment of BPO-related LUTS with iTIND demonstrated a significant and durable reduction in symptoms and improvement of functional parameters and quality of life at 3 years of follow-up. No late post-operative complications, ejaculatory dysfunction or additional treatment failures were observed between 24 and 36 months.

Topics: Aged; Aged, 80 and over; Alloys; Follow-Up Studies; Humans; Lower Urinary Tract Symptoms; Male; Middle Aged; Prognosis; Prospective Studies; Prostatic Hyperplasia; Prostatic Neoplasms; Prostheses and Implants; Quality of Life

Benign prostatic hyperplasia is a common and progressive disease affecting aging men which has a significant impact on quality of life. The second-generation Temporarily Implanted Nitinol Device (iTind) is an FDA approved temporary prostatic urethral device which can be deployed using standard flexible cystoscopy without sedation or general anesthesia. The device is left in-situ for 5 to 7 days and is then entirely removed in the office, using an open-ended silicone catheter. Prospective, randomized data indicate that iTind has favorable functional and sexual patient outcomes. Readers will familiarize themselves with iTind, significant historical studies and the technique for deploying iTind using a flexible cystoscope in the office setting.

Topics: Alloys; Humans; Lower Urinary Tract Symptoms; Male; Prospective Studies; Prostatic Hyperplasia; Quality of Life

Topics: Alloys; Follow-Up Studies; Humans; Lower Urinary Tract Symptoms; Male; Prospective Studies; Prostatic Hyperplasia

Several prostatic stents were developed in the last three decades, none of which were able to provide a real alternative in patients unfit or unwilling to undergo classical prostatic surgeries. In this study, we report the results of the use of a newly developed prostatic stent--the Allium™ Triangular Prostatic Stent (TPS).. The Allium TPS is a highly flexible, nitinol-built polymer-covered stent, which prevents tissue ingrowth and reduces encrustations. Between 2008 and 2014, at two centers (Israel and Turkey), the stent was inserted under local or regional anesthesia in 51 patients with benign prostatic obstruction (BPO) who are unwilling or unfit for surgery. Patients were followed for 12 months from surgery. The primary outcome was symptom improvement as measured by the international prostate symptom score (IPSS) and improvement in peak urinary flow.. Stent insertion was successful in all patients. The mean IPSS decreased from 26.4 to 7.7 on the last follow-up. The mean peak flow increased from 5.5 mL/second before stent insertion to 16.0 mL/second 1 year thereafter. The main adverse effect was transient pain in nine patients. No stent migration or obstruction was seen. Patients reported satisfaction and improvement in quality of life.. Our short-term results show that Allium TPS is safe and effective for the treatment of patients with BPO.

Topics: Aged; Aged, 80 and over; Alloys; Cystoscopes; Endoscopy; Equipment Design; Humans; Israel; Male; Middle Aged; Prostatic Hyperplasia; Quality of Life; Stents; Turkey; Urethral Obstruction

Topics: Alloys; Follow-Up Studies; Humans; Lower Urinary Tract Symptoms; Male; Prostatic Hyperplasia

To report the first clinical experience with a temporary implantable nitinol device (TIND; Medi-Tate(®) ) for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).. In all, 32 patients with LUTS were enrolled in this prospective study, which was approved by our Institutional Ethics Committee. Inclusion criteria were: age >50 years, International Prostate Symptom Score (IPSS) of ≥10, maximum urinary flow rate (Qmax ) of ≤12 mL/s, and prostate volume of <60 mL. The TIND was implanted within the bladder neck and the prostatic urethra under light sedation, using a rigid cystoscope. The device was removed 5 days later in an outpatient setting. Demographics, perioperative results, complications (according to the Clavien system), functional results and quality of life (QoL) were evaluated. Follow-up assessments were made at 3 and 6 weeks, and 3, 6 and 12 months postoperatively. The Student's t-test, analysis of variance (anova), Kruskall-Wallis test, and simple and multiple linear regression models were used in the statistical analyses.. The mean patient age was 69.4 years, the mean (standard deviation, sd) prostate volume was 29.5 (7.4) mL and the Qmax was 7.6 (2.2) mL/s. The median (interquartile range, IQR) IPSS was 19 (14-23) and QoL score was 3 (3-4). All the implantations were successful, with no intraoperative complications recorded. The mean operative time (sd) was 5.8 (2.5) min and the median (IQR) postoperative stay was 1 (1-2) day. All but one of the devices (96%) was removed 5 days at after implantation in an outpatient setting. Four complications (12.5%) were recorded, including urinary retention (one, 3.1%), transient incontinence due to device displacement (one, 3.1%), prostatic abscess (one, 3.1%), and urinary tract infection (one, 3.1%). Multiple regression analysis failed to identify any independent prognostic factor for complications. There were statistically significant differences in the IPSS, QoL score and Qmax when comparing pre- and postoperative results at every time point. After 12 months, the median (IQR) IPSS and QoL score were 9 (7-13) and 1 (1-2), respectively, and the mean (sd) Qmax was 12 (4.7) mL/s. The mean variations with respect to baseline conditions at the same time points were -45% for the IPSS and +67% for Qmax . At 12 months after surgery (last follow-up visit), no patients required medical therapy or surgical procedures for BPH.. TIND implantation is a feasible and safe minimally invasive option for the treatment of BPH-related LUTS. The functional results are encouraging and the treatment significantly improved patient QoL. Further studies are required to assess durability of TIND results and to optimise the indications of such a procedure.

Topics: Aged; Alloys; Cystoscopy; Feasibility Studies; Follow-Up Studies; Humans; Lower Urinary Tract Symptoms; Male; Middle Aged; Minimally Invasive Surgical Procedures; Postoperative Complications; Prospective Studies; Prostatic Hyperplasia; Prostheses and Implants

To report the use of a newly constructed, covered, retrievable, expandable nitinol stent with barbs to overcome the problem of stent migration associated with conventional covered prostatic expandable stents and to evaluate prospectively the technical feasibility and clinical effectiveness of the stents in patients with benign prostatic hyperplasia (BPH).. A covered retrievable expandable nitinol stent with four barbs was placed with use of an 18-F stent delivery system in seven consecutive patients with symptomatic BPH who had high operative risks. Age range of patients was 62-83 years (mean 74 years). In cases in which the stent migrated, it was replaced with a stent with eight barbs. The stents were routinely removed 4 months after placement using a 21-F stent removal set.. Stent placement was technically successful and well tolerated in six of the seven patients. The remaining patient needed a second stent placement after removal of the first stent. The stent with four barbs migrated into the urinary bladder in four patients (57%); three of these patients received a second stent with eight barbs with good results, and the fourth patient did not need further treatment because his symptoms improved. Routine removal of the stent 4 months after placement was performed in three of the seven patients with good results.. Retrievable stents with eight barbs seem to overcome the problem of stent migration associated with conventional prostatic expandable stents. Preliminary results suggest that stents with barbs are both feasible and effective in patients with BPH.

Topics: Aged; Aged, 80 and over; Alloys; Catheterization; Device Removal; Feasibility Studies; Foreign-Body Migration; Humans; Male; Pilot Projects; Prospective Studies; Prostatic Hyperplasia; Prosthesis Design; Radiography, Interventional; Republic of Korea; Stents; Time Factors; Treatment Outcome; Ureteroscopy

Topics: Alloys; Equipment Safety; Foreign-Body Migration; Hematuria; Humans; Male; Prostatic Hyperplasia; Prostatic Neoplasms; Prosthesis Design; Stents; Urinary Incontinence; Urination

We report our experience with a new thermosensitive stent (Memotherm), which has been invented recently as an alternative method for treatment of benign prostatic hyperplasia. The wall of this stent is a thermoreactive mesh made of nitinol, which reaches its maximum force of expansion at body temperature. Its high degree of flexibility allows the Memotherm stent to fit the natural course of the prostatic urethra. This stent is available in different sizes between 2 and 8 cm to meet the demand for different lengths of prostatic urethra. Furthermore, the meshed structure of this stent allows its atraumatic removal. From April 1992 to September 1993, 54 consecutive patients with benign prostatic hyperplasia and Memotherm stents inserted. The mean patient age was 76.1 years (range 61-98 years). Patients were considered suitable for treatment with the Memotherm stent when they presented with a poor operative risk. Mean prostatic volume was 51.9 +/- 25 ml (20-150 ml), and on average a stent measured 32.3 +/- 9.5 mm (20-70 mm). Preoperatively, only 14 patients (26%) were able to void, and 40 patients (74%) had had a transurethral or suprapubic catheter placed. After placement of the Memotherm stent, 53 of 54 patients were able to void. In the patients who were able to void preoperatively, the mean maximum flow rate increased from 4.5 ml/s to 15.8 ml/s within the first 6 months after treatment. Within the same period of time, the mean residual urine volume decreased from 194.4 ml to 11.8 ml, and the AUA 6-Symptom Score improved from 24 to 3.5 points. All differences are statistically significant (P < 0.02).(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Aged; Alloys; Body Temperature; Catheters, Indwelling; Cystoscopes; Epithelium; Equipment Design; Follow-Up Studies; Humans; Male; Middle Aged; Prostate; Prostatic Hyperplasia; Stents; Urinary Bladder Neck Obstruction; Urodynamics

The nitinol (shape memory alloy, SMA) spiral was used in 39 patients with benign prostatic hyperplasia (BPH). Caine experiment indicated that the spiral could be embedded by prostatic urethra epithelium in 6 months. The new transitional epithelium between spiral wires was originated from the urethra transitional epithelium as proved by immunohistochemical staining. The parts of spiral project over the bladder cavity formed incrustation on the spiral tip. The nitinol is of super-elastic property, corrosive-resistance and excellent biocompatibility, in addition to unique shape memory effect. We treated 39 patients with BPH by self-made coaxial sheath introducing Chinese nitinol spiral into the prostatic urethra, with a successful rate of 89.7%. Follow-up for 3-26 months showed no incrustation and migration of the spiral.

Topics: Aged; Aged, 80 and over; Alloys; Animals; Dogs; Humans; Male; Middle Aged; Nickel; Prostatic Hyperplasia; Stents; Titanium; Urethral Obstruction