Prostatic Stent

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Alberto Pablo Corica - One of the best experts on this subject based on the ideXlab platform.

  • use of a temporary Prostatic Stent after transurethral microwave thermotherapy reduced voiding symptoms and bother without exacerbating irritative symptoms
    Urology, 2008
    Co-Authors: Martin Dineen, Neal D Shore, Mark J Saslawsky, Jeffrey H Lumerman, Alberto Pablo Corica
    Abstract:

    Objectives To evaluate the ability of a temporary Prostatic Stent (Spanner [Sp]) to manage voiding symptoms, irritative symptoms, and bother after transurethral microwave thermotherapy (TUMT) for Prostatic obstruction. Methods Patients were randomized to the Sp (n = 100) or standard of care (SOC, n = 86) after TUMT with 3 to 10 days of routine catheterization. We evaluated International Prostate Symptom Score (IPSS) voiding subscore, IPSS irritative subscore, voiding diary data, and Benign Prostatic Hyperplasia Impact Index (BII) 7 to 10 days before TUMT and repeated them 1, 2, 4 (Stent removal), 5, and 8 weeks after Stent insertion. Results After 1 week of Stent use, the Sp group experienced significantly greater improvements in the IPSS voiding subscore (Sp = −4.9 versus SOC = −2.3, P = 0.002) and individual voiding symptoms assessed by the IPSS (intermittency, weak stream, and straining) and voiding diary data (stream strength, and strain). After 2 weeks, the Sp group showed a trend toward greater improvements in IPSS voiding ( P = 0.059) and irritative ( P = 0.058) subscores and reported significantly less bother (BII, Sp = −2.1 versus SOC = −1.1, P = 0.033). After Stent removal, the Sp group reported significantly greater improvements in the IPSS irritative subscore (5 weeks: Sp = −4.0 versus SOC = −2.7, P = 0.029; 8 weeks: Sp = −5.0 versus SOC = −4.0, P = 0.050), individual voiding (stream strength and dysuria), and irritative (frequency and urgency) symptoms and bother (5 weeks: Sp = −4.0 versus SOC = −2.3, P = 0.002; 8 weeks: Sp = −5.0 versus SOC = −3.1, P = 0.001). Conclusions The Spanner, a temporary Prostatic Stent, improved voiding symptoms and bother without exacerbating irritative symptoms. Improvements in symptoms and bother were sustained after Stent removal.

  • a temporary intraurethral Prostatic Stent relieves Prostatic obstruction following transurethral microwave thermotherapy
    The Journal of Urology, 2007
    Co-Authors: Neal D Shore, Martin Dineen, Mark J Saslawsky, Jeffrey H Lumerman, Alberto Pablo Corica
    Abstract:

    Purpose: The Spanner™, a novel Prostatic Stent, was evaluated for safety, efficacy and patient tolerance when used to relieve Prostatic obstruction following transurethral microwave thermotherapy.Materials and Methods: Following transurethral microwave thermotherapy and routine post-procedure Foley catheterization at 1 of 9 clinical sites 186 patients meeting study criteria were randomized to receive a Spanner (100) or the standard of care (86). Baseline evaluations included post-void residual urine, uroflowmetry, International Prostate Symptom Score and International Prostate Symptom Score quality of life question. These evaluations were repeated at visits 1, 2, 4, 5 and 8 weeks after randomization (Spanner insertion) with the addition of the Spanner satisfaction questionnaire, ease of use assessment and adverse events recording. The Spanner was removed after 4 weeks, at which time the Spanner and standard of care groups underwent cystourethroscopy.Results: At the 1 and 2-week visits the Spanner group sh...

  • a novel temporary Prostatic Stent for the relief of Prostatic urethral obstruction
    BJUI, 2004
    Co-Authors: Alberto Pablo Corica, B T Larson, A Sagaz, Thayne R Larson
    Abstract:

    OBJECTIVES To determine the effect of a novel temporary Prostatic Stent (The SpannerTM, AbbeyMoor Medical, Inc., Minnesota, USA) on variables of voiding function and quality of life among patients with Prostatic urethral obstruction. PATIENTS AND METHODS The Stent design is very similar to the proximal 4–6 cm of a Foley catheter; this includes a proximal balloon to prevent distal displacement, a urine port situated cephalad to the balloon, and a reinforced Stent of various lengths to span most of the Prostatic urethra. There is also a distal anchor mechanism attached by sutures, and a retrieval suture which extends to the meatus and deflates the proximal balloon when pulled. The Stent was inserted under topical anaesthesia in 30 patients. The maximum flow rate (Qmax), voided volume (VV), postvoid residual (PVR), the International Prostate Symptom Score (IPSS) and Stent position were assessed. RESULTS Stents remained in situ for a mean (range) of 57 (1–98) days. The mean overall Qmax at baseline and after insertion were 8.2 and 11.6 mL/s, representing a 42% improvement (P < 0.001); the respective mean overall VVs were similar, at 219.7 and 221.6 mL (0.9% increase, not significant) and the PVRs were 312.1 and 112.3 mL, representing a 64% decrease (P = 0.004). The overall mean IPSS declined from 22.3 before to 7.1 after insertion, representing a 68% decrease (P < 0.001). There were only minor adverse events. The stability, patency and lack of migration of the device were confirmed radiographically up to 12 weeks of use. CONCLUSIONS This early study shows that this temporary Prostatic Stent is easily inserted and removed, remains anchored in position, and significantly improves the Qmax, PVR and IPSS while preserving volitional voiding and continence.

  • A novel temporary Prostatic Stent for the relief of Prostatic urethral obstruction
    BJUI, 2004
    Co-Authors: Alberto Pablo Corica, B T Larson, A Sagaz, Thayne R Larson
    Abstract:

    OBJECTIVES To determine the effect of a novel temporary Prostatic Stent (The SpannerTM, AbbeyMoor Medical, Inc., Minnesota, USA) on variables of voiding function and quality of life among patients with Prostatic urethral obstruction. PATIENTS AND METHODS The Stent design is very similar to the proximal 4–6 cm of a Foley catheter; this includes a proximal balloon to prevent distal displacement, a urine port situated cephalad to the balloon, and a reinforced Stent of various lengths to span most of the Prostatic urethra. There is also a distal anchor mechanism attached by sutures, and a retrieval suture which extends to the meatus and deflates the proximal balloon when pulled. The Stent was inserted under topical anaesthesia in 30 patients. The maximum flow rate (Qmax), voided volume (VV), postvoid residual (PVR), the International Prostate Symptom Score (IPSS) and Stent position were assessed. RESULTS Stents remained in situ for a mean (range) of 57 (1–98) days. The mean overall Qmax at baseline and after insertion were 8.2 and 11.6 mL/s, representing a 42% improvement (P 

Jean J M C H De La Rosette - One of the best experts on this subject based on the ideXlab platform.

  • the effect of a temporary Prostatic Stent on sexual function
    Central European Journal of Urology 1\ 2010, 2009
    Co-Authors: Marleen M Van Dijk, Hessel Wijkstra, Mathijs A Van Dijk, Pilar Laguna, Jean J M C H De La Rosette
    Abstract:

    Introduction. This study was conducted to explore the effects of the bell-shaped Horizon Prostatic Stent on sexual function in the treatment of patients with LUTS/ BPH. Materials and methods. 108 Patients with LUTS/BPH were prospectively enrolled in the study. All Stents were inserted in an outpatient setting under local anesthesia. To assess sexual function, the 15 item International Index of Erectile Function (IIEF) questionnaire was used. A comparison was made between the total score of the IIEF and the different domains (erectile function (EF), orgasmic function (OF), sexual desire (SD), intercourse satisfaction (IS), and overall satisfaction (OS)) at baseline, one month, and three months after placement of Stents. In addition, patients were given the general assessment question “have you experienced any retrograde or painful ejaculations?”. results. At baseline, one patient complained of painful ejaculations (1%). After one month, four (4%) patients complained of painful and two (2%) complained of retrograde ejaculations. A statistically significant decline in the mean OF and IS scores was found. After three months, the IS score significantly improved and the decrease in the OF was smaller than after one month. However, the number of patients reporting painful and retrograde ejaculation was again higher than at baseline (three (4%) and five (7%) percent respectively). There was no change in the total IIEF score or the other subscores of the IIEF at one and three month(s). Conclusion. The bell-shaped Horizon Prostatic Stent had a negative influence on OF, which did not improve with time. The first month after Stent placement, IS was lower than at baseline. After three months however, IS significantly improved compared to baseline. The Stent did not negatively affect the total IIEF score or the other domains of the IIEF.

  • clinical utility of blind placement Prostatic Stent in patients with benign Prostatic obstruction a prospective study
    Urology, 2006
    Co-Authors: Hessel Wijkstra, Marleen M Van Dijk, Kittinut Kijvikai, Panuwat Lertsithichai, Jean J M C H De La Rosette
    Abstract:

    Abstract Objectives To assess the efficacy and safety of two versions of a blind placement temporary Prostatic Stent in the treatment of patients with benign Prostatic obstruction. Methods Two versions of a Prostatic Stent (blind placement Stent 1 [BPS-1] and BPS-2) were blindly inserted in an outpatient setting under local anesthesia. An assessment of voiding function, symptom scores, and complications was performed at baseline, directly after Stent insertion, and at 14 and 28 days after Stent placement. Results A total of 55 men were enrolled in the trial. Most Stents of both types were successfully placed. Spontaneous voiding was achieved in all patients immediately after Stent insertion, with improvements in voiding parameters and symptom scores. In patients with the BPS-1, migration occurred in 85%. In patients with the BPS-2, migration occurred in 5%. The median indwelling time of the Stent was 16 and 38 days for the BPS-1 and BPS-2, respectively. Removal was successful in all but 1 case (BPS-2). Conclusions The BPS-1 is not suitable for clinical practice because of the significantly high migration rate. The bulbar segment of the BPS-2 can prevent Stent migration. However, patients experienced significant discomfort after insertion of the BPS-2. The voiding parameters and symptom scores of the BPS-2 were not significantly improved. Therefore, the BPS-2 is also not useful for clinical practice. Additional adjustment in the design of the BPS is needed to overcome these problems.

  • hourglass shaped nitinol Prostatic Stent in treatment of patients with lower urinary tract symptoms due to bladder outlet obstruction
    Urology, 2005
    Co-Authors: Marleen M Van Dijk, C A Mochtar, Hessel Wijkstra, Pilar M Laguna, Jean J M C H De La Rosette
    Abstract:

    Abstract Objectives To assess the efficacy and safety of the thermoexpandable hourglass-shaped nitinol Prostatic Stent in the treatment of patients with lower urinary tract symptoms due to bladder outlet obstruction. Methods The Stents were inserted in an outpatient setting under local anesthesia and direct vision. Five different Stent lengths (2.0 to 4.0 cm) were used, depending on the length of the Prostatic urethra. Assessment of voiding function and symptom scores was performed at baseline, directly after Stent insertion, at 14 days, and 1, 3, 6, and 12 months after Stent placement. Results We enrolled 35 men in the trial. In 5 patients, insertion of the Stent failed, mainly because of anatomical limitations. After all placement procedures, minimal temporary hematuria was observed. Spontaneous voiding was achieved in all patients, with immediate significant improvements in voiding parameters and symptom scores. The median indwelling time of the Stent was 70 days. Kaplan-Meier survival analysis showed that at 14 days and at 3, 6, and 12 months, the Stent was still in situ in 73%, 40%, 33%, and 23% of the patients, respectively. The main reason for removal of the Stent was migration (93%), in most cases toward the bladder. Removal was uneventful in all but 1 case. Conclusions The placement of the thermoexpandable hourglass-shaped nitinol Stent results in relief of outflow obstruction and improvement of symptom scores. Because of the high migration rate, however, this Stent design needs further improvement to be suitable for clinical practice.

Hessel Wijkstra - One of the best experts on this subject based on the ideXlab platform.

  • the effect of a temporary Prostatic Stent on sexual function
    Central European Journal of Urology 1\ 2010, 2009
    Co-Authors: Marleen M Van Dijk, Hessel Wijkstra, Mathijs A Van Dijk, Pilar Laguna, Jean J M C H De La Rosette
    Abstract:

    Introduction. This study was conducted to explore the effects of the bell-shaped Horizon Prostatic Stent on sexual function in the treatment of patients with LUTS/ BPH. Materials and methods. 108 Patients with LUTS/BPH were prospectively enrolled in the study. All Stents were inserted in an outpatient setting under local anesthesia. To assess sexual function, the 15 item International Index of Erectile Function (IIEF) questionnaire was used. A comparison was made between the total score of the IIEF and the different domains (erectile function (EF), orgasmic function (OF), sexual desire (SD), intercourse satisfaction (IS), and overall satisfaction (OS)) at baseline, one month, and three months after placement of Stents. In addition, patients were given the general assessment question “have you experienced any retrograde or painful ejaculations?”. results. At baseline, one patient complained of painful ejaculations (1%). After one month, four (4%) patients complained of painful and two (2%) complained of retrograde ejaculations. A statistically significant decline in the mean OF and IS scores was found. After three months, the IS score significantly improved and the decrease in the OF was smaller than after one month. However, the number of patients reporting painful and retrograde ejaculation was again higher than at baseline (three (4%) and five (7%) percent respectively). There was no change in the total IIEF score or the other subscores of the IIEF at one and three month(s). Conclusion. The bell-shaped Horizon Prostatic Stent had a negative influence on OF, which did not improve with time. The first month after Stent placement, IS was lower than at baseline. After three months however, IS significantly improved compared to baseline. The Stent did not negatively affect the total IIEF score or the other domains of the IIEF.

  • clinical utility of blind placement Prostatic Stent in patients with benign Prostatic obstruction a prospective study
    Urology, 2006
    Co-Authors: Hessel Wijkstra, Marleen M Van Dijk, Kittinut Kijvikai, Panuwat Lertsithichai, Jean J M C H De La Rosette
    Abstract:

    Abstract Objectives To assess the efficacy and safety of two versions of a blind placement temporary Prostatic Stent in the treatment of patients with benign Prostatic obstruction. Methods Two versions of a Prostatic Stent (blind placement Stent 1 [BPS-1] and BPS-2) were blindly inserted in an outpatient setting under local anesthesia. An assessment of voiding function, symptom scores, and complications was performed at baseline, directly after Stent insertion, and at 14 and 28 days after Stent placement. Results A total of 55 men were enrolled in the trial. Most Stents of both types were successfully placed. Spontaneous voiding was achieved in all patients immediately after Stent insertion, with improvements in voiding parameters and symptom scores. In patients with the BPS-1, migration occurred in 85%. In patients with the BPS-2, migration occurred in 5%. The median indwelling time of the Stent was 16 and 38 days for the BPS-1 and BPS-2, respectively. Removal was successful in all but 1 case (BPS-2). Conclusions The BPS-1 is not suitable for clinical practice because of the significantly high migration rate. The bulbar segment of the BPS-2 can prevent Stent migration. However, patients experienced significant discomfort after insertion of the BPS-2. The voiding parameters and symptom scores of the BPS-2 were not significantly improved. Therefore, the BPS-2 is also not useful for clinical practice. Additional adjustment in the design of the BPS is needed to overcome these problems.

  • the bell shaped nitinol Prostatic Stent in the treatment of lower urinary tract symptoms experience in 108 patients
    European Urology, 2006
    Co-Authors: M M Van Dijk, C A Mochtar, Hessel Wijkstra, M P Laguna, J J M C H De La Rosette
    Abstract:

    Abstract Objectives To assess the efficacy, safety, and durability of the bell-shaped nitinol Prostatic Stent in the treatment of moderate to severe lower urinary tract symptoms caused by benign Prostatic enlargement in otherwise healthy patients. Methods Stents were inserted in an outpatient setting under local anaesthesia. Assessments included maximum urinary flow (Qmax), postvoid residual (PVR) urine volume, International Prostate Symptom Score (IPSS), including quality of life (QoL) item, at baseline and follow-up visits. Results 108 men were enrolled in the trial. Stents were successfully inserted in 97% of the patients. Spontaneous voiding was achieved in all patients. After one month Qmax (+3.7ml/s), PVR (−99ml), IPSS (−12) and QoL (−1.7) all showed statistically significant improvements compared to baseline. Substantial improvements, however, were maintained for only one to two months. The main complications were haematuria (19%), urge incontinence (22%), and migration (15%). The median indwelling time was 105 days. The main reason for removal of Stents was worsening of symptoms, which might be attributable to the tilting of Stents within the Prostatic urethra, found upon removal. Conclusions Insertion of the bell-shaped nitinol Prostatic Stent temporarily improves voiding parameters and symptom scores. Because of the limited durability, however, the bell-shaped Prostatic Stent is not suitable for clinical practice.

  • hourglass shaped nitinol Prostatic Stent in treatment of patients with lower urinary tract symptoms due to bladder outlet obstruction
    Urology, 2005
    Co-Authors: Marleen M Van Dijk, C A Mochtar, Hessel Wijkstra, Pilar M Laguna, Jean J M C H De La Rosette
    Abstract:

    Abstract Objectives To assess the efficacy and safety of the thermoexpandable hourglass-shaped nitinol Prostatic Stent in the treatment of patients with lower urinary tract symptoms due to bladder outlet obstruction. Methods The Stents were inserted in an outpatient setting under local anesthesia and direct vision. Five different Stent lengths (2.0 to 4.0 cm) were used, depending on the length of the Prostatic urethra. Assessment of voiding function and symptom scores was performed at baseline, directly after Stent insertion, at 14 days, and 1, 3, 6, and 12 months after Stent placement. Results We enrolled 35 men in the trial. In 5 patients, insertion of the Stent failed, mainly because of anatomical limitations. After all placement procedures, minimal temporary hematuria was observed. Spontaneous voiding was achieved in all patients, with immediate significant improvements in voiding parameters and symptom scores. The median indwelling time of the Stent was 70 days. Kaplan-Meier survival analysis showed that at 14 days and at 3, 6, and 12 months, the Stent was still in situ in 73%, 40%, 33%, and 23% of the patients, respectively. The main reason for removal of the Stent was migration (93%), in most cases toward the bladder. Removal was uneventful in all but 1 case. Conclusions The placement of the thermoexpandable hourglass-shaped nitinol Stent results in relief of outflow obstruction and improvement of symptom scores. Because of the high migration rate, however, this Stent design needs further improvement to be suitable for clinical practice.

C A Mochtar - One of the best experts on this subject based on the ideXlab platform.

  • the bell shaped nitinol Prostatic Stent in the treatment of lower urinary tract symptoms experience in 108 patients
    European Urology, 2006
    Co-Authors: M M Van Dijk, C A Mochtar, Hessel Wijkstra, M P Laguna, J J M C H De La Rosette
    Abstract:

    Abstract Objectives To assess the efficacy, safety, and durability of the bell-shaped nitinol Prostatic Stent in the treatment of moderate to severe lower urinary tract symptoms caused by benign Prostatic enlargement in otherwise healthy patients. Methods Stents were inserted in an outpatient setting under local anaesthesia. Assessments included maximum urinary flow (Qmax), postvoid residual (PVR) urine volume, International Prostate Symptom Score (IPSS), including quality of life (QoL) item, at baseline and follow-up visits. Results 108 men were enrolled in the trial. Stents were successfully inserted in 97% of the patients. Spontaneous voiding was achieved in all patients. After one month Qmax (+3.7ml/s), PVR (−99ml), IPSS (−12) and QoL (−1.7) all showed statistically significant improvements compared to baseline. Substantial improvements, however, were maintained for only one to two months. The main complications were haematuria (19%), urge incontinence (22%), and migration (15%). The median indwelling time was 105 days. The main reason for removal of Stents was worsening of symptoms, which might be attributable to the tilting of Stents within the Prostatic urethra, found upon removal. Conclusions Insertion of the bell-shaped nitinol Prostatic Stent temporarily improves voiding parameters and symptom scores. Because of the limited durability, however, the bell-shaped Prostatic Stent is not suitable for clinical practice.

  • hourglass shaped nitinol Prostatic Stent in treatment of patients with lower urinary tract symptoms due to bladder outlet obstruction
    Urology, 2005
    Co-Authors: Marleen M Van Dijk, C A Mochtar, Hessel Wijkstra, Pilar M Laguna, Jean J M C H De La Rosette
    Abstract:

    Abstract Objectives To assess the efficacy and safety of the thermoexpandable hourglass-shaped nitinol Prostatic Stent in the treatment of patients with lower urinary tract symptoms due to bladder outlet obstruction. Methods The Stents were inserted in an outpatient setting under local anesthesia and direct vision. Five different Stent lengths (2.0 to 4.0 cm) were used, depending on the length of the Prostatic urethra. Assessment of voiding function and symptom scores was performed at baseline, directly after Stent insertion, at 14 days, and 1, 3, 6, and 12 months after Stent placement. Results We enrolled 35 men in the trial. In 5 patients, insertion of the Stent failed, mainly because of anatomical limitations. After all placement procedures, minimal temporary hematuria was observed. Spontaneous voiding was achieved in all patients, with immediate significant improvements in voiding parameters and symptom scores. The median indwelling time of the Stent was 70 days. Kaplan-Meier survival analysis showed that at 14 days and at 3, 6, and 12 months, the Stent was still in situ in 73%, 40%, 33%, and 23% of the patients, respectively. The main reason for removal of the Stent was migration (93%), in most cases toward the bladder. Removal was uneventful in all but 1 case. Conclusions The placement of the thermoexpandable hourglass-shaped nitinol Stent results in relief of outflow obstruction and improvement of symptom scores. Because of the high migration rate, however, this Stent design needs further improvement to be suitable for clinical practice.

J J M C H De La Rosette - One of the best experts on this subject based on the ideXlab platform.

  • the bell shaped nitinol Prostatic Stent in the treatment of lower urinary tract symptoms experience in 108 patients
    European Urology, 2006
    Co-Authors: M M Van Dijk, C A Mochtar, Hessel Wijkstra, M P Laguna, J J M C H De La Rosette
    Abstract:

    Abstract Objectives To assess the efficacy, safety, and durability of the bell-shaped nitinol Prostatic Stent in the treatment of moderate to severe lower urinary tract symptoms caused by benign Prostatic enlargement in otherwise healthy patients. Methods Stents were inserted in an outpatient setting under local anaesthesia. Assessments included maximum urinary flow (Qmax), postvoid residual (PVR) urine volume, International Prostate Symptom Score (IPSS), including quality of life (QoL) item, at baseline and follow-up visits. Results 108 men were enrolled in the trial. Stents were successfully inserted in 97% of the patients. Spontaneous voiding was achieved in all patients. After one month Qmax (+3.7ml/s), PVR (−99ml), IPSS (−12) and QoL (−1.7) all showed statistically significant improvements compared to baseline. Substantial improvements, however, were maintained for only one to two months. The main complications were haematuria (19%), urge incontinence (22%), and migration (15%). The median indwelling time was 105 days. The main reason for removal of Stents was worsening of symptoms, which might be attributable to the tilting of Stents within the Prostatic urethra, found upon removal. Conclusions Insertion of the bell-shaped nitinol Prostatic Stent temporarily improves voiding parameters and symptom scores. Because of the limited durability, however, the bell-shaped Prostatic Stent is not suitable for clinical practice.