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1.
Biomaterials ; 25(7-8): 1225-32, 2004.
Artigo em Inglês | MEDLINE | ID: mdl-14643596

RESUMO

In vitro degradation of self-reinforced PLGA 80L/20G material and bioabsorbable stents was studied in artificial urine and phosphate buffer solution (PBS) to define if the media have an effect on the degradation rate in urological applications. After six weeks, the Mv of the samples immersed in PBS was 40% (16.7 kDa) from the initial value and 57% (24.0 kDa) for the samples immersed in artificial urine. The strength loss of samples that were immersed in PBS was slower when compared with samples in artificial urine. The bending strength of samples immersed 15 weeks in artificial urine was 43% (21.7 MPa) of the bending strength of samples immersed in PBS (50.9 MPa), and the shear strength was 13% (artificial urine 3.7 MPa, PBS 28.8 MPa), respectively. The maximum compression force in PBS was slightly over at the initial level after 2 weeks of immersion. It decreased to half (102.2N) of the initial value (204.1N) in 8 weeks, and after 12 weeks it was 25% (50.8 N) of the initial value. The compression force in artificial urine was 35% (66.8 N) of the initial value (193.9 N) after 8 weeks. In 12 weeks it had lowered to 26 N in artificial urine, which was 14% of the initial value. The degradation rate of self-reinforced L-lactic and glycolic acid stents in vitro tests in artificial urine was coinciding with our clinical test. Based on these results, it is possible to make a sufficiently accurate in vitro model for the degradation rate of bioabsorbable polymers for urological applications.


Assuntos
Implantes Absorvíveis , Materiais Biocompatíveis/química , Análise de Falha de Equipamento/métodos , Ácido Láctico/química , Teste de Materiais/métodos , Ácido Poliglicólico/química , Polímeros/química , Stents , Urina/química , Absorção , Força Compressiva , Copolímero de Ácido Poliláctico e Ácido Poliglicólico , Resistência ao Cisalhamento , Resistência à Tração
2.
Biomaterials ; 19(7-9): 677-81, 1998.
Artigo em Inglês | MEDLINE | ID: mdl-9663740

RESUMO

The aim of this study was to evaluate the bacterial adherence to biodegradable self-reinforced polyglycolic acid (SR-PGA) and self-reinforced poly-DL-lactic acid (SR-PLA 96) spiral stents in vitro. They are used as temporary urethral stents in urology. Gold-plated metal wire, polyurethane and latex were used as controls. Materials were incubated up to 28 days in artificial urine, after which a bacterial suspension was added. After detaching by sonication the adhesive bacteria were analysed as colony forming units (CFUs) and by scanning electron microscopy (SEM) analysis. Adhesion was more significantly correlated to stent bacterial type than to the tested material in both assays. No encrustation was seen on SR-PGA or SR-PLA 96. SR-PGA and SR-PLA 96 had no effect on the bacterial growth. In conclusion, the bacterial properties are equally or more important than the material properties in the adhesion process.


Assuntos
Aderência Bacteriana , Materiais Biocompatíveis , Ácido Láctico , Ácido Poliglicólico , Polímeros , Stents , Bacteriúria/microbiologia , Bacteriúria/urina , Enterococcus faecalis/crescimento & desenvolvimento , Escherichia coli/crescimento & desenvolvimento , Microscopia Eletrônica de Varredura , Poliésteres , Proteus mirabilis/crescimento & desenvolvimento , Pseudomonas aeruginosa/crescimento & desenvolvimento , Infecções Urinárias/microbiologia , Infecções Urinárias/terapia
3.
Biomaterials ; 23(17): 3575-82, 2002 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-12109681

RESUMO

The possibility to decide the speed and rate of expansion of stents is of great clinical importance by reason of the varying requirements for different indications to use stents. Self-reinforced bioabsorbable stents can be made self-expanding owing to the viscoelastic memory of the material. Stents are stable at room temperature and expansion occurs at body temperature. The level at which the expansion stops depends on the material, crystallinity, initial diameter of spira and annealing temperature. The expansion rate can be estimated by logarithmic equation, if material, draw ratio and diameter of stent wire are constant. This is, however, possible only if processing parameters are constant. Based on the present results annealing temperature and expansion time were seen to be directly proportional to the expansion rate of the stent.


Assuntos
Materiais Biocompatíveis , Stents , Animais , Elasticidade , Humanos , Técnicas In Vitro , Ácido Láctico , Masculino , Teste de Materiais , Poliésteres , Ácido Poliglicólico , Copolímero de Ácido Poliláctico e Ácido Poliglicólico , Polímeros , Próstata/cirurgia , Temperatura , Viscosidade
4.
Pancreas ; 21(1): 14-21, 2000 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-10881928

RESUMO

We sought to develop a biodegradable pancreatic stent that could be easily placed at operation into the human pancreatic duct and the degradation of which could be easily followed up. Spiral-shaped, gamma-sterilized stents were manufactured of 0.4-mm polylactide wire in which there was added 23 weight-% barium sulfate. The biodegradability of the stents was studied in vitro at two different pH values, the first resembling that of pancreatic juice and the other that of bile. The effects of enzymoactivity in the test solution and the composition of the stents (with or without barium addition) also were tested. These kinds of stents have been experimented with in two pilot patients. Degradation of the stents occurred from 24 to 52 weeks of incubation. Alkaline milieu together with the presence of pancreatic enzyme made the stents degrade twice as fast as when either alkaline milieu or enzyme was present. In the milieu resembling pancreatic juice, barium sulfate had no effect on the degradation time. Neither of the pilot patients had any postoperative complications. Biodegradable, x-ray-positive stents degrade faster in pancreatic than in biliary milieu. Their safety and efficacy in human pancreaticojejunal anastomoses need further study.


Assuntos
Anastomose Cirúrgica/instrumentação , Jejuno/cirurgia , Ductos Pancreáticos/cirurgia , Neoplasias Pancreáticas/cirurgia , Poliésteres , Stents , Idoso , Materiais Biocompatíveis , Biodegradação Ambiental , Feminino , Humanos , Excisão de Linfonodo , Imageamento por Ressonância Magnética , Masculino , Suco Pancreático , Projetos Piloto , Poliésteres/farmacocinética , Desenho de Prótese
5.
Arch Otolaryngol Head Neck Surg ; 126(8): 985-91, 2000 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-10922232

RESUMO

OBJECTIVES: To design and develop a biodegradable tracheal stent that can be used internally to stabilize and support surgically reconstructed airways. DESIGN: In vitro mechanical and degradative properties of 80:20 poly(D,L-lactide-co-glycolide) (PLGA) "finger-like" stents were determined. The stents were then tested in vivo in rabbits that underwent anterior patch tracheoplasties with fascia lata grafts. Comparisons were made between a control group and an internal stent group for stridor development, overall group mortality, reconstructed airway lumen size, and histological findings. SUBJECTS: Twenty-five New Zealand white rabbits. RESULTS: The average dry modulus for the internal stents was 6800 kPa. All of the internal stents cracked by 4 weeks in buffer solution. Significant mass loss was not noted in vitro until after 5 weeks in buffer solution. By 14 weeks, the stents were nearly 100% degraded. The attrition rate for the control group was 23% compared with 17% for the experimental group. The stridor rate for the control group was also higher at 38% compared with 17% for the stented group. The stented rabbits had a significantly smaller average stenosis (23%) across the entire reconstruction site than the control group (34%) (P<.05). CONCLUSION: Biodegradable PLGA stents degrade in a predictable fashion and have a statistically significant effect in augmenting anterior patch tracheoplasties with fascia lata grafts in rabbits.


Assuntos
Materiais Biocompatíveis/uso terapêutico , Modelos Animais de Doenças , Ácido Láctico/uso terapêutico , Ácido Poliglicólico/uso terapêutico , Polímeros/uso terapêutico , Stents , Animais , Fenômenos Biomecânicos , Fáscia , Copolímero de Ácido Poliláctico e Ácido Poliglicólico , Coelhos , Sons Respiratórios/diagnóstico , Traqueia/citologia , Traqueia/cirurgia , Transplantes
6.
J Endourol ; 11(6): 391-7, 1997 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-9440846

RESUMO

Since the early 1970s, bioabsorbable polymers have been used increasingly as suture and device materials. Bioabsorbable materials are high-molecular-weight polymers of polylactide (PLA; poly[lactic acid]) or polyglycolide (PGA; poly[glycolic acid]). The mechanical properties of self-reinforced (SR) devices (SR-PGA, SR-PLLA, and SR-PLA96 spiral stents) are acquired by special processing methods from polymer materials. As a result, the spiral stent has an expansion property of up to 70% of its original outer diameter, 50% of which may occur in 30 minutes. The stent may also have variable degradation properties in different parts of the device. The use of bioabsorbable devices in urology is novel. Today, SR-PGA spirals (Biofix) to be used for the prostatic urethra are commercially available but with restrictions. Their indications are the prevention of urinary retention after thermal therapy of prostatic hyperplasia, temporary treatment of urinary retention in patients waiting for surgery, and the early-phase resolution of bladder outlet obstruction in patients waiting for the effect of medical therapy. Stents can be also used to observe the effects of prostatic surgery on bladder function. The SR-PLLA and SR-PLA96 spiral stents are still under development for use in the anterior urethra, prostatic urethra, and ureters. Further experimental and controlled clinical studies are needed to find out the suitability of bioabsorbable devices in urology. Many efforts have been made to discover the best possible materials, models, coating materials, and additives of bioabsorbable stents in urology.


Assuntos
Materiais Biocompatíveis , Stents , Urologia/instrumentação , Absorção , Animais , Materiais Biocompatíveis/química , Biodegradação Ambiental , Fenômenos Biomecânicos , Cães , Feminino , Humanos , Masculino , Poliésteres/química , Ácido Poliglicólico/química , Desenho de Prótese , Obstrução Ureteral/cirurgia , Estreitamento Uretral/cirurgia
7.
J Endourol ; 16(10): 759-62, 2002 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-12542880

RESUMO

BACKGROUND AND PURPOSE: Biodegradable urethral stents have been used clinically for some years mainly in order to prevent postoperative urinary retention after minimally invasive thermotreatment of benign prostatic hyperplasia. We previously reported a 15-month-follow-up pilot study of a bioabsorbable self-expandable, self-reinforced poly-L-lactic acid (SR-PLLA) urethral stent in combination with optical urethrotomy in the treatment of recurrent urethral strictures. The present aim was to evaluate the long-term results of this new treatment modality. PATIENTS AND METHODS: A series of 22 patients with severe urethral strictures (mean number of earlier urethrotomies 2.5) were involved. An SR-PLLA spiral stent with a bioabsorption time of 10 to 12 months was inserted into the urethra at the stricture site immediately after optical urethrotomy. Uroflowmetry, measurement of postvoiding residual urine, urine culture, and urethroscopy were performed preoperatively and at 1 and 3 months and then every 3 months up to 12 months, with subsequent follow-up visits every 6 months. The mean follow-up was 46 months. RESULTS: The treatment was successful in 8 of the 22 patients (36%). Six recurrences were found within the stented area and 15 outside. Patients with failure have since been treated with several urethrotomies and repeat self-dilatations or free skin urethroplasties. CONCLUSIONS: The results of the use of a bioabsorbable SR-PLLA urethral stent for the treatment of recurrent strictures were encouraging. Without this additional therapy, the recurrence rate of strictures might have been much higher. The main problem was sudden collapse of the stent, possibly induced by outer compression. A new generation of bioabsorbable stents is already under development.


Assuntos
Implantes Absorvíveis , Ácido Láctico , Polímeros , Stents , Estreitamento Uretral/terapia , Desenho de Equipamento , Falha de Equipamento , Seguimentos , Humanos , Masculino , Poliésteres , Recidiva , Resultado do Tratamento , Ureteroscopia , Urinálise , Micção/fisiologia , Urodinâmica/fisiologia
8.
J Endourol ; 13(2): 107-12, 1999 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-10213104

RESUMO

OBJECTIVE: To evaluate the suitability of a new biodegradable double-helical spiral self-reinforced poly-L,D-lactide copolymer (SR-PLA 96; L/D ratio 96/4) stent as a device for ureteral stenting in respect to changes in kidney function during the biodegradation process. MATERIALS AND METHODS: Sixteen dogs were used as experimental animals and were subdivided into two groups of eight. In Group A, both ureters were cut transversally, sutured, and stented. The right ureter was stented using an SR-PLA 96 stent, whereas a double-J C-Flex stent was used on the left side. Cystotomy was performed at 6 weeks to remove the double-J stents. In Group B, the right ureter of each dog was cut and stented in similar manner using an SR-PLA 96 stent, whereas the left ureters served as untreated controls, and cystotomy was not performed. Serum creatinine and nitrogen values were measured, urine was analyzed for signs of infection, and renal function was evaluated by urography and renography examinations preoperatively and at 6, 12, and 24 weeks postoperatively, at which time points, the dogs were euthanized and the ureters dissected to find persistent SR-PLA 96 particles and macroscopic local changes. There were no urinary tract infections found during the study. RESULTS: In the SR-PLA 96-stented ureters, obstructive hydronephrosis and stricture formation were observed in two cases (11%), with distal displacement of the SR-PLA 96 stent in another case (5.5%). In two additional renal units, a temporary prolongation in the kidney washout time was observed at 6-week renogram examinations. In the C-Flex-stented ureters, temporary changes in renography studies were observed in three cases (37.5%) at 6 weeks. Kidney washout times were protracted at 6 weeks in the pigtail-stented ureters in Group A as a sign of a pressure rise in the renal pelvis secondary to the direct connection between the renal pelvis and bladder, whereas pressure remained normal in SR-PLA 96-stented ureters. In Group B, renal function remained normal after ureteral repair in SR-PLA 96-stented ureters compared with the controls. CONCLUSIONS: The double-helical apical stent design offers some advantages over a double-J design. The risk of pressure-induced kidney damage is lowered, because there is no direct connection between the bladder and renal pelvis, and the risk of upper urinary tract infections is reduced. The biodegradation of the device necessitates the removal of the stent. These preliminary results suggest that a biodegradable SR-PLA 96 stent with more effective expansion capacity can be used for stenting after a ureteral repair.


Assuntos
Implantes Absorvíveis , Materiais Biocompatíveis , Poliésteres , Stents , Obstrução Ureteral/cirurgia , Animais , Biodegradação Ambiental , Modelos Animais de Doenças , Cães , Seguimentos , Rim/diagnóstico por imagem , Rim/fisiopatologia , Testes de Função Renal , Complicações Pós-Operatórias , Renografia por Radioisótopo , Obstrução Ureteral/diagnóstico , Obstrução Ureteral/fisiopatologia , Urografia
10.
Scand Audiol ; 29(4): 276-83, 2000.
Artigo em Inglês | MEDLINE | ID: mdl-11195948

RESUMO

This study was done to examine the short-term and long-term effects of multichannel cochlear implantation on speech perception in Finnish-speaking adults. The subjects comprise 20 adults. Pure-tone thresholds (0.125-8kHz), discrimination of phoneme quantity, sentence recognition, word recognition, phoneme recognition and listening performance were studied before and after implantation. After switch-on of the implant, the median pure-tone threshold values in the sound field were comparable to the level of mild hearing impairment. Most improvement in sentence recognition took place during the 6 months after the switch-on (mean score 74%). In word recognition, most improvement took place during the 12 months after the switch-on (mean score 66%), and clear improvement was noted even thereafter. In phoneme recognition, the performance of the subjects improved over the entire follow-up period, and 24 months after the switch-on the mean score was 52%. Individual variation was seen in the performance of the subjects. With 3 months of listening experience, all subjects were able to recognize some speech without speechreading, and they gained good functional benefit from the implant. The use of speech recognition tests with different degrees of difficulty is essential for the follow-up of adult cochlear implant subjects.


Assuntos
Implante Coclear/instrumentação , Surdez/reabilitação , Percepção da Fala/fisiologia , Adulto , Idoso , Audiometria de Tons Puros , Surdez/diagnóstico , Surdez/epidemiologia , Feminino , Finlândia/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Fonética , Índice de Gravidade de Doença , Testes de Discriminação da Fala
11.
Scand Audiol ; 30(2): 112-8, 2001.
Artigo em Inglês | MEDLINE | ID: mdl-11409788

RESUMO

This study was done to survey the effect of cochlear implantation on hearing level, speech perception and listening performance in Finnish-speaking adults. The subjects of the study comprise 67 adults. Pure-tone thresholds (0.125-8 kHz), word recognition and listening performance were studied before and after implantation. After switch-on of the implant, the median values of PTA(0.5-4 kHz) in the sound field were fairly stable across the evaluation period. Three months after switch-on of the implant, the mean word recognition score was 54%. There was clear improvement in the mean word recognition scores over a longer period of time, the mean score being 71% 24 months after switch-on. Six months after switch-on, the majority of subjects (40/48) were able to recognize some speech without speechreading, and 26 of these 48 subjects were able to use the telephone with a known speaker, gaining good functional benefit from the implantation.


Assuntos
Implante Coclear , Surdez/cirurgia , Percepção da Fala , Adulto , Idoso , Audiometria de Tons Puros/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Cuidados Pós-Operatórios , Complicações Pós-Operatórias , Cuidados Pré-Operatórios , Inquéritos e Questionários , Resultado do Tratamento
12.
Scand Audiol Suppl ; (52): 45-7, 2001.
Artigo em Inglês | MEDLINE | ID: mdl-11318480

RESUMO

This study was done to investigate the effect of a multichannel cochlear implant on speech perception and the functional benefit of cochlear implantation in Finnish-speaking postlingually deafened adults. Fourteen subjects were enrolled. Sentence and word recognition were studied with open-set tests auditorily only. One year after implantation, the listening performance was assessed by case histories and interviews. Before implantation for subjects with a hearing aid, the mean recognition score was 38% for sentences and 17% for words. One year after switching on the implant, the mean recognition score was 84% for sentences and 70% for words. Before implantation, the majority of the subjects were not aware of environmental sounds and only a few were able to recognize some environmental sounds. One year after switching on the implant, the majority of the subjects were able to use the telephone with a familiar speaker. All the subjects were able to recognize speech auditorily only and had thus gained good functional benefit from the implant.


Assuntos
Implante Coclear , Surdez/reabilitação , Percepção da Fala/fisiologia , Estimulação Acústica/instrumentação , Adulto , Desenho de Equipamento , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento
13.
Scand Audiol Suppl ; (52): 51-3, 2001.
Artigo em Inglês | MEDLINE | ID: mdl-11318482

RESUMO

This study was done to investigate the effects of a multichannel cochlear implant on phoneme perception in Finnish-speaking postlingually deafened adults. Phoneme recognition was studied with 100 prerecorded nonsense syllables (open-set) presented at 70 dB SPL, auditorily only, in a free-field situation. Ten subjects were tested before implantation both with and without a hearing aid (HA), and 3, 6 and 12 months after switching on the implant. Before implantation without a HA, the subjects did not recognize vowels, consonants or syllables. Four of the subjects used a HA before implantation, and the mean recognition scores of these subjects were 34% for vowels, 28% for consonants and 13% for syllables. One year after switching on the implant, the mean recognition scores were 77% for vowels, 66% for consonants and 46% for syllables. According to phonological analysis vowels appear to be easier to perceive than consonants during the first stage after multichannel cochlear implantation.


Assuntos
Implante Coclear , Surdez/reabilitação , Percepção da Fala , Estimulação Acústica/instrumentação , Adulto , Desenho de Equipamento , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fonética , Testes de Discriminação da Fala , Resultado do Tratamento
14.
Br J Urol ; 80(6): 903-7, 1997 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-9439406

RESUMO

OBJECTIVE: To evaluate the safety and tissue effects on canine uroepithelium and prostate of biodegradable self-reinforced polyglycolic acid (SR-PGA) and self-reinforced poly-DL-lactic acid (SR-PLA) spiral stents compared to stainless-steel (SS) spiral stents. MATERIAL AND METHODS: Twenty-five dogs (median body weight 12 kg) underwent a one-stage midline laparotomy and cystotomy. A side-firing Nd:YAG laser fibre was placed in the prostatic urethra antegradely and laser power applied at a setting of 20 W for 10 s in each side lobe, followed by dilatation to 4 mm diameter and insertion of a spiral stent. Dogs were randomized to receive an SR-PGA, SR-PLA or SS stent and no catheter was placed post-operatively. The dogs were killed after a follow-up of 1, 3 or 6 months and the bladder, prostate and urethra removed. Routine histological sections were prepared from the bladder, prostate, the proximal urethra immediately below the prostate and the distal urethra. RESULTS: Histological examination showed a mild to moderate foreign-body reaction and an acute inflammatory reaction after 1 month in the SR-PGA and the SR-PLA groups. The tissue effect was minimal in the SR-PGA group after 6 and 12 months. The SS stent group had more fibrosis, chronic inflammation and oedema at all follow-up assessments. There were erosions of the epithelium with subepithelial oedema in the animals with the SS stent. No dysplasia was detected and some remnants of the suture material were evident in the area of the cystotomy closure. There was one stricture at the apex of prostate in the SR-PGA group at 3 months in one re-operated dog. CONCLUSION: The histopathological changes in tissues caused by SR-PGA and SR-PLA stents were generally minor and decreased during the follow-up. The biocompatibility of SR-PGA and SR-PLA stents was good when combined with Nd:YAG laser treatment of the prostate.


Assuntos
Ácido Láctico/uso terapêutico , Lasers , Ácido Poliglicólico/uso terapêutico , Polímeros/uso terapêutico , Próstata/efeitos da radiação , Aço Inoxidável , Stents , Animais , Biodegradação Ambiental , Cães , Epitélio , Masculino , Poliésteres
15.
J Urol ; 157(1): 173-6, 1997 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-8976244

RESUMO

PURPOSE: A randomized controlled study was done to evaluate the efficacy of the self-reinforced polyglycolic acid spiral stent compared to a suprapubic catheter, and combined suprapubic and indwelling catheters in the prevention of urinary retention after visual laser ablation of the prostate. MATERIALS AND METHODS: We studied 72 men with benign prostatic hyperplasia who underwent placement of a suprapubic catheter and visual laser ablation of the prostate. In 27 men in group 1 the self-reinforced polyglycolic acid spiral stent was inserted into the prostatic urethra after visual laser ablation of the prostate, while 23 in group 2 received no other devices. In 22 men in group 3 an indwelling catheter was left in situ for an average of 6.5 days. RESULTS: Voiding began 1 or 2 days postoperatively in 20 of 27 patients (median 1 day) in group 1, and 8 of 23 (median 6 days) in group 2. In 16 of 22 men in group 3 voiding began 1 or 2 days (median 6) after removal of the indwelling catheter. Improvements in patient weighted symptom score, mean peak urinary flow rate and post-void residual volume were significant (p < 0.001) at 6 months of followup in all groups. The overall infection rate was 30%. CONCLUSIONS: The self-reinforced polyglycolic acid spiral stent is superior to the suprapubic catheter alone, and to combined indwelling and suprapubic catheters for the treatment of postoperative urinary retention after laser therapy, offering possibilities for shorter catheterization time.


Assuntos
Cateteres de Demora , Terapia a Laser , Ácido Poliglicólico , Prostatectomia/métodos , Stents , Retenção Urinária/prevenção & controle , Idoso , Idoso de 80 Anos ou mais , Biodegradação Ambiental , Desenho de Equipamento , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Prostatectomia/efeitos adversos , Retenção Urinária/etiologia
16.
J Urol ; 154(6): 2089-92, 1995 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-7500465

RESUMO

PURPOSE: The efficacy and safety of a new biodegradable (self-reinforced polyglycolic acid) spiral stent in securing free voiding despite edema after visual laser ablation of the prostate were studied. MATERIALS AND METHODS: A biodegradable spiral stent was inserted into the prostatic urethra in 22 patients immediately after visual laser ablation of the prostate. Uroflowmetry, measurement of residual urine volume, urine culture, cystoscopy and assessment of symptomatic improvement were done before, and 1, 3 and 6 months after visual laser ablation of the prostate. RESULTS: All 22 patients voided freely on day 1 or 2 after visual laser ablation of the prostate. However, 4 patients later had urinary retention due to a short spiral or too rapid spiral degradation. Half of the patients experienced a transient decrease in flow with some obstructive symptoms at 3 weeks that lasted 1 to 2 weeks. At 4 weeks all spirals were degraded and 3 patients had a positive urine culture. The maximum flow rate increased and the residual urine volume decreased significantly concomitantly with significant symptomatic improvement. CONCLUSIONS: The self-reinforced polyglycolic acid spiral stent can effectively and safely prevent postoperative urinary retention after visual laser ablation of the prostate.


Assuntos
Fotocoagulação a Laser/efeitos adversos , Ácido Poliglicólico , Prostatectomia/efeitos adversos , Prostatectomia/métodos , Stents , Retenção Urinária , Retenção Urinária/prevenção & controle , Idoso , Idoso de 80 Anos ou mais , Biodegradação Ambiental , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Retenção Urinária/etiologia
17.
Br J Urol ; 80(3): 439-43, 1997 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-9313664

RESUMO

OBJECTIVE: To evaluate the efficacy and safety of a biodegradable self-reinforced poly-DL-lactic acid (SR-PLA) spiral stent compared with a suprapubic catheter after visual laser ablation of the prostate (VLAP) in a randomized study. PATIENTS AND METHODS: The study comprised 45 patients (mean age 67.6 years, range 52-81) with bladder outlet obstruction caused by benign prostatic hyperplasia who received either a SR-PLA stent (22 patients) and a suprapubic catheter, or a suprapubic catheter only (23 patients) after undergoing VLAP. The suprapubic catheter was removed when voiding started. The response to VLAP and the effect of the stent or catheter were assessed using symptom scores, peak flow rate (Qmax), post-void residual volume (PVR), stent degradation, infection and outcome. RESULTS: Voiding started on the first or second day after treatment in 18 (median one day) of 22 patients with a spiral stent and in eight (median 6 days) of 23 patients with only the suprapubic catheter. The mean degradation time of the SR-PLA stent was 6 months; spiral fragments were found in the prostatic urethra or the urinary bladder in 20 of the patients on cystoscopy. Improvements in patient-weighted symptom score, mean Qmax and PVR were significant in both groups at the 6 month follow-up. The infection rate increased with the duration of suprapubic catheterization, from 25% (0-3 days) to 44% (> 3 days). Stones were seen in two stented patients during the follow-up. CONCLUSION: The SR-PLA spiral stent is safe and effective for the treatment of post-operative urinary retention after laser therapy. The degradation time of the stent was unnecessarily long compared with the duration of prostatic swelling and tissue sloughing after laser therapy. The infection rate depends on the duration of suprapubic catheterization.


Assuntos
Fotocoagulação a Laser/métodos , Ácido Poliglicólico/uso terapêutico , Hiperplasia Prostática/complicações , Stents , Retenção Urinária/terapia , Idoso , Idoso de 80 Anos ou mais , Materiais Biocompatíveis , Biodegradação Ambiental , Humanos , Masculino , Pessoa de Meia-Idade , Hiperplasia Prostática/cirurgia , Infecções Urinárias/etiologia
18.
J Urol ; 160(6 Pt 1): 2033-6, 1998 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-9817317

RESUMO

PURPOSE: We studied whether a new bioabsorbable self-expandable, self-retaining and self-reinforced poly-l-lactic acid double spiral stent is able to prevent the edges of a cut recurrent urethral stricture from adhering together and the scar from shrinking, thus obviating stricture recurrence. MATERIALS AND METHODS: A bioabsorbable spiral stent was inserted into the stricture site in the urethra immediately after optical urethrotomy in 22 patients with recurrent urethral stricture. Uroflowmetry, measurement of residual urine volume, urine culture and urethroscopy were performed before and 1, 3, 6 and 12 months after optical urethrotomy. RESULTS: All 22 patients voided freely on day 1 or 2 after urethrotomy. The stent slipped partially proximal to the stricture and had to be changed in only 1 patient. The stent was totally epithelialized in all but 1 patient at 6 months and had degraded in all at 12 months. The improvement in flow rate was maintained during followup except in 10 patients with stricture recurrence, which was outside the stent area usually close to the external sphincter in 7 and in the stent area in 3. All recurrences were treated with repeat optical urethrotomy and a new stent was inserted. Urinary infections developed in 2 patients and were successfully treated with oral antibiotics. CONCLUSIONS: The self-expandable self-reinforced poly-l-lactic acid double spiral stent is a promising new method in the treatment of recurrent urethral strictures. There is no need to remove the device and no foreign material remains in the urethra. However, longer followup and controlled studies are needed to evaluate all benefits and side effects of this new treatment modality.


Assuntos
Implantes Absorvíveis , Ácido Láctico , Polímeros , Stents , Estreitamento Uretral/terapia , Adulto , Idoso , Idoso de 80 Anos ou mais , Humanos , Masculino , Pessoa de Meia-Idade , Poliésteres , Recidiva
19.
J Urol ; 162(5): 1764-7, 1999 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-10524932

RESUMO

PURPOSE: Recently a first X-ray-positive bioabsorbable urethral stent was developed by our group. The stent is made from self-reinforced poly-L,D-lactic acid (SR-PLA 96/4) blended with barium sulfate. The aim of this study was to evaluate the biocompatibility properties of the new stent materials. MATERIALS AND METHODS: Rods made from pure SR-PLA 96/4 and SR-PLA 96/4 blended with barium sulfate were inserted into the dorsal muscles of a rabbit. Rods made from latex and silicone were used as positive and negative controls. To evaluate the long-term effect of BASO4 after the bioabsorption of the polymer, fast degrading SR-PGA (self-reinforced polyglycolic acid) and SR-PLA + BASO4 rods were used as controls. Urethral stents made from SR-PLA 96/4 and X-ray-positive SR-PLA 96/4 stents were inserted cystoscopically into the rabbit urethra. Metal stents were used as controls. The animals were sacrificed after 1 week, 1 month or 6 months. RESULTS: In the muscle implantation samples acute tissue reactions due to operative trauma were seen in all specimens at 1 week. After 6 months chronic inflammatory changes and foreign body reaction were seen only in the positive controls. The stent worked well in the rabbit urethra, its biocompatibility was good and there was less encrustation than in the metal stents. CONCLUSIONS: This first X-ray-positive bioabsorbable urethral stent showed no toxic tissue effects.


Assuntos
Implantes Absorvíveis , Materiais Biocompatíveis , Ácido Láctico , Polímeros , Stents , Uretra , Animais , Masculino , Teste de Materiais , Poliésteres , Coelhos , Raios X
20.
Scand J Urol Nephrol ; 34(4): 262-6, 2000 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-11095085

RESUMO

OBJECTIVE: Interstitial laser coagulation (ILC) of the prostate induces necrosis, oedema and increased risk for postoperative urinary retention. The present randomized study was carried out to investigate the feasibility and efficacy of a biodegradable self-reinforced polyglycolic acid (SR-PGA) stent in preventing postoperative urinary retention and the need for prolonged catheterization after ILC treatment. MATERIAL AND METHODS: 35 males with benign prostatic enlargement (BPE) entered the study: 21 in the ILC + stent group and 14 in the ILC group without a stent. A suprapubic catheter was inserted for all patients and ILC was performed. The SR-PGA stent was inserted immediately after laser therapy in the stent group and kept open until the next morning when it was closed and the patient started trying to void. The suprapubic catheter was removed after voiding had started and the urinary bladder emptied adequately. RESULTS: In the ILC + stent group voiding started on the first postoperative day in 17 patients and on the second day in 2 patients. Voiding was delayed in 2 cases: in 1 case due to inadequate length of the stent and in the other as a result of the stent placement being too proximal. There was 1 case of urinary retention due to early degradation of the stent. In the ILC-only group voiding started on average 6.1 days postoperatively. At 1 month follow-up, the mean peak urinary flow rate had increased significantly in the ILC + stent group (p < 0.05) but not in the ILC-only group (p = 0.26). Improvements in symptom scores were significant in both groups (p < 0.005) but in terms of the mean peak urinary flow rates at 6 months follow-up the improvement was significant only in the stent group (p < 0.05). CONCLUSIONS: The use of a SR-PGA stent enabled early voiding and is safe and effective in the treatment of postoperative urinary retention after ILC. The 3-4 week degradation time of the SR-PGA stent was too short for some patients. There is still a need for further development work to improve the stents and larger controlled studies to show the true value of biodegradable stents in the treatment of BPE.


Assuntos
Fotocoagulação a Laser/métodos , Ácido Poliglicólico/uso terapêutico , Hiperplasia Prostática/complicações , Stents , Retenção Urinária/prevenção & controle , Idoso , Materiais Biocompatíveis , Biodegradação Ambiental , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Hiperplasia Prostática/cirurgia , Retenção Urinária/etiologia
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