Viscoelastic memory and self-expansion of self-reinforced bioabsorbable stents.

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.

A randomised study to evaluate the efficacy of a biodegradable stent in the prevention of postoperative urinary retention after interstitial laser coagulation of the prostate.

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.

Bacterial adherence to self-reinforced polyglycolic acid and self-reinforced polylactic acid 96 urological spiral stents in vitro.

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.

The biodegradable self-reinforced poly-DL-lactic acid spiral stent compared with a suprapubic catheter in the treatment of post-operative urinary retention after visual laser ablation of the prostate.

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.

A randomized study to compare biodegradable self-reinforced polyglycolic acid spiral stents to suprapubic and indwelling catheters after visual laser ablation of the prostate.

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.

Effects of biodegradable self-reinforced polyglycolic acid, poly-DL-lactic acid and stainless-steel spiral stents on uroepithelium after Nd:YAG laser irradiation of the canine prostate.

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.

Bioabsorbable and biodegradable stents in urology.

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.

Biodegradable self-reinforced polyglycolic acid spiral stent in prevention of postoperative urinary retention after visual laser ablation of the prostate-laser prostatectomy.

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.