Bone anchored sling for the treatment of post-prostatectomy incontinence.

PURPOSE: This ongoing study evaluates the safety and efficacy of a new minimally invasive sling procedure for treating post-prostatectomy incontinence. MATERIALS AND METHODS: A total of 16 men 56 to 74 years old (mean age 67) underwent the procedure using the Straight-In bone anchoring system. Time after prostatectomy was 1.5 to 5 years (mean 2.5). Of the 16 patients 14 had urodynamically confirmed stress urinary incontinence, while 2 had mixed incontinence with stress incontinence and detrusor instability. The procedure is performed with the patient in the lithotomy position using a perineal approach. Four miniature bone screws with pre-attached pairs of No. 1 polypropylene sutures are placed directly into the medial aspect of the inferior rami of the pubic bone. A pair of bone anchors is placed just below the symphysis on each side, and the second pair is inserted 3 to 4 cm. lower. To support the bulbar urethra a gelatin coated polyethylene terephthalate trapezoid shaped sling or cadaveric fascia lata is tied to the pubic bone using the 4 pairs of sutures attached to the bone anchors. Urethral resistance is increased to 30 to 50 cm. water above baseline pressure. RESULTS: Followup was 4 to 20 months (mean 12.2). Of the 14 men with the preoperative urodynamic diagnosis of genuine stress incontinence 12 were cured of incontinence, defined as subjectively dry with no or only 1 pad used daily for security without any episode of leakage, while 2 were improved subjectively with a decrease of 50% or more in pads daily. Two other patients with the preoperative diagnosis of mixed urinary incontinence were improved. Postoperatively urodynamic study in these patients revealed resolved stress incontinence but persistent urge urinary incontinence. They responded to anticholinergics and are completely dry. Intraoperative and postoperative complications were minimal with no erosion, infection or osseous complications. CONCLUSIONS: This new minimally invasive male sling procedure is safe and efficacious. Adjusting sling tension by measuring urethral resistance results in a low rate of over correction and failure. Further experience is needed to establish this procedure as treatment for post-prostatectomy incontinence.

Long-term follow-up of the in-flowtrade mark intraurethral insert for the treatment of women with voiding dysfunction.

OBJECTIVE: The aim of the current study is to report the long-term follow-up of women treated with the In-Flowtrade mark device for periods longer than 1 year. Abstract METHODS: The efficacy of the intraurethral insert was evaluated in 92 women. Data regarding their urodynamic diagnosis, complications and satisfaction were collected. RESULTS: Early and late discontinuation of the device use was recorded in 52 patients (56.5%) and 19 patients (20.6%), respectively. Twenty-one patients (22.8%) are now being followed for more than 1 year with a follow-up time of 12-44 months (mean 24.6). Complications include device migration into the bladder (4 patients), asymptomatic bacteriuria (15 patients), and symptomatic urinary tract infections (4 cases, 1 of them pyelonephritis). In the 3 women who were sexually active before treatment, the use of the device did not preclude sexual intercourse, although mild dyspareunia was reported in 1 patient. Two patients complained of episodic inconvenience between their legs during walking. All patients were satisfied with the device and preferred it to previous treatment modalities used. The reasons for early and late discontinuation of treatment are described and discussed. CONCLUSIONS: The In-Flowtrade mark intraurethral insert can serve as a long-term treatment for the management of women with voiding difficulties. Women who continue treatment for a prolonged time are satisfied with the device use. Further studies comparing this treatment with other modalities are needed to support the role of the In-Flowtrade mark device in the management of women with voiding dysfunction.

Transvaginal bone anchored sling.

INTRODUCTION: To describe a new technique for the treatment of stress urinary incontinence by the transvaginal creation of a sling anchored to the pubic bone. This technique is minimally invasive and easy to learn, with minimal morbidity and complications. TECHNICAL CONSIDERATIONS: Miniature bone screws with No. 1 polypropylene sutures attached to them and a battery-operated screw inserter are used for the fixation of a biocompatible fabric sling to the pubic bone. The procedure is performed transvaginally with no abdominal or suprapubic incisions. One screw is inserted on each side of the urethra into the pubic bone below the bladder neck. A tunnel is made submucosally between these two holes just below the bladder neck, and the sling is passed through it. Using the sutures on each side of the urethra, the sling edges are tied and pulled toward the pubic bone. The openings made in the vaginal mucosa are closed with absorbable sutures. CONCLUSIONS: This sling procedure is minimally invasive, safe, and effective. Further experience and longer follow-up are necessary to establish its role in the treatment of women with stress urinary incontinence.

A remote controlled intraurethral insert for artificial voiding: a new concept for treating women with voiding dysfunction.

PURPOSE: Many patients with voiding dysfunction find clean intermittent catheterization unsatisfactory. We evaluated the efficacy of the new remote controlled intraurethral In-Flow Catheter insert for treating women with voiding dysfunction. MATERIALS AND METHODS: We evaluated the efficacy of the intraurethral insert in 92 women with a mean age of 56 years. The insert is available in various sizes to adapt to individual urethras. It comprises a valve and pump assembly. A remote control unit is operated to open the valve and activate the pump, generating active urine flow. RESULTS: In 45 patients (49%) the device was removed after a mean of 7.1 days due to local discomfort or urinary leakage around the insert. At a mean followup of 7.6 months (range 2 to 26) 47 women (51%) continued to use the device, and all are dry with complete bladder emptying. The insert was replaced periodically at a mean of 38 days to prevent salt deposits in and around it which lead to urine leakage. Asymptomatic bacteriuria developed in 22 patients (46.8%). Clinical urinary tract infections resolved in 3.9% of all patients-months with oral antibiotics. No dyspareunia was reported. All patients were satisfied with the insert and preferred it to previous treatment modalities. CONCLUSIONS: This new remote controlled intraurethral insert is safe and effective in women with voiding difficulties.

Minimally invasive pervaginam procedures for the treatment of female stress incontinence using a new pubic bone anchoring system.

The purpose of this ongoing study is to evaluate the safety and efficacy of new minimally invasive pervaginam cystourethropexy and sling procedures for the treatment of female genuine stress urinary incontinence. A total of 75 women (mean age, 52.8 years) underwent either a cystourethropexy or a sling procedure. A miniature bone anchor and a staple-like bone anchor driver were used for the fixation of periurethral tissue or a xenogenic sling to the pubic bone. With a mean follow-up of eight months, 61 patients (82%) were completely cured of stress incontinence, 10 (14%) reported a more than 50% decrease in pad usage, and 4 patients showed failure early following surgery. The exclusively pervaginam cystourethropexy and sling procedures are minimally invasive, safe, and effective. Further experience and longer follow-up are necessary to establish their role in the treatment of women with stress urinary incontinence.

Pubic bone anchoring in the treatment of women with stress urinary incontinence: new applications to an old concept.

The concept of using the pubic bone as a support for the bladder neck and urethra in the treatment of women with genuine stress urinary incontinence is well established, and is applied in traditional procedures such as Marshall-Marchetti-Krantz and the Burch colposuspensions. Recently, minimally invasive techniques, including the use of laparoscopic surgery and pubic bone anchoring systems, have been introduced. These new techniques, attempt to combine the advantages of retropubic procedures while remaining minimally invasive. A search of the English literature was carried out, traditional and new procedures using the pubic bone as a support for the bladder neck and urethra are described, and their efficacy and complications are reviewed and discussed. Traditional procedures have proved to be highly effective and well tolerated, with good long-term outcomes. The early results of innovative minimally invasive techniques are promising, but further experience and longer follow-up is needed to establish their role in the treatment of female stress urinary incontinence.

Incisionless per vaginal bone anchor cystourethropexy for the treatment of female stress incontinence: experience with the first 50 patients.

PURPOSE: We evaluated the safety and efficacy of a new minimally invasive surgical procedure for the treatment of women with genuine stress urinary incontinence. MATERIALS AND METHODS: A total of 50 women (mean age 51 years) was treated for type I or II stress urinary incontinence. A miniature bone anchor and a staple like bone anchor driver were used for fixation of periurethral tissue to the public bone. RESULTS: The procedure was successfully performed in all patients without intraoperative bleeding. No significant persistent postoperative pain was noted and only 1 patient had urinary tract infection. Concomitant vaginal hysterectomy, cystocele repair or perineoplasty was performed in 33 cases. At 12-month followup 41 patients (82%) are completely continent, 7 patients (14%) reported more than 50% decrease in pad usage and 2 cases are considered surgical failures. Mean operative time was 28 minutes. CONCLUSIONS: Data suggest that our new minimally invasive procedure provides a safe, effective and easy to learn alternative for treatment of women with anatomical stress incontinence.

Bladder neck suspension using bone anchors for the treatment of female stress incontinence.

A new technique and related devices for the treatment of urinary incontinence in women was developed and tested. The technique involves soft tissue to bone fixation by means of miniature bone anchors and a bone anchor inserter. The novel bone anchors are made of a shape-memory nickel titanium alloy (Nitinol) attached to Polypropylene or Gortex suture. A spring-loaded bone anchor inserter drives the anchors through the vaginal wall to a predetermined depth into the pubic bone medulla regardless of the bone's hardness, with no incision or drilling required. The device allows for the performance of a minimally invasive transvaginal bladder neck suspension. The procedure has minimal morbidity and a short learning curve. This technique was evaluated clinically in 15 women with incontinence, with a mean follow-up of 6 months. Good urinary continence was achieved in all patients, with no mechanical failures.

A new intraurethral sphincter prosthesis with a self contained urinary pump.

An intraurethral sphincter prosthesis with a self contained urinary pump for the management of atonic bladder in women was developed and tested. The prosthesis is comprised of a short, self retaining silicone catheter in which there is a valve and pump. Available in a range of lengths and diameters according to urethral size, its insertion is similar to that of a urethral catheter. The prosthesis is secured by a novel fixation method that has soft expandable silicone fins at the bladder neck and a flexible flange at the external meatus. It is activated by a small hand-held control device. To urinate, the activator is placed on the lower abdomen area and the "on" button is pressed, providing energy to the pump by a magnetic coupling method. Once activated, the valve opens and the pump rotates at a high speed, drawing urine from the bladder and pushing it forward, allowing the patient to "void" with a urine flow of 10 to 12 cc/sec. When the bladder is completely evacuated, the pumping ceases and the valve closes, restoring continence. The device was evaluated clinically in 17 women. Fifteen of the patients had a range of use of 2 weeks to 16 months during which they were dry and had complete bladder emptying. Two patients did not tolerate the device because of uninhibited detrusor contractions and, in both cases, it was removed without complication after 5 days.

Self-expandable and highly flexible nitinol stent: immediate and long-term results in dogs.

We sought to investigate the acute and long-term patency rates and the histologic response of coronary arteries to a self-expandable nitinol coil stent. Twenty-two stents were implanted. Angiographic patency was demonstrated acutely in all but one dog, in which the stent was released in a small branch (1 mm); mismatch in stent-to-artery diameters resulted in vessel closure. Two dogs died from anesthesia overdose and two from bleeding within 24 hours. All dogs were treated with aspirin (80 mg/day) and warfarin (2.5 mg/day) for up to 1 month. Sixteen dogs were monitored for 1 to 2 weeks, 1 month, 3 months, 6 months, and 1 year and underwent subsequent angiography and histopathologic examination. Angiographic artery dimensions measured immediately after stent implantation (2.72 +/- 0.4 mm) did not differ from those noted at follow-up (2.68 +/- 0.44 mm, p not significant). Histologic examination showed outward stent pressure compressing the internal elastic membrane and media in most cases. Intimal hyperplasia started at 2 weeks and was most apparent at 3 and 6 months. Mean intimal thickness was 30.7 +/- 10.9 mu, 141.8 +/- 105.4 mu, 227.1 +/- 104.1 mu, 211.8 +/- 99.1 mu, and 170.1 +/- 42.7 mu at 1 to 2 weeks and 1, 3, 6 and 12 months, respectively. Therefore the nitinol self-expandable stent provokes a moderate cellular proliferative response that reaches its maximum in 3 to 6 months without further progression.

A new, large calibre, self-expanding and self-retaining temporary intraprostatic stent (ProstaCoil) in the treatment of prostatic obstruction.

OBJECTIVE: To determine the benefits of a new self-expanding and self-retaining large calibre temporary intraprostatic coil stent in patients with bladder outflow obstruction due to benign prostatic hypertrophy. PATIENTS AND METHODS: Sixty-five patients with bladder outflow obstruction have been studied with a follow-up period of 3-28 months (mean 16). RESULTS: Thirty patients became eligible for surgery and had their stent removed without difficulty 3-12 months after stent insertion. Only one stent was removed because of urgency and incontinence. Stent repositioning was required in five patients and 14 complained of temporary dysuria or perineal pain. Twenty-seven patients continue to pass urine through their stent without difficulty. CONCLUSION: Because of its large diameter and its temporary nature this new stent allows endoscopic examination of the bladder and has few side effects. This stent should be considered as an alternative to a urethral catheter or other temporary stents in patients who are unfit for surgery.

Self-expandable Nitinol stent for cardiovascular applications: canine and human experience.

The initial experimental and clinical experience with the cardiovascular self-expandable Nitinol stent (vascular and coronary versions) is described. The stent is designed as a helical coil with two terminal balls that are used for restraining it on the delivery catheter. Upon release, the stent self-expands immediately. A temporary stent version continues with a long wire that can be removed by pulling it as a straight wire through a small profile catheter. The stent uncoils in its own groove upon removal, a relatively atraumatic procedure. The stents have been studied in dogs and in peripheral arteries in patients. The results show a transient nonocclusive proliferative response to the stent that is maximal at 3-6 mo. The removability of the permanent stent has been proven in dogs. The preliminary results in patients are encouraging and demonstrate its feasibility for permanent and potentially temporary arterial support.

A new self-expandable and removable metal stent for biliary obstruction--a preliminary report.

We report our experience with a new self expandable metallic stent, a coil spring made from a nickel-titanium alloy. The super elastic characteristic of this metal offers a very strong radial force and previous dilatation of biliary strictures is not necessary. The stent is endoscopically inserted constricted over an introducing catheter, expanding spontaneously after release to its original 8 mm diameter. During the last six months, eleven stents were inserted in nine patients with pancreatic carcinoma to relieve jaundice. Another stent was percutaneously implanted treating a benign stricture in a patient with a choledochojejunostomy after a Whipple operation. Clinical improvement was achieved in all the patients except in one who died from liver metastases 5 weeks later. In two patients, although stents were obstructed after 2 and 4 months from insertion, they were easily removed by pulling their distal end through the endoscopic working channel. After a mean follow up of 4.5 months, patients had no evidence of biliary reobstruction. Although follow-up is short, these results are encouraging, and this new metallic stent seems to have several advantages over the current commercially available ones.

The incidence of congenital penile curvature.

To determine the incidence of congenital penile curvature a group of 500 consecutive male neonates at our institution were examined for this anomaly. In this group there were 3 cases of congenital penile curvature, for an incidence of 0.6%.

New, self-expanding, self-retaining temporary coil stent for recurrent urethral strictures near the external sphincter.

Strictures near the external sphincter are a cause for concern. They can be managed by manipulation (e.g. urethral dilatation) or by anastomotic urethroplasty. Permanently implanted metallic stents have recently been used to treat recurrent urethral strictures. This report presents the results of using a temporary metallic coil stent (UROCOIL-S) in 20 patients with recurrent bulbomembranous strictures. In 13 patients the stent was left in place for 10 months and was then removed by a simple manipulation. After a mean follow-up of 10 months (range 3-14), the stricture recurred in only 1 patient. The use of a temporary (but long-term) stent for the treatment of urethral stricture is a new approach and the results are encouraging.

New temporary coil stent (Urocoil) for treatment of recurrent urethral strictures.

The Urocoil is a temporarily inserted self-expanding and self-retaining coil stent made of medical-grade stainless steel that is inserted under fluoroscopy after topical anesthesia of the urethra. This stent was used for 16 patients with a variety of recurring urethral strictures who had been managed in the past by repeated dilatations and urethrotomies. The stent was left in place for 6 months. Unlike permanently implanted mesh stents, no tissue growth into the lumen occurred with this stent, making its removal a simple procedure. With a follow-up of 3 to 9 months after removal, no recurrence of the strictures was observed. This temporary stent seems to be effective in the treatment of recurring urethral strictures. Satisfactory and promising results were obtained without leaving a foreign body permanently in the urethra.

New treatment modality for penile urethral strictures using a self-expanding and self-retaining coil stent: UroCoil. Follow-up of 16 months after removal of the stent.

Twelve penile urethral strictures which were managed in the past (2-21 years) by dilatations, urethrotomies, or by urethroplasty, were treated by an insertion of a temporary but long-term metallic coil stent. In 9 cases, the stent was left in place 6-9 months; in 3 cases, the stent is still in place. During the time the stent was inside, 4 patients who were sexually active before insertion of the stent were able to continue sexual activity. During a mean follow-up time of 16 months (range 4-24 months) after the removal of the stent, in only 1 case did the stricture recur. At present, this new internal device is the only one which can stent the penile part of the urethra temporarily without interfering with the sexual activity of the patient, and without causing pain or the risk of urethral perforation.

Temporarily implanted urethral coil stent for the treatment of recurrent urethral strictures: a preliminary report.

A new urethral stent developed for use in recurrent urethral strictures is presented. This metallic coil is self-expanding when released from its introducing catheter. The stent was used in 18 patients with recurrent strictures necessitating frequent dilation or urethrotomy. The stent is introduced under fluoroscopic guidance after internal urethrotomy or simple dilation. Strictures of 5 to 60 mm. were treated successfully with this device. All strictures were distal to the external sphincter. No serious complications attributed to the device were recorded. When necessary, the stent could be repositioned either under fluoroscopic control or endoscopically. This device can hold the stenotic area of the urethra open for long intervals allowing for complete healing. Even after 6 months the stent is not covered with urethral epithelium and does not become incorporated into the urethral wall. It can be removed easily without an operation by simple manipulation. The large internal caliber permits passage of endoscopes up to 17F in patients who require cystoscopy. The device can be removed before transurethral resections and then a new stent can be inserted at the end of the procedure. Mean followup of our patients with the stent indwelling was 8 months (range 4 to 11 months). Followup after removal of the stent (6 patients) was 3 to 8 months (mean 5 months). The patients voided well during followup and were fully continent. No incrustations were noted in the removed stents even after 6 months and no stent became obstructed due to tissue proliferation or incrustation. In 1 patient the stricture recurred after 3 months and a new stent was inserted. Urine sterilization was obtained in 7 patients with infected urine after relatively short courses of antibiotics. This stent seems to be a promising tool for the nonoperative treatment of recurrent urethral strictures.