Long-term results of the FemSoft urethral insert for the management of female stress urinary incontinence.

A 5-year ongoing, controlled multicenter study enrolled 150 women. Outcome measures included pad weight tests (PWT), voiding diary (VD), quality of life (QOL) and satisfaction questionnaires. Outcome measures during the baseline period were compared to evaluations during follow-up. Concurrent evaluations with and without device use were also performed. Safety evaluations included urinalysis and culture, leak-point pressure (LPP) and cystoscopy. Adverse events (AE) were recorded throughout the study. One to 2 years of follow-up were collected on all study participants (mean 15 months). Statistically significant reductions in overall daily incontinence episodes (P<0.001) and PWT urine loss (P<0.001) were observed with the device at all follow-up intervals, and 93% of women had a negative PWT at 12 months. Women were satisfied with ease of use of the device, comfort and dryness, and significant improvements in QOL were observed (P<0.001). Subgroup analysis revealed that the insert was effective, despite the presence of urgency, low LPP, failed surgery and advanced age. AE included symptomatic urinary tract infection in 31.3%, mild trauma with insertion in 6.7%, hematuria in 3.3%, and migration in 1.3% of women. The results of PWT and VD demonstrated device efficacy. Women were satisfied and significant improvements in QOL were observed. AE were transient and required minimal or no treatment. The urethral insert should be considered as an option for the management of SUI.

Sphincteric stent versus external sphincterotomy in spinal cord injured men: prospective randomized multicenter trial.

PURPOSE: In a prospective randomized multicenter trial we compared the treatment results of conventional external sphincterotomy with those of UroLume sphincteric stent prosthesis placement in men with spinal cord injury and external detrusor-sphincter dyssynergia. MATERIALS AND METHODS: We randomized 57 men with spinal cord injury in whom urodynamics verified external detrusor-sphincter dyssynergia into 2 groups to undergo either sphincter defeating procedure. We compared the primary urodynamic parameter of maximum detrusor pressure, and secondary urodynamic parameters of bladder capacity and post-void residual urine volume in men who underwent sphincterotomy or sphincteric stent placement. Parameters were measured preoperatively, and 3, 6, 12 and 24 months postoperatively. Patients completed questionnaires regarding voiding sensation and quality of life issues at each followup visit. RESULTS: Demographic data of the 26 patients treated with sphincterotomy and the 31 treated with sphincteric stent placement were statistically similar. Preoperatively mean maximum detrusor pressure plus or minus standard deviation in sphincterotomy and stent cases was 98.3 +/- 27.6 and 95.7 +/- 27.7 cm. water, respectively (p = 0.73). At 12 months mean maximum detrusor pressure decreased to 48.9 +/- 16.4 and 52.6 +/- 31.6 cm. water in the sphincterotomy and stent groups, respectively (p = 0). Preoperatively mean bladder capacity in sphincterotomy and stent cases was 245 +/- 158 and 251 +/- 145 ml., respectively (p = 0.87). Bladder capacity did not change significantly in either treatment group throughout followup. Preoperatively mean post-void residual urine volume in the sphincterotomy and stent groups was 212 +/- 163 and 168 +/- 114 ml., respectively (p = 0.33). Residual urine volume decreased in each group at some but not all followup evaluations. The duration of hospitalization was greater for sphincterotomy than stenting (p = 0.036). Six stents required explantation. CONCLUSIONS: The UroLume stent is as effective as conventional external sphincterotomy for treating external detrusor-sphincter dyssynergia. However, sphincteric stent placement is advantageous because it involves shorter hospitalization and is potentially reversible.

Treating urinary incontinence in the elderly population: accepting the challenge.

Health care professionals who choose to treat the elderly have a responsibility to be knowledgeable about incontinence. The elderly present challenging and complex problems that may require a collaborative approach from a dedicated team, to include family members, home health nurses, continence nurses, physical therapists, as well as primary care physicians, geriatricians, urologists, and gynecologists. The elderly patient should be reminded that they are a member of that team and their commitment and participation will facilitate successful outcomes.

Epidemiology of current treatment for sexual dysfunction in spinal cord injured men in the USA model spinal cord injury centers.

This study is a prospective multicenter cooperative survey of the evaluation and treatment of erectile dysfunction in men with spinal cord injury (SCI). Uniform database questionnaires were completed prospectively by patients seeking therapy for erectile dysfunction. Eighty-five SCI men aged 17-68 years (mean age = 26 +/- 17) were enrolled. Mean duration of traumatic SCI was 3 +/- 3.2 years (Range = 0.3-18 years). The level of injury was cervical in 20 patients, thoracic in 31, lumbar in 29 and sacral in five. Patients were fully evaluated and then counseled as to their therapeutic options. Twenty-eight chose to use a vacuum erection device (VED), 26 preferred pharmacological penile injection and five used both intracorporeal therapy and VED. The remainder were managed with marriage and sexual counseling in 10 patients, three underwent penile prosthesis placement and two used topical pharmacotherapy. Four patients used other forms of treatment and in nine no therapy was recommended. Of the patients that used pharmacologic injection only, 74 percent used papaverine as a single agent, 20 percent used papaverine with phentolamine, five percent used prostaglandin E (PGE1) alone and one percent used a mixture. Patients using injection therapy report sexual intercourse a mean of 3 +/- 3.4 times per month as compared with 5 +/- 3.2 times per month in those using VED. Five intracorporeal injection patients developed priapism while two patients using the VED developed subcutaneous bleeding and one developed penile ischemia. We conclude that although a spectrum of erectile dysfunction treatment is present among SCI centers, VED and pharmacological penile injection are by far the two most popular methods of treatment and papaverine is the most common drug. The incidence of complications is small in the model centers.

Reversible clinical outcome after sphincter stent removal.

PURPOSE: We determined whether the self-expanding sphincter stent, a potential alternative to conventional external sphincterotomy for the treatment of detrusor external sphincter dyssynergia, causes a permanent effect on the lower urinary tract. MATERIALS AND METHODS: Four spinal cord injured men with voiding symptoms of detrusor external sphincter dyssynergia as noted by complete urological evaluation, including a video urodynamic study, were treated with the self-expanding sphincter stent. However, the device was explanted 6 months or longer after insertion in all 4 cases due to stent migration (3) and difficulty with condom catheter urinary drainage (1). RESULTS: All stents were removed completely without damage to the urethra. Mean voiding pressure decreased from 62.5 +/- 39.4 to 20.7 +/- 6.5 cm. water after sphincter stent placement. One year after stent explantation mean voiding pressure remained unchanged from preoperative values of 58.5 +/- 21.5 cm. water. No patient had stress urinary incontinence or endoscopically apparent urethral strictures. CONCLUSIONS: The stent can be removed even after complete epithelialization and an extended interval without damage to external sphincter function or urethral stricture formation. The urinary sphincter stent is an effective, reversible treatment for patients with detrusor external sphincter dyssynergia.

Collagen injections for intrinsic sphincter deficiency in the neuropathic urethra.

Twelve subjects experiencing stress urinary incontinence caused by spinal injury or myelomeningocele were treated by periurethral injection of a bulking agent, glutaraldehyde cross-linked (GAX) collagen. Of the 11 subjects who completed the program, seven were either cured or improved and four were only slightly improved or no better following injection. The valsalva (abdominal) leak point pressure (LPP) rose an average of 57 cm H2O (pre-treatment mean of 60 cm H2O versus post-treatment mean of 117 cm H2O) and none of the patients experienced significant complications during the mean follow-up period of 24 months. Every subject injected was able to maintain an intermittent catheterization program after treatment. These data support the use of GAX collagen as an alternative or adjunct therapy to pharmacotherapy, surgical reconstruction or implantation of a prosthesis in the management of stress urinary incontinence in the neuropathic urethra.

Management of sphincter dyssynergia using the sphincter stent prosthesis in chronically catheterized SCI men.

This effort represents a subset analysis of the long-term Multicenter North American Trial of the UroLume sphincter stent prosthesis to determine the effect of the sphincter stent prosthesis in SCI men afflicted with detrusor-external sphincter dyssynergia (DESD) and chronically managed with an indwelling urinary catheter. Forty-one of 153 male patients in this study were evaluated urodynamically before and after placement of the sphincter stent prosthesis. Of the 41 patients, 34 (81 percent) suffered cervical-level injury while 10 patients (25 percent) had been treated previously with external sphincterotomy. Forty patients (98 percent) were troubled with recurrent urinary tract infections (UTI), with a mean of 4.6 +/- 3 episodes of UTI per year. Seven patients (17 percent) demonstrated hydronephrosis prior to stent placement. Follow-up ranged from six to 44 months. Voiding pressures decreased from a mean of 77 +/- 23 cmH2O preoperatively to 35 +/- 18 cmH2O at 12 months (n = 34) and 33 +/- 20 cmH2O at 24 months (n = 22) after stent insertion (p = 0.001). Post-void residual urinary volume decreased from 202 +/- 187 ml preinsertion to 64 +/- 69 ml at 24 months (p = 0.001) postinsertion. Maximum cystometric capacity remained constant at 201 +/- 144 ml preinsertion to 203 +/- 79 ml at 24 months (p = 0.75) postinsertion. No significant changes in any of the urodynamic parameters occurred after 24 months of follow-up between patients with (n = 10) and without (n = 31) previous external sphincterotomy. Neither hemorrhage requiring blood transfusion, obstructive hyperplastic epithelial overgrowth, stent encrustation or stone formation, nor soft tissue erosion occurred in any patient.(ABSTRACT TRUNCATED AT 250 WORDS)

Nonsurgical management of threatened upper urinary tracts and incontinence in children with myelomeningocele.

The 2 major urological objectives in treating the child with myelomeningocele are to preserve renal function and achieve continence. We report our success in managing these cases with nonsurgical therapy. From 1981 to 1991, 45 patients with myelomeningocele 1 to 15 years old were evaluated urodynamically before and after initiating nonsurgical treatment. Pretreatment urodynamics identified 2 groups. Group 1 consisted of 31 patients with leak point pressure of 40 cm. water or more of whom 10 had grades II to V/V vesicoureteral reflux and 4 had moderate or severe hydronephrosis. Group 2 consisted of 14 incontinent patients with leak point pressure of less than 40 cm. water and no reflux or hydronephrosis. Both groups were treated with intermittent catheterization, anticholinergic medications and fluid restriction. Within a mean followup of 5.5 years nonsurgical intervention resulted in lowering maximum detrusor pressure at maximum cystometric capacity to less than 40 cm. water in 22 of 31 group 1 patients (71%), and in resolving vesicoureteral reflux in 7 of 10 (70%) and hydronephrosis in 3 of 4 (75%) group 1 patients. Of 4 patients in group 1 with persistent high grade vesicoureteral reflux or severe hydronephrosis 3 (10%) required augmentation cystoplasty. With nonsurgical management 18 patients (40%) were completely continent, 18 (40%) required 2 or less pads daily and 9 (20%) required more than 2 pads daily. Nonsurgical management alone was effective in preserving the upper urinary tract in 90% of patients and it provided satisfactory continence in 80%. Surgical management should be reserved for the minority of patients whose upper tract changes do not resolve and for those whose degree of continence is not satisfactory with nonsurgical management.

Treatment of drug and alcohol abuse in spinal cord injury veterans.

An innovative program has been developed at the VAMC in Long Beach, California, for the treatment of spinal cord injured veterans who are also drug or alcohol dependent. The program employs a multimodal therapeutic community model in which patients progress through successive phases, each involving increasing responsibilities and privileges. This presentation deals with the design and results of a research instrument created for the evaluation of the Drug Dependence Treatment Program (DDTP). The instrument is a posttreatment, parameter study of the multidisciplinary program. The questions asked of former patients of the DDTP were designed to investigate intrapersonal and interpersonal integration, both directly and discreetly. Questions were asked regarding arrests, length of time at domicile, hospital admissions, and use of drugs or alcohol--specifically, present use of the substance misused at the time of admission to treatment. Life-style stability or change was investigated and confirmed with collateral support, as evidenced by comparing information drawn from the 3-month period prior to admission to the treatment program with the 3-month period immediately preceding administration of the instrument. Results from the preliminary data support substantial gain in individual patient psychological and social integration. It is significant that 56% of former patients were not using treatment admission drugs.