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Pubovaginal sling using cadaveric fascia and bone anchors: disappointing early results.

PURPOSE: Pubovaginal sling procedures offer highly effective treatment for patients with female stress urinary incontinence. A recent modification of this technique is the use of cadaveric fascia lata as a sling material supported with titanium anchors placed bilaterally in the pubic bone. We reviewed our experience with this procedure and assessed our outcome. MATERIALS AND METHODS: A total of 154 consecutive patients underwent a bone anchored, cadaveric fascia pubovaginal sling procedure by a single surgeon from July 1998 to June 1999. All patients were evaluated preoperatively with a detailed history, pelvic examination and radiographic or multichannel video urodynamic studies to diagnose stress urinary incontinence. Our technique begins with the nonincision placement of titanium bone anchors transvaginally into the pubic bone bilaterally. A 2 cm. wide tunnel is created bluntly beneath the vaginal epithelium between the 2 puncture sites with a right angle clamp. A 2 x 7 cm. strip of cadaveric fascia is then passed through the tunnel, into the retropubic space and secured to 2-0 polypropylene sutures attached to the anchors. After securing the sling, the transvaginal puncture sites are closed with 2-0 polyglactin sutures. Patients were seen postoperatively at 6 weeks, and 3 and 6-month followup. Patient age averaged 60 years (range 38 to 85), with an overall average length of followup from surgery of 10.6 months (range 6 to 16). All patients were mailed a self-administered questionnaire and participated in a telephone interview with an office nurse to retrospectively assess outcome and evaluate for recurrent stress urinary incontinence. Recurrent stress urinary incontinence was graded as 0-none, 1-rare, 2-moderate and 3-severe. Repeat pubovaginal sling procedure that was performed in patients with grades 2 to 3 stress urinary incontinence was considered a failure for the purpose of our study. RESULTS: Of all 154 patients 58 (37.6%) had recurrent moderate to severe (grades 2 to 3) stress urinary incontinence at followup. A total of 26 patients underwent a second pubovaginal sling procedure for a reoperation rate of 16.9%. Intraoperative findings at reoperation revealed the titanium anchors to be in position, the polypropylene sutures to be intact, and retropubic fibrosis and scarring of the urethropelvic ligament suggesting appropriate retropubic placement of the sling in all cases. Uniformly all allogenic cadaveric fascia used for sling material appeared to be fragmented, attenuated or simply absent. Average time to reoperation was 9 months (range 3 to 15). CONCLUSIONS: Early results using a bone anchored cadaveric fascia pubovaginal sling procedure were discouraging. Based on findings at reoperation, we attribute this result to the failure of our sling material and have abandoned the use of cadaveric fascia allografts in all pubovaginal slings at our institution.

Adult↗

[Disappointing long-term experiences of patients with penile prosthesis].

OBJECTIVE: To describe the long-term experience with the implantation of a penile prosthesis as a last resort treatment for erectile dysfunction. DESIGN: Retrospective and descriptive. METHOD: During the period 1986-1996, 124 men received a penile prosthesis. Basic information was obtained from medical files. Seventy-six men could be traced and were sent a questionnaire. Sixty patients and 44 partners participated in the study. RESULTS: The median time since the implantation was 81.3 months (range: 13-139). The chance of reoperation was 35%. Seventeen percent of the patients and 25% of the spouses regretted the decision to have the implantation. Thirty-one percent no longer used the prosthesis and 15% had never used it. Twenty percent of the patients and 31% of the partners noticed an improvement in their sexual relationship whereas 26% and 23% respectively noticed a decline. Twenty percent of the patients sometimes failed to penetrate despite the prosthesis. Nevertheless, 66% would advise implantation to someone else. Almost 50% of the men reported spontaneous tumescence during sexual arousal. CONCLUSION: After the implantation of a penile prosthesis, the reoperation rate was high, and many patients and their partners were dissatisfied with their sexual relationship despite regaining a functional erection. Implantation requires thorough sexological counselling both before and after the operation.

Adult↗

Rofecoxib: new preparation. A disappointing NSAID analgesic.

(1) Rofecoxib, a nonsteroidal antiinflammatory drug, is licensed in France for symptom relief in osteoarthritis. It is promoted by MSD-Chibret as a "specific inhibitor of type 2 cyclooxygenases (COX-2)". (2) The clinical dossier includes trials versus other antiinflammatory drugs, but the reports available are generally vague. Rofecoxib has not been compared with paracetamol. (3) In these trials rofecoxib 12.5-25 mg/day was no more effective than the comparators (ibuprofen or diclofenac) used at maximal recommended doses. (4) Relative to other nonsteroidal antiinflammatory drugs prescribed at high doses to selected patients in the controlled conditions of clinical trials, rofecoxib only moderately reduces the risk of severe gastrointestinal reactions (1.3% versus 1.8% after a year of treatment) and dyspeptic disorders (23.5% versus 25.5%). (5) Questions persist on other adverse effects, especially those potentially affecting the kidneys and heart. (6) Rofecoxib is subject to the same precautions (pregnancy, interactions, etc.) as other nonsteroidal antiinflammatory drugs.

Analgesics↗

Celecoxib in osteoarthritis and rheumatoid arthritis: new preparation. As disappointing as rofecoxib.

(1) The reference treatment for drug-based symptomatic relief of osteoarthritis and rheumatoid arthritis is paracetamol and low-dose ibuprofen. (2) The clinical file on celecoxib, a drug promoted as a selective COX-2 inhibitor, is bulky but fails to answer several practical questions, mainly because it lacks comparative trials against paracetamol and low-dose NSAIDs. (3) In osteoarthritis, three double-blind trials versus naproxen and placebo in a total of 3 258 patients show that the analgesic effect of celecoxib 200 mg/day is moderate and does not differ significantly from that of naproxen. Giving celecoxib in one or two daily doses makes no difference in terms of efficacy. (4) In rheumatoid arthritis, two double-blind trials against naproxen and placebo in a total of 2252 patients, and a double-blind trial versus sustained-release diclofenac, show that the symptomatic effect of celecoxib is moderate and no different from that of the comparator NSAIDs. (5) There is no evidence that the safety profile of celecoxib is very different from that of other NSAIDs. The advantage in terms of gastrointestinal adverse effects appears very slight. According to clinical trials and pharmacovigilance data, celecoxib is in no way exempt from the severe gastrointestinal adverse effects generally associated with NSAIDs. (6) In short, celecoxib changes nothing in the management of osteoarthritis and rheumatoid arthritis.

Anti-Inflammatory Agents, Non-Steroidal↗

Four bladder tumor markers have a disappointingly low sensitivity for small size and low grade recurrence.

PURPOSE: We determine the sensitivity and specificity of 3 bladder tumor markers in urine, including NMP22 assay (Matritech, Newton, Massachusetts), BTA stat test (Bion Diagnostic Sciences, Inc., Redmond, Washington) and UBC antigen (IDL Biotech, Sollentuna, Sweden), and bladder wash cytology for new and recurrent bladder cancer. We examine whether tumor size, grade, and stage influence sensitivity and specificity of the markers. MATERIALS AND METHODS: A total of 304 samples in 250 patients were studied. There were 174 patients who had a history of bladder cancer, including 93 with and 81 without recurrent tumor at cystoscopy. The other group of patients consisted of 66 with newly diagnosed bladder tumor and 64 investigated for microscopic hematuria that was found to be idiopathic. BTA stat was assayed according to manufacturer instructions. NMP22 and UBC were measured in urine with an enzyme-linked immunosorbent assay. A cutoff level of 4 for NMP22 and 1 for UBC was chosen to get the same specificity for new tumors as BTA stat (75%) RESULTS: There was a highly significant difference (p <0.001) in all markers between patients with new bladder tumors and those without. The difference was less pronounced for tumor recurrence for NMP22, UBC and BTA stat (p=0.002, 0.016 and 0.244, respectively). The difference between new and recurrent tumors disappeared when corrected for tumor size, grade and stage. The sensitivity for new tumors was 65%, 75% and 60% for NMP22, BTA stat and UBC, respectively. Cytology had a sensitivity of 41% for new tumors at a specificity of 94%. The specificity for recurrence was 64% for NMP22, 54% BTA stat and 72% UBC. The sensitivity was 45% for NMP22, 55% BTA stat and 40% UBC. CONCLUSIONS: Tumor size, grade and stage have a strong impact on sensitivity, and specificity for all 3 tested tumor markers as well as bladder wash cytology. The tumor markers or any combination of them cannot replace followup cystoscopy, mainly because most recurrences are small. The role of the markers for screening high risk populations and as a complement to followup cystoscopy remains to be evaluated.

Aged↗

[Gene therapy of hemophilia--the next disappointment?].

Since the very beginning the evident target of gene therapy were monogenic disease, though the number of applicated protocols in the treatment by oncologic processes has become much higher now. Several clinical studies, using viral vectors or direct transfer of plasmids containing sequences of human factor VIII, from which the central part (domain B) had been deleted gave satisfactory results concerning the transfer effectivity. On the other hand the amount of factor VIII produced in recipients was decreasing and was no more detectable after one year after administration of transfected fibroblasts.

Factor VIII↗

[Evaluation of the Dutch Organ Donation Act: mostly disappointments].

In 1998, the Organ Donation Act became effective in the Netherlands. From the recent evaluation of this act, it appears that one of its important goals, the increase in organ donation, has not been achieved. The number of organ donations has decreased. Only one-third of the Dutch adult population has responded to the request to register in the Central Organ Donor Registry. All people aged 18 years and older are sent a form on which they can indicate whether or not they consent to donating their organs after death. When a non-registered person dies, the relatives will refuse organ donation in at least 75% of the cases. The most important means for improving this situation are the implementation of a presumed consent law, special attention to public education on the principle of reciprocity (quid pro quo), and an improvement of the procurement programs in the donor hospitals.

Humans↗