Giuseppe Brisinda

A comparison of injections of botulinum toxin and topical nitroglycerin ointment for the treatment of chronic anal fissure.

BACKGROUND AND METHODS Lateral internal sphincterotomy, the most common treatment for chronic anal fissure, may cause permanent injury to the anal sphincter, which can lead to fecal incontinence. We compared two nonsurgical treatments that avert the risk of fecal incontinence. We randomly assigned 50 adults with symptomatic chronic posterior anal fissures to receive treatment with either a total of 20 U of botulinum toxin injected into the internal anal sphincter on each side of the anterior midline or 0.2 percent nitroglycerin ointment applied twice daily for six weeks. RESULTS After two months, the fissures were healed in 24 of the 25 patients (96 percent) in the botulinum-toxin group and in 15 of the 25 (60 percent) in the nitroglycerin group (P=0.005). No patient in either group had fecal incontinence. At some time during treatment, five patients in the nitroglycerin group had transient, moderate-to-severe headaches that were related to treatment. None of the patients in the botulinum-toxin group reported adverse effects. Ten patients who did not have a response to the assigned treatment - 1 in the botulinum-toxin group and 9 in the nitroglycerin group - crossed over to the other treatment; the fissures subsequently healed in all 10 patients. There were no relapses during an average of about 15 months of follow-up. CONCLUSIONS Although treatment with either topical nitroglycerin or botulinum toxin is effective as an alternative to surgery for patients with chronic anal fissure, botulinum toxin is the more effective nonsurgical treatment.

A Comparison of Botulinum Toxin and Saline for the Treatment of Chronic Anal Fissure

Background Chronic anal fissure is a tear in the lower half of the anal canal that is maintained by contraction of the internal anal sphincter. Sphincterotomy, the most widely used treatment, is a surgical procedure that permanently weakens the internal sphincter and may lead to anal deformity and incontinence. Methods We conducted a double-blind, placebo-controlled study of botulinum toxin for the treatment of chronic anal fissure in 30 consecutive symptomatic adults. All the patients received two injections (total volume, 0.4 ml) into the internal anal sphincter; the treated group (15 patients) received 20 U of botulinum toxin A, and the control group (15 patients) received saline. Success was defined as healing of the fissure (formation of a scar), and symptomatic improvement was defined as the presence of a persistent fissure without symptoms. Results After two months, 11 patients in the treated group and 2 in the control group had healed fissures (P = 0.003); 13 in the treated group and 4 in the cont...

Relief by botulinum toxin of voiding dysfunction due to benign prostatic hyperplasia: results of a randomized, placebo-controlled study

OBJECTIVES To evaluate the therapeutic role of botulinum toxin injection in men with benign prostatic hyperplasia. METHODS Men with benign prostatic hyperplasia were enrolled in a randomized, placebo-controlled study. After a baseline evaluation, each participant received 4 mL of solution injected into the prostate gland. Patients in the control group received saline solution and patients in the treated group received 200 U of botulinum toxin A. The outcome of each group was evaluated by comparing the symptom scores, serum prostate-specific antigen concentration, prostate volume, postvoid residual urine volume, and peak urinary flow rates. RESULTS Thirty consecutive patients were enrolled. No local complications or systemic side effects were observed in any patient. After 2 months, 13 patients in the treated group and 3 in the control group had subjective symptomatic relief (P = 0.0007). In patients who received botulinum toxin, the symptom score was reduced by 65% compared with baseline values and the serum prostate-specific antigen concentration by 51% from baseline. In patients who received saline, the symptom score and serum prostate-specific antigen concentration were not significantly changed compared with the baseline values and 1-month values. Follow-up averaged 19.6 +/- 3.8 months. CONCLUSIONS Botulinum toxin injected into the prostate seems to be a promising approach for the treatment of benign prostatic hyperplasia. It is safe, effective, and well-tolerated. Furthermore, it is not related to the patients willingness to complete treatment.

Botulinum toxin injections in the internal anal sphincter for the treatment of chronic anal fissure: long-term results after two different dosage regimens.

OBJECTIVE To investigate the effects of two different dosage regimens of botulinum toxin to induce healing in patients with idiopathic anal fissure. SUMMARY BACKGROUND DATA Chronic anal fissure is maintained by contraction of the internal anal sphincter. Sphincterotomy, which is successful in 85% to 95% of patients, permanently weakens the sphincter and therefore might be associated with anal deformity and incontinence. METHODS Fifty-seven consecutive outpatients were evaluated. Type A botulinum toxin was injected into the internal anal sphincter. RESULTS Patients were divided into two treatment groups based on the number of botulinum toxin units injected. Patients in the first group were treated with 15 units and retreated with 20 units. Patients in the second group were treated with 20 units and retreated with 25 units. Two months after treatment, 10 patients in the first group and 23 patients in the second group had a healing scar. Symptomatic improvement was observed in 13 patients in the first group and in 24 patients in the second group. Statistical analysis showed that resting anal pressure varied from baseline values as a function of treatment; in contrast, the treatment had no effect on maximum voluntary pressure. Long-term healing was achieved in 13 patients in the first group and in all patients in the second group who underwent a complete treatment. CONCLUSIONS Botulinum toxin is safe and effective in the treatment of anal fissure. It is less expensive and easier to perform than surgical treatment. No adverse effects resulted from injections of the toxin. The higher dosage is effective in producing long-term healing without complications.

Influence of botulinum toxin site of injections on healing rate in patients with chronic anal fissure

BACKGROUND Botulinum toxin induces healing in patients with idiopathic anal fissure. METHODS Fifty patients affected by posterior anal fissure were treated with 20 units of botulinum toxin, injection in the internal anal sphincter on each side of the posterior midline (group I) or on each side of the anterior midline (group II). RESULTS At 2 months evaluation, a healing scar was observed in 15 patients of group I and in 22 patients of group II(P = 0.025). Resting anal pressure was significantly different from the baseline values at 1-month as well as at 2-month check-ups in both groups, but the values were significantly lower in patients of group II. CONCLUSIONS The intersite comparison revealed that anterior injection of the internal anal sphincter resulted in improved lowering of resting anal pressure and produced an earlier healing scar.

Randomized clinical trial comparing botulinum toxin injections with 0·2 per cent nitroglycerin ointment for chronic anal fissure

In recent years treatment of chronic anal fissure has shifted from surgical to medical. This study compared the ability of two non‐surgical treatments—botulinum toxin injections and nitroglycerin ointment—to induce healing in patients with idiopathic anal fissure.

Botulinum toxin in the treatment of outlet obstruction constipation caused by puborectalis syndrome.

PURPOSE: Puborectalis syndrome has been difficult to treat. We investigated the efficacy of botulinum toxin in treating patients with puborectalis syndrome who had previously failed to respond to electromyographic biofeedback sessions and who refused to use anal dilators. METHODS: Of a group of 50 patients with chronic outlet obstruction constipation, four patients with puborectalis syndrome were included in the study. The patients were studied using anorectal manometry, defecography, and electromyography and then treated with 30 units of Type A botulinum toxin, injected into two sites on either side of the puborectalis muscle, under ultrasonographic guidance. RESULTS: One patient was lost to follow-up. After treatment in other patients, the frequency of natural bowel movements increased from zero to six per week and laxatives were needed by only one patient. Anorectal manometry demonstrated decreased tone during straining from (mean ± standard deviation) 96.2 ± 12 mmHg to 42.5 ± 13 mmHg at four weeks (P=0.003) and 63.2 ± 22 mmHg at eight weeks (P=0.009). Defecography performed eight weeks after treatment showed improvement in the anorectal angle, which increased from 94 ± 11° to 114 ± 13° (P=0.01), and evacuation of barium paste. Electromyography demonstrated mild paradoxical contraction. However, 16 weeks after treatment one of these three patients suffered symptomatic recurrence. This patient was re-treated with 50 units of toxin; eight months later he required a further 60 units. Seven months after the last injection he reported normal daily bowel movements without the use of laxatives. CONCLUSIONS: Botulinum toxin injection should be considered as a simple therapeutic approach in patients with puborectalis syndrome. The use of higher dosage and a more precise method of toxin injections under transrectal ultrasonography account for the long-term higher success rate. However, because the effects of the toxin wear off within three months of administration, repeated injections could be necessary to maintain the clinical improvement.

Relief by botulinum toxin of voiding dysfunction due to prostatitis

Obstructive urinary symptoms due to chronic non-bacterial prostatitis are due to incomplete relaxation of the bladder neck or inappropriate contraction of the external urethral sphincter during voiding. Patients may respond to adrenergic blocking drugs; if effective, treatment may need to be continued indefinitely. Botulinum toxin has been used to weaken striated and smooth muscles. Toxin injections into the external urethral sphincter to relieve urethral obstruction were described by Dykstra and Sidi. Apart from treatment of detrusor-sphincter dyssynergia, we have found no reports in the literature on the treatment of voiding dysfunction in non-bacterial prostatitis. Four consecutive men (mean age 30·7 [SD 5·7] years) with chronic non-bacterial prostatitis and poor bladder emptying because of spastic external urethral sphincter (mean duration of symptoms 18 [3] months), who failed to respond to tamsulosin 0·4 mg once daily for more than 4 months were enrolled. All the patients were examined, had uroflowmetric studies to assess times of urinary flow (TQ) and maximum urinary flow (TQmax), maximum flow (Qmax), average flow (Qave), and total urinary volume (Vcomp), and had anorectal manometry at rest (RT) and after maximum contraction (MC). An increased value of TQ and TQmax with a normal value of Qmax was taken to be indicative of incomplete relaxation of bladder neck. 1, 4, and 8 weeks after treatment, patients underwent the same assessments. With the patient lying on his left side, a 26-gauge monopolar needle electrode was inserted in the perineum in the anterior midline, about 1·5–2·0 cm from the anus and directed toward the prostatic apex, without sedation or local anaesthesia. 30 U of type A botulinum toxin were injected. No local complications or systemic side-effects were seen. Within 1 week of injection all patients had a striking improvement in their voiding; none complained of urinary incontinence. At 4 weeks, three patients showed a continuing improvement. At 8 weeks, the same three patients were satisfied with the therapy and none of them complained of urinary incontinence. The patients were followed up for a mean of 12 months. No relapse occurred in the three patients who improved. 6 weeks after treatment, the fourth patient reported worsening voiding. He was also depressed and required fluoxetine. He was re-treated with 50 U of botulinum toxin and the urinary symptoms improved. Uroflowmetric study showed a decrease in TQ and TQmax values at 1, 4, and 8 weeks compared with baseline values (table). Other variables were not changed.

Experience with Type A Botulinum Toxin for Treatment of Outlet-Type Constipation

BACKGROUND:Puborectalis syndrome remains a therapeutic challenge for todays physicians. Traditional approaches include use of fiber, laxatives, enemas, biofeedback training, and surgery. These often were tried sequentially and had conflicting or even disappointing results. We investigated the efficacy of injections of botulinum toxin in improving rectal emptying in patients with defecatory disorders involving spastic pelvic-floor muscles.METHODS:Twenty-four consecutive patients with chronic outlet obstruction constipation resulting from puborectalis syndrome were included in the study. The patients were treated with 60 units of type A botulinum toxin, injected into two sites on either side of the puborectalis muscle under ultrasonographic guidance.RESULTS:At 2 months, evaluation inspection revealed a symptomatic improvement in 19 patients. Anorectal manometry demonstrated decreased tone during straining from 98 ± 24 to 56 ± 20 mmHg at a 1-month evaluation (p < 0.01) and 56 ± 29 mmHg at a 2-month follow-up (p < 0.01). Pressure during straining was lower than resting anal pressure at the same time in all patients. Defecography after the treatment showed improvement in anorectal angle during straining, which increased from 98 ± 9° to 121 ± 15° (p < 0.01).CONCLUSIONS:Botulinum toxin injections should be considered as a simple therapeutic approach in patients with obstructed defecation. The treatment is safe and effective, especially with the use of the ultrasonographic guidance that accounts for a more precise injection and consequently better long-term results. Otherwise, given the limited effect of the toxin, repeated injections may be necessary to maintain the clinical improvement.

Botulinum neurotoxin to treat chronic anal fissure: results of a randomized ‘Botox vs. Dysport’ controlled trial

Background : Botulinum neurotoxin induces healing in patients with idiopathic fissure. The optimal dosage is not well established.