Ropinirole in the Treatment of Patients With Restless Legs Syndrome: A US-Based Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Abstract

Injury of the ureter or bladder is one of the more serious complications of hysterectomy, and three fourths of ureteral injuries are associated with gynecologic operations. Most injuries involve the lower 3 cm of the ureter, and they usually are one-sided.This study is a retrospective review of ureteral injuries that occurred in the past 7 years in conjunction with total laparoscopic hysterectomy (TLH), performed in 106 women, or subtotal LH (STLH) in 232. Ureteral injuries were diagnosed by postoperative vaginal sonography and confirmed by intravenous pyelography (IVP). Cystoscopy was performed in some cases at the end of hysterectomy by injecting indigo carmine intravenously. In earlier cases, bipolar cautery was used to occlude the uterine artery, creating the possibility that a nearby thermal injury could be misdiagnosed. Subsequently, the artery was secured with a new hemoclip, the Hem-o-lok, which made possible exact closure of the uterine artery.Four of these women incurred ureteral injuries and one had a laceration of the bladder. None of the injuries occurred when cystoscopy was routinely performed or when bipolar cautery was avoided. The bladder injury, which complicated the TLH, was diagnosed intraoperatively and was repaired laparoscopically. Three of the ureteral injuries followed STLH, and one TLH. All these injuries were diagnosed 1 to 2 weeks postoperatively when patients described prolonged flank pain and lower abdominal pressure. None of the affected patients were febrile. Vaginal sonography demonstrated urinoma. After confirmation of the diagnosis by either IVP or computed tomography, 3 patients underwent nephrostomy for 3 weeks and then had the ureter reimplanted. The remaining patient had a ureteral stent placed.The investigators believe that the risk of ureteral injury during TLH or STLH can be minimized by using a clip rather than cautery to control the uterine vessels and by routinely performing cystoscopy after total or subtotal laparoscopic hysterectomy. GYNECOLOGY Volume 61, Number 8 OBSTETRICAL AND GYNECOLOGICAL SURVEY ABSTRACTNumerous studies-some of them randomized-have failed to find major differences in cure rates of cervical intraepithelial neoplasia (CIN) among cryotherapy, laser treatment, and loop electrosurgical excision. The investigators have, in the past 2 decades, treated CIN in 2107 women by gadolinium (Nd-YAG) laser conization that vaporized the base. The procedure took only 12 minutes on average. Just over 10% of women lost more than 20 mL of blood during the procedure. Approximately 7% of patients, 98% of them postmenopausal, had cervical obstruction during follow up.Either no CIN or grade 1-3 CIN was found in 92.8% of cone specimens, whereas 7.2% exhibited invasive disease. Women lacking invasive disease were followed between 16 months and 21 years. The rate of incomplete excision was 12.3% in patients having CIN in the cone specimen, but the rate of persistent or recurrent disease was only 1.2%. Of 230 patients with postoperative CIN and positive surgical margins, 83...

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Tolerability of Gabapentin Enacarbil in Subjects with Restless Legs Syndrome

“…20 The reductions in IRLS total score observed in the present study are also comparable with those reported for dopamine agonists that are currently approved for treatment of RLS. [31][32][33][34][35] A significant mean reduction in IRLS total score from baseline was also reported with GEn 600 mg (-13.8) compared with placebo (-9.8), and a greater proportion of GEn 600 mg-treated subjects were rated by investigators as CGI-I responders (72.8% compared with 44.8%, respectively). These results contrast with findings from a 2-week study of GEn 600 mg reported by Walters et al that demonstrated a nonsignificant mean reduction from baseline in IRLS total score at Week 2 LOCF (-9.1) compared with placebo (-8.9), and no significant difference in the proportion of CGI-I responders (GEn 600 mg, 58.6%; pla- jects in the present study reported significant sleep disturbance at baseline on the MOS Sleep Scale domains compared with a healthy cohort sample of the US population.…”

Treatment of Restless Legs Syndrome

“…Ropinirole IR has been evaluated in multiple randomized, placebo-controlled trials. These studies uniformly demonstrate that ropinirole is an effective treatment for RLS, improving RLS symptoms, sleep, and quality of life [80][81][82][83][84]. Improvement with ropinirole occurred approximately 1 week after the initiation of therapy.…”

Sleep improvement for restless legs syndrome patients. Part IV: meta-analysis comparison of effect sizes of vibratory stimulation sham pads and placebo pills

“…Details of the placebo analysis of 12 RLS drug trials [17][18][19][20][21][22][23][24][25][26][27][28] and the two VS trials 4,29 have been previously published. Controls for the drug trials were pharmacologically inert pills identical in appearance to study drugs.…”