The GoMo study: a randomized clinical trial assessing neonatal pain with Gomco vs Mogen clamp circumcision.

OBJECTIVE: Our objective was to compare the pain/stress levels of newborns among the 2 most common circumcision techniques after resident-wide education. STUDY DESIGN: The study period of this randomized control trial was October 2012 through March 2014. Following informed consent, full-term males from uncomplicated singleton pregnancies were randomized to Gomco (n=137) or Mogen (n=137) devices. Resident-wide education for an obstetrics and gynecology residency program at a single institution was performed to ensure standardized training. All infants received a subcutaneous ring block before the procedure and oral sucrose intraoperatively. The primary outcome was neonatal pain assessed physiologically by salivary cortisol levels (enzyme-linked immunosorbent assay) and clinically by a validated neonatal pain score (crying, requires increased oxygen administration, increased vital signs, expression, sleeplessness [CRIES]). Secondary outcomes were immediate complications, duration of procedure, and short-term outcomes as reported by mothers and pediatricians. A sample size of 274 (accounting for 20% loss of follow-up) was determined sufficient to detect a mean difference of 1.22 µg/dL in cortisol levels (Gomco, SD±3.34; Mogen, SD±0.81) with 80% power, P=.05 level of significance. RESULTS: A total of 251 infants completed the protocol. There were no significant differences in maternal or neonatal demographics including preoperative heart rate and mean arterial pressure. In the Mogen circumcision, the percentage change of cortisol was significantly lower than Gomco (279.1±498.15 vs 167.75±272.22; P=.049). There were no differences in postoperative CRIES scores. Postoperative heart rate was higher in infants undergoing Gomco circumcision than Mogen circumcision (138.7±16.5 vs 133.4±17.5; P=.015) as was mean arterial blood pressure (63.3±9.2 vs 60.4±8.6; P=.012). Mogen circumcisions were shorter (7.00±2.97 vs 3.65±1.84 minutes; P<.001). There were no significant differences in bleeding complications. A total of 168 maternal surveys were completed, with 98.7% maternal satisfaction in Gomco vs 98.9% in Mogen. There were no reports of bleeding after discharge or circumcision revisions in either group to date. CONCLUSION: Mogen clamp is associated with less neonatal pain physiologically by significantly lower percentage change in salivary cortisol, lower heart rate, and mean arterial blood pressure. There was no difference in CRIES scores. Mogen clamp circumcision duration is significantly shorter than Gomco clamp. Both methods demonstrate satisfactory maternal and pediatrician short-term follow-up.

Vulvovaginal candidiasis from non-albicans species: retrospective study of recurrence rate after fluconazole therapy.

OBJECTIVE: To investigate the recurrence rate of vulvovaginal candidiasis from non-albicans species after fluconazole therapy. STUDY DESIGN: A retrospective cohort of 127 patients with symptomatic vulvovaginal candidiasis by nonalbicans species referred from primary care physicians were evaluated between 1995 and 2004. Complete history, physical examination, basic metabolic panel, and bacterial and fungal cultures were performed. All patients received a daily dose of fluconazole for 30 days. Follow-up evaluations were done at 1, 3, 6, and 12 months. RESULTS: The recurrence rate for all non-albicans vulvovaginitis was 40.2%, 46.5%, 50.4% and 54.2% at 1, 3, 6, and 12 months, respectively. Patients with symptomatic recurrences were more likely to be younger than 35 years of age, older than 65, nulliparous and fastidious vulvar cleaners and were more likely to have concomitant bacterial infections. CONCLUSION: The recurrence rate of symptomatic vulvovaginal candidiasis colonized by non-albicans species after fluconazole therapy was 50.4% at 6 months and 54.2% at 12 months. Nulliparity and age <35 or > 65 years and fastidious vulvar cleaning were positively associated with symptomatic recurrent episodes.

Various surgical approaches to treat voiding dysfunction following anti-incontinence surgery.

OBJECTIVE: The aims of this study are to report the efficacy of retropubic urethrolysis, vaginal urethrolysis, and cutting of synthetic suburethral slings in treating postoperative voiding dysfunction that occurs after anti-incontinence surgery and to report the recurrence rate of stress urinary incontinence (SUI). METHODS: All patients from January 1996 to October 2003 who presented with voiding dysfunction following an anti-incontinence procedure and who subsequently underwent either retropubic urethrolysis, vaginal urethrolysis, or synthetic suburethral sling takedown were included in the study. Pre- and postoperative irritative symptoms (urinary frequency or urgency), obstructive symptoms (hesitancy, voiding difficulty, and incomplete emptying), and stress urinary incontinence symptoms were obtained in a standardized fashion. The Incontinence Impact Questionnaire and Urogenital Distres Invetory quality of life (QOL) questionnaires were also obtained to objectify these symptoms. Other objective postoperative analysis included simple uroflowmetry, measurement of postvoid residual (PVR), and simple or subtracted cystometry. RESULTS: Forty-four patients were included in the study (suburethral sling takedown = 14, vaginal urethrolysis = 20, and retropubic urethrolysis = 10), 77% of whom had objective follow-up. Preoperatively, 31 patients (70.5%) had irritative symptoms, 41 (93.2%) had obstructive symptoms, and 6 (13.6%) had symptoms of stress urinary incontinence (SUI), while postoperatively, these symptoms were found in 30 (68.2%), 11 (25.0%), and 18 (40.9%), respectively. Postoperatively, 6 patients (17.6%) had a PVR > 100 cc, 5 patients (14.7%) had a bladder contractions, and 16 patients (47.1%) demonstrated the sign or diagnosis of (SUI). Additionally, there was a statistically significant improvement in both QOL questionnaires. CONCLUSIONS: Various surgical approaches may be used to treat voiding dysfunction following an anti-incontinence procedure. Following a vaginal or retropubic urethrolysis or takedown of a synthetic suburethral sling, obstructive symptoms are likely to improve, irritative symptoms may remain unchanged, and almost half will develop recurrence of SUI.

Tension-free vaginal tape: a quality-of-life assessment.

OBJECTIVE: To assess whether tension-free vaginal tape (TVT) results in significant improvements in urinary incontinence and its effect on patients' quality of life (QOL) utilizing two validated questionnaires. METHODS: One hundred sixty-two tension-free vaginal tape procedures were performed at two sites between October 1998 and January 2001. All patients were requested to complete the Incontinence Impact Questionnaire (IIQ-7) and Urinary Distress Inventory (UDI-6) as part of their preoperative assessment. History, physical, and demographic data were also collected. All subjects underwent subtracted cystometry and urethral function tests prior to surgery. A combination of mail and phone follow-up was used to obtain postoperative IIQ-7 and UDI-6 scores in October 2001. Data were analyzed with the Wilcoxon matched-pairs signed-ranks test. RESULTS: One hundred fifty-one patients completed the pre- and postoperative quality-of-life forms and were included in the analysis. Mean follow-up was 22.1 months (range 6.1-49.8). There were significant improvements in postoperative scores for both the IIQ-7 and the UDI-6 (P <.001). Significant improvements were also seen in subscales measuring urge symptoms, stress incontinence symptoms, and symptoms of voiding dysfunction. These improvements were consistent, regardless of type or severity of stress incontinence. CONCLUSION: The IIQ-7 and UDI-6 are validated tools that can be used to provide some objective evidence for the impact of urinary incontinence on patients' lives. Utilizing these two validated quality-of-life tools we show that tension-free vaginal tape results in significant improvement in patient quality of life and symptoms of urgency, stress incontinence, and voiding dysfunction.