Should progressive perineal dilation be considered first line therapy for vaginal agenesis?

PURPOSE: In women with vaginal agenesis progressive perineal dilation provides a minimally invasive method to create a functional vagina without the attendant risks or complications of traditional surgical options. We report our 12-year experience with this technique. MATERIALS AND METHODS: Patients with vaginal agenesis treated at our institution were analyzed retrospectively and followed prospectively using case report forms and semistructured interviews. Patients diagnosed with vaginal agenesis were counseled on vaginal reconstruction options. Those electing progressive perineal dilation were instructed on the proper use of vaginal dilators by one of us (MRL) and advised to dilate 2 or 3 times daily for 20 minutes. All patients received physician, nursing and social work education and counseling. Parameters reviewed included primary diagnosis, start and end of vaginal dilation, dilation frequency, dilator size, sexual activity and whether the patient experienced pain or bleeding with dilation or sexual activity. Functional success was defined as the ability to achieve sexual intercourse, vaginal acceptance of the largest dilator without discomfort or a vaginal length of 7 cm. Univariate and multivariate analysis was performed to identify factors associated with successful neovaginal creation. RESULTS: From 1996 to 2008 we enrolled 69 females with vaginal agenesis in a progressive perineal dilation program. The primary diagnosis was Mayer-Rokitansky-Küster-Hauser syndrome in 64 patients. Mean age at the start of vaginal dilation was 17.5 years (range 14 to 35) Mean followup was 19 months (range 0 to 100). Four patients (5.7%) were lost to followup. In 7 of the remaining 65 patients (12%) treatment failed due to noncompliance and 50 (88%) achieved functional success at a median of 18.7 months. Patients who dilated frequently (once daily or greater) achieved a functional neovagina at a mean +/- SD of 4.3 +/- 2.4 months. Functional success correlated positively with frequent (once daily or greater) dilation and the initiation of sexual activity. Complications were minor. Three patients reported infrequent pain and 2 reported a single episode of bleeding with dilation. A total of 18 sexually active patients reported satisfactory intercourse without dyspareunia. CONCLUSIONS: Progressive perineal dilation for neovaginal creation is a valuable, minimally invasive therapy to create a functional vagina with a high success rate and a much lower complication rate than that in published surgical series. Given these findings, progressive perineal dilation should be offered as first line therapy in adolescents with a congenitally absent vagina.

Comparison of an automated and point-of-care immunoassay to GC-MS for urine oxycodone testing in the clinical laboratory.

OxyContin, a controlled-release formulation of oxycodone, is increasingly abused. Monitoring patient compliance by urine drug testing may deter illegal diversion of OxyContin. Two urine immunoassays were evaluated with a 100 ng/mL cutoff for oxycodone. The Microgenics Corporation Oxycodone DRI on the Bayer ADVIA 1650 and a point-of-care (POC) immunoassay, Monitect Oxycodone POC from Branan Medical Corporation, were compared to gas chromatography-mass spectrometry (GC-MS) with a detection limit of 50 ng/mL free oxycodone. Between-day precision for DRI yielded coefficients of variation from 3.9% to 7.0% at 75 and 125 ng/mL. Fifty-two positive and 52 negative urines were tested. The DRI had a 100% agreement with GC-MS. Two positive specimens had free oxycodone < 50 ng/mL, but oxycodone metabolites, oxymorphone and oxycodone glucuronide > 100 ng/mL, were identified by GC-MS analysis. The POC assay had two false positives and 15 indeterminate (+/-) results. Codeine or hydrocodone was present in all but one of these samples. There was no interference with DRI from morphine, codeine, hydrocodone, hydromorphone, dihydrocodeine, or 6-monoacetyl morphine. Four-hundred and ninety urine samples were subsequently tested with DRI to estimate the oxycodone-positive rate at our hospital, and 47 (9.4%) were positive. The confirmation rate with GC-MS for free oxycodone, not including metabolites, was 93%. The Microgenics DRI offers good performance for oxycodone urine testing and is a better choice for the clinical laboratory than the POC assay. Confirmation of screened positive samples requires a method that can detect total oxycodone and oxymorphone.