A multicenter prospective trial evaluating fetal bovine dermal graft (Xenform® Matrix) for pelvic reconstructive surgery.

BACKGROUND: A prospective multicenter clinical study was performed to evaluate the safety and efficacy of a bovine dermal graft (Xenform® Matrix, Boston Scientific, Natick, MA, USA) during vaginal reconstructive surgery. METHODS: Forty-five women with ICS stage 2 or higher pelvic organ prolapse (POP) were enrolled at 4 centers. POP-Q, pelvic floor function (PFDI-20), sexual function (PISQ-12), and patient satisfaction tools were used to assess subjects at baseline, and at 2 and 6 weeks, and 3, 6 and 12 months post surgery. The significance of symptom score changes at 6 months and 1 year were determined by the t-test for paired data. Forty-three of the 45 patients completed the 12 month study. RESULTS: The majority of the subjects had cystocele (98%) and/or rectocele (84%) defects at study entry. At 12 months, 74% of the defects had improved to a stage 0 or 1. Mean PFDI-20 scores improved by 72% (p < 0.001) at 12 months, and PISQ-12 scores were maintained during the follow-up period indicating no decline in sexual function. Three subjects experienced one serious adverse event each; one of the adverse events (constipation) was deemed by the study physician to be unrelated to Xenform®. One subject had severe pyelonephritis resulting in dialysis. This subject had a previous history of pyelonephritis, sepsis and acute renal failure. The third subject had a reported recurrent cystocele of moderate severity, possibly related to the device. No graft related erosions or pain lasting more than 30 days were reported. No subjects withdrew due to an adverse event. CONCLUSION: This study is the first to investigate the use of Xenform® Matrix in vaginal reconstructive surgery among patients with POP. Significant improvement was maintained at 12 months utilizing both objective and subjective assessment tools, confirming the safety and efficacy of this material in vaginal surgery. TRIAL REGISTRATION: ClinicalTrials.gov NCT01244165.

The distance between the perceived and the actual arcus tendineus fascia pelvis during vaginal paravaginal repair.

OBJECTIVE: This study was undertaken to determine whether the arcus tendineus fascia pelvis (ATFP) can be accurately identified from the paravaginal space (PVS) without entering the retropubic space (RPS). STUDY DESIGN: Eight patients undergoing vaginal paravaginal repair were enrolled. The paravaginal dissection was completed to the most cephalad portion of the PVS without entering the RPS. The apex of each PVS was stained with methylene blue. The RPS was entered, the ATFP visualized, and 4 sutures were placed along its length to be used for the repair. The perpendicular distance between each suture and the most cephalad area of stain was measured. RESULTS: The mean distance from the perceived to actual ATFP at each suture point (1-4) was 3.5 cm, 2.75 cm, 2.0 cm, and 0.91 cm, respectively. CONCLUSION: In these 8 cases, the RPS had to be entered to accurately identify the ATFP. The degree of error increases as the ischial spine is approached (P < .001).

Metastatic colon carcinoma found within an enterocele sac: a case report.

The incidental finding of cancer in a hernial sac is rare, but there are many case reports in the literature. There has never been a report of carcinoma found in an enterocele sac. We present the case of a 77-year-old female with symptomatic pelvic organ prolapse who presented for reconstructive pelvic surgery and was found to have metastatic adenocarcinoma contained within an enterocele sac. Incidental diagnosis of asymptomatic carcinoma found on typically discarded tissue from surgical procedures is rare. However, routine pathologic review of all tissue removed from a patient may save a life if carcinoma is found early.

Reduction clitoroplasty: a technique for debulking the enlarged clitoris.

Clitoral reduction, especially in an adult, is a rare procedure which often leaves the glans clitoris without the capacity for tactile sensation. We present the case of a 34-year-old woman with symptomatic clitoromegaly since puberty who underwent a clitoral reduction procedure designed to preserve the neurovascular supply of the glans clitoris. The surgical technique presented here removes the corpora cavernosa of the clitoris, but conserves important neurovascular attachments. While this procedure was done on an adult, it could just as easily be performed on children or adolescents with clitoromegaly, typically the at-risk group for this condition.