Vaginal Exposure Research Articles

Infected Synthetic Mid-Urethral Sling: Mesh or Mess?

Abstract Background: Synthetic mid-urethral sling (MUS) is a commonly used procedure to relieve stress urinary incontinence. Excellent cure rates make it a surgery of choice, but bothersome mesh-related symptoms can be distressing to the patient. Case: Retropubic synthetic MUS combined with laparoscopic-assisted vaginal hysterectomy in a 46-year-old woman resulted in postoperative chronic purulent discharge from the suprapubic sinus at the exit site of the sling, and profuse vaginal discharge from mesh exposure, of 5 years' duration. Her symptoms persisted in spite of repeated abdominal surgical explorations of the sinus tract and excision of the vaginally exposed mesh. Finally, exploration with complete removal of the infected mesh gave her relief. Conclusions: Relief from chronic suprapubic sinus and vaginal mesh exposure caused by infected synthetic MUS can be achieved only with complete removal of the sling. (J GYNECOL SURG 28:288)

Delayed vaginal and urethral mesh exposure: 10 years after TVT surgery

Delayed mesh exposure after tension-free vaginal tape (TVT) procedure is rare. We report a case of mesh exposure into the vagina and urethra that developed 10 years after TVT surgery. A 58-year-old postmenopausal woman presented with mixed urinary incontinence. She was investigated, and her stress urinary incontinence was cured with a TVT procedure 10 years ago. She was then scheduled follow-up annually. Two years postsurgery, a granulation tissue was observed and excised at the vaginal incision site. Vaginal examination 10 years postsurgery showed vaginal mesh erosion 0.5 cm from urethral meatus. Cystoscopy revealed concomitant urethral erosion at the posterior urethral wall. Mesh excision was performed, and urethra and vagina were repaired in layers. Postoperative recovery was uneventful. This finding shows that, although rare, complications can occur even after 10 years of TVT surgery.

Comparison of vaginal mesh extrusion rates between a lightweight type I polypropylene mesh versus heavier mesh in the treatment of pelvic organ prolapse

The objective of the study was to compare extrusion (vaginal mesh exposure) rates in patients undergoing transvaginal prolapse repair with the trocar-based Apogee and/or Perigee devices (American Medical Systems, Minnetonka, MN, USA) using either the original type I polypropylene mesh (IntePro, American Medical Systems, Minnetonka, MN, USA) or a newer generation lightweight type I mesh (IntePro Lite, American Medical Systems, Minnetonka, MN, USA). Data were pooled from three similarly designed prospective multicenter studies evaluating the safety and efficacy of Perigee for correction of the anterior (AC) and/or Apogee to repair the posterior/apical (PC/A) compartments. The first two studies utilized IntePro (mesh density 50 g/m(2)) and the third utilized IntePro Lite (mesh density 25.2 g/m(2)). Data were pooled to form IntePro and IntePro Lite groups for comparison. Patient demographics were recorded. Risk factors for vaginal mesh exposure were also considered. Two hundred and sixty-three patients were implanted with Perigee and/or Apogee with IntePro for a total of 371 heavier mesh implants (174 Perigee, 197 Apogee) compared to 86 patients who underwent Perigee and/or Apogee with IntePro Lite for a total of 116 lightweight mesh implants (60 Perigee, 56 Apogee). Demographics and potential risk factors for extrusion were compared between the two groups. Mean follow-up was 2.0 years and similar between the two groups. In the AC, there were 234 implants, with mesh extrusion occurring in 8.0 % following IntePro compared to 5.0 % following IntePro Lite (p = 0.57). In the PA/C, there were 253 implants, with mesh extrusion occurring in 13.7 % following IntePro compared to 7.1 % following IntePro Lite (p = 0.25). Overall mesh extrusion rates in 487 implants in all compartments were found to be 11.1 % with IntePro versus 6.0 % with IntePro Lite with an estimated odds ratio of 1.93 (95 % confidence interval 0.84-4.44, p = 0.12). No statistically significant difference in extrusion rates were seen following use of IntePro versus IntePro Lite; however, the 46 % reduction in rate of mesh exposure observed in those receiving the lighter weight mesh may represent clinical importance.

Long-term follow-up of persistent vaginal polypropylene mesh exposure for transvaginally placed mesh procedures

The surgical treatment of a cystocele via the vaginal route may require the placement of a synthetic mesh below the bladder. However, the placement of a synthetic mesh via the vaginal route can be associated with specific complications, such as vaginal mesh exposure. There is a lack of data concerning the long-term follow-up of asymptomatic persistent vaginal polypropylene mesh exposure. This was a retrospective case series of nine patients presenting with persistent vaginal mesh exposure following the placement of a macroporous monofilament polypropylene mesh for cystocele treatment. Expectant management has been proposed since the patients were asymptomatic. The median follow-up duration was 121 months [interquartile range (IQR) 119-132]. The median surface area of vaginal mesh exposure (1 cm(2); IQR 1-1) did not change significantly during the follow-up. No pelvic or perineal abscess occurred during the follow-up. Only one of them was sexually active; she complained of dyspareunia at the last follow-up, but refused renewed surgery since she had sexual intercourse on only a small number of occasions per year. Clinical examination using the International Continence Society Pelvic Organ Prolapse Quantification system: Ba -3 to -2 (n = 7; 88 %), Ba -1 (n = 1; 12 %), Ba 0 or greater (n = 0). Persistent asymptomatic vaginal polypropylene mesh exposure is associated with few complications at long-term follow-up.

Traitement de la rectocèle par une prothèse biologique de derme porcin inter-rectovaginale associé à une sacropexie infracoccygienne

To evaluate an infracoccygeal colpopexy procedure by tension-free synthetic tape for vaginal apical prolapse associated with a posterior mesh procedure using porcine dermal graft for rectocele repair. A retrospective study concerning 35 women. The surgical procedure included rectocele repair with porcine dermal collagen implant (porcine dermal matrix, native) associated with transgluteal infracoccygeal sacropexy using a polypropylene sling. Median follow up was 48 months (42-54). A vaginal hysterectomy was associated in 43% and a cure of cystocele was associated in 63% of cases. No intra-operative complication was noted. The prevalence of dyschesia decreased from 25% (eight patients) preoperatively to 3% (one patient) postoperatively. No cases of de novo dyspareunia was noted. Five (14%) patients had a recurrent prolapse (two cases of rectocele stage 2, one case of grade 3 rectocele associated with a cystocele, a case of uterine prolapse associated with cystocele and one case of recurrent isolated uterine prolapse). Among them, three patients (9%) required a re-intervention for prolapse recurrence. No vaginal mesh exposure was observed. Perineal pain was reported by 12 (33%) patients at one month follow-up, but no patient complained with perineal pain one year follow-up. Infracoccygeal sacropexy associated with rectocele repair using porcine dermal collagen implant was associated with satisfactory results at medium term follow-up.

A three-incision approach to treat persistent vaginal exposure and sinus tract formation related to ObTape mesh insertion.

Mentor Corporation's ObTape has been associated with considerable morbidity. An unacceptably high exposure rate has been noted, and in some cases, multiple procedures may be necessary for complete mesh removal. We evaluated a patient who had prior ObTape placement complicated with persistent vaginal discharge and granulation tissue formation related to persistent mesh exposure (3Bc-T2-S2) followed by sinus tract formation (6Cd-T3-S3) according to the International Urogynecological Association Classification. We performed a three-incision approach (abdominal, vaginal, and groin) for the complete removal of the retained portion of the transobturator tape. This three-incision technique represents a viable option for removal of transobturator tape causing persistent clinical issues.

Serious Complications From a Single-Incision Midurethral Sling Placement

The single-incision midurethral sling has been introduced as an alternative to the traditional midurethral sling. Complications have been reported rarely. A 57-year-old multiparous woman with history of osteogenesis imperfecta type I underwent single-incision midurethral sling placement for stress urinary incontinence. She developed bladder mesh erosion, vaginal mesh exposure, and an urethrovaginal fistula. This case raises awareness of the potential complications that can arise after single-incision midurethral sling placement and emphasizes the importance of patient selection and preoperative evaluation before undergoing minimally invasive procedures.

An unusual case of vaginal tape exposure following tension-free vaginal tape

Vaginal tape exposure following tension-free vaginal tape (TVT) is uncommon. The exact cause of tape exposure is unknown. But tape characteristics, infection and defective healing are thought to be the causes. Presenting symptoms of tape exposure can be very distressing to the patients. Management of tape exposure can sometimes be a challenge to clinicians. In this, we report a case of persistent vaginal tape exposure following TVTwhich eventually turned out to be a secondary vaginal carcinoma. Case report

Predictors of Outcome after Transvaginal Mesh for Pelvic Organ Prolapse

Introduction: We aim to report outcomes and predictors of outcome of transvaginal mesh (TVM) for pelvic organ prolapse (POP). We also report frequency, severity, risk factors, and management of mesh-related complications after TVM. Materials and methods: We performed retrospective chart review of TVM performed from 2005 to 2010. There were 67 patients followed for a mean duration of eighteen months. Complications were reported using the International Continence Society and International Urogynecological Association classification system for prosthesis/graft complication. Results: Success rate was 88% (97% for anterior repair, 100% for posterior repair and 71% for combined repair) and complications occurred in 13 patients (19%), including vaginal hematoma, pelvic pain, urinary retention, dyspareunia and vaginal mesh exposure (in 9 patients). On multivariable logistic regression, recurrence was significantly higher with combined repair (P = 0.021), overall complication was significantly associated with younger age (P = 0.019), and mesh exposure was significantly associated with age and combined repair. All mesh-related complications were vaginal exposures occurring at median of 6 months postoperatively. Two patients were managed conservatively with vaginal estrogen cream, while seven patients elected surgical excision of exposed mesh with primary re-approximation of the vaginal epithelium. There were no excision-related complications, and in no case was the defect large enough to require closure with graft or secondary material. Conclusion: Combined anterior and posterior repair using TVM is associated with failure, younger age is associated with higher rate of complication, and combined repair and younger age are associated with mesh-related complication specifically.

Incidence of Extrusion Following Type I Polypropylene Mesh “Kit” Repairs in the Correction of Pelvic Organ Prolapse

Introduction and Hypothesis. We sought to determine the mesh extrusion (vaginal exposure) rates and subject outcomes following IntePro (Type I polypropylene) mesh “kit” repairs for vaginal prolapse. Methods. Data were pooled from two prospective multicenter studies evaluating the safety and efficacy of the Perigee and Apogee (American Medical Systems, Minnetonka, Minn, USA) to treat anterior and posterior/apical prolapses, respectively. Extrusions involving the anterior compartment (AC) or posterior compartment/apex (PC/A) were recorded. Results. Two hundred sixty women underwent mesh placement, with a total of 368 mesh units inserted (173 in the AC and 195 in the PC/A). Extrusions were noted in 13 (7.5%) of AC implants and 27 (13.8%) of PC/A implants through 12 months. No difference was seen between those with and without extrusion in regard to anatomic cure, postoperative painor quality of life at 1 year. Conclusions. Extrusion had no apparent effect on short-term outcomes. Given the unknown long-term sequellae of vaginal mesh exposure, a thorough assessment of risks and benefits of transvaginal mesh placement should be considered at the time of preoperative planning.

Is antibiotic prophylaxis necessary for midurethral sling procedures? A series of 174 cases without preoperative antibiotics

Despite the lack of evidence, antibiotic prophylaxis has been recommended for midurethral sling procedures. The goal of this study was to evaluate the rate of infectious complications in women undergoing midurethral sling procedures without antibiotic prophylaxis. We reviewed the baseline characteristics and postoperative infectious complications of 174 consecutive women who underwent midurethral sling procedures without prophylactic antibiotics from April 2005 to January 2010. Patients undergoing concomitant vaginal surgery were excluded. The average age, parity, and body mass index of were 51.3 ± 12.6years, 2.4 ± 1.3, and 30.1 ± 7.4kg/m(2), respectively. There were no wound infections, 2 (1.4%) vaginal mesh exposures and 12 (8%) cases of bacteriuria. The risk of infections is low when a midurethral sling is performed without antibiotic prophylaxis. Antibiotic prophylaxis does not appear to offer any benefit in midurethral sling procedures.

The mesh debate

The U.S. Food and Drug Administration (FDA) published asecond warning to medical practitioners and patients on“Complications Associated with Transvaginal Placement ofSurgical Mesh for Pelvic Organ Prolapse” in July 2011.Following this, on the advice of legal advisors the researchand ethics committee of one of our hospitals (P.L.D)recommended that no further synthetic mesh be used forany incontinence or prolapse surgery. This recommendationwas a case of “throwing the baby out with the bath water”and was not ratified following further discussion. However,it is an indication of the perfect storm referred to byBrubaker and Shull in this issue of the InternationalUrogynecology Journal [1]. In order to give a range ofopinions we are also publishing in this issue the views ofother well-known gynaecologists on the usage of syntheticgrafts [2, 3].So how did we get to this? Polypropylene syntheticmesh has been used in urogynaecology since the 1960s totreat stress incontinence [4]. However, it was not untilUlmsten and Petros developed the TVT sling with itsadvantages of same-day surgery and less postoperative painand morbidity that the mid-urethral sling became thecommonest stress incontinence operation performed world-wide. This success led to the development of a number ofsimilar slings by many commercial companies. Complica-tions did occur, frequently related to inexperienced trocarpositioning and incorrect placement of tape in the bladder,small bowel or blood vessels. The incidence of polypro-pylene mesh-related complication was low, with a less than1% rate of infection or mesh exposure, although this wasnot the case when non-polypropylene tapes were used,when infection and rejection rates were high. These werethen discontinued, but not until considerable damage hadbeen done.The problem with transvaginal polypropylene mesh wasevident from the beginning. In a prospective randomisedstudy by Julian in 1996 of 24 patients with mesh versusnon-mesh for surgical treatment of recurrent cystocele [5],there was a better anatomical result with no recurrence inthe mesh group but 3 of the 12 patients had mesh exposure.When we reported our 2-year results in 2004, our meshexposure rate was 9% [6]. It was interesting that the resultsof a meta-analysis of recent studies published this year byAbed et al. [7] showed an incidence of 10.3%. Therefore,little progress has been made in this critical area despite theuse of softer, lighter polypropylene meshes.These exposures are often asymptomatic, but maycause symptoms of discharge, bleeding and pain, espe-cially during intercourse, both to the patient and herpartner. Bowel and bladder perforation are rare but occurespecially if these organs have been injured. These meshexposures in most cases require excision of the exposedmesh and vaginal closure, usually under general anaes-thesia as day surgery. In some cases multiple attempts atrepair are required for recurring mesh exposures. Asmesh exposures can occur late, long-term studies(10yearsormore)maybeneededtoknowthetruemesh exposure complication rate. Vaginal exposure of

A guide for standardizing colposcopic observations for the evaluation of topical microbicide products in the pigtailed macaque model

This laboratory has been conducting colposcopy on Macaca nemestrina research animals since the mid-1990s. Our observations are always based on those recorded in human studies, and we have developed a standardized colposcopic observation form specifically for pigtailed macaque studies. All findings are based on the ‘Manual for the Standardization of Colposcopy for the Evaluation of Vaginal Products: Update 2004’, developed by WHO and CONRAD for use with humans [1]. Our studies have been conducted exclusively at the Washington National Primate Research Center (WaNPRC) in Seattle, Washington. Approval for the use of monkeys was obtained from the Institutional Animal Care and Use Committee at the University of Washington. Animals were handled humanely, and the experiments were performed within the National Institutes of Health's animal-use guidelines, in compliance with the Guide for the Care and Use of Laboratory Animals and the Animal Welfare Act. The contents of this manuscript are solely the responsibility of the authors and do not necessarily represent the official views of the National Institute of Allergy and Infectious Diseases or the National Institutes of Health. Our earliest studies were conducted with a modified endoscope, which was hand held through the speculum-opened vagina. It was attached to a video camera for video documentation of mucosal tissue assessments. We have since upgraded to a Leisegang swing arm colposcope, fitted with a digital camera and a video recording unit (CooperSurgical, Inc., Trumbull, CT, USA). Standardized studies conducted in this laboratory assess cervicovaginal tissues prior to and after single and repeated vaginal exposures to test products. One or two members of a team of cross-trained colposcopists conduct the vaginal examinations. The findings are recorded on standardized observation sheets and documented by still and video photography. Our primary use of colposcopy in the macaques is to evaluate the safety of topical microbicide products being developed for eventual use by humans [4–12]. Similar use of colposcopy in various rhesus and cynomolgus macaque models has been reported by other laboratories [2, 3, 13–16]. It is our hope that the terminology and photo atlas presented here will provide a reference for documenting colposcopic findings across multiple macaque models.

Twelve months effect on voiding function of retropubic compared with outside-in and inside-out transobturator midurethral slings

The purpose of this study is to compare retropubic tension-free vaginal tape (TVT) with transobturator out-in TOT and in-out TVT-O for female stress urinary incontinence. Uroflow rate was primary; continence rates, quality of life (QoL) and complication pattern were secondary endpoints. A prospective randomised trial with 2:1:1 randomisation at two Swiss teaching hospitals. Patients were followed up at 12 months. Eighty TVT, 40 transobturator tape (TOT) and 40 TVT-O were randomised. At 12 months, there was no difference in Qmax among the groups. Continence was comparable (≥ 89%). QoL was improved significantly in all groups (P < 0.05). Five vaginal tape exposures occurred (one TVT, four TOT, zero TVT-O; P = 0.028). Two percent (1/52) of sexually active patients after TVT, 17% (5/29) after TOT, but 0% (0/25) after TVT-O reported de novo female sexual dysfunction (P = 0.011). We considered this clinically important enough to stop enrolment. There was no difference for Qmax at 12 months between TVT, TOT and TVT-O. Female sexual dysfunction and tape exposure may be higher with a transobturator tape.

High Susceptibility to Repeated, Low-Dose, Vaginal SHIV Exposure Late in the Luteal Phase of the Menstrual Cycle of Pigtail Macaques

Fluctuations in susceptibility to HIV or SHIV during the menstrual cycle are currently not fully documented. To address this, the time point of infection was determined in 19 adult female pigtail macaques vaginally challenged during their undisturbed menstrual cycles with repeated, low-dose SHIV(SF162P3) exposures. Eighteen macaques (95%) first displayed viremia in the follicular phase, as compared with 1 macaque (5%) in the luteal phase (P < 0.0001). Due to a viral eclipse phase, we estimated a window of most frequent virus transmission between days 24 and 31 of the menstrual cycle, in the late luteal phase. Thus, susceptibility to vaginal SHIV infection is significantly elevated in the second half of the menstrual cycle when progesterone levels are high and when local immunity may be low. Such susceptibility windows have been postulated before but not definitively documented. Our data support the findings of higher susceptibility to HIV in women during progesterone-dominated periods including pregnancy and contraceptive use.

Partner dyspareunia—a report of six cases

One of the rarely cited complications of the use of alloplastic materials in pelvic floor surgery is dyspareunia of the partner caused by prominence or vaginal exposure of the sling material. Even though this entity is real and an important problem, it is rarely reported in literature. We report six cases of partner dyspareunia, in which there were two incidences of partner penile injury, occurring as a complication of synthetic midurethral sling surgery. There were three tension-free vaginal tapes, two transobturator tapes and one anterior intravaginal sling in the series. Time interval between tape insertion and the presentation of complications ranged from 3 to 48 months. Vaginal exposure was seen in five of the six cases and in one patient prominence of sling material without exposure was noted. Recognizing partner dyspareunia as an important complication of the vaginal use of alloplastic prosthesis is not only important in preoperative counseling of patients but also to avoid legal implications.

Vaginal prolapse repair using the Prolift™ kit: a registry of 100 successive cases

Objectives To evaluate anatomical, functional outcomes and complications inherent to the treatment of pelvic organ prolapse by implantation of polypropylene mesh, using the Prolift™ kit. Materials and methods Single-center observational study of 100 successive patients enrolled in a registry, who underwent Prolift™ prolapse repair. Data on prior treatments, associated procedures and per- and post-operative complications were collected and the patients were seen after 2, 6 and 12 months. Anatomical outcomes were assessed using the International Continence Society Pelvic Organ Prolapse Quantification (ICS POP-Q) system. Function was assessed in terms of urinary and digestive problems, and impact on sex life. Failure was defined as relapse of POP-Q Grade 2 or more. Results Of the 100 patients, 32 had an anterior, 14 a posterior, 54 a total Prolift™; 53 had concomitant urinary incontinence surgery. At 6 and 12 months respectively, 8% and 12% of the patients were lost to follow-up. Mean operating time was 39.8 min. With respect to peri-operative complications, there was no bladder or rectal damage but three patients experienced bleeding (≥300 ml) without needing transfusion. POP-Q Grades before surgery were: Grades III–IV cystocele in 65.7% of the anterior Prolift™ patients; Grades II–III rectocele in the posterior; and 77.8% of total were Grade III and 11.1% Grade IV. The incidence of recurrence was 3.6% at Month 6 and 10.2% at Month 12. Significant ( p < 0.05) improvements were seen in median scores for the various POP-Q items. With respect to functional problems, stress urinary incontinence was cured in 92% of the patients but 7.7% reported new-onset urinary incontinence after one year. One case of vaginal exposure after one year was observed and major or symptomatic mesh retraction was observed in 8%. New-onset dyspareunia was reported by 11.1% of the patients. Conclusions These results confirm the feasibility of using the Prolift™ kit in the repair of prolapse via a vaginal approach and the low per- and post-operative morbidity associated with that technique. Nevertheless, longer-term evaluation is required to confirm the results.

Collagen-coated polypropylene mesh in vaginal prolapse surgery: an observational study

Objective We evaluated the efficacy and safety of a collagen-coated polypropylene mesh with a trans-obturator approach for cystocele repair. Study design We considered as eligible for our study 97 patients with a stage ≥2 cystocele according to the Pelvic Organ Prolapse Staging System (POP-Q), with or without associated apical or posterior vaginal wall prolapse. They were also evaluated pre- and post-operatively using validated questionnaires (P-QoL, Wexner and PISQ-12). Patients underwent cystocele repair using Avaulta ® Biosynthetic Anterior Support System (CR Bard Inc., Billerica, USA). Objective anatomical cure was defined when points Ba, C and Bp were at stage 0 (good outcome) or stage 1 (satisfactory outcome). The McNemar chi-square test was used to compare categorical variables, the paired t-test for continuous parametric variables, and the Mann–Whitney test for continuous non-parametric variables. Results All patients completed the 1-year follow-up. We observed an anatomical cure rate of 64.9% for anterior vaginal wall prolapse (point Ba < −1), and a statistically significant improvement in storage, voiding, post-micturition and prolapse-related symptoms. Quality of Life and sexuality were also statistically improved, while we found no impact on anorectal function. We also observed the development of vaginal mesh exposure in 21 patients (21.6%). Conclusion Our data suggest that the collagen-coated polypropylene mesh, as we used it, gives a high recurrence rate (35.1%) and a high exposure rate (21.6%) at one-year follow-up, and is consequently unsatisfactory for the treatment of anterior vaginal wall prolapse.

Marker Paper: The Urethral Microbiome of Adolescent Males

Project ID: 46317 – No publication moratorium.The microflora of the anterior male urethra during adolescence is poorly described and no data address the range of “typical” urethral organisms during adolescence as functions of pubertal development or onset of various types of partnered sexual activity. This means that current understanding of the urethral microbiome in adolescent men rests entirely on limited data inferred from adults, and from epidemiologic and behavioral explanations. Marked ethnic group variation in adolescent sexual behaviors and disparity in conditions such as sexually transmitted infections (STI) justifies exploration of potential ethnic group differences in the male urethral microbiome. Some research among adult males suggests important interactions between the male urethral microbiota and STI, but this research has not been extended to younger men.We will characterize the male urethral microbiome in longitudinal urine samples collected from a multi-ethnic cohort of adolescent males. The two specific aims of the project include Specific Aim 1. Describe the developmental urethral microbiome of adolescent males: Aim 1a. as a function of pubertal development; Aim 1b. as a function of racial/ethnic group; Aim 1c. as a function of oral-genital, vaginal, and anal sexual exposures; and, Aim 1d. as a function of circumcision status. Specific Aim 2. Describe variation in the urethral microbiome of adolescent males in the context of STI and identify organisms associated with acute and persistent non-specific urethritis: Aim 2a. to identify components of the microbiome associated with specific STI; Aim 2b. to compare the urethral microbiome of adolescent males who do and do not develop STI; and Aim 2c. to characterize microbial profiles associated with development of acute and persistent idiopathic urethritis.Microbial flora will be assessed as function of pubertal development, sexual activity, and incident STI. Subjects will be Latino (N=24), African-American (N=24), and Euro-American (N=24) males, ages 14 – 17 at enrollment; total N=72). Participants will be recruited from an urban community within an area of high prevalence of STI. Socio-demographic data will be collected at enrollment. Daily behavioral and symptomologic data will be collected via cell phone, which will also be used for cohort maintenance and scheduling of sample collections. Urine and penile coronal sulcus samples will be collected at enrollment and up to 36 1-month follow-up samples and selected contingent trigger samples triggered by specific symptoms and behaviors for characterization of microbiome using high-throughput 16s rRNA phylogeny, Q-PCR and metagenomic sequencing. STI testing by nucleic acid amplification will be done as well to better understand interactions between the urethral microbiome and infection. Cell phones also will be used to initiate alternate day sample collection for 14 days (7 samples) following trigger events such as specific sexual acts, antibiotic use, condom failure, or genital symptoms.

Marker Paper: The Urethral Microbiome of Adolescent Males

AbstractProject ID: 46317 – No publication moratorium.The microflora of the anterior male urethra during adolescence is poorly described and no data address the range of “typical” urethral organisms during adolescence as functions of pubertal development or onset of various types of partnered sexual activity. This means that current understanding of the urethral microbiome in adolescent men rests entirely on limited data inferred from adults, and from epidemiologic and behavioral explanations. Marked ethnic group variation in adolescent sexual behaviors and disparity in conditions such as sexually transmitted infections (STI) justifies exploration of potential ethnic group differences in the male urethral microbiome. Some research among adult males suggests important interactions between the male urethral microbiota and STI, but this research has not been extended to younger men.We will characterize the male urethral microbiome in longitudinal urine samples collected from a multi-ethnic cohort of adolescent males. The two specific aims of the project include Specific Aim 1. Describe the developmental urethral microbiome of adolescent males: Aim 1a. as a function of pubertal development; Aim 1b. as a function of racial/ethnic group; Aim 1c. as a function of oral-genital, vaginal, and anal sexual exposures; and, Aim 1d. as a function of circumcision status. Specific Aim 2. Describe variation in the urethral microbiome of adolescent males in the context of STI and identify organisms associated with acute and persistent non-specific urethritis: Aim 2a. to identify components of the microbiome associated with specific STI; Aim 2b. to compare the urethral microbiome of adolescent males who do and do not develop STI; and Aim 2c. to characterize microbial profiles associated with development of acute and persistent idiopathic urethritis.Microbial flora will be assessed as function of pubertal development, sexual activity, and incident STI. Subjects will be Latino (N=24), African-American (N=24), and Euro-American (N=24) males, ages 14 – 17 at enrollment; total N=72). Participants will be recruited from an urban community within an area of high prevalence of STI. Socio-demographic data will be collected at enrollment. Daily behavioral and symptomologic data will be collected via cell phone, which will also be used for cohort maintenance and scheduling of sample collections. Urine and penile coronal sulcus samples will be collected at enrollment and up to 36 1-month follow-up samples and selected contingent trigger samples triggered by specific symptoms and behaviors for characterization of microbiome using high-throughput 16s rRNA phylogeny, Q-PCR and metagenomic sequencing. STI testing by nucleic acid amplification will be done as well to better understand interactions between the urethral microbiome and infection. Cell phones also will be used to initiate alternate day sample collection for 14 days (7 samples) following trigger events such as specific sexual acts, antibiotic use, condom failure, or genital symptoms.