Recurrent and complicated urinary tract infections in women: Utility of advanced testing to enhance care.

BACKGROUND: The United States currently faces a public health crisis with regarding to antibiotic-resistant bacteria, and new urinary tract infection (UTI) diagnostics are needed. Women with recurrent UTI (rUTI) and complicated UTI (cUTI) are at particular risk given their complexity and the paucity of adequate testing modalities. The standard urine culture (SUC) is the cornerstone for diagnosis, but it has many shortcomings. These pitfalls lead to dissatisfaction and frustration among women afflicted with rUTI and cUTI, as well as overuse of antibiotics. One innovation is PCR UTI testing, which has been shown to outperform SUC among symptomatic women. AIMS: This article discusses UTI PCR testing, as well as a possible role in clinical practice. MATERIALS AND METHODS: Published literature was reviewed and summarized. RESULTS: Management of rUTI and cUTI is complex, and providers should have all diagnostics available to facilitate providing optimal care. Urine PCR testing faces reimbursement issues despite fulfilling clinical indication parameters as described by insurance companies. DISCUSSION: The role of UTI PCR testing remains unclear. Reimbursement issues have led to underuse and limited real-world outcomes reinforcing benefit. CONCLUSION: This study proposes an algorithm for PCR testing among women with rUTI and cUTI.

Subcutaneous testosterone pellet therapy for reversal of male osteoporosis: a review and case report.

PURPOSE: To describe the effects of consistent levels of testosterone in a pellet form and it's potential to reverse osteoporosis. METHODS: This is a descriptive case report of a 54 year male with a spontaneous fracture and osteoporosis in the presence of what many consider a normal male testosterone level. RESULTS: After discovering and documenting osteoporosis by DXA scan, the patient was shown to reverse the diagnosis of osteoporosis in a year on pelleted testosterone therapy. Consistent levels of 943 ng/dL were achieved; the patient also experienced improvements in quality of life and sleep apnea. CONCLUSION: Testosterone deficiency (TD) is a clinical syndrome and osteoporosis can be found in levels above standard "criteria" of 300. This patient did not realize a benefit on injections both physical and clinically and both improved on pelleted testosterone. This should be further studied and considered for TD in men.

Safety, tolerability and short-term efficacy of transvaginal fractional bipolar radiofrequency therapy for symptoms of stress and or mixed incontinence in conjunction with genitourinary syndrome of menopause.

INTRODUCTION: Radiofrequency (RF) energy application stimulates collagen and elastin remodeling to restore the elasticity, and moisture of the superficial vaginal mucosa. This is the first study to report on the use of microneedling to deliver RF energy to the vaginal canal. Microneedling increases the response of the collagen contraction and neocollagenesis in deeper layers of tissue, thus increasing the support to the surface. The novel intravaginal microneedling device used in this study allows penetration of the needles to 1, 2, or 3 mm. OBJECTIVE: A prospective study to evaluate the safety and short-term outcome of a single fractional RF treatment of the vaginal canal in a series of women with coexistent stress or mixed incontinence (MUI) and genitourinary syndrome of menopause (GSM). METHODS: Twenty women who had symptoms of SUI and or MUI in conjunction with GSM were given a single vaginal treatment that consisted of fractional bipolar RF energy using the EmpowerRF platform with the Morpheus8V applicator (InMode). RF energy was delivered into the vaginal walls via 24 microneedles, at a depth of 1, 2, and 3 mm. Outcomes were evaluated by "cough" stress test, questionnaires (MESA SI, MESA UI, iQoL, UDI-6) and evaluation of vaginal tissue through the VHI scale at 1-, 3-, and 6-months post-treatment compared to baseline. Biopsies were performed at baseline and 3-months on five patients for histological reference and tissue evaluation. RESULTS: Eight out of eight outcomes measured from baseline to 6-months post-treatment showed improvement. The parameters scored in the questionnaires including frequency, urgency, nocturia, urge incontinence, and stress incontinence showed significant improvement in all areas at the 1-, 3-, and 6-month follow-up sessions compared to baseline. CONCLUSIONS: The results showed evidence that fractional RF energy delivered vaginally is safe, well tolerated, and provide short term improvement of SUI and or MUI in conjunction with GSM.

Transvaginal radiofrequency energy for the treatment of urinary stress incontinence: A comparison of monopolar and bipolar technologies in both pre- and post-menopausal patients.

AIM: A study to compare the effect of two different radio frequency energy models (mono polar and bipolar) for the treatment of urinary stress incontinence. METHODS: Retrospective chart review, which was conducted at 2 sites, 69 patients received treatment with a bipolar radiofrequency device. Out of those 69 patients, 13 patients received bipolar in conjugation with CO2 laser treatment, while 32 patients received monopolar frequency. The study protocol normally consists of three sessions of treatment. Each session was four weeks apart with a whole 6-month duration follow-up. Results were evaluated by urogenital distress inventory (UDI)-6 questionnaire before and after treatment. RESULTS: The bipolar group improved UDI-6 scores across time more so than did the monopolar group with some evidence suggesting that the bipolar radiofrequency treatment was more effective compared to the monopolar radiofrequency. Three months after treatment, the bipolar group UDI-6 values were lower than those of the monopolar group. Six months after treatment, the UDI-6 scores increased in both groups, suggesting decrease efficacy with time however, the bipolar group's UDI-6 scores were consistently lower than the monopolar group's scores. CONCLUSION: This study shows benefit of both monopolar and bipolar radiofrequency device in patients with stress urinary incontinence and mixed UI, with bipolar RF more efficacious than monopolar RF. More randomized prospective studies are needed to confirm these findings.

Clinical utility of radiofrequency energy for female genitourinary dysfunction: past, present, and future.

INTRODUCTION AND HYPOTHESIS: Radiofrequency (RF) energy has been delivered in a variety of methods to the vagina, bladder, and periurethral tissue to improve myriad genitourinary complaints. Currently, practitioners are promoting transvaginal RF treatments with a minimal understanding of the various platforms and data to support or refute their utilization. This review explores how various RF technologies create desired tissue effects, review the published literature reporting outcomes of various treatment regimes, and peer into potential future uses of this technology in urogynecology. METHODS: A comprehensive literature review was performed for articles pertaining to RF energy use in women for genitourinary complaints with regard to stress urinary incontinence (SUI), genitourinary syndrome of menopause (GSM), female sexual dysfunction (FSD), and overactive bladder (OAB). RESULTS: Radiofrequency energy devices heat tissues via direct or micro-needling applications with the goal of stimulating collagen remodeling, neovascularization, and potentially modulation of nerve function. By altering the approach and location of energy application, many new devices have been marketed for treatment of conditions such as SUI, GSM, FSD, and OAB. Available studies demonstrate promising efficacy and favorable safety; however, interpretation of studies is greatly limited by poor study quality and reporting. CONCLUSIONS: Despite a lack of high-quality evidence for efficacy, safety, and durability in the literature, practitioners around the world continue to promote RF technology for a variety of genitourinary complaints. Currently, it appears that RF energy can potentially treat a variety of genitourinary conditions, but more robust data are needed to substantiate evidence-based use.

Diagnosis and management of overactive bladder: A review.

AIM: Overactive bladder (OAB) is a common and troublesome condition that can significantly impair quality of life. This review aims to educate providers of obstetrics and gynecology services about available therapies for OAB and what to expect following treatment. METHODS: Here, we review published data from studies that have evaluated available treatments for OAB. Relevant articles published over the past 2 decades, including large multicenter trials, were identified through a literature search using PubMed.gov, and the references in those articles were also manually searched to find additional articles. Treatment guidelines and product labels were also reviewed. RESULTS: Behavioral therapy is recommended as a first choice for OAB management; pharmacologic treatment (anticholinergics, ß3 -adrenoceptor agonists) as second-line treatment; and onabotulinumtoxinA, peripheral tibial nerve stimulation, and sacral nerve stimulation as third-line therapy for patients refractory or intolerant to first- and second-line treatments. A stepwise approach to treatment through first-, second-, and third-line therapies is recommended, recognizing this may not be appropriate for all patients. CONCLUSIONS: To optimize symptom control and set realistic expectations, patients should be carefully monitored and counseled appropriately on available treatment options.

Patient Characteristics that May Influence the Effect of Urethral Injection Therapy for Female Stress Urinary Incontinence.

PURPOSE: Urethral injection therapy is a well-known treatment of female stress urinary incontinence but to our knowledge the optimal group of recipients has not been established. In this study we examined which patient characteristics are associated with success after urethral injection therapy. MATERIALS AND METHODS: This study is a post hoc analysis of a previously published, randomized, 33-center study of the hydrogel bulking agent Bulkamid® vs the collagen gel Contigen®. Regardless of the treatment women were considered cured if there were no stress incontinence episodes in the bladder diary and no stress incontinence symptoms on the ICIQ-UI-SF (International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form), improved if there was a 50% or greater reduction in stress incontinence episodes and no effect if there was less than a 50% reduction in stress incontinence episodes 1 year after treatment. RESULTS: Of the 345 women who were initially randomized 291 were included in this study. A total of 191 women received hydrogel and 100 received collagen. At 1 year 74 women (25%) were cured, 164 (56%) were improved and 53 (18%) showed no effect. On multivariate logistic regression analysis age 60 years or greater and fewer than 2.5 daily stress incontinence episodes were associated with cure. In this group 90% of women experienced a treatment effect and 38% were cured compared with a 13% cure rate in those younger than 60 years with 2.5 or more daily stress incontinence episodes. CONCLUSIONS: Urethral injection therapy was more effective to treat stress urinary incontinence in women 60 years old or older with fewer than 2.5 daily stress incontinence episodes. It had a 90% success rate in these women.

Road to recovery after transvaginal surgery for urethral mesh perforation: evaluation of outcomes and subsequent procedures.

INTRODUCTION AND HYPOTHESIS: Urethral injury resulting from transvaginal mesh slings is a rare complication with an estimated incidence of <1%. Our objective was to review the surgical management and functional outcomes of women presenting with urethral mesh perforation following midurethral sling (MUS) placement. METHODS: This was a retrospective multicenter review of women who from January 2011 to March 2016 at two institutions underwent mesh sling excision for urethral perforation with Female Pelvic Medicine and Reconstructive Surgery fellowship-trained surgeons. Data comprising preoperative symptoms, operative details, and postoperative outcomes were collected by telephone (n 13) or based on their last follow-up appointment. RESULTS OBTAINED: Nineteen women underwent transvaginal sling excision for urethral mesh perforation. Eight (42%) patients had undergone previous sling revision surgery. Sixty percent of women had resolution of their pelvic pain postoperatively. At follow-up, 92% reported urinary incontinence (UI), and three had undergone five additional procedures for vaginal prolapse mesh exposure (n 1), incontinence (onabotulinum toxin injection n 1, rectus fascia autologous sling n 1), prolapse (colpopexy n 1), and pain (trigger-point injection n 1). Patient global impression of improvement data was available for 13 patients, of whom seven (54%) rated their postoperative condition as Very much better or Much better. CONCLUSIONS: The management of urethral mesh perforation is complex. Most women reported resolution of their pelvic pain and a high rate of satisfaction with their postoperative condition despite high rates of incontinence.

Vaginal and laparoscopic mesh hysteropexy for uterovaginal prolapse: a parallel cohort study.

BACKGROUND: There is growing interest in uterine conservation at the time of surgery for uterovaginal prolapse, but limited data compare different types of hysteropexy. OBJECTIVE: We sought to compare 1-year efficacy and safety of laparoscopic sacral hysteropexy and vaginal mesh hysteropexy. STUDY DESIGN: This multicenter, prospective parallel cohort study compared laparoscopic sacral hysteropexy to vaginal mesh hysteropexy at 8 institutions. We included women ages 35-80 years who desired uterine conservation, were done with childbearing, and were undergoing 1 of the above procedures for stage 2-4 symptomatic anterior/apical uterovaginal prolapse (anterior descent at or beyond the hymen [Aa or Ba ≥ 0] and apical descent at or below the midvagina [C ≥ -TVL/2]). We excluded women with cervical elongation, prior mesh prolapse repair, cervical dysplasia, chronic pelvic pain, uterine abnormalities, and abnormal bleeding. Cure was defined as no prolapse beyond the hymen and cervix above midvagina (anatomic), no vaginal bulge sensation (symptomatic), and no reoperations. Pelvic Organ Prolapse Quantification examination and validated questionnaires were collected at baseline and 12 months including the Pelvic Floor Distress Inventory Short Form, Female Sexual Function Index, and Patient Global Impression of Improvement. In all, 72 subjects/group were required to detect 94% vs 75% cure (80% power, 15% dropout). Intention-to-treat analysis was used with logistic regression adjusting for baseline differences. RESULTS: We performed 74 laparoscopic sacral hysteropexy and 76 vaginal mesh hysteropexy procedures from July 2011 through May 2014. Laparoscopic patients were younger (P < .001), had lower parity (P = .006), were more likely premenopausal (P = .008), and had more severe prolapse (P = .02). Laparoscopic procedure (174 vs 64 minutes, P < .0001) and total operating time (239 vs 112 minutes, P < .0001) were longer. There were no differences in blood loss, complications, and hospital stay. One-year outcomes for the available 83% laparoscopic and 80% vaginal hysteropexy patients revealed no differences in anatomic (77% vs 80%; adjusted odds ratio, 0.48; P = .20), symptomatic (90% vs 95%; adjusted odds ratio, 0.40; P = .22), or composite (72% vs 74%; adjusted odds ratio, 0.58; P = .27) cure. Mesh exposures occurred in 2.7% laparoscopic vs 6.6% vaginal hysteropexy (P = .44). A total of 95% of each group were very much better or much better. Pelvic floor symptom and sexual function scores improved for both groups with no difference between groups. CONCLUSION: Laparoscopic sacral hysteropexy and vaginal mesh hysteropexy had similar 1-year cure rates and high satisfaction.

Lasers for pelvic floor dysfunctions: is there evidence?

PURPOSE OF REVIEW: The purpose of this review is to discuss the available energy sources used in the vaginal canal that are currently being promoted for certain pelvic floor conditions and explore the body of peer-reviewed literature supporting their use. RECENT FINDINGS: The majority of research has focused on the use of fractional CO2 laser treatment for genitourinary syndrome of menopause (GSM). Most of these studies are nonrandomized prospective studies, but their data consistently shows an improvement in symptoms without significant side effects. SUMMARY: Vaginal laser treatment for GSM is of particular interest to gynecologists as it provides patients with a history of estrogen receptor positive breast cancer, thromboembolic event, or other contraindication to hormone therapy, an effective treatment option. Currently, we are in the early stages of scientific investigation into the use of lasers in the treatment of pelvic floor dysfunction, but the emerging data is encouraging. The existing data is limited to mostly observational studies with additional quality randomized controlled trials and sham studies needed to ensure that physicians are providing the optimum evidence-based treatments to their patients. At the present time there is insufficient data to promote these therapies for stress incontinence, vaginal tightening, or other pelvic floor abnormalities.

Two cases of female urethral reconstruction with acellular porcine urinary bladder matrix.

INTRODUCTION AND HYPOTHESIS: Female urethral reconstruction via the traditional routes can be limiting for various reasons. Current literature on the use of acellular biologic grafts derived from viscera for female urethral reconstruction is limited. We present two cases of women with complete loss of their posterior urethra presenting for urethral reconstruction. METHODS: Two cases of urethral reconstruction using acellular porcine urinary bladder matrix (UBM), along with labial fat pad transposition and biologic pubovaginal sling are presented. RESULTS: In both cases the UBM graft showed successful conversion to what appeared to be normal urethral mucosa. One woman showed significant improvement in continence and the other showed complete continence. CONCLUSIONS: Female urethral reconstruction using acellular porcine UBM is a viable option for patients who have lost a significant portion of their urethra. Both cases demonstrated transition of the graft into the posterior wall of the urethra with significant improvement in continence. Further studies are needed to confirm that acellular porcine UBM can transform to urethral mucosa in women requiring urethral reconstruction.

Entry into the peritoneal cavity in posthysterectomy prolapse: an educational video.

INTRODUCTION AND HYPOTHESIS: Entry into the peritoneal cavity can be challenging in patients with posthysterectomy prolapse; however, it is important for vaginal surgeons to be able to enter the peritoneal cavity using various techniques to perform an intraperitoneal vaginal vault suspension. METHODS: We present surgical footage of various methods of accessing the peritoneal cavity in posthysterectomy prolapse using posterior, anterior and apical approaches. RESULTS: This video highlights surgical techniques that can be used to enter the peritoneal cavity in posthysterectomy prolapse in a safe and reliable manner. CONCLUSIONS: Vaginal surgeons should be able to safely and confidently identify and enter the peritoneal cavity using various approaches to perform an intraperitoneal vaginal vault suspension.

Fractional CO2 laser of the vagina for genitourinary syndrome of menopause: Is the out-of-pocket cost worth the outcome of treatment?

OBJECTIVES: The purpose of this study is to assess patient's satisfaction treatment outcomes and out-of-pocket expense for the fractional CO2 laser (SmartXide) in the treatment of genitourinary symptoms of menopause (GSM). MATERIALS AND METHODS: A multicenter retrospective cohort study of patients who completed a course of three vaginal treatments with the SmartXide11 Fractional CO2 laser. Patients contacted via telephone and asked to participate in questionnaires to evaluate for adverse outcomes since last treatment, symptom severity before and after treatment, patient satisfaction with treatment, patient satisfaction with out-of-pocket expense, and sexual function. RESULTS: Of the 368 patients contacted, 122 agreed to be interviewed. No patients reported seeking emergent medical treatment. Patient reported vaginal dryness significantly improved following treatment (P < 0.05). The frequency of intercourse increased from "once a month" to "few times a month" (P < 0.001). The vast majority of patients reported being satisfied with their treatment results (86%) and with the cost of treatment (78%). Satisfaction with the out-of-pocket expense did not correlate with household income (P = 0.07). CONCLUSION: The SmartXide Fractional CO2 laser is a safe and efficacious treatment for GSM. This treatment is associated with a high level of patient satisfaction with both treatment results and out-of-pocket expense. Lasers Surg. Med. 49:882-885, 2017. © 2017 Wiley Periodicals, Inc.

Fractional CO2 Laser Treatment of the Vestibule for Patients with Vestibulodynia and Genitourinary Syndrome of Menopause: A Pilot Study.

INTRODUCTION: Chronic vulvar pain and burning remains one of the most perplexing problems faced by practicing gynecologists. AIM: To evaluate the effectiveness and safety of the application of micro-ablative fractional CO2 laser to the vulvar vestibule in the management of patients with vulvar pain from vestibulodynia or genitourinary syndrome of menopause. METHODS: Patients (N = 70) underwent fractional micro-ablative CO2 laser treatment for vestibular pain plus vestibulodynia (n = 37) or genitourinary syndrome of menopause (n = 33). Inclusion criteria were the existence of vestibular atrophic changes and the absence of moderate or severe pelvic floor hypertonic dysfunction. MAIN OUTCOME MEASURES: A visual analog scale of pain and the Marinoff score of dyspareunia were chosen to evaluate improvement. Grading of vestibular health also was quantified using a four-point scoring system (0 = no atrophy, 3 = severe atrophy). Data were collected at baseline, at weeks 4, 8, and 12, and 4 months after the final treatment. RESULTS: For visual analog scale and dyspareunia scoring and for the overall vestibular health index scoring, statistically significant improvement was noted after three sessions of vestibular fractional CO2 laser treatment. Improvement gradually increased throughout the study period and was maintained through the 4-month follow-up visit. There was no statistically significant difference in outcomes between the two study groups. No adverse events from fractional CO2 laser treatment were noted. Overall, 67.6% of patients stated significant improvement from the laser procedure. CONCLUSION: This preliminary case series showed encouraging results using fractional CO2 laser treatment of the vestibule in women with vestibulodynia and genitourinary syndrome of menopause.

Does preoperative anal physiology testing or ultrasonography predict clinical outcome with sacral neuromodulation for fecal incontinence?

INTRODUCTION AND HYPOTHESIS: To determine the value of preoperative anal physiology testing and transanal ultrasonography in predicting clinical response to sacral neuromodulation for fecal incontinence. METHODS: We report a retrospective study of all patients treated with sacral neuromodulation for fecal incontinence in a single practice between 2011 and 2014 was performed. Patient demographics included age, gender, comorbidities, presence of an ultrasound-defined external sphincter defect, and history of prior anal sphincter repair. Cleveland Clinic Florida (CCF) scores were used to assess the severity of fecal incontinence at baseline, and at 3, 6 and 12 months. Pearson's correlation coefficient was used to evaluate the relationship between preoperative physiology testing and ultrasonography and patient outcome. RESULTS: Sacral neuromodulation was trialed in 60 patients, of whom 31 had anorectal physiology testing and 29 did not. Patients who were tested were younger (60.9 vs. 71.4 years, p = 0.013) and more likely to have had a prior overlapping sphincteroplasty (40.5% vs. 15%, p = 0.043). Among patients who progressed to complete system implantation, CCF scores at 3 and 12 months were similar whether they had physiology testing or not. Likewise, patient outcome did not correlate with the finding of an ultrasound-defined external sphincter defect. Pearson's correlation coefficient was used to evaluate the relationship between the test results and the 3-month CCF scores. CCF scores 3 months after full system implantation did not correlate with the presence or size of an external sphincter defect, resting or squeeze pressure, pudendal nerve terminal motor latency, rectoanal inhibitory reflex, or minimum detectable volume. CONCLUSIONS: Anal physiology testing and ultrasonography were not predictive of clinical outcomes among patients treated with sacral neuromodulation for fecal incontinence.

A pilot randomized trial of levator injections versus physical therapy for treatment of pelvic floor myalgia and sexual pain.

INTRODUCTION AND HYPOTHESIS: Our aim was to determine the effects of pelvic floor physical therapy (PT) and levator-directed trigger-point injections (LTPI) on sexual function and levator-related pelvic pain. STUDY DESIGN: A randomized trial among women with pelvic floor myalgia (PFM) was performed wherein participants received either PT or LTPI. Pain was assessed and 1 month posttreatment completion. Levator-based pain was assessed using a numeric rating scale (NRS) and the Patient Global Impression of Improvement (PGI-I) scale. Sexual function was assessed using the Female Sexual Function Index (FSFI). RESULTS: Twenty-nine women completed the study (17 had PT, 12 had LTPI). Both groups reported reduction in vaginal pain: mean NRS change from baseline of 4.47 [standard deviation (SD) 2.12) for PT and 4.67 (SD 1.72) for LTPI (p = 0.8)]. A >50 % improvement in NRS was documented among 59 % of women receiving PT and 58 % receiving LTPI (p = 1.0). Consistent with NRS scores, mean PGI-I score was 2.50 (SD 1.17) for PT and 2.17 (SD 1.01) for LTPI (p = 0.5). Mean change in FSFI favored PT [PT +8.87 (SD 5.60), LTPI +4.00 (SD 5.24), p = 0.04], reflecting improvement in the sexual pain domain favoring PT (p = 0.02). However, the time in weeks to effect improvement favored LTPI if controlling for the degree of change in NRS (p = 0.01) and FSFI (p = 0.01). CONCLUSIONS: Vaginal myalgia and sex-related pain improved with pelvic floor PT and LTPI. Time-to-effect improvement and significance of therapy are dependent on treatment type.

Case report: diagnosis and management of peritoneovaginal fistula.

Fallopian tube vaginal fistula, a form of peritoneovaginal fistula, is an uncommon cause of persistent vaginal leakage after hysterectomy. Fallopian tube vaginal fistula resulting in peritoneal leakage has been reported in conjunction with a prolapsed fimbria. Herein is presented a case of fallopian tube vaginal fistula without a visibly prolapsed tubal fimbria. The patient was a 43-year-old woman with a 6-year history of cyclic vaginal leakage with onset shortly after vaginal hysterectomy. Examination using a vaginal speculum revealed a clear vaginal fluid but no distinct lesion or mass in the vagina, and bimanual examination did not reveal a vesicovaginal or ureterovaginal fistula. Laparoscopic surgical exploration revealed a densely adherent fallopian tube attached to the vaginal cuff, forming a fallopian tube vaginal fistula.

Efficacy and safety of polyacrylamide hydrogel for the treatment of female stress incontinence: a randomized, prospective, multicenter North American study.

PURPOSE: Bulkamid® is a new polyacrylamide hydrogel bulking agent for stress urinary incontinence that is injected in the urethral submucosa using a specifically designed device. We evaluated the safety and efficacy of Bulkamid vs Contigen® collagen gel for stress urinary incontinence or stress predominant mixed urinary incontinence. MATERIALS AND METHODS: This was a single-blind, randomized, prospective, 33-center, 2-arm parallel study of hydrogel vs collagen gel with followup to 1 year. At baseline patients underwent physical examination and bladder testing, and completed quality of life questionnaires and bladder diaries. After randomization patients could receive up to 3 injections at 1-month intervals. Patients were assessed 3, 6, 9 and 12 months after bulking. They completed bladder diaries and quality of life questionnaires, and pad weight was tested. At the last visit Valsalva leak point pressure was measured. Subjective and objective incontinence outcomes and adverse events were compared. RESULTS: Of the 345 women 229 were randomized to hydrogel and 116 were randomized to collagen gel. At 12 months a 50% or greater decrease in leakage and incontinence episodes was seen in 53.2% and 55.4% of patients who received hydrogel and collagen gel, respectively. At 12 months 47.2% of patients with hydrogel and 50% with collagen gel reported zero stress incontinence episodes, and 77.1% and 70%, respectively, considered themselves cured or improved. Major adverse events were rare in each group. CONCLUSIONS: Bulkamid is not inferior to Contigen. It has a favorable, persistent effect on stress urinary incontinence with a low risk of serious adverse events. Bulkamid is a new, simple, office based bulking system that shows promise as a treatment in women with stress urinary incontinence, particularly since Contigen is no longer commercially available.

Evaluation and management of complications from synthetic mesh after pelvic reconstructive surgery: a multicenter study.

OBJECTIVE: The purpose of this study was to describe the evaluation and management of synthetic mesh-related complications after surgery for stress urinary incontinence (SUI) and/or pelvic organ prolapse (POP). STUDY DESIGN: We conducted a multicenter, retrospective analysis of women who attended 4 US tertiary referral centers for evaluation of mesh-related complications after surgery for SUI and/or POP from January 2006 to December 2010. Demographic, clinical, and surgical data were abstracted from the medical record, and complications were classified according to the Expanded Accordion Severity Classification. RESULTS: Three hundred forty-seven patients sought management of synthetic mesh-related complications over the study period. Index surgeries were performed for the following indications: SUI (sling only), 49.9%; POP (transvaginal mesh [TVM] or sacrocolpopexy only), 25.6%; and SUI + POP (sling + TVM or sacrocolpopexy), 24.2%. Median time to evaluation was 5.8 months (range, 0-65.2). Thirty percent of the patients had dyspareunia; 42.7% of the patients had mesh erosion; and 34.6% of the patients had pelvic pain. Seventy-seven percent of the patients had a grade 3 or 4 (severe) complication. Patients with TVM or sacrocolpopexy were more likely to have mesh erosion and vaginal symptoms compared with sling only. The median number of treatments for mesh complications was 2 (range, 1-9); 60% of the women required ≥2 interventions. Initial treatment intervention was surgical for 49% of subjects. Of those treatments that initially were managed nonsurgically, 59.3% went on to surgical intervention. CONCLUSION: Most of the women who seek management of synthetic mesh complication after POP or SUI surgery have severe complications that require surgical intervention; a significant proportion require >1 surgical procedure. The pattern of complaints differs by index procedure.