Two-Year Results of Burch Compared With Midurethral Sling With Sacrocolpopexy: A Randomized Controlled Trial.

OBJECTIVE: To evaluate 1- and 2-year urinary continence rates after Burch retropubic urethropexy compared with a retropubic midurethral sling for women with urinary incontinence undergoing sacrocolpopexy. METHODS: We conducted a planned secondary analysis of a multicenter, randomized, single-blind trial comparing Burch with a sling that enrolled participants from June 2009 to August 2013. Objective outcome measures of continence were assessed at 1- and 2-year follow-up through office visits and validated questionnaires. Overall continence was defined as a negative stress test, no retreatment for stress incontinence, and no self-reported urinary incontinence (International Consultation on Incontinence Questionnaire, Short Form, score, 0). Stress-specific continence was defined as fulfillment of the first two criteria and no self-reported stress-related incontinence. Primary outcomes were assessed with intention-to-treat and within-protocol analyses. Comparisons between groups were evaluated using χ or Fisher exact test. RESULTS: The two groups were similar in all measured baseline features. Outcome assessments at 2 years were available for 48 of 57 patients (84%) in the sling group and 45 of 56 patients (80%) in the Burch group. With intention-to-treat analysis, the sling group had significantly higher rates of overall continence than the Burch group (49% [28/57] vs 29% [16/56]; 95% CI for absolute risk difference 3.0-38.1; P=.03) at 1- but not 2-year follow-up (47% [27/57] vs 32% [18/56]; 95% CI for absolute risk difference -2.6 to 33.1; P=.10). The sling group had significantly higher rates of stress-specific continence than the Burch group at 1-year (70% [40/57] vs 46% [26/56]; 95% CI for absolute risk difference 6.1-41.4; P=.01) and 2-year (70% [40/57] vs 45% [25/56]; 95% CI for absolute risk difference 7.9-43.2; P=.006) follow-up. No difference was detected in prolapse recurrence, voiding dysfunction, antimuscarinic medication use, urgency incontinence, or patient satisfaction. CONCLUSION: Among women with baseline urinary incontinence undergoing sacrocolpopexy, the retropubic midurethral sling resulted in higher stress-specific continence rates than Burch retropubic urethropexy at 1- and 2-year follow-up.

Burch Retropubic Urethropexy Compared With Midurethral Sling With Concurrent Sacrocolpopexy: A Randomized Controlled Trial.

OBJECTIVE: To compare efficacy and safety of retropubic Burch urethropexy and a midurethral sling in women with stress urinary incontinence (SUI) undergoing concomitant pelvic floor repair with sacrocolpopexy. METHODS: Women were randomly assigned to Burch retropubic urethropexy (n=56) or retropubic midurethral sling (n=57) through dynamic allocation balancing age, body mass index, history of prior incontinence surgery, intrinsic sphincter deficiency, preoperative incontinence diagnosis, and prolapse stage. Overall and stress-specific continence primary outcomes were ascertained with validated questionnaires and a blinded cough stress test. RESULTS: Enrollment was June 1, 2009, through August 31, 2013. At 6 months, no difference was found in overall (29 midurethral sling [51%] compared with 23 Burch [41%]; P=.30) (odds ratio [OR] 1.49, 95% confidence interval [CI] 0.71-3.13) or stress-specific continence rates (42 midurethral sling [74%] compared with 32 Burch [57%]; P=.06) (OR 2.10, 95% CI 0.95-4.64) between groups. However, the midurethral sling group reported greater satisfaction (78% compared with 57%; P=.04) and were more likely to report successful surgery for SUI (71% compared with 50%; P=.04) and to resolve pre-existing urgency incontinence (72% compared with 41%; P=.03). No difference was found in patient global impression of severity or symptom improvement, complication rates, or mesh exposures. CONCLUSION: There was no difference in overall or stress-specific continence rates between midurethral sling and Burch urethropexy groups at 6 months. However, the midurethral sling group reported better patient-centered secondary outcomes.

Health-related quality of life and outcomes after surgical treatment of complications from vaginally placed mesh.

INTRODUCTION AND HYPOTHESIS: We aimed to report on health-related quality of life after surgical excision of vaginally placed mesh for treatment of pelvic organ prolapse and to identify predictors of successful surgical management. METHODS: We identified patients who underwent surgery for treatment of complications from vaginally placed mesh from January 1, 2003, through December 31, 2011, and conducted a follow-up survey. Logistic regression models were used to identify predictors of successful treatment. RESULTS: We identified 114 patients who underwent surgery for mesh-related complications and 68 underwent mesh excision. Of the 68 patients, 44 (64.7%) completed the survey. Of the 44 responders, 41 returned their consent form and were included in the analysis. Only 22 (54%) patients reported a successful outcome after mesh excision. Of 29 (71%) sexually active patients, 23 had dyspareunia before mesh excision and only 3 patients reported resolution of dyspareunia after excision. We reported a multivariable model for predicting successful surgical outcome with an area under the curve for the receiver operator characteristic of 0.781. In this model, complete excision of mesh, new overactive bladder symptoms after mesh placement, and a body mass index higher than 30 kg/m were associated with successful patient-reported outcomes; adjusted odds ratios (95% confidence intervals) were 5.46 (1.10-41.59), 7.76 (1.18-89.55), and 8.41 (1.35-92.41), respectively. CONCLUSIONS: Only half of the patients who had surgery for vaginally placed mesh complications reported improvement after surgery, with modest improvement in dyspareunia. Patients who had complete mesh excision, new overactive bladder symptoms, and obesity were more likely to report improvement.

Metastasis of squamous cell cervical carcinoma to the orbit of the eye.

► We compare characteristics of our case with five previously reported cases. ► We discuss possible mechanisms of dissemination and metastasis to the distant site. ► We discuss treatment options, but poor outcome was noted in all six cases.

Attributes of successful and unsuccessful female pelvic medicine and reconstructive surgery fellowship applicants.

OBJECTIVE: : To evaluate qualifications of successful applicants to Female Pelvic Medicine and Reconstructive Surgery (FPMRS) fellowship programs. METHODS: : A 55-point web-based survey was sent to 49 applicants participating in the 2008 FPMRS Match. RESULTS: : The survey achieved a 59% response rate, with a total of 29 respondents. Regarding prematch educational preparations pursued by applicants, 11 of the 24 matched respondents (46%) trained at residencies that offered FPMRS fellowship training. About 19 matched applicants (19/21, 90%) and 2 unmatched applicants (2/5, 40%) received a letter of recommendation from a "nationally-known" female pelvic medicine surgeon. About 40% of matched and unmatched applicants authored at least one manuscript. CONCLUSIONS: : If these respondents are representative of all fellowship candidates in FPMRS match, then it would be expected that combined application costs for all candidates would be almost $350,000.

Factors used by female pelvic medicine and reconstructive surgery fellowship directors to select their fellows.

INTRODUCTION AND HYPOTHESIS: We report the attributes of Female Pelvic Medicine and Reconstructive Surgery (FPM&RS) fellowship applicants that are most valued by fellowship program directors during the ranking process. METHODS: Anonymous questionnaires were filled out by FPM&RS fellowship program directors following the 2008 match. The survey was designed to assess the relative importance of various factors in the ranking of fellowship applicants. RESULTS: Surveys were sent to 67 program directors, and 21 completed the survey (31%). Items ranked as the most important in the selection process were a high quality obstetrics and gynecology residency education (8.2+/-1.2), followed by clinical research experience (7.4+/-1.4). Ability to work well with staff and work ethic were considered to be the most important subjective criteria. CONCLUSIONS: Our results support anecdotal evidence that placed emphasis on research experience and interpersonal skills in the selection of FPM&RS fellows.

Suture end length as a function of knot integrity.

OBJECTIVE: To evaluate tension at the failure of 3 commonly used sutures when suture ends were cut to 3 lengths. STUDY DESIGN: Knots were tied using U.S. Pharmacopeia Size 0-0 polyglactin 910, silk, or polydioxanone sutures. The knots were tied randomly on a jig by the same surgeon. End lengths were then cut to random lengths of 0, 3, and 10 mm. We compared the individual knot strength when subjected to tensile forces via tensiometer with the point of knot failure, which was defined as untying and/or breaking of the knot. RESULTS: Three types of suture were divided into 3 groups based on end lengths for a total of 178 knots. A logistic regression analysis showed the odds of knots coming untied were highest for polyglactin 910 (odds ratio [OR] = 33.7; 95% confidence interval [CI] = 4.1-277.1). End length also had a significant effect on knots untying, with the 0-mm knots being more likely to come untied (OR, 21.2; 95% CI, 2.9-153.0). Post hoc tests for a 3 x 3 analysis of variance found that silk knots failed at significantly lower tension than polydioxanone (p < 0.001) and polyglactin 910 (p < 0.001) knots. CONCLUSIONS: The knots with an end length of 0 mm were significantly more likely to come untied than either 3- or 10-mm knots. Among all the materials, polyglactin 910 was the most prone to untying; however, it resulted in untying at a mean tension greater than the breaking point of silk.

Risk factors for pelvic floor repair after hysterectomy.

OBJECTIVE: Having demonstrated that prior history of prolapse was a risk factor for pelvic floor repair procedures after hysterectomy, the objective of this study was to assess medical risk factors for pelvic floor repair after hysterectomy. METHODS: Using the Rochester Epidemiology Project database of 8,220 Olmsted County, Minnesota, women who had hysterectomy for benign indications from 1965-2002, we conducted a nested case-control study in 144 pairs, comparing women who underwent pelvic floor repair after hysterectomy (case group) with women matched for known risk factors (ie, age, pelvic floor disorders at baseline, year and type of hysterectomy, and pelvic floor repair during hysterectomy) (control group). RESULTS: The median duration between hysterectomy and pelvic floor repair was 13 years. Chronic pulmonary disease (odds ratio [OR] 14.3, 95% confidence interval [CI] 1.2-178), but not obstetric history, obesity, indication for hysterectomy, or chronic constipation, was associated with an increased risk of pelvic floor repair after hysterectomy. Between the hysterectomy and subsequent pelvic floor repair, overall pelvic organ prolapse severity changed by one grade or less in 54 case patients (38%, group A) but increased by two or more grades in 72 case patients (50%, group B). In group A, but not group B, uterine prolapse (OR 25, 95% CI 2.1-300) and chronic pulmonary disease (OR 22, 95% CI 1.5-328) at baseline remained risk factors for pelvic floor repair after hysterectomy. CONCLUSION: In this matched case-control study, chronic pulmonary disease was the only risk factor for pelvic floor repair after hysterectomy for benign indications, underscoring the need to address pulmonary status before surgery.

Complications from vaginally placed mesh in pelvic reconstructive surgery.

INTRODUCTION AND HYPOTHESIS: We describe complications associated with the use of transvaginal mesh for treatment of pelvic organ prolapse. METHODS: We retrospectively identified patients referred to our institution from January 2003 through September 2007 who had complications after vaginal placement of mesh. RESULTS: We identified 21 patients with a mean (SD) age of 61 (11) years. Types of mesh used included mesh kits (n = 9, 43%), nontrocar mesh augmentation (n = 5, 24%), IVS Tunneller (n = 4, 19%), and unspecified (n = 3, 14%). Eleven patients (52%) underwent more than one procedure before referral. Only three patients were referred by the original treating surgeon. Complications included mesh erosions in 12 women, dyspareunia in ten, and recurrent prolapse in nine. Sixteen patients (76%) were managed surgically. Follow-up survey among sexually active patients showed 50% with persistent dyspareunia. CONCLUSIONS: Use of vaginal mesh for pelvic reconstruction can produce complications. Multiple interventions may be necessary, and bothersome symptoms may persist.

Re-operation rates after permanent sacral nerve stimulation for refractory voiding dysfunction in women.

OBJECTIVES: To describe the development of screening tests and to identify re-operation rates after the permanent implant phase, and its characteristics, of the Interstim (Medtronic, Inc., Minneapolis, MI, USA) device for sacral nerve stimulation (SNS). PATIENTS AND METHODS: We retrospectively reviewed the charts of women who had SNS between January 1998 and December 2005; their demographic, clinical and surgical information was abstracted. Descriptive statistics, chi-square and analysis of variance were used to compare the results. RESULTS: In all, 95 patients had 105 test procedures; 30 peripheral nerve evaluation (PNE) and 75 staged tined leads. Response rates were lower in the PNE than in the tined lead (40% vs 67%, P = 0.01). The indication for SNS was associated with the response rate, with urinary retention having the highest response (71%, P = 0.01). For the 55 implanted devices, there were 18 revisions (33%) and eight explants (15%). The main reasons for revision or explants were loss of efficacy (16/26) and pain at the implant site (six of 26). The median (range) time to intervention after implantation was 17 (1.2-75.0) months, and this was significantly associated with the indication. Revisions due to pain at the implant site were within the first year, and re-operations due to loss of efficacy after 1-2 years, whereas battery replacement was required on average 4 years after initial implantation. CONCLUSIONS: This study confirms the higher response rates of the tined-lead staged technique over PNE. Unobstructive urinary retention had the highest response rates. The reason for revision appeared to be largely predicted by the length of time since implantation.

Incidence of pelvic floor repair after hysterectomy: A population-based cohort study.

OBJECTIVE: The objective of the study was to assess the incidence of and risk factors for pelvic floor repair (PFR) procedures after hysterectomy. STUDY DESIGN: Using the Rochester Epidemiology Project database, we tracked the incidence of PFRs through June 2006 among 8220 Olmsted County, MN, women who had a hysterectomy for benign indications between 1965 and 2002. RESULTS: The cumulative incidence of PFR after hysterectomy was 5.1% by 30 years. This risk was not influenced by age at hysterectomy or calendar period. Future PFR was more frequently required in women who had prolapse, whether they underwent a hysterectomy alone (eg, vaginal [hazard ratio (HR) 4.3; 95% confidence interval (CI) 2.5 to 7.3], abdominal [HR 3.9; 95% CI 1.9 to 8.0]) or a hysterectomy and PFR (ie, vaginal [HR 1.9; 95% CI 1.3 to 2.7] or abdominal [HR 2.9; 95% CI 1.5 to 5.5]). CONCLUSION: Compared with women without prolapse, women who had a hysterectomy for prolapse were at increased risk for subsequent PFR.