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.
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.
To determine which factors predict resolution of urgency urinary incontinence (UUI) in women with mixed urinary incontinence after undergoing midurethral sling (MUS) or Burch anti-incontinence procedures. This is a secondary analysis of a randomized clinical trial comparing MUS and Burch urethropexy in women with symptomatic or occult SUI undergoing prolapse repair with sacrocolpopexy. UUI was based on the response to the International Consultation on Incontinence Questionnaire (ICIQ) at baseline so long as the urgency incontinence symptoms did not exceed 50% of her overall incontinence bother. Primary outcome was resolution of UUI at 6 months which was based on response to the question “How often do you get a sudden, uncomfortable urge or desire to pass urine that makes you to want to stop what you are doing and rush to the bathroom but you do not get there in time (you leak or wet pads)?” from the Overactive Bladder Symptom Score Questionnaire (OABSS) questionnaire. Those whose response changed from “a few times a month” or more at baseline to “never” or “rarely” and who did not initiate anti-muscarinic medication following surgery were considered to have resolution of UUI. Variables were compared between women with and without resolution of UUI using the chi-square test or Fisher's exact test for categorical variables and the two-sample t-test or Wilcoxon rank-sum test for continuous variables. A total of 67 women with a preoperative diagnosis of mixed urinary incontinence had completed baseline and 6-month follow-up surveys and 2 were excluded because they underwent repeat anti-incontinence procedure before 6-month visit. Out of 65 women that were included in the sub-analysis, 46 women had responded “a few times a month” or more to the above mentioned question from OABSS questionnaire at baseline. Twenty-two (47.8%) women underwent Burch urethropexy and 24 (52.2%) underwent MUS procedure. Twenty-three out of 46 women (50.0%) met the criteria for resolution of UUI at 6-month follow-up. Compared to women without resolution, women with resolution of UUI were more likely to have higher baseline BMI (mean, 30.7 vs 27.1 kg/m2, p = 0.02). There was no difference in the average baseline ICIQ, OAB-q severity and OAB-q HRQL scores amongst women with and without resolution. However, there was a significant improvement in bother symptoms from baseline to 6 months as reported by ICIQ, OAB-q severity and OAB-q HRQL scores in women with resolution of UUI compared to those without resolution. Elevated BMI was associated with resolution of UUI following incontinence surgery in women with a preoperative diagnosis of mixed urinary incontinence undergoing sacrocolpopexy. Baseline UUI severity was not a predictor of improvement.
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(2) 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.
Introduction: Obesity is a major public health issue, associated with significant medical and psychosocial co-morbidities. Patients undergoing bariatric surgery report a decline in sexual function; in a recent study female sexual dysfunction (FSD) was reported in 51 % of female bariatric patients. Objectives: To review and summarise published literature on the effects of bariatric surgery on female sexual dysfunction. Method: Search strategy Articles were identified using a search of the National Centre for Biotechnology Information (NCBI) PubMed from January 1996 to December 2013. Selection criteria Original studies on adult female obese patients undergoing bariatric surgery were identified, which reported changes in sexual function (SF) validated by the Female Sexual Function Index (FSFI) preand postprocedure. The FSFI evaluates SF using 6 domains: − desire, arousal, lubrication, orgasm, satisfaction and pain. Exclusions included studies with non-surgical weight loss methods and mixed populations (female and male). Main outcome measures were post-operative changes in FSFI and body mass index (BMI). Results: Six studies were included in the final review. The total number of patients was 360. Statistical analysis using a forest plot revealed a significant reduction in BMI (p<0.001) and improvement in FSFI overall score (p=0.003) and five specific domains (desire p=0.005, Int Urogynecol J (2014) 25 (Suppl 1):S1–S240 S126
A RANDOMIZED COMPARISON OF INCONTINENCE PROCEDURES PERFORMED CONCOMITANTLY WITH ABDOMINAL SACRAL COLPOPEXY: THE BURCH VERSUS MID-URETHRAL SLING TRIAL E. C. Trabuco, C. J. Klingele, R. Blandon, J. A. Occhino, M. E. McGree, A. L. Weaver, M. A. Lemens, J. B. Gebhart; OBSTETRICS AND GYNECOLOGY, Mayo Clinic, Rochester, MN, OBSTETRICS AND GYNECOLOGY, SAINT LUKE’S Hosp. OF KANSAS CITY, Univ. OF MISSOURI KANSAS CITY SCHOOL OF MEDICINE, KANSAS CITY, MO, DIVISION OF BIOMEDICAL STATISTICS AND INFORMATICS, Mayo Clinic, Rochester, MN. Introduction: The CARE trial demonstrated that stress continent women have significantly less bothersome stress incontinence symptoms following sacrocolpopexy combined with a Burch urethropexy compared to sacrocolpopexy alone. However, it is not clear which surgical approach to address urinary incontinence is optimal in women who have symptomatic SUI and are undergoing sacrocolpopexy. Objective: To compare the efficacy and safety of Burch retropubic urethropexy and retropubic mid-urethral sling (MUS) in women with symptomatic stress (SUI) or stress predominant mixed incontinence (MUI) undergoing concomitant pelvic floor repairs with a sacrocolpopexy. Methods: IRB-approved, randomized, single-blinded trial comparing Burch with MUS in women with symptomatic urinary incontinence and prolapse undergoing a sacrocolpopexy. Patients were randomized using a dynamic allocation approach to achieve balance between intervention groups regarding age, BMI, history of prior incontinence surgery, pre-operative diagnosis, and prolapse stage. Two primary outcomes were assessed at 6 weeks and 6 months during a medical visit and with completion of validated questionnaires. Patients were objectively continent if at follow-up they 1) had a negative standardized stress test performed by a masked observer; 2) no interim re-treatment for stress urinary incontinence; and 3) no self-reported urinary incontinence (International Consultation on Incontinence Questionnaireshort form score of 0). As SUI surgery is not meant to address urge incontinence, patients were considered to have stress-specific continence if they fulfilled criteria 1 and 2 above and 3) had no self-reported stress-related leakage of urine (‘‘never’’ or ‘‘rarely’’ response to all 6 questions from the SUI subscale of the Medical, Epidemiological, Social Aging questionnaire). Comparisons were evaluated using the chi-square test or Fisher’s exact test, as appropriate. Results: There was no difference in age, BMI, history of prior incontinence surgery, pre-operative diagnosis, prolapse stage, or baseline incontinence severity between groups. Six-month follow-up was available on 104 patients (92%) of the 113 patients randomized (53/57MUS and 51/56 Burch). Although there was no difference in objective continence between MUS and Burch patients with complete 6-month follow-up (66.0% (35/53) vs. 54.9% (28/51), p=0.25), patients who had a MUS had higher stress-specific continence at 6 months (81.1% (43/53) vs. 62.7% (32/1); p=0.04). The findings remained consistent when the patients lacking follow-up were classified as failures for each outcome (objective continence: 61.4% (35/57) vs. 50.0% (28/56), p=0.22; stress-specific continence: 75.4% (43/57) vs. 57.1% (32/56), p=0.04). There was no difference in the rate of de novo urge incontinence between MUS and Burch (10.7% (3/28) vs. 7.7% (2/26), p=0.99). Amongst patients with baseline urgency urinary incontinence (answered ‘‘a few times a month’’ or worse to question 6 of the overactive bladder symptom score [22 MUS and 22 Burch]), 77.3% of theMUS patients had improvement in, 13.6% reported no change, and 9.1% had exacerbation of their symptoms, compared to 59.1%, 27.3%, and 13.6%, respectively, for the Burch patients (p=0.52). Patients who had a MUS procedure had higher satisfaction (answered ‘‘somewhat’’ or ‘‘completely’’: 93.8% vs. 72.3%: p=0.005), higher patient perception of improvement (rated 10 on 10-point VAS: 71.4% vs. 51.1%, p=0.04) and were more likely to report having had a successful surgery for SUI (rated 10 on a 10-point VAS: 72.3% vs. 47.8%; p=0.02). There was no difference in patient global impression of severity, the rate of complications or mesh exposures between groups. Conclusions: In women with baseline SUI undergoing concomitant prolapse repairs with a sacrocolpopexy, MUS resulted in greater patient satisfaction and higher urinary continence rates compared to Burch retropubic urethropexy. References: 1. L. Brubaker et al., N Engl J Med 354, 1557 (Apr 13, 2006). 2. K. Avery, J. Donovan, T. Peters, et al., Neurourol Urodyn 23, 322 (May 24, 2004). 3. A. Diokno, B. Brock, M. Brown, et al., J Urol 136, 1022 (Nov, 1986). Disclosures: Emanuel Trabuco: No disclosures. CHRISTOPHERKLINGELE: No disclosures. ROBERTA BLANDON: No disclosures. JOHN OCCHINO: No disclosures. MICHAELA MCGREE: No disclosures. AMY WEAVER: No disclosures. MAUREEN LEMENS: No disclosures. JOHN GEBHART: Elsevier: Book royalties, Royalty. UpToDate: Royalties, Royalty.
► 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.
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.
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.
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.
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 19652002, 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.
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.
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.
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.
Purpose: Bariatric surgery has become an effective long-term treatment for obesity. A small number of patients presents with post-op symptoms suggestive of gastrojejunal anastomosis (GJA) obstruction. These patients usually undergo a costly workup consisting of gastrographin upper gastrointestinal series (UGIS) and/or upper endoscopy. The purpose of this study was to determine whether there was a correlation between gastrographin UGIS and upper endoscopy in determination of GJA strictures after Roux-en-Y-bariatric surgery. Such information may result in changes in the current diagnostic algorithm. Methods: Between July 2001 and October 2003, 535 patients underwent Roux-en-Y surgery at our institution. 52 of them presented with symptoms suggestive of gastrointestinal obstruction and underwent upper endoscopies, gastrographin UGIS, or both. UGIS consisted of antero-posterior or left posterior obliques. A radiologist masked to the endoscopy results selected and measured a single projection, which best-represented anastomotic diameter. In addition, all 52 patients underwent 1 to 6 upper endoscopies per patient by four endoscopists. Anastomotic diameters were approximated comparing anastomosis to the diameter of Pentax EG endoscope (9 mm). Pearson's correlation coefficient and linear regression were used to evaluate the relationship between endoscopic and radiographic findings. Results: Fifty- two (36 women and 16 men) of 535 (9.7%) bariatric patients underwent endoscopic and radiographic investigations secondary to their obstructive symptoms. Mean age 44.5 years (SD 10.21), mean number of endoscopies 2.67(SD 1.34). Mean diameter on endoscopy was 5.97 mm(SD 2.51) and x-ray 6.83 mm (SD 3.43). There was good correlation between the radiographic and endoscopic findings by both Pearson's correlation coefficient (0.44, p = 0.02) and single linear regression using endoscopic diameter as the outcome and x-ray findings as the predictor (Beta Coeff. 0.27, p = 0.025, 95% CI 0.30–0.49). Conclusions: Gastrographin UGIS significantly correlated with endoscopic GJA findings in Roux-en-Y bariatric patients. UGIS is a less invasive alternative for evaluating bariatric patients who present with obstructive symptoms, and may help to guide treatment without the use of endoscopy in this sick population.