Robert E. Gutman

Vaginal Mesh for Prolapse A Randomized Controlled Trial

OBJECTIVE: To present 3-month outcomes of a double-blind, multicenter randomized controlled trial comparing traditional vaginal prolapse surgery without mesh with vaginal surgery with mesh. METHODS: Women with pelvic organ prolapse quantification prolapse stages 2–4 were randomized to vaginal colpopexy repair with mesh or traditional vaginal colpopexy without mesh. The primary outcome measure was objective treatment success (pelvic organ prolapse quantification stage 1 or lower) at 3 months. Secondary outcome measures included quality-of-life variables and complication rates. RESULTS: Sixty-five women were recruited from January 2007 to August 2009, when the study was halted due to predetermined stopping criteria for vaginal mesh erosion at a median follow-up of 9.7 months (range, 2.4–26.7 months). Thirty-two women underwent mesh colpopexy (24 anterior mesh, eight total mesh), and 33 women had vaginal colpopexies without mesh (primarily uterosacral ligament suspension) and concurrent colporrhaphy. There were no statistically significant baseline differences between the mesh and no-mesh groups with respect to demographics, menopausal status, and race. Analysis of the mesh and no-mesh women found no difference with respect to overall recurrence (mesh: 19 [59.4%] compared with no mesh: 24 [70.4%], P=.28). There were five (15.6%) vaginal mesh erosions. Two cystotomies and one blood transfusion occurred in the mesh group only. Subjective cure of bulge symptoms was noted in 93.3% of mesh patients and 100% of no-mesh patients. Furthermore, subjective quality-of-life measurements did not differ between the two groups at baseline or 3 months postoperatively. CONCLUSION: At 3 months, there is a high vaginal mesh erosion rate (15.6%) with no difference in overall objective and subjective cure rates. This study questions the value of additive synthetic polypropylene mesh for vaginal prolapse repairs. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, www.clinicaltrials.gov, NCT00475540. LEVEL OF EVIDENCE: I

Is there a pelvic organ prolapse threshold that predicts pelvic floor symptoms

OBJECTIVE The objective of this study was to determine the minimum threshold level at which maximum anatomic prolapse predicts bothersome pelvic floor symptoms. STUDY DESIGN We performed a cross-sectional study of women older than 40 years undergoing gynecologic and urogynecologic examinations using Pelvic Organ Prolapse Quantification (POP-Q) examinations to assess support and Pelvic Floor Distress Inventory questionnaires to assess symptoms. Across the spectrum of prolapse severity, we calculated receiver operating characteristic (ROC) curves and areas under the curves (AUCs) for each symptom. RESULTS Of 296 participants, age was 56.3 +/- 11.2 years, and 233 (79%) were white. POP-Q stage was 0 in 39 (13%), 1 in 136 (46%), 2 in 89 (30%), and 3 in 33 (11%). ROC analysis for each symptom revealed an AUC of 0.89 for bulging/protrusion; 0.81 for splinting to void; 0.55-0.62 for other prolapse and urinary symptoms; and 0.48-0.56 for bowel symptoms. Using a threshold of 0.5 cm distal to the hymen, the sensitivity (69%) and specificity (97%) were high for protrusion symptoms but poor for most other symptoms considered. CONCLUSION Vaginal descensus 0.5 cm distal to the hymen accurately predicts bulging/protrusion symptoms; however, we could not identify a threshold of prolapse severity that predicted other pelvic floor symptoms.

Evaluation of clinical methods for diagnosing bacterial vaginosis.

OBJECTIVE: To determine whether the current clinical criteria for diagnosing bacterial vaginosis can be simplified by using 2 clinical criteria rather than the standard 3 of 4 criteria (Amsels criteria). METHODS: This was a prospective observational study of 269 women undergoing a vaginal examination in the Womens Primary Care Center, Division of Research, or Colposcopy Clinic at Women & Infants Hospital. All 4 clinical criteria for diagnosing bacterial vaginosis were collected, and Gram stain was used as the gold standard. Sensitivity and specificity were calculated for each individual criterion, combinations of criteria, and a colorimetric pH and amine card. Receiver operating characteristic curve was generated to estimate the preferred pH and percentage of clue cells for diagnosing bacterial vaginosis. RESULTS: The prevalence of bacterial vaginosis in our study population was 38.7%. Vaginal pH was the most sensitive of all the criteria, at 89%, and a positive amine odor was the individual criteria with the highest specificity, at 93%. Similar specificity was seen with combinations of 2 criteria and Amsels criteria. Receiver operating characteristic curve analysis yielded a preferred pH and percentage of clue cells of 5.0 and 20%, respectively. However, a pH of 4.5 or greater improves sensitivity with minimal loss of specificity. CONCLUSION: The clinical criteria for diagnosing bacterial vaginosis can be simplified to 2 clinical criteria without loss of sensitivity and specificity. LEVEL OF EVIDENCE: II-2

One-year objective and functional outcomes of a randomized clinical trial of vaginal mesh for prolapse

OBJECTIVE The purpose of this study was to show 12-month outcomes of a randomized trial that compared vaginal prolapse repair with and without mesh. STUDY DESIGN Women with stage ≥2 prolapse were assigned randomly to vaginal repair with or without mesh. The primary outcome was prolapse stage ≤1 at 12 months. Secondary outcomes included quality of life and complications. RESULTS All 65 evaluable participants were followed for 12 months after trial stoppage for mesh exposures. Thirty-two women had mesh repair; 33 women had traditional repair. At 12 months, both groups had improvement of pelvic organ prolapse-quantification test points to similar recurrence rates. The quality of life improved and did not differ between groups: 96.2% mesh vs 90.9% no-mesh subjects reported a cure of bulge symptoms; 15.6% had mesh exposures, and reoperation rates were higher with mesh. CONCLUSION Objective and subjective improvement is seen after vaginal prolapse repair with or without mesh. However, mesh resulted in a higher reoperation rate and did not improve 1-year cure.

Uterine-preserving POP surgery

Introduction and hypothesisTo review the safety and efficacy of uterine preservation surgery.MethodsEvery four years and as part of the Fifth International Collaboration on Incontinence we reviewed the English-language scientific literature after searching PubMed, Medline, Cochrane library and Cochrane database of systematic reviews, published up to January 2012. Publications were classified as level 1 evidence (randomised controlled trials [RCT] or systematic reviews), level 2 (poor quality RCT, prospective cohort studies), level 3 (case series or retrospective studies) and level 4 case reports. The highest level of evidence was utilised by the committee to make evidence-based recommendations based upon the Oxford grading system. Grade A recommendation usually depends on consistent level 1 evidence. Grade B recommendation usually depends on consistent level 2 and/or 3 studies, or “majority evidence” from RCTs. Grade C recommendation usually depends on level 4 studies or “majority evidence” from level 2/3 studies or Delphi processed expert opinion. Grade D “no recommendation possible” would be used where the evidence is inadequate or conflicting and when expert opinion is delivered without a formal analytical process, such as by Delphi.ResultsA wide variety of surgical options remain for women presenting with uterine prolapse without contraindications to uterine preservation. However, long-term data are limited and the need for subsequent hysterectomy unknown (grade C). Sacrospinous hysteropexy is as effective as vaginal hysterectomy and repair in retrospective comparative studies and in a meta-analysis with reduced operating time, blood loss and recovery time. However, in a single RCT there was a higher recurrence rate associated with sacrospinous hysteropexy compared with vaginal hysterectomy (grade D). Severe prolapse increases the risk of recurrent prolapse after sacrospinous hysteropexy. In consistent level 2 evidence sacrospinous hysteropexy with mesh augmentation of the anterior compartment was as effective as hysterectomy and mesh augmentation with no significant difference in the rate of mesh exposure between the groups (grade B). Level 1 evidence from a single RCT suggests that vaginal hysterectomy and uterosacral suspension were superior to sacral hysteropexy based on reoperation rates, despite similar anatomical and symptomatic improvement (grade C). Consistent level 2 and 3 evidence suggests that sacral hysteropexy (open or laparoscopic) was as effective as sacral colpopexy and hysterectomy in anatomical outcomes; however, the sacral colpopexy and hysterectomy were associated with a five times higher rate of mesh exposure compared with sacral hysteropexy (grade B). Performing hysterectomy at sacral colpopexy was associated with a four times higher risk of mesh exposure compared with sacral colpopexy without hysterectomy (grade B).ConclusionWhile uterine preservation is a viable option for the surgical management of uterine prolapse the evidence on safety and efficacy is currently lacking.

Abdominal sacrocolpopexy: anatomic outcomes and complications with Pelvicol, autologous and synthetic graft materials

OBJECTIVE The purpose of this study was to compare anatomic outcomes and graft-related complications (GRCs) for abdominal sacrocolpopexy (ASC) with Pelvicol (CR BARD, Murray Hill, NJ), autologous fascia, and synthetic grafts. STUDY DESIGN This is a retrospective cohort study of ASC from 2001-2005. We reviewed anatomic outcomes and GRCs. Apical failure was defined as >stage 0. RESULTS Of 259 ASC procedures, Pelvicol was used in 102 procedures (39%); synthetic mesh in 134 procedures (52%), and autologous fascia in 23 procedures (9%). Mean postoperative follow up was 1.1 years. Apical failure by graft group were Pelvicol 10 (11%), synthetics 1 (1%), and autologous 1 (7%; P = .011). All 7 reoperations for apical prolapse were in the Pelvicol group. GRCs occurred in 16% of the cases, with a higher proportion of erosions in the Pelvicol group (11% vs 3% and 4%; P = .045). Reoperations as a result of GRC were similar between groups. CONCLUSION ASC is more likely to fail with Pelvicol than with synthetic or autologous grafts. The use of Pelvicol did not reduce graft-related complications in this population.

Outcomes of abdominal and minimally invasive sacrocolpopexy: a retrospective cohort study.

Objective To compare perioperative and postoperative surgical outcomes between and among open and minimally invasive sacrocolpopexies (MISCs). Methods We performed a multicenter retrospective cohort study comparing abdominal sacrocolpopexy (ASC) and MISC from January 1999 to December 2010. Results A total of 1124 subjects underwent sacrocolpopexy, with 589 ASCs and 535 MISCs. Within the MISC group, 273 were laparoscopic (LSC) and 262 were robotic (RSC). Abdominal sacrocolpopexy was associated with greater overall complication rate compared with MISC (20.0% vs 12.7%; P = 0.001). After controlling for difference in length of follow-up, there was no significant difference in the rate of anatomical failure between the ASC and MISC groups. The MISC group had shorter hospitalization, less blood loss, but longer operative times compared with the ASC group. When comparing LSC to RSC, there was no difference in anatomic failures (7.7% vs 6.9%; P = 0.74). However, LSC was associated with more complications compared with RSC (18% vs 7%; P < 0.02). In addition, LSC had higher blood loss, less operative time, and shorter hospital stay compared with RSC. Conclusion Although anatomic results are similar, ASC is associated with a higher rate of complications compared with MISC.

Interest in cosmetic vulvar surgery and perception of vulvar appearance

OBJECTIVE The objective of the study was to determine whether reproductive-age women are more likely to perceive their vulva as abnormal compared with older-aged women. STUDY DESIGN Women aged 18-44 years (group 1) and 45-72 years (group 2) completed a survey on demographics, grooming patterns, vulvar perceptions, and source of information about the vulva. RESULTS There was no difference between group 1 and group 2 in how often women looked at their vulva or their perception of having a normal vulva (91% vs 93%, P = .76). Both groups were satisfied with the appearance of their vulva (81% vs 82%, P = .71). A higher percentage in group 2 would consider cosmetic surgery if cost were not an issue versus group 1 (15% vs 8%, P = .05). CONCLUSION A womans age does not have an impact on her perception of a normal vulva. The majority of women perceived their vulva to be normal and were satisfied with its appearance. However, older women are more interested in cosmetic vulvar surgery.

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.

Short-term outcomes of robotic versus conventional laparoscopic sacral colpopexy.

Objective This study aimed to compare operative times and short-term outcomes between robotic and laparoscopic sacral colpopexy. Methods A retrospective cohort study using a convenience sample was performed comparing patients who underwent robotic and laparoscopic sacral colpopexy during a 4-year period. Operative time, blood loss, perioperative complications, and objective cure of prolapse at 3 months were compared. Results Robotic procedures in 65 women and laparoscopic sacral colpopexy procedures in 23 women were performed. Median preoperative prolapse was stage 3 for both groups. There was no statistically significant difference in the median operative time between the robotic and laparoscopic groups, although this did not include robot setup time and did include concurrent procedures that differed significantly between groups (334 vs 325 minutes, P = 0.30). Estimated blood loss was lower in the robotic group (50 vs 100 mL, P = 0.003). Median hospital stay was 1 day in both groups (P = 0.23). There were no differences in overall objective cure rates between robotic and laparoscopic groups at 3 months of follow-up (87.1% vs 91.3%, P = 0.72). Perioperative complications, including visceral injury and mesh erosion, did not differ significantly between these groups. Conclusions Robotic and laparoscopic sacral colpopexy had similar operative times, short-term anatomic cure rates, perioperative complications, and length of hospital stay.