Charles R. Rardin

Uterine preservation during surgery for uterovaginal prolapse: a review

The traditional surgical treatment for uterovaginal prolapse has been vaginal hysterectomy. For many reasons, women may request uterine preservation at the time of prolapse surgery. The purpose of this paper is to review the medical literature pertaining to the role of uterine preservation during reconstructive surgery for uterovaginal prolapse. A MEDLINE search of literature in the English language (1966 to current) was carried out using the keywords ‘hysterectomy’, ‘hysteropexy’, ‘uterine preservation’, ‘uterine suspension’ and ‘uterovaginal prolapse.’ Fourteen articles primarily addressing the surgical repair of uterovaginal prolapse with uterine preservation were included in this review. Papers primarily addressing other forms of pelvic organ prolapse, incontinence or obliterative procedures were excluded. Existing procedures and their clinical outcomes were reviewed. The current literature suggests that uterine preservation during surgery for uterovaginal prolapse may be an option in appropriately selected women who desire it; prospective, randomized trials are needed to corroborate this.

Single-Incision Mini-Sling Compared With Tension-Free Vaginal Tape for the Treatment of Stress Urinary Incontinence: A Randomized Controlled Trial.

OBJECTIVE: To compare the efficacy of a single-incision mini-sling, placed in the “U” position, with tension-free vaginal tape (TVT) in the treatment of stress urinary incontinence. METHODS: Women with urodynamic stress incontinence with or without genital prolapse were randomized to receive a mini-sling or TVT (N=263). Those randomized to the mini-sling received two “sham” suprapubic incisions to facilitate blinding. The primary outcome was subjective cure (absence of any urinary incontinence or retreatment) as assessed at 1 year. This trial was a noninferiority study design. RESULTS: Participants receiving the mini-sling were less likely to have a bladder injury (0.8% compared with 4.8%; P=.0.46), more likely to be discharged without a catheter (78.5% compared with 63%; P=.008), and had less pain for postoperative days 1–3. One year after surgery, the rate of cure was similar between treatment groups (mini-sling 55.8% compared with TVT 60.6%; mean difference, 4.8%; 95% confidence interval, −16.7 to +7.2); however, this did not meet our predefined noninferiority criteria of −12%. Incontinence severity at 1 year was greater with the mini-sling than with TVT (mean severity score ± SD: 2.2±2.7 compared with 1.5±1.9; P=.015), resulting predominantly from a higher proportion of participants with “severe” incontinence postoperatively (16% compared with 5%; P=.025). CONCLUSION: The mini-sling placed in the “U” position results in similar subjective cure rates to TVT 1 year after surgery but postoperative incontinence severity is greater with the mini-sling than with TVT. LEVEL OF EVIDENCE: I

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.

Porcine subintestinal submucosal graft augmentation for rectocele repair: a randomized controlled trial.

OBJECTIVE: To estimate the effect of porcine subintestinal submucosal graft augmentation on improving anatomic and subjective rectocele repair outcomes compared with native tissue repair. METHODS: We conducted a randomized controlled trial at two sites, including women with at least stage 2 symptomatic rectocele. Anatomic and subjective outcomes (vaginal bulge and defecatory) were collected 12 months postoperatively, including blinded Pelvic Organ Prolapse Quantification (POP-Q) examinations. Anatomic failure was defined as points Ap or Bp −1 or greater on POP-Q. Subjective failure was defined as no improvement or worsening of symptoms. We estimated number needed to treat and adjusted odds ratios (ORs). Assuming graft use is associated with 93% anatomic success, 63 women per group would be needed to detect a 20% difference at &agr;=.05 and &bgr;=.20. RESULTS: One hundred sixty women were randomized; 137 had 12-month anatomic data (67 graft; 70 control). There was no difference in anatomic failure (12% compared with 9%, P=.5), vaginal bulge symptom failure (3% compared with 7%, P=.4, number needed to treat=26) or defecatory symptom failure (44% compared with 45%, P=.9, number needed to treat=91) for graft compared with control, respectively. Both groups reported improvement in vaginal bulge and defecatory symptoms (P<.05 for all). On multiple logistic regression, graft use was not associated with a decreased odds of anatomic failure (adjusted OR 1.36, 95% confidence interval [CI] 0.44–4.25), vaginal bulge symptoms (adjusted OR 0.46, 95% CI 0.08–2.68), or defecatory symptoms (adjusted OR 0.98, 95% CI 0.48–2.03). CONCLUSION: Although rectocele repair by either approach is associated with improved symptoms, subintestinal submucosal graft augmentation was not superior to native tissue for anatomic or subjective outcomes at 12 months. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00321867. LEVEL OF EVIDENCE: I

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.

Ethylene vinyl alcohol copolymer erosions after use as a urethral bulking agent.

BACKGROUND: Ethylene vinyl alcohol copolymer was approved for use by the U.S. Food and Drug Administration (FDA) in December 2004 for the treatment of stress urinary incontinence. CASE: We report on two patients who underwent injection with ethylene vinyl alcohol copolymer who were later found to have urethral erosions. CONCLUSION: Information regarding complications after ethylene vinyl alcohol copolymer urethral injections is currently limited. We performed a search of the FDA labeling information, Manufacturer and User Facility Device Experience database, and abstracts presented at scientific meetings regarding complications with this material. Symptomatic and asymptomatic erosions of ethylene vinyl alcohol copolymer in the urethra, bladder, and vaginal mucosa are possible complications after this procedure.

The impact of multichannel urodynamics upon treatment recommendations for female urinary incontinence.

The aim of this study was to evaluate whether multichannel urodynamic testing changes a physician’s treatment recommendations when managing women with urinary incontinence. In this prospective reader study, four fellowship-trained urogynecologists reviewed 39 abstracted cases of urinary incontinence on two occasions: first without and subsequently with urodynamic data. Treatment recommendations were made for each case after each review. The probability of urodynamic data modifying treatment recommendations was estimated for each reader and for the population of readers using a random effects logistic regression to account for reader variability. The overall probability that urodynamic data would change treatment was 26.9% (95% confidence interval (CI), 18.6%, 37.2%) for medical treatments and 45.5% (95% CI, 37.8%, 53.4%) for surgical treatments. Reader-to-reader differences accounted for 3% and <1% of the total variance for medical and surgical treatments, respectively. Multichannel urodynamic evaluations are significantly associated with changes in medical and surgical treatment recommendations in a referral population.

The debate over robotics in benign gynecology.

The debate over the role of the da Vinci surgical robotic platform in benign gynecology is raging with increasing fervor and, as product liability issues arise, greater financial stakes. Although the best currently available science suggests that, in the hands of experts, robotics offers little in surgical advantage over laparoscopy, at increased expense, the observed decrease in laparotomy for hysterectomy is almost certainly, at least in part, attributable to the availability of the robot. In this authors opinion, the issue is not whether the robot has any role but rather to define the role in an institutional environment that also supports the safe use of vaginal and laparoscopic approaches in an integrated minimally invasive surgery program. Programs engaging robotic surgery should have a clear and self-determined regulatory process and should resist pressures in place that may preferentially support robotics over other forms of minimally invasive surgery.

Recurrent Thigh Abscess with Necrotizing Fasciitis from a Retained Transobturator Sling Segment

A woman who underwent transobturator sling surgery for urinary incontinence experienced early vaginal mesh erosion, and underwent a partial sling removal. Several months later, she developed recurrent right thigh and groin abscesses and necrotizing fasciitis. The source of the infection, a retained segment of mesh in the obturator space, was identified only after several operative procedures and referrals. This case illustrates several of the areas of concern with the introduction of new surgical materials and techniques.

Management of Laparoscopic Bladder Injuries

Injuries to the urinary system have been reported in up to 8% of minimally invasive gynecologic surgeries. Intraoperative recognition of a bladder injury allows for immediate repair and decreased postoperative morbidity rates. Although laparoscopic repair of such injuries requires advanced surgical skills, it affords the patient the benefits of minimally invasive surgery. In addition, laparoscopic visualization of the intravesical anatomy may help to delineate the relationship of the ureters to the bladder injury, thus avoiding further complication. This article will review the techniques and devices used to facilitate laparoscopic cystotomy repair.