Restrictive opioid prescribing after surgery for prolapse and incontinence: a randomized, noninferiority trial.

BACKGROUND: Opioids are routinely prescribed for postoperative pain control after gynecologic surgery with growing evidence showing that most prescribed opioids go unused. Restrictive opioid prescribing has been implemented in other surgical specialties to combat the risk for opioid misuse and diversion. The impact of this practice in the urogynecologic patient population is unknown. OBJECTIVE: This study aimed to determine if a restrictive opioid prescription protocol is noninferior to routine opioid prescribing in terms of patient satisfaction with pain control after minor and major surgeries for prolapse and incontinence. STUDY DESIGN: This was a single-center, randomized, noninferiority trial of opioid-naïve patients who underwent minor (eg, colporrhaphy or mid-urethral sling) or major (eg, vaginal or minimally invasive abdominal prolapse repair) urogynecologic surgery. Patients were excluded if they had contraindications to all multimodal analgesia and if they scored ≥30 on the Pain Catastrophizing Scale. Subjects were randomized on the day of surgery to the standard opioid prescription protocol (wherein patients routinely received an opioid prescription upon discharge [ie, 3-10 tablets of 5 mg oxycodone]) or to the restrictive protocol (no opioid prescription unless the patient requested one). All patients received multimodal pain medications. Participants and caregivers were not blinded. Subjects were asked to record their pain medication use and pain levels for 7 days. The primary outcome was satisfaction with pain control reported at the 6-week postoperative visit. We hypothesized that patient satisfaction with the restrictive protocol would be noninferior to those randomized to the standard protocol. The noninferiority margin was 15 percentage points. Pain level scores, opioid usage, opioid prescription refills, and healthcare use were secondary outcomes assessed for superiority. RESULTS: A total of 133 patients were randomized, and 127 (64 in the standard arm and 63 in the restrictive arm) completed the primary outcome evaluation and were included in the analysis. There were no statistically significant differences between the study groups, and this remained after adjusting for the surgery type. Major urogynecologic surgery was performed in 73.6% of the study population, and minor surgery was performed in 26.4% of the population. Same-day discharge occurred for 87.6% of all subjects. Patient satisfaction was 92.2% in the standard protocol arm and 92.1% in the restrictive protocol arm (difference, -0.1%; P=.004), which met the criterion for noninferiority. No opioid usage in the first 7 days after hospital discharge was reported by 48.4% of the patients in the standard protocol arm and by 70.8% in the restrictive protocol arm (P=.009). Opioid prescription refills occurred in 8.5% of patients with no difference between the study groups (9.4% in the standard arm vs 6.7% in the restrictive arm; P=.661). No difference was seen in the rate of telephone calls and urgent visits for pain control between the study arms. CONCLUSION: Among women who underwent minor and major surgery for prolapse and incontinence, patient satisfaction rates were noninferior after restrictive opioid prescribing when compared with routine opioid prescribing.

Same-day Discharge Following Vaginal Hysterectomy and Native-tissue Apical Repair for Uterovaginal Prolapse: A Prospective Cohort Study.

INTRODUCTION AND HYPOTHESIS: The safety and feasibility of same-day discharge (SDD) has been consistently reported across the benign and gynecologic oncology literature. However, outcomes of SDD in the urogynecology population are sparse. The objectives of this study were to describe the success of SDD following vaginal hysterectomy and native-tissue colpopexy, and to compare the incidence of postoperative adverse events in patients discharged same-day versus postoperative day 1 (POD1). Further objectives were to compare pain, quality of recovery (QoR), and satisfaction between the groups. METHODS: This was a single-center, prospective cohort study of patients with planned SDD. A standardized ERAS protocol was utilized. The QoR-40 questionnaire was administered at baseline, POD2, and the 6-week postoperative visit. Pain scores were captured similarly, and a satisfaction survey was administered at 6 weeks. The primary outcome was composite adverse events defined as any postoperative adverse event and/or health care utilization, excluding telephone calls, and urinary tract infection. RESULTS: A total of 101 patients were enrolled in the study; the primary outcome was available for 99. SDD was achieved for 76 patients (77.0%); 23 patients stayed overnight (23.2%). The overall incidence of composite adverse events was 20.2% (95% CI, 13.5-29.2), and was not different between the groups (26.1% vs 18.4%, p = 0.42). Additionally, there were no differences in the QoR-40 or pain scores on POD2 and at 6 weeks. Patient satisfaction was high and similar between the groups. CONCLUSIONS: Successful SDD was achieved in 77.0% of the patients. SDD following vaginal hysterectomy and native-tissue colpopexy appears to be safe, feasible, and associated with good QoR and a high degree of patient satisfaction.

The Current Evidence and How-To on Combined Sacrocolpopexy and Rectopexy.

INTRODUCTION AND HYPOTHESIS: Multicompartment prolapse is a complex pelvic floor condition that can involve coordination of both urogynecologists and colorectal surgeons. METHODS: Concomitant sacrocolpopexy and ventral rectopexy is a safe and effective approach to treating this condition. RESULTS: The combined procedure has high rates of patient satisfaction and symptom improvement, including defecatory dysfunction, sexual health, and overall increased quality of life. CONCLUSION: Concomitant sacrocolpopexy with ventral rectopexy is safe and improves overall outcomes.

Healthcare Resource Utilization Following Minimally Invasive Sacrocolpopexy: Impact of Concomitant Rectopexy.

INTRODUCTION AND HYPOTHESIS: Combined surgical procedures with sacrocolpopexy (SCP) and rectopexy (RP) are more commonly being performed for treatment of multicompartment pelvic organ prolapse. This study aimed to compare healthcare resource utilization (HRU) within 6 weeks following combined surgery (SCP-RP) versus SCP alone (SCP-only). We hypothesized that concomitant RP does not impact HRU. METHODS: A retrospective cohort study of patients who underwent minimally invasive SCP from 2017 to 2022 was conducted at a tertiary referral center. Patients were grouped based on the performance of concomitant RP. HRU was defined as a composite of unscheduled office visits, emergency department visits, and readmissions before the 6-week postoperative visit. HRU was compared in the SCP-RP and SCP-only groups. Multivariable regression analysis was performed to identify factors associated with HRU. RESULTS: There were 144 patients in the SCP-RP group and 405 patients in the SCP-only group. Patient characteristics were similar between the two groups, with the following exceptions: the SCP-RP group was older, more likely to have comorbid conditions, and live >60 miles from the hospital. Of the 549 patients, 183 (33.3%) had ≥1 HRU encounter within 6 weeks after surgery. However, there was no difference between the SCP-RP and SCP-only groups in composite HRU (34.0% vs 33.1%, p = 0.84). The most common reasons for HRU were pain, urinary tract infection symptoms, and wound issues. Concomitant mid-urethral sling was associated with a two-fold increased risk of HRU after surgery. CONCLUSIONS: One in 3 patients undergoing minimally invasive SCP had at least one unanticipated encounter within 6 weeks after surgery. Concomitant RP was not associated with increased postoperative HRU.

Revision sacrocolpopexy: tips and tricks for optimal outcomes.

INTRODUCTION AND HYPOTHESIS: The aim of this video is to highlight important considerations and techniques for revision sacrocolpopexy in women with symptomatic recurrence of pelvic organ prolapse after sacrocolpopexy. METHODS: In this video, we show five patients who presented with recurrent symptomatic pelvic organ prolapse after prior sacrocolpopexy. We demonstrate techniques for robotic-assisted laparoscopic sacrocolpopexy revision including surgical dissection, revision of existing mesh, and/or addition of new mesh. CONCLUSIONS: Overall, revision sacrocolpopexy requires an individualized approach. These surgeries are often challenging because of adhesions and altered anatomy from the prior sacrocolpopexy. The reviewed considerations and techniques can be useful for ensuring a safe and effective outcome.

Intermediate term outcomes after transvaginal uterine-preserving surgery in women with uterovaginal prolapse.

INTRODUCTION AND HYPOTHESIS: There is growing interest in and performance of uterine-preserving prolapse repairs. We hypothesized that there would be no difference in pelvic organ prolapse (POP) recurrence 2 years following transvaginal uterosacral ligament hysteropexy (USLH) and sacrospinous ligament hysteropexy (SSLH). METHODS: This is a retrospective cohort study with a cross-sectional survey of women who underwent transvaginal uterine-preserving POP surgery from May 2016 to December 2017. Patients were included if they underwent either USLH or SSLH. POP recurrence was defined as a composite of subjective symptoms and/or retreatment. A cross-sectional survey was used to assess pelvic floor symptoms and patient satisfaction. RESULTS: A total of 47 women met the criteria. Mean age was 52.8 ± 12.5 years, and all had a preoperative POP-Q stage of 2 (55.3%) or 3 (44.7%). Thirty (63.8%) underwent SSLH and 17 (36.2%) underwent USLH. There were no differences in patient characteristics or perioperative data. There was no difference in composite recurrence (26.7% [8] vs 23.5% [4]) and retreatment (6.7% [2] vs 0%) retrospectively between SSLH and USLH groups at 22.6 months. Survey response rate was 80.9% (38) with a response time of 30.7 (28.0-36.6) months. The majority of patients (84.2%) reported POP symptom improvement, and both groups reported great satisfaction (89.5%). In respondents, 13.2% (5) reported subjective recurrence and 5.3% (2) underwent retreatment, with no differences between hysteropexy types. There were no differences in other pelvic floor symptoms. CONCLUSIONS: Although 1 in 4 women experienced subjective POP recurrence after transvaginal uterine-preserving prolapse repair and <5% underwent retreatment at 2 years, our results must be interpreted with caution given our small sample size. No differences in outcomes were identified between hysteropexy types; however, additional studies should be performed to confirm these findings. Both hysteropexy approaches were associated with great patient satisfaction.

Effect of sacrospinous hysteropexy with graft vs vaginal hysterectomy with uterosacral ligament suspension on treatment failure in women with uterovaginal prolapse: 5-year results of a randomized clinical trial.

BACKGROUND: Vaginal hysterectomy with suture apical suspension is commonly performed for uterovaginal prolapse. Sacrospinous hysteropexy with graft (vaginal mesh hysteropexy) is an alternative, although in 2019 the Food and Drug Administration removed this mesh product from the United States market. OBJECTIVE: Our objective was to compare the efficacy and adverse events of these 2 procedures. STUDY DESIGN: At 9 clinical sites in the United States National Institutes of Health and National Institute of Child Health and Human Development Pelvic Floor Disorders Network, 183 postmenopausal women requesting vaginal surgery for symptomatic uterovaginal prolapse were enrolled in a multisite randomized superiority clinical trial, comparing a sacrospinous hysteropexy with graft (hysteropexy) with a vaginal hysterectomy with uterosacral ligament suspension (hysterectomy). Participants consented to remain masked to treatment assignment for the study duration. Study visits were conducted at 6-month intervals through 60 months. The primary treatment failure composite outcome (retreatment of prolapse, prolapse beyond the hymen, or prolapse symptoms) was evaluated with survival modeling. Secondary outcomes included complications or adverse events, individual anatomic measures of the pelvic organ prolapse quantification examination, and presence, severity, and impact and bother of prolapse, urinary, bowel, and pain symptoms as measured by validated questionnaires. The 3-year published results suggested better primary outcomes with sacrospinous hysteropexy with graft, but the differences were not statistically significant (P=.06). This study reports the 5-year outcomes. RESULTS: A total of 183 women with a mean age of 66 years were randomized between April 2013 and February 2015; 93 were randomized to hysteropexy and 90 were randomized to hysterectomy. Notably, 175 were included in the trial, and 156 (89%) completed the 5-year follow-up. The primary outcome showed fewer failures for hysteropexy than hysterectomy through 5 years (adjusted hazard ratio, 0.58; 95% confidence interval, 0.36-0.94; P=.03), with failure rates of 37% vs 54%, respectively, resulting in a difference of -18% (95% confidence interval, -33% to -3%) at 5 years. With the exception of the Urogenital Distress Inventory, no group differences were demonstrated in patient-reported pelvic floor symptoms, prolapse symptoms, bowel function symptoms, general quality of life, body image, or pelvic pain. At their last visit through 5 years, 70% of participants (129 of 183) reported they remained masked to their treatment with no difference in masking between groups. Adverse events for hysteropexy vs hysterectomy included mesh exposure (8% vs 0%), granulation tissue after 12 weeks (1% vs 12%), and suture exposure after 12 weeks (3% vs 21%), respectively. CONCLUSION: Among women with symptomatic uterovaginal prolapse undergoing vaginal surgery, sacrospinous hysteropexy with graft resulted in a lower composite failure rate than vaginal hysterectomy through 5 years. There were no meaningful differences in patient-reported outcomes between groups. Our results suggest that this vaginal mesh hysteropexy procedure should be made available to patients.

A prospective randomized trial comparing Restorelle® Y mesh and flat mesh for laparoscopic and robotic-assisted laparoscopic sacrocolpopexy: 24-month outcomes.

OBJECTIVE: To compare prolapse recurrence and the incidence of mesh exposure between Restorelle® Y mesh and dual flat mesh. METHODS: A randomized trial of women undergoing laparoscopic (LSC) or robotic (RSC) sacrocolpopexy for post-hysterectomy vaginal prolapse. Subjects were randomized to either Y mesh or dual flat mesh. Subjects underwent a pelvic examination with POP-Q and evaluation of any mesh exposure, and the PFDI-20 was administered at 6, 12 and 24 months postoperatively. Subjective recurrence was defined by symptomatic vaginal bulge. All subjects underwent pelvic examination with POP-Q at 6, 12 and 24 months. Objective recurrence was defined by descent of the apex > 1/3 into the vaginal canal, anterior or posterior vaginal descent beyond the hymen, or retreatment for prolapse. RESULTS: Sixty-two patients were enrolled, and 59 patients were implanted with mesh: 30 Y mesh (17 LSC, 13 RSC) and 29 flat mesh (18 LSC, 11 RSC). There were no differences in patient characteristics between the groups. At 24 months, data were available for 44 (74.5%) patients. There were no mesh exposures for all subjects. PFDI-20 scores improved significantly for all subjects with no differences in mean improvement by mesh configuration. There were no differences in subjective and objective recurrence rates between the groups. Four patients (9.1%) complained of subjective vaginal bulge symptoms while nine (20.5%) patients had an objective recurrence (77.8% [7] examination only and 22.2% [2] reoperation). There were no apical recurrences. Of those patients who had a recurrence on examination only (n = 7), 85.7% (6) were asymptomatic. CONCLUSIONS: At 24 months, there were no differences in subjective outcomes and prolapse recurrence in patients who underwent sacrocolpopexy with the Restorelle® Y mesh versus dual flat mesh. One in five patients experienced an objective recurrence; however, there were no apical recurrences and the majority were asymptomatic.

A randomized controlled noninferiority trial of reduced vs routine opioid prescription after prolapse repair.

BACKGROUND: Given the accelerating opioid crisis in the United States and evidence that patients use fewer opioid tablets than prescribed, surgeons may choose to decrease prescribed quantities. The effect this may have on patient satisfaction with pain control after hospital discharge is unknown. OBJECTIVE: The primary objective of this study was to compare patient satisfaction with postoperative pain control between patients receiving a routine or reduced quantity opioid prescription after prolapse repair. Secondary objectives included a comparison of opioid-related side-effects, the number of opioid tablets used, and the number of excess tablets prescribed between these groups. STUDY DESIGN: This was a single-center, unmasked, 2-arm, randomized controlled noninferiority trial of women who underwent a prolapse repair with a planned overnight hospitalization. Patients were assigned randomly to 1 of 2 study arms: routine (28 tablets of oxycodone 5 mg) or reduced (5 tablets) prescription of opioid tablets. Patients were eligible if they were at least 18 years of age and undergoing a prolapse repair with an anticipated overnight hospital stay. Exclusion criteria included a history of chronic pain, preoperative opioid use, intolerance to study medication, or a score of ≥30 on the Pain Catastrophizing Scale. In addition to their opioid prescription, all patients received multimodal pain medications at discharge. Patients were asked to complete 6 weeks of diaries to record pain and medication use. The primary outcome (patient satisfaction) was collected as part of a postoperative survey completed at patients' routine postoperative visit 6 weeks after surgery. The sample size for noninferiority was calculated at 59 patients per group for a total of 118 patients. RESULTS: One hundred eighteen patients were assigned randomly; the primary outcome was available for 116. The majority of patients were white, postmenopausal, and nonsmokers; the mean age was 62±10.4 years. The most common surgery was a hysterectomy with native tissue repair (n=71; 60%). One hundred ten patients (93%) were satisfied with postoperative pain control. Statistical analysis constructed for noninferiority showed that the difference between the groups was <15% (93% vs 93%; P=.005). Subjects in the reduced arm reported requiring an additional opioid prescription more frequently than in the routine arm (15% vs 2%; P=.01). Patients in the routine arm used more opioid tablets than the reduced arm (median, 3 [interquartile range, 0-14] vs 1 [interquartile range, 0-3]), but overall opioid utilization was low. As such, patients in the routine arm had significantly more unused opioid tablets (median, 26 [interquartile range, 15-28] vs 4 [interquartile range, 2-5]). CONCLUSION: Patient satisfaction with pain control was noninferior in patients who received a reduced quantity of opioid tablets after prolapse repair compared with those who received a routine prescription. A large quantity of excess opioid tablets was seen in both groups. Surgeons should consider prescribing 5-10 opioid tablets after prolapse repair surgery and consider applying these findings to postoperative prescribing after other gynecologic procedures.

Does concurrent posterior repair for an asymptomatic rectocele reduce the risk of surgical failure in patients undergoing sacrocolpopexy?

PURPOSE: To determine if a concurrent posterior repair for an asymptomatic rectocele at the time of sacrocolpopexy reduces the incidence of surgical failure. METHODS: This is a retrospective chart review with a cross-sectional follow-up survey of all patients who underwent sacrocolpopexy from 2004 to 2014. Demographic and operative data were collected from the medical record. For the cross-sectional portion, patients were contacted to obtain information on symptoms and retreatment after surgery. In this study, we included patients with an asymptomatic rectocele on examination, defined as Ap or Bp ≥ -1 on POP-Q without defecatory dysfunction, which was defined as constipation based on the Rome III criteria, dyschezia, excessive straining and/or splinting to have a bowel movement. The primary outcome was a composite score of subjective bulge symptoms or retreatment for prolapse. RESULTS: Three hundred forty-four patients met the inclusion criteria: 185 (53.8%) had a sacrocolpopexy only (SCP) and 159 (46.2%) had a concurrent posterior repair (SCP + PR). The composite failure rate was 10.2% (95% CI = 7.4-13.8%), with a 13.5% (25) failure rate in the SCP group compared with 6.3% (10) in the SCP + PR group (p = 0.03). On multivariable logistic regression, the adjusted odds of failure was 2.79 in the SCP compared with the SCP + PR group (CI 1.25-6.23; P = 0.01). The rates of de novo defecatory dysfunction following surgery were low (SCP = 5.6% vs. SCP + PR = 7.5%, p = 0.55). CONCLUSIONS: For patients with asymptomatic rectoceles, a concurrent posterior repair at the time of sacrocolpopexy reduces the odds of composite patient-centered failure without an increased rate of dyspareunia or de novo defecatory dysfunction.

Revitalizing research in genitourinary syndrome of menopause.

Genitourinary syndrome of menopause is defined as the collection of signs and symptoms of the genitourinary tract from menopause, previously known as vulvovaginal atrophy. The Food and Drug Administration has approved select hormonal and nonhormonal treatment for vaginal atrophy, including systemic estrogen, vaginal estrogen, estrogen receptor modulators, and dehydroepiandrosterone. These medications can increase the risk of thromboembolic disease and malignancy; furthermore, the cost of the medications have been increasing. Energy-based therapy such as the fractional CO2 laser energy or nonablative photothermal Erbium:YAG-laser has emerged as an alternative treatment option for genitourinary syndrome of menopause. However, in July of 2018, the Food and Drug Administration released a statement cautioning women against vaginal rejuvenation devices and highlighted the paucity of long-term clinical research in this field. This statement may result in patients' hesitation to seek care for genitourinary syndrome of menopause. These recent events should be a call to action to urge physicians to address the barriers that exist in the treatment of genitourinary syndrome of menopause because of limited clinical research, cost of treatment, and fear.

Route of hysterectomy during minimally invasive sacrocolpopexy does not affect postoperative outcomes.

INTRODUCTION AND HYPOTHESIS: Hysterectomy can be performed during sacrocolpopexy, but there are limited studies comparing the effect of route of hysterectomy on adverse events. We hypothesized there would be no difference in adverse events or patient-reported outcomes in women who underwent minimally invasive sacrocolpopexy with either vaginal or supracervical hysterectomy. METHODS: This was a retrospective chart review with a cross-sectional survey component sent to all consenting patients. Patients were identified by procedure code for sacrocolpopexy and hysterectomy from January 2005 to June 2016. RESULTS: Of the 161 subjects meeting the inclusion criteria, 116 underwent supracervical and 45 vaginal hysterectomy. Overall incidence of perioperative adverse events was low. Vaginal hysterectomy cases were faster (276 vs. 324 min, p < 0.001) and had higher rates of postoperative stress incontinence (22 vs. 9%, p = 0.03). Thirty-one (19%) of all subjects had recurrent prolapse; 10 (6%) underwent repeat surgery. Three (1%) subjects had a mesh exposure (no difference between groups), all treated conservatively. Ninety-six (60%) subjects responded to the survey with a median follow-up of 56 (9-134) months. Ninety-one percent (87) of respondents reported being better since surgery, and 91% (87) reported they would choose the surgery again. Twenty-eight percent (27) reported a surgery-related complication including pain, urinary and bowel symptoms; 8% (8) reported evaluation for recurrent prolapse symptoms, all treated conservatively; 4% (4) of respondents reported a mesh exposure. CONCLUSIONS: Incidence of adverse events is low and not different between patients undergoing minimally invasive sacrocolpopexy with concurrent supracervical or vaginal hysterectomy. One in three patients report pelvic floor symptoms postoperatively, but long-term satisfaction is high.

Effect of Vaginal Mesh Hysteropexy vs Vaginal Hysterectomy With Uterosacral Ligament Suspension on Treatment Failure in Women With Uterovaginal Prolapse: A Randomized Clinical Trial.

Importance: Vaginal hysterectomy with suture apical suspension is commonly performed for uterovaginal prolapse. Transvaginal mesh hysteropexy is an alternative option. Objective: To compare the efficacy and adverse events of vaginal hysterectomy with suture apical suspension and transvaginal mesh hysteropexy. Design, Setting, Participants: At 9 clinical sites in the US Pelvic Floor Disorders Network, 183 postmenopausal women with symptomatic uterovaginal prolapse were enrolled in a randomized superiority clinical trial between April 2013 and February 2015. The study was designed for primary analysis when the last randomized participant reached 3 years of follow-up in February 2018. Interventions: Ninety-three women were randomized to undergo vaginal mesh hysteropexy and 90 were randomized to undergo vaginal hysterectomy with uterosacral ligament suspension. Main Outcomes and Measures: The primary treatment failure composite outcome (re-treatment of prolapse, prolapse beyond the hymen, or prolapse symptoms) was evaluated with survival models. Secondary outcomes included operative outcomes and adverse events, and were evaluated with longitudinal models or contingency tables as appropriate. Results: A total of 183 participants (mean age, 66 years) were randomized, 175 were included in the trial, and 169 (97%) completed the 3-year follow-up. The primary outcome was not significantly different among women who underwent hysteropexy vs hysterectomy through 48 months (adjusted hazard ratio, 0.62 [95% CI, 0.38-1.02]; P = .06; 36-month adjusted failure incidence, 26% vs 38%). Mean (SD) operative time was lower in the hysteropexy group vs the hysterectomy group (111.5 [39.7] min vs 156.7 [43.9] min; difference, -45.2 [95% CI, -57.7 to -32.7]; P = <.001). Adverse events in the hysteropexy vs hysterectomy groups included mesh exposure (8% vs 0%), ureteral kinking managed intraoperatively (0% vs 7%), granulation tissue after 12 weeks (1% vs 11%), and suture exposure after 12 weeks (3% vs 21%). Conclusions and Relevance: Among women with symptomatic uterovaginal prolapse undergoing vaginal surgery, vaginal mesh hysteropexy compared with vaginal hysterectomy with uterosacral ligament suspension did not result in a significantly lower rate of the composite prolapse outcome after 3 years. However, imprecision in study results precludes a definitive conclusion, and further research is needed to assess whether vaginal mesh hysteropexy is more effective than vaginal hysterectomy with uterosacral ligament suspension. Trial Registration: ClinicalTrials.gov Identifier: NCT01802281.

Should we offer ventral rectopexy to patients with recurrent external rectal prolapse?

BACKGROUND: For patients with rectal prolapse undergoing Ventral Rectopexy (VR), the impact of prior prolapse surgery on prolapse recurrence is not well described. PURPOSE: The purpose of this study was to compare recurrence rates after VR in patients undergoing primary and repeat rectal prolapse repairs. DESIGN: This study is a prospective cohort study. METHODS: IRB-approved prospective data registry of consecutive patients undergoing VR for full-thickness external rectal prolapse between 2009 and 2015. MAIN OUTCOME MEASURES: Rectal prolapse recurrence was defined as either external prolapse through the anal sphincters or symptomatic rectal mucosa prolapse warranting additional surgery. Preoperative and postoperative morbidity and functional outcomes were analyzed. Actuarial recurrence rates were calculated using the Kaplan-Meier method. RESULTS: A total of 108 VRs were performed during the study period. Seventy-two were primary and 36 repeat repairs. Seven cases were open, 23 laparoscopic, and 78 robotic. Six cases were converted from laparoscopic/robotic to open. In 63 patients, VR was combined with gynecological procedures. There were no statistical differences between primary or recurrent prolapse for the following: demographics, operative time, concomitant gynecologic procedures, complications, blood loss, and graft material type. Length of stay was longer in patients with a history of prior prolapse surgery (p = 0.01). Prolapse recurrence rates for primary repairs were reported at 1.4, 6.9, and 9.7% and for recurrent prolapse procedures 13.9, 25, and 25% at 1, 3, and 5 years (p = 0.13). Mean length of follow-up was similar between groups. Time to recurrence was significantly shorter in patients undergoing repeat prolapse surgery 8.8 vs 30.7 months (p = 0.03). CONCLUSIONS: VR is a better option for patients undergoing primary rectal prolapse repair.

Assessing ureteral patency using 10% dextrose cystoscopy fluid: evaluation of urinary tract infection rates.

BACKGROUND: Intravenous indigo carmine has routinely been used to confirm ureteral patency after urogynecologic surgery. Recent discontinuation of the dye has altered clinical practice. In the absence of indigo carmine, we have used 10% dextrose in sterile water (D10) as cystoscopic fluid to evaluate ureteral patency. Glucosuria has been associated with urinary tract infection (UTI) in vivo and significantly enhanced bacterial growth in vitro. The concern is that the use of D10 would mimic a state of glucosuria albeit transient and increase the risk of postoperative UTI. OBJECTIVES: The objectives of this study were to compare the rates of postoperative UTI and lower urinary tract (LUT) injuries between patients who underwent instillation of D10 vs normal saline at the time of intraoperative cystoscopy after urogynecological surgery. STUDY DESIGN: This was a retrospective cohort study of all women who underwent cystoscopic evaluation of ureteral patency at the time of urogynecological surgery from May through December 2014 at a tertiary care referral center. We compared patients who received D10 cystoscopy fluid vs those who used normal saline. Outcomes included UTI and diagnosis of ureteral or LUT injuries. UTI was diagnosed according to Centers for Disease Control and Prevention guidelines by symptoms alone, urine dipstick, urinalysis, or urine culture. Descriptive statistics compared the rates of UTI between the 2 groups, and a multivariable model was fit to the data to control for potential confounders and significant baseline differences between the groups. RESULTS: A total of 303 women were included. D10 was used in 113 cases and normal saline (NS) was used in 190. The rate of UTI was higher in the D10 group than the NS group: 47.8% (95% confidence interval [CI], 38.3-57.4) vs 25.9% (95% CI, 19.8-32.8, P < .001). After adjusting for age, pelvic organ prolapse stage, use of perioperative estrogen, days of postoperative catheterization, menopausal status, diabetes mellitus, and history of recurrent UTI, the UTI rate remained significantly higher with the use of D10 (adjusted odds ratio, 3.4 [95% CI, 1.6-7.5], P = .002) compared with NS. Overall, 3 cases of transient ureteral kinking (1.0%) and one cystotomy (0.3%) were identified intraoperatively. However, ureteral and LUT injuries were not different between groups. No unidentified injuries presented postoperatively. CONCLUSION: Although the use of D10 cystoscopy fluid has been successful in identifying ureteral patency in the absence of indigo carmine, it is associated with an increased rate of postoperative UTI compared with NS.

Surgical excision of urethral prolapse.

INTRODUCTION: Urethral prolapse is a rare condition that results in the eversion of the urethral mucosa through the distal urethra. Management is divided into two categories: conservative and surgical treatment. METHODS: We present a case of urethral prolapse with severe symptoms that were minimally responsive to topical estrogen. Surgical excision was achieved with resection of the redundant urethral mucosa. RESULTS: This video highlights surgical techniques that can be used for the excision of urethral prolapse. CONCLUSIONS: The management of urethral prolapse should be individualized based on symptom severity, anatomical compromise, and surgical morbidity. Surgical management should be considered in cases of vascular compromise or failed medical management.

The effect of surgical start time in patients undergoing minimally invasive sacrocolpopexy.

INTRODUCTION AND HYPOTHESIS: The objective was to determine if the surgical start time affects operating room time and the incidence of perioperative adverse events in patients undergoing minimally invasive sacrocolpopexy. METHODS: This is a retrospective cohort of 396 women who underwent laparoscopic and robotic sacrocolpopexy at a tertiary care center between January 2006 and December 2012. Cases were divided into those with a first, second or third start time. Operating room (OR) time was defined as time the patient entered the room to time out of the room (minutes) and the case time was defined as the period between incision and closure (minutes). Adverse events were defined a priori and also reported using the Clavien-Dindo grading scale. Logistic regression analysis was performed for categorical variables and multiple linear regression analysis for continuous variables. RESULTS: A total of 145 robotic and 261 conventional laparoscopic minimally invasive sacrocolpopexies were performed. Operating room time data were available for 396 cases. Of the cases, 63.9 % (253 out of 396) had a first start, 32.1 % (127 out of 396) had a second start, and 4 % (16 out of 396) had a third start. Robotic and concomitant rectopexy cases were more likely to be performed as first-start cases and operating room time and case time were longest for first-start cases. However, after adjusting for mode of surgery, concomitant procedures, previous surgeries, BMI, and age, this finding was no longer statistically significant. There was no difference in the rate of perioperative adverse events among first-, and second-/third-start cases. CONCLUSION: Surgical case start time does not appear to be associated with operating time or the incidence of perioperative adverse events in patients undergoing minimally invasive sacrocolpopexy.

Anticholinergic therapy vs. onabotulinumtoxina for urgency urinary incontinence.

BACKGROUND: Anticholinergic medications and onabotulinumtoxinA are used to treat urgency urinary incontinence, but data directly comparing the two types of therapy are needed. METHODS: We performed a double-blind, double-placebo-controlled, randomized trial involving women with idiopathic urgency urinary incontinence who had five or more episodes of urgency urinary incontinence per 3-day period, as recorded in a diary. For a 6-month period, participants were randomly assigned to daily oral anticholinergic medication (solifenacin, 5 mg initially, with possible escalation to 10 mg and, if necessary, subsequent switch to trospium XR, 60 mg) plus one intradetrusor injection of saline or one intradetrusor injection of 100 U of onabotulinumtoxinA plus daily oral placebo. The primary outcome was the reduction from baseline in mean episodes of urgency urinary incontinence per day over the 6-month period, as recorded in 3-day diaries submitted monthly. Secondary outcomes included complete resolution of urgency urinary incontinence, quality of life, use of catheters, and adverse events. RESULTS: Of 249 women who underwent randomization, 247 were treated, and 241 had data available for the primary outcome analyses. The mean reduction in episodes of urgency urinary incontinence per day over the course of 6 months, from a baseline average of 5.0 per day, was 3.4 in the anticholinergic group and 3.3 in the onabotulinumtoxinA group (P=0.81). Complete resolution of urgency urinary incontinence was reported by 13% and 27% of the women, respectively (P=0.003). Quality of life improved in both groups, without significant between-group differences. The anticholinergic group had a higher rate of dry mouth (46% vs. 31%, P=0.02) but lower rates of catheter use at 2 months (0% vs. 5%, P=0.01) and urinary tract infections (13% vs. 33%, P<0.001). CONCLUSIONS: Oral anticholinergic therapy and onabotulinumtoxinA by injection were associated with similar reductions in the frequency of daily episodes of urgency urinary incontinence. The group receiving onabotulinumtoxinA was less likely to have dry mouth and more likely to have complete resolution of urgency urinary incontinence but had higher rates of transient urinary retention and urinary tract infections. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women's Health; ClinicalTrials.gov number, NCT01166438.).

Incidence of adverse events after uterosacral colpopexy for uterovaginal and posthysterectomy vault prolapse.

OBJECTIVE: We sought to describe perioperative and postoperative adverse events associated with uterosacral colpopexy, to describe the rate of recurrent pelvic organ prolapse (POP) associated with uterosacral colpopexy, and to determine whether surgeon technique and suture choice are associated with these rates. STUDY DESIGN: This was a retrospective chart review of women who underwent uterosacral colpopexy for POP from January 2006 through December 2011 at a single tertiary care center. The electronic medical record was queried for demographic, intraoperative, and postoperative data. Strict definitions were used for all clinically relevant adverse events. Recurrent POP was defined as the following: symptomatic vaginal bulge, prolapse to or beyond the hymen, or any retreatment for POP. RESULTS: In all, 983 subjects met study inclusion criteria. The overall adverse event rate was 31.2% (95% confidence interval [CI], 29.2-38.6), which included 20.3% (95% CI, 17.9-23.6) of subjects with postoperative urinary tract infections. Of all adverse events, 3.4% were attributed to a preexisting medical condition, while all other events were ascribed to the surgical intervention. Vaginal hysterectomy, age, and operative time were not significantly associated with any adverse event. The intraoperative bladder injury rate was 1% (95% CI, 0.6-1.9) and there were no intraoperative ureteral injuries; 4.5% (95% CI, 3.4-6.0) of cases were complicated by ureteral kinking requiring suture removal. The rates of pulmonary and cardiac complications were 2.3% (95% CI, 1.6-3.5) and 0.8% (95% CI, 0.4-1.6); and the rates of postoperative ileus and small bowel obstruction were 0.1% (95% CI, 0.02-0.6) and 0.8% (95% CI, 0.4-1.6). The composite recurrent POP rate was 14.4% (95% CI, 12.4-16.8): 10.6% (95% CI, 8.8-12.7) of patients experienced vaginal bulge symptoms, 11% (95% CI, 9.2-13.1) presented with prolapse to or beyond the hymen, and 3.4% (95% CI, 2.4-4.7) required retreatment. Number and type of suture used were not associated with a higher rate of recurrence. Of the subjects who required unilateral removal of sutures to resolve ureteral kinking, 63.6% did not undergo suture replacement; this was not associated with a higher rate of POP recurrence. CONCLUSION: Perioperative and postoperative complication rates associated with severe morbidity after uterosacral colpopexy appear to be low. Uterosacral colpopexy remains a safe option for the treatment of vaginal vault prolapse.