A survey of patient tolerance and satisfaction with capsaicin for neuroproliferative vestibulodynia.

Background: Topical capsaicin has been used to treat vulvodynia but has been poorly studied for use in neuroproliferative provoked vestibulodynia (PVD); capsaicin decreases allodynia by blocking vanilloid receptors (TRPV1) on C-afferent nociceptors, but the therapy causes discomfort to the point of intolerance in some patients. Aim: The present study evaluated tolerability and efficacy of topical capsaicin to treat neuroproliferative PVD. Methods: Patients with neuroproliferative PVD prescribed 0.025% capsaicin compounded in VersaBase cream were identified through prescription records. Outcome measures included the Female Sexual Function Index (FSFI), the Female Sexual Distress Scale-Revised, and a 22-question questionnaire assessing patient experience and treatment tolerability. Outcomes: Among tolerant patients, capsaicin significantly decreased vestibular pain, but tolerance was highly variable. Results: Twenty-five patients responded to the follow-up questionnaire. The average age at presentation was 30 years (range, 18-52 years). Eighty percent of patients tolerated capsaicin application for the full 20 minutes within a median time of 1 to 2 weeks. Of the 16 patients reporting tolerance to 20-minute application, 12 (60%) experienced improvement in vestibular pain. On an 11-point numeric rating scale, the mean pain score was 8.96 and the median score was 10 with first application. Among all participants, 16 (64%) had reduction in pain during treatment. Fifty-six percent of patients would recommend capsaicin as a treatment for vulvar pain. Qualitative content analysis focused on categories of efficacy, value, and feasibility, which indicated that those able to tolerate the treatment experienced improvement while using the medication. The mean Female Sexual Distress Scale-Revised score was 35.96 at baseline compared with 25.09 at follow-up (P < .0001). On a numeric rating scale, the mean self-reported vulvar pain score was 8.2 at baseline compared with 5.35 when using capsaicin consistently (P < .0001). The mean FSFI pain domain score was 2.45 at baseline compared with 0.98 at follow-up (P = .005). While not statistically significant, the mean total FSFI score was 15.44 at baseline compared with 17.84 at follow-up (P = .3730). Clinical Implications: Capsaicin is helpful for some patients with PVD, but thorough counseling is important because of highly variable tolerance. Strengths and Limitations: Strengths include examination of a poorly studied therapy and inclusion of narrative responses from patients to inform counseling. Limitations include small sample size, retrospective design, and low survey response rate. Conclusion: Patients should be appropriately selected and thoroughly counseled given high levels of intolerance, but capsaicin therapy may be considered for patients with neuroproliferative PVD who have failed conservative treatments and wish to avoid surgery.

Immunogenicity of 2-Dose HPV Vaccine Series for Postpartum Women: An Open-Label, Nonrandomized, Noninferiority Trial.

Importance: Postpartum human papillomavirus (HPV) vaccination is a promising strategy to increase HPV vaccination uptake in the US, particularly for reaching vaccine-naive women and those who lack health insurance beyond the pregnancy period. However, completion of the 3-dose vaccine regimen is challenging. Objective: To evaluate the immunogenicity of a 2-dose postpartum HPV vaccination regimen (0 and 6 months) and assess whether it is noninferior to a 3-dose postpartum HPV vaccination regimen (0, 1-2, and 6 months) administered to historical controls. Design, Setting, and Participants: A noninferiority, open-label, nonrandomized immunogenicity trial was conducted from August 4, 2020, to June 23, 2022, of postpartum patients aged 15 to 45 years who delivered at 2 hospitals in Baltimore, Maryland. Historical controls were adolescents and young women aged 16 to 26 years. Intervention: Two doses of the nonavalent HPV vaccine administered 6 months apart. Main Outcomes and Measures: The primary outcome was noninferiority (90% CI, lower bound >0.67) of the geometric mean titer (GMT) ratio for HPV-16 among postpartum women compared with historical controls. Secondary outcomes were noninferiority of GMT ratios for the other 8 HPV types and percentage seroconversion for each HPV type. As a noninferiority trial, the primary analysis used the per-protocol analysis. Results: Of 225 enrolled participants, the mean (SD) age at baseline was 29.9 (6.8) years, and 171 (76.0%) were HPV-16 seronegative at baseline. Of these 171 participants, 129 (75.4%) received a second vaccine dose and completed the subsequent 4-week serologic measurements. Relative to historical controls, the HPV-16 GMT ratio was 2.29 (90% CI, 2.03-2.58). At month 7, HPV-16 GMT was higher after the 2-dose regimen (7213.1 mMU/mL [90% CI, 6245.0-8331.4 mMU/mL]) than among historic controls after the 3-dose regimen (3154.0 mMU/mL [90% CI, 2860.2-3478.0 mMU/mL]). Similarly, the lower bound of the 90% CI of the GMT ratio was above 1 for the 8 HPV types 6, 11, 18, 31, 33, 45, 52, and 58. A total of 118 of 134 women (88.1%) seroconverted for HPV-16 after the first dose; 4 weeks after the second dose, the seroconversion rate was 99% or greater for all HPV types. Conclusions and Relevance: This study suggests that immunogenicity of a 2-dose HPV vaccination regimen given 6 months apart among postpartum women was noninferior to a 3-dose regimen among young historical controls. Most women seroconverted after the first dose of the 2-dose regimen. These results demonstrate that postpartum vaccination using a reduced schedule may be a promising strategy to increase HPV vaccine series completion. Trial Registration: ClinicalTrials.gov Identifier: NCT04274153.

Satisfaction with opioid prescription and use after minor gynaecologic surgery: a pilot prospective study.

To describe predictors of patient satisfaction with pain control including opioid prescribing practices, patients undergoing minor gynaecologic and urogynaecologic surgeries were included in a prospective cohort study. Satisfaction with postoperative pain control by opioid prescription status was analysed using bivariate analysis and multivariable logistic regression, controlling for potential confounders. Among participants completing both postoperative surveys, 112/141 (79.4%) reported pain control satisfaction by day 1-2 and 118/137 (86.1%) by day 14. While we were underpowered to detect a true difference in satisfaction by opioid prescription, there were no differences in opioid prescription among patients satisfied with pain control [52% vs. 60% (p = .43) among satisfied patients at day 1-2 and 58.5% vs. 37% (p = .08) at day 14]. Significant predictors of pain control satisfaction were postoperative day (POD) 1-2 average pain at rest [aOR 0.72 (95% CI 0.52-0.99), p = .04], rating of shared decision-making [aOR 1.16 (95% CI 1.004-1.34), p = .04], amount of pain relief [aOR 1.28 (95% CI 1.07-1.54), p = .008) and POD 14 shared decision-making rating [aOR 1.45 (95% CI 1.19-1.77), p = .002].Impact StatementWhat is already known on this subject? There are little data published on opioid prescription rates after minor gynaecologic procedures and no formal evidence-based guidance for gynaecologic providers for opioid prescribing. Few publications describe rates of opioid prescription and use following minor gynaecologic procedures. In the setting of a dramatic escalation of opioid misuse in the United States over the last decade, we sought to describe our practice of opioid prescription following minor gynaecologic procedures and answer the question of whether patient satisfaction is affected by opioid prescription, fill and use.What do the results of this study add? Though underpowered to detect our primary outcome, our results suggest that patient satisfaction with pain control may primarily be significantly affected by the patient's subjective assessment of shared decision-making with the gynaecologist.What are the implications of these findings for clinical practice and/or further research? Ultimately, these preliminary findings suggest a larger cohort is needed to answer the question of whether pain control satisfaction is influenced by receipt/fill/use of opioids after minor gynaecologic surgery.

The impact of anxiety on postoperative pain following pelvic reconstructive surgery.

INTRODUCTION AND HYPOTHESIS: Despite the prevalence of anxiety, its impact on postoperative pain remains poorly characterized. The present study was aimed at assessing the impact of preoperative anxiety on postoperative pain in patients undergoing pelvic reconstructive surgery. We hypothesized that greater anxiety would be associated with increased postoperative pain for patients undergoing pelvic reconstructive surgery. METHODS: This was a prospective multi-center observational study in Baltimore between September 2018 and June 2019. The Beck Anxiety Inventory was used to assess preoperative anxiety and the validated Surgical Pain Scale instrument was used to assess pain in the postoperative period. The association between anxiety and postoperative pain was analyzed using multivariate logistic regression, adjusting for relevant confounders. RESULTS: A total of 149 patients undergoing pelvic reconstructive surgery completed preoperative surveys. The median age of the study population was 59. The prevalence of preoperative anxiety (anxiety score > 9) in our study population was 26.8% (95% CI 19.7-34.0%). Women with preoperative anxiety reported higher postoperative pain on days 1-2 (relative odds 1.05, 95% confidence interval 1.01-1.10) and day 14 (relative odds 1.53, 95% confidence interval 1.00-2.34). CONCLUSIONS: A large fraction of women undergoing pelvic reconstructive surgery have moderate to severe preoperative anxiety. Women with preoperative anxiety appear to have greater odds of increased postoperative pain. Understanding this association may help surgeons with preoperative counseling and expectations regarding postoperative pain.

Predictors of new persistent opioid use after benign hysterectomy in the United States.

BACKGROUND: Despite substantial reductions in the past decade, prescription opioids continue to cause widespread morbidity and mortality in the United States. Little is known regarding patterns and predictors of opioid use among women undergoing benign hysterectomy. OBJECTIVE: This study aimed to identify the incidence and predictors of new persistent opioid use after benign hysterectomy among opioid-naïve women from a set of demographic, operative, and opioid prescription characteristics of patients. STUDY DESIGN: In this retrospective cohort study, we identified women undergoing benign hysterectomy from 2011 to 2016 using a validated national insurance claims database (IBM MarketScan Commercial Database). After excluding women with prevalent opioid use (from 365 to 31 days preoperatively), we identified patients who received a perioperative opioid prescription (30 days before to 14 days after hysterectomy) and evaluated them for new persistent opioid use, defined as at least 1 prescription from 15 to 90 days and at least 1 prescription from 91 to 365 days postoperatively. Multivariate logistic regression was used to examine demographic, clinical, operative, and opioid prescription-related factors associated with new persistent use. International Classification of Diseases, Ninth and Tenth Revisions, and Clinical Classification Software codes were used to identify hysterectomies, preoperative pain and psychiatric diagnoses, surgical indications, and surgical complications included as covariates. RESULTS: We identified 114,260 women who underwent benign hysterectomy and were not prevalent opioid users, of which 93,906 (82.2%) received at least 1 perioperative opioid prescription. Of 93,906 women, 4334 (4.6%) developed new persistent opioid use. Logistic regression demonstrated that new persistent use odds is significantly increased by younger age (18-34 years; adjusted odds ratio, 1.97; 95% confidence interval, 1.69-2.30), southern geographic location (adjusted odds ratio, 2.03; 95% confidence interval, 1.79-2.27), preoperative psychiatric and pain disorders (anxiety: adjusted odds ratio, 1.20 [95% confidence interval, 1.09-1.33]; arthritis: adjusted odds ratio, 1.30 [95% confidence interval, 1.21-1.40]), >1 perioperative prescription (adjusted odds ratio, 1.53; 95% confidence interval, 1.24-1.88), mood disorder medication use (adjusted odds ratio, 1.51; 95% confidence interval, 1.40-1.64), tobacco smoking (adjusted odds ratio, 1.65; 95% confidence interval, 1.45-1.89), and surgical complications (adjusted odds ratio, 1.84; 95% confidence interval, 1.69-2.00). Although statistically nonsignificant, total morphine milligram equivalent of ≥300 in the first perioperative prescription increased persistent use likelihood by 9% (95% confidence interval, 1.01-1.17). Dispensing of a first perioperative prescription before the surgery, as opposed to after, increased new persistent use odds by 61% (95% confidence interval, 1.50-1.72). Each additional perioperative day covered by a prescription increased the likelihood of persistent use by 2% (95% confidence interval, 1.02-1.03). In contrast, minimally invasive hysterectomy (laparoscopic: adjusted odds ratio, 0.89 [95% confidence interval, 0.71-0.88]; vaginal: adjusted odds ratio, 0.82 [95% confidence interval, 0.72-0.93]) and a more recent surgery year (2016 vs reference 2011: adjusted odds ratio 0.58; 95% confidence interval, 0.51-0.65) significantly decreased its likelihood. CONCLUSION: New persistent opioid use after hysterectomy was associated with several patient, operative, and opioid prescription-related factors. Considering these factors may be beneficial in counseling patients and shared decision-making about perioperative prescription to decrease the risk of persistent opioid use.

Dorsal clitoral nerve injury following transobturator midurethral sling.

INTRODUCTION: Transobturator slings can be successfully used to treat stress urinary incontinence and improve quality of life through a minimally invasive vaginal approach. Persistent postoperative pain can occur and pose diagnostic and therapeutic dilemmas. Following a sling procedure, a patient complained of pinching clitoral and perineal pain. Her symptoms of localized clitoral pinching and pain became generalized over the ensuing years, eventually encompassing the entire left vulvovaginal region. AIM: The aim of this study was to highlight the clinical utility of conventional pain management techniques used for the evaluation and management of patients with postoperative pain following pelvic surgery. METHODS: We described a prototypical patient with persistent pain in and around the clitoral region complicating the clinical course of an otherwise successful sling procedure. We specifically discussed the utility of bedside sensory assessment techniques and selective nerve blocks in the evaluation and management of this prototypical patient. RESULTS: Neurosensory assessments and a selective nerve block enabled us to trace the source of the patient's pain to nerve entrapment along the dorsal nerve of the clitoris. We then utilized a nerve stimulator-guided hydrodissection technique to release the scar contracture. CONCLUSION: This case demonstrates that the dorsal nerve of the clitoris is vulnerable to injury directly and/or indirectly. Assimilation of a time-honored pain management construct for the evaluation and management of patients' pain may improve outcomes while obviating the need for invasive surgery.

Sterilization: A Review and Update.

Sterilization is a frequently used method of contraception. Female sterilization is performed 3 times more frequently than male sterilization, and it can be performed immediately postpartum or as an interval procedure. Methods include mechanical occlusion, coagulation, or tubal excision. Female sterilization can be performed using an abdominal approach, or via laparoscopy or hysteroscopy. When an abdominal approach or laparoscopy is used, sterilization occurs immediately. When hysteroscopy is used, tubal occlusion occurs over time, and additional testing is needed to confirm tubal occlusion. Comprehensive counseling about sterilization should include discussion about male sterilization (vasectomy) and long-acting reversible contraceptive methods.

Single-item or two-item literacy screener to predict the S-TOFHLA among adult hemodialysis patients.

OBJECTIVE: We compared single-item (SILS) and two-item (TILS) literacy screeners in predicting Short Test of Functional Health Literacy in Adults (S-TOFHLA) scores. METHODS: Adult hemodialysis patients completed SILS, which determines need for assistance when reading written medical information; TILS (last grade completed and self-reported reading ability); and S-TOFHLA. Receiver operator characteristic curves (ROC) and stratum specific likelihoods were calculated. RESULTS: Of 227 participants, median S-TOFHLA was 24 (IQR 15-34). 129 (55%) participants had adequate, 70 (30%) inadequate, and 37 (16%) marginal health literacy. SILS and TILS predicted S-TOFHLA scores equivalently. Test characteristics predicting inadequate health literacy were: SILS sensitivity for threshold >1, 54% (95%CI: 44, 64), for >2, 39% (29, 49) and specificity for >1, 73% (64, 80), for >2, 93% (87, 97), area under the ROC of 0.67 (0.60-0.74); TILS sensitivity for threshold >1, 72% (62, 80), for >2, 30% (21, 40) and specificity for >1, 54% (45, 63), for >2, 86% (79, 92), area under the ROC of 0.66 (0.59-0.73). CONCLUSION: SILS and TILS had similar test characteristics in predicting S-TOFHLA. PRACTICE IMPLICATIONS: While a positive result on either test increases the likelihood that a patient has low health literacy, the SILS is easier to administer and score.