Clinical recommendations for use of lidocaine lubricant during bowel care after spinal cord injury prolong care routines and worsen autonomic dysreflexia: results from a randomised clinical trial.

STUDY DESIGN: Clinical trial. OBJECTIVE: Spinal cord injury (SCI) impacts autonomic function and bowel management. Bowel care is a potential trigger for autonomic dysreflexia (AD; paroxysmal hypertension elicited by sensory stimuli below the level of lesion). AD can be life threatening so strategies to minimise AD are prioritised after SCI. Lidocaine lubricant is recommended during bowel care with the rationale to minimise the sensory stimulus, reducing AD. The objective of this study was to assess whether lidocaine lubricant (Xylocaine 2%) ameliorates AD during at-home bowel care compared with standard lubricant (placebo). SETTING: Community. METHOD: Participants (n = 13; age 44.0 ± 3.3 years) with high-level SCI (C3-T4) performed their normal at-home bowel care on two days, each time using a different lubricant, with continuous non-invasive cardiovascular monitoring. Injury to spinal autonomic (sympathetic) nerves was determined from low-frequency systolic arterial pressure (LF SAP) variability. RESULTS: Participants displayed reduced autonomic function (LF SAP 3.02 ± 0.84 mmHg2), suggesting impaired autonomic control. Bowel care duration was increased with lidocaine (79.1 ± 10.0 min) compared to placebo (57.7 ± 6.3 min; p = 0.018). All participants experienced AD on both days, but maximum SAP was higher with lidocaine (214.3 ± 10.5 mmHg) than placebo (196.7 ± 10.0 mmHg; p = 0.046). Overall, SAP was higher for longer with lidocaine (6.5 × 105 ± 0.9 × 105 mmHg • beat) than placebo (4.4 × 105 ± 0.6 × 105 mmHg • beat; p = 0.018) indicating a higher burden of AD. Heart rate and rhythm disturbances were increased during AD, particularly with lidocaine use. CONCLUSIONS: At-home bowel care was a potent trigger for AD. Our findings contradict recommendations for lidocaine use during bowel care, suggesting that anaesthetic lubricants impair reflex bowel emptying, resulting in longer care routines with an increased burden of AD.

Consumer protection provided by the European medical device and cosmetic legislation for condoms and lubricants.

Personal lubricants and lubricants used in condoms contain a number of ingredients which are also present in cosmetic products. These have to comply to the medical device regulation (745/2017) which should provide the same level of consumer protection, if not more, as foreseen in the legal framework of cosmetics (1223/2009). In the current study we developed an analytical method capable of identifying and quantifying 15 ingredients, commonly found in lubricants and cosmetics. Based upon their most important toxicological endpoint, the substances involved were grouped in three toxicological classes provoking either irritation, contact allergic dermatitis or systemic toxicity. The method was applied on 30 condoms and 54 personal lubricants present on the EU market. Their safety was assessed using the same reasoning as commonly applied for cosmetic ingredients. Higher mucosae susceptibility, the main exposed area for lubricants, was taken into account in this assessment. The results show that the majority of the products studied are safe. Nevertheless, for some products the safety could not be confirmed. The results also highlight the fact that there is no consensus for a number of ingredients, used as well in cosmetics as in medical devices. Alignment between both legislations would improve the safety of these products and further raise the general level of consumer protection.

Specific Skin Lesions of Sarcoidosis Located at Venipuncture Points for Blood Sample Collection.

It has been suggested that the predilection of sarcoidosis to affect scars is due to the presence of antigens or foreign bodies that can serve as a stimulus for granuloma formation. Several patients with sarcoidosis-specific skin lesions in venous puncture sites have been reported. However, in these patients the pathogenesis of the cutaneous lesions is not clear because the presence of foreign bodies is not to be expected. Our objective was to describe 3 patients who developed specific lesions of sarcoidosis in areas of venipuncture and to discuss their possible pathogenesis. The database of the Sarcoid Clinic of Bellvitge Hospital (an 800-bed university referral center providing tertiary care to approximately 1 million people in Barcelona, Spain) was reviewed to detect those patients with specific cutaneous lesions of systemic sarcoidosis in areas of venipuncture. Three patients with biopsy-proven specific cutaneous lesions of systemic sarcoidosis in areas of venipuncture for blood collection were detected (3 women, mean age 56 years). In one case, the histopathological image shows the hypothetical path of a needle through the skin. In 2 cases, an amorphous birefringent material was detected under polarized light. This material was consistent with silicone. In patients who are developing sarcoidosis, the smallest amount of oil used as lubricant in the needle for sample blood collection may induce the formation of granulomas. In addition to exploring scars, it is advisable to explore the cubital folds to detect specific cutaneous lesions of sarcoidosis.

Effects of Vaginal Lubricants on In-Vitro Progressive Spermatozoa Motility.

Vaginal lubricants are used to solve intercourse difficulties or as sexual enhancers, but recent reports raise questions about their safety in terms of fertility. In this study, twenty semen samples were tested against commercially available vaginal lubricants for progressive spermatozoa motility and vitality with varying exposure time intervals. Results showed that the vaginal lubricant which least affected progressive spermatozoa motility was the oil-based vaginal lubricant, which kept the mean percentage of progressive spermatozoa motility within the minimum normal range of 32%, following 60 minutes of exposure. The silicone-based vaginal lubricant produced similar results to the oil-based vaginal lubricant, however the progressive spermatozoa motility dropped below the minimum normal range within 60 minutes of exposure. The fertility lubricant did not produce mean progressive motilities that were within the normal minimum range at any of the three time intervals, producing poor results overall. The vaginal lubricant which produced the poorest results was the water-based, which immobilized all of the spermatozoa within 5 minutes of exposure and killed on average 95.23% within 60 minutes. Although further assessment is required, these results highlight potential fertility issues related to the formulation of commercially available vaginal lubricants.

A randomized clinical trial in subjects with dry mouth evaluating subjective perceptions of an experimental oral gel, an oral rinse and a mouth spray compared to water.

PURPOSE: This multicenter, randomized, parallel group study analyzed the effectiveness of an experimental oral gel, a commercially available oral rinse and a commercially available mouth spray versus water alone at relieving self-reported symptoms of dry mouth over a 28-day home use treatment period. The effects of the study treatments on dry mouth-related quality of life (QoL) were also investigated. METHODS: Eligible subjects were stratified by dry mouth severity (mild, moderate or severe) and randomized to receive one of the study treatments. Prior to first use they completed a questionnaire designed to assess their baseline dry mouth-related QoL. Following first use and on Day 8 (2 hours post-treatment only) and Day 29, subjects completed the modified Product Performance and Attributes Questionnaire (PPAQ) I at 0.5, 1, 2 and 4 hours post-treatment. Subjects further assessed treatment performance using the PPAQ II questionnaire on Days 8 and 29 and the dry mouth-related QoL questionnaire on Day 29. RESULTS: In 396 randomized subjects almost all comparisons of responses to PPAQ I, including those for the primary endpoint (response to PPAQ I Question 1 'Relieving the discomfort of dry mouth' after 2 hours on Day 29), were statistically significant in favor of active treatment groups versus water (P < 0.05). All comparisons of responses to PPAQ II on Days 8 and 29 were statistically significant in favor of active treatments versus water (P < 0.05). Moreover, nearly all comparisons for dry mouth-related QoL scores on Day 29 were statistically significant in favor of the active treatments versus water. All the dry mouth management strategies in this trial were well tolerated.

Postoperative Granulomas at Liposuction Incision Sites.

Since most liposuction incisions heal uneventfully, difficult healing in such incisions must be investigated. In the cases of two gynecomastia liposuction patients in which a water-based lubricating gel was used on the liposuction incisions, the incisions failed to heal. For both patients, workup uncovered palisading granulomas at the lateral inframammary fold incision sites several months after otherwise successful surgeries. These two cases are presented and the previous literature is reviewed, with consideration given to the etiology and prevention of such granulomas. LEVEL OF EVIDENCE 5: Risk.

Banned Devices; Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove. Final rule.

The Food and Drug Administration (FDA or Agency) has determined that Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove present an unreasonable and substantial risk of illness or injury and that the risk cannot be corrected or eliminated by labeling or a change in labeling. Consequently, FDA is banning these devices.

The effect of vaginal lubrication on unsatisfactory results of cervical smears.

OBJECTIVE: Speculum lubrication with water-based gels before cervical smear sampling has been investigated and commented on thoroughly during the last decade. The present meta-analysis was based on randomized and quasi-randomized control trials and evaluated its impact on unsatisfactory cytologic results. We also assessed its efficacy in producing lower pain scores during speculum insertion. MATERIALS AND METHODS: We searched MEDLINE (1966- 2013), Scopus (2004-2013), Clinicaltrials.org (1997-2013), Popline (1973-2013), Cochrane Central Register of Controlled Trials (CENTRAL) (1999-2013), and Google Scholar (2004-2013) engines for published randomized control trials, as well as the reference lists from all the included studies. RESULTS: Five randomized trials and 2 quasi-randomized trials were included in the present review involving 8,717 women. Unsatisfactory results based on conventional cytology did not statistically differ among procedures performed with lubricated speculums and those without (odds ratio = 0.94, 95% CI = 0.64-1.37). Consequently, pain scores also did not differ significantly among the 2 groups (odds ratio = -0.37, 95% CI = -1.10 to 0.36). Only 2 studies evaluated unsatisfactory results on liquid-based cytology, precluding firm results. CONCLUSIONS: It seems that speculum lubrication does not interfere with the rates of unsatisfactory results when examination is based on conventional cytology. Conversely, however, the limited number of studies evaluating speculum lubrication on liquid-based cytology precludes firm conclusions.

Associations of sexually transmitted infections with condom problems among young men who have sex with men.

BACKGROUND: Young men who have sex with men (YMSM) are disproportionately infected with sexually transmitted infections (STIs). Condom use is the most widely available means of preventing the transmission of STIs, but effectiveness depends on correct use. Condom errors such as using an oil-based lubricant have been associated with condom failures such as breakage. Little research has been done on the impact of condom problems on the likelihood of contracting an STI. METHODS: Data came from Crew 450, a longitudinal study of HIV risk among YMSM (N = 450). All self-report data were collected using computer-assisted self-interview technology, and clinical testing was done for gonorrhea, chlamydia, and HIV. RESULTS: Nearly all participants made at least 1 error, with high rates of using oil-based lubricant and incomplete use. No differences were found in rates of condom problems during anal sex with a man versus vaginal sex with a woman. Black YMSM reported significantly higher use of oil-based lubricants than white and Hispanic YMSM, an error significantly associated with HIV status (adjusted odds ratio, 2.60; 95% confidence interval, 1.04-6.51). Participants who reported a condom failure were significantly more likely to have an STI (adjusted odds ratio, 3.27; 95% confidence interval, 1.31-8.12). CONCLUSIONS: Young men who have sex with men report high rates of condom problems, and condom failures were significantly associated with STIs after controlling for unprotected sex. Educational programs are needed to enhance correct condom use among YMSM. Further research is needed on the role of oil-based lubricants in explaining racial disparities in STIs and HIV.

Effect of vaginal lubricants on natural fertility.

PURPOSE OF REVIEW: Vaginal lubricants are commonly utilized to facilitate more comfortable and enjoyable intercourse. The impact of these lubricants on fertility is unclear. The aim of this review is to summarize the current in-vitro and clinical data pertaining to lubricants' effect on natural conception. RECENT FINDINGS: In-vitro studies suggest lubricants can be toxic to sperm in the artificial laboratory environment. Lubricants formulated to be nontoxic to sperm have no effect on sperm motility or viability in vitro compared to controls. However, a recent longitudinal cohort study suggests lubricant use and choice has no effect of fecundity. SUMMARY: As a result of the conflicting in-vitro and clinical data, the effect of vaginal lubricants on fertility is still unresolved. A randomized controlled trial is needed to determine the effects of vaginal lubricants on fertility.

The effects of vaginal lubricants on sperm function: an in vitro analysis.

BACKGROUND: Despite being marketed as "sperm friendly", some vaginal lubricants are known to be detrimental to sperm function and therefore could negatively affect fertility. Many others have not yet been assessed in regards to their effect on sperm function. This issue may concern couples trying to conceive both naturally and via artificial reproductive technologies (ART). AIM: The aim of this research was to analyse the effects that lubricants, commonly used in the setting of natural conception and ART, have on sperm function in an in vitro setting. This was done by assessing sperm motility, vitality and DNA fragmentation following treatment with commercial lubricants or control preparations. We have attempted to mimic the conditions of the vaginal environment in our clinical trial, and so have compiled a list of lubricants that are likely to have minimal negative effect on sperm function in vivo or are "sperm friendly". METHODS: Ten samples were obtained for the study from patients attending a fertility clinic. Once collected, the sperm samples were prepared by density gradient centrifugation and incubated with 11 different lubricants including positive and negative controls for 30 min at 37 °C to mimic the temperature inside the female reproductive tract. Sperm motility, vitality and DNA fragmentation were assessed to determine the effects of the lubricants on sperm function and DNA integrity. RESULTS: Nine lubricants were investigated including Sylk™, Conceive Plus®, glycerol, Johnson's® Baby Oil, SAGE® Culture Oil, Yes®, Forelife™, MaybeBaby® and Pre-seed®. The lubricant which had the best results in terms of vitality, at 92%, was Pre-seed® and the worst was Forelife™ with 28% vitality. In terms of motility, Pre-seed® resulted in the highest percentage of spermatozoa with progressive motility at 86% and Sylk™ resulted in the lowest percentage of progressively motile cells in the sample with 31% of sperm progressively motile. There were no significant effects on DNA integrity. CONCLUSIONS: Pre-seed® was the lubricant which had the least negative effect on sperm function, with Conceive Plus® a close second, due to the significantly higher sperm motility and vitality parameters measured following lubricant exposure.

The acceptability, feasibility, and efficacy (phase I/II study) of the OVERcome (Olive Oil, Vaginal Exercise, and MoisturizeR) intervention to improve dyspareunia and alleviate sexual problems in women with breast cancer.

INTRODUCTION: Almost half of breast cancer survivors experience chronic sexual problems. Despite the negative effects of dyspareunia on physical and overall quality of life, sexual dysfunction remains underreported and undertreated in clinical practice. This is likely due to the paucity of evidence-based interventions to improve sexual functioning. AIM: The study aims to prospectively evaluate the acceptability, feasibility, and efficacy of a novel intervention (Olive Oil, Vaginal Exercise, and MoisturizeR [OVERcome]) to improve sexual problems following breast cancer treatment. MAIN OUTCOME MEASURES: Dyspareunia, sexual functioning, quality of life, distress, and pelvic floor muscles (PFMs) functioning were evaluated. METHODS: Twenty-five women with dyspareunia were instructed to perform pelvic floor muscle (PFM) relaxation exercises twice/day to prevent/manage PFM overactivity, apply a polycarbophil-based vaginal moisturizer three times/week to alleviate vaginal dryness, use olive oil as a lubricant during intercourse, and complete a weekly compliance diary. PFM relaxation training was administered by a physiotherapist at weeks 0 and 4, with follow-up at weeks 12 and 26. At each visit, women completed validated self-report questionnaires and the physiotherapist recorded objective measures of PFM functioning. RESULTS: OVERcome resulted in significant improvements in dyspareunia, sexual function, and quality of life over time (all P<0.001). PFM relaxation training was reported to be effective (P≤0.001). Maximum benefits were observed at week 12. Most women rated PFM relaxation exercises (92%), vaginal moisturizer (88%), and olive oil (73%) as helpful, indicating that the intervention was acceptable. Unexpectedly, six cases (11%) of vaginal stenosis were noted during initial screening. CONCLUSIONS: This novel intervention is acceptable to patients with demonstrated efficacy in improving dyspareunia and sexual function following breast cancer. Delivery of the OVERcome intervention appears feasible in a clinical setting, providing a potential treatment for this important clinical issue. The unexpected number of observed cases of stenosis further highlights the underreporting of sexual problems in this population, deserving further exploration.

Acceptability of potential rectal microbicide delivery systems for HIV prevention: a randomized crossover trial.

We assessed the acceptability of three of over-the-counter products representative of potential rectal microbicide (RM) delivery systems. From 2009 to 2010, 117 HIV-uninfected males (79 %) and females (21 %) who engage in receptive anal intercourse participated in a 6-week randomized crossover acceptability trial. Participants received each of three products (enema, lubricant-filled applicator, suppository) every 2 weeks in a randomized sequence. CASI and T-ACASI scales assessed product acceptability via Likert responses. Factor analysis was used to identify underlying factors measured by each scale. Random effects models were fit to examine age and gender effects on product acceptability. Three underlying factors were identified: Satisfaction with Product Use, Sexual Pleasure, and Ease of Product Use. For acceptability, the applicator ranked highest; however, differences between product acceptability scores were greatest among females and younger participants. These findings indicate that RM delivery systems impact their acceptability and should be considered early in RM development to enhance potential use.

The slippery slope: lubricant use and rectal sexually transmitted infections: a newly identified risk.

BACKGROUND: Use of lubricant products is extremely common during receptive anal intercourse (RAI) yet has not been assessed as a risk for acquisition of sexually transmitted infections (STIs). METHODS: Between 2006 and 2008, a rectal health and behavior study was conducted in Baltimore and Los Angeles as part of the University of California, Los Angeles Microbicide Development Program (NIAID IPCP# #0606414). Participants completed questionnaires, and rectal swabs were tested for Neisseria gonorrhoeae and Chlamydia trachomatis with the Aptima Combo 2 assay, and blood was tested for syphilis (for RPR and TPHA with titer) and HIV. Of those reporting lubricant use and RAI, STI results were available for 380 participants. Univariate and multivariate regressions assessed associations of lubricant use in the past month during RAI with prevalent STIs. RESULTS: Consistent lubricant use during RAI in the past month was reported by 36% (137/380) of participants. Consistent past month lubricant users had a higher prevalence of STI than inconsistent users (9.5% vs. 2.9%; P = 0.006). In a multivariable logistic regression model, testing positive for STI was associated with consistent use of lubricant during RAI in the past month (adjusted odds ratio: 2.98 95% confidence interval: 1.09, 8.15) after controlling for age, gender, study location, HIV status, and numbers of RAI partners in the past month. CONCLUSIONS: Findings suggest some lubricant products may increase vulnerability to STIs. Because of wide use of lubricants and their potential as carrier vehicles for microbicides, further research is essential to clarify if lubricant use poses a public health risk.

Association of lubricant use with women's sexual pleasure, sexual satisfaction, and genital symptoms: a prospective daily diary study.

INTRODUCTION: Although lubricant use is commonly recommended to women for solo and partnered sexual activities, little is known about women's use of lubricant or their relationship to sexual pleasure and satisfaction. AIM: The aim of this study was to assess: (i) how adult women used lubricant during partnered and solo sexual activities; (ii) relations between women's reports of sexual pleasure and satisfaction and their use of a lubricant during a particular sexual event; and (iii) to what extent lubricant use was associated with subsequent genital symptoms. METHODS: A total of 2,453 women completed a 5-week internet-based, double-blind prospective daily diary study in which they were assigned to use one of six water- or silicone-based lubricants. MAIN OUTCOME MEASURES: Baseline data included demographics, contraceptive use, and sexual behavior during the 4 weeks prior to study enrollment. Daily diary data included reports of penile-vaginal sex, penile-anal sex, solo sex, lubricant use, lubricant application, ratings of sexual pleasure and satisfaction, and genital symptoms. RESULTS: Water-based lubricants were associated with fewer genital symptoms compared with silicone-based lubricants. In addition, the use of a water-based or silicone-based lubricant was associated with higher ratings of sexual pleasure and satisfaction for solo sex and penile-vaginal sex. Water-based lubricant use was associated with higher ratings of sexual pleasure and satisfaction for penile-anal sex as compared with no lubricant use. CONCLUSION: The water- and silicone-based lubricants used in this study were associated with significantly higher reports of sexual pleasure and satisfaction and rarely associated with genital symptoms.

Chemical and traumatic occupational eye exposures in aviation personnel.

INTRODUCTION: The eye is vulnerable to chemical exposure and foreign body infiltration in the occupational setting. Individuals working in the aviation field are prone to these types of exposures. METHODS: We conducted a 28-mo retrospective chart review to document the number of airline workers complaining of chemical or foreign body exposure to the eye at an onsite airport medical clinic. The International Classification of Diseases, Ninth Revision (ICD-9), code for chemical conjunctivitis (372.5), was used to identify patients' charts. We documented the type of treatment that was initiated and whether there was eye damage. We further investigated the chemical composition of the products and whether there was any associated toxicity. RESULTS: Few instances of chemical exposure and foreign body infiltration were found. Patients were exposed to the following products: lubricants (e.g., naphthenic oils), hydraulic fluid (e.g., petroleum or phosphate ester based), jet fuel (e.g., kerosene), and de-icing agents (e.g., propylene glycol). There was no documentation regarding the use of personal protection equipment in the patients' charts. All patients received eye irrigation with normal saline. No sequelae were documented. CONCLUSION: Airline personnel are exposed to a variety of chemical agents in the workplace. None of the agents that workers were exposed to in this small study exhibited toxic effects to the eye. Proper use of personal protection equipment in aviation personnel may limit the number of chemical and foreign body eye exposures.

Prediction of treatment outcome in burning mouth syndrome patients using machine learning based on clinical data.

The purpose of this study is to apply a machine learning approach to predict whether patients with burning mouth syndrome (BMS) respond to the initial approach and clonazepam therapy based on clinical data. Among the patients with the primary type of BMS who visited the clinic from 2006 to 2015, those treated with the initial approach of detailed explanation regarding home care instruction and use of oral topical lubricants, or who were prescribed clonazepam for a minimum of 1 month were included in this study. The clinical data and treatment outcomes were collected from medical records. Extreme Gradient-Boosted Decision Trees was used for machine learning algorithms to construct prediction models. Accuracy of the prediction models was evaluated and feature importance calculated. The accuracy of the prediction models for the initial approach and clonazepam therapy was 67.6% and 67.4%, respectively. Aggravating factors and psychological distress were important features in the prediction model for the initial approach, and intensity of symptoms before administration was the important feature in the prediction model for clonazepam therapy. In conclusion, the analysis of treatment outcomes in patients with BMS using a machine learning approach showed meaningful results of clinical applicability.