Simulated Intercourse Research Articles

Validity and Reliability of a New Inertial Device for Monitoring Range of Motion at the Pelvis during Sexual Intercourse.

To understand the physical demands of sexual intercourse, it is necessary to monitor the kinematic parameters of this activity using relatively non-invasive technology. The aims of this study are to analyze the validity and reliability of an inertial device for monitoring the range of motion at the pelvis during simulated intercourse and compare the range of motion (ROM). Twenty-six adults were monitored during intercourse using an inertial device (WIMU) and a motion capture system (gold standard) in a test that consisted of 4 sets of 20 simulated in–out cycles (IOC) in missionary and cowgirl positions. Men and women were tested separately in a laboratory setting for simulated intercourse aims. There were no differences between the WIMU and the gold standard system at fast pace (p > 0.05), whereas there were differences at slow pace (~2.04°; p ≤ 0.05; d = 0.17). Intraclass correlation coefficients (ICCs) for the relationship between systems was very close to 1 at both paces (slow: 0.981; fast: 0.998). The test–retest reliability analysis did not show any difference between sets of measurements. In conclusion, WIMU could be considered as a valid and reliable device for IOC range of motion monitoring during sexual intercourse in missionary and cowgirl positions.

A Comparative Pre-Phase I Study of the Impact of Gel Vehicle Volume on Distal Colon Distribution, User Experience, and Acceptability.

For persons at risk of HIV infection who practice receptive anal intercourse (RAI), topical rectal microbicides represent a promising option for coitally dependent protection. The study compared colorectal distribution and user sensory experiences of two different volumes of rectal gel for suitability as rectal microbicide. Eight HIV-negative men with a history of recent RAI were enrolled into a two-period, sequence-randomized dosing study comparing 3.5 and 10 ml of radiolabeled (1 mCi 99mTc-DTPA) universal placebo, hydroxyethyl cellulose gel. Each participant received two doses in the research unit, one of each volume, separated by a washout period of at least 2 weeks. Each research unit dose was followed by a self-administered take-home dose in the context of preparing for RAI. Safety and gastrointestinal distribution were assessed after the research unit doses, safety, perceptibility, and acceptability, were assessed after take-home doses. There were no adverse effects of Grade 2 or higher and all resolved spontaneously. Both volumes were well tolerated and received high acceptability scores. Perceptibility scores showed meaningful effect size differences ranging from Cohen's d = 0.5 to d = 1.2. The 3.5 and 10 ml gel volumes distributed similarly (p > .2) within the rectosigmoid, ranging from 0.69 to 18.84 cm and 1.21 to 19.01 cm from the anorectal junction, respectively. Both volumes covered the typical gastrointestinal distribution of ejaculate following simulated intercourse based on other studies. Either of these gel volumes could reasonably be pursued for the next phase of development of rectal microbicides.

HuMOVE: a low-invasive wearable monitoring platform in sexual medicine.

To investigate an accelerometer-based wearable system, named Human Movement (HuMOVE) platform, designed to enable quantitative and continuous measurement of sexual performance with minimal invasiveness and inconvenience for users. Design, implementation, and development of HuMOVE, a wearable platform equipped with an accelerometer sensor for monitoring inertial parameters for sexual performance assessment and diagnosis, were performed. The system enables quantitative measurement of movement parameters during sexual intercourse, meeting the requirements of wearability, data storage, sampling rate, and interfacing methods, which are fundamental for human sexual intercourse performance analysis. HuMOVE was validated through characterization using a controlled experimental test bench and evaluated in a human model during simulated sexual intercourse conditions. HuMOVE demonstrated to be a robust and quantitative monitoring platform and a reliable candidate for sexual performance evaluation and diagnosis. Characterization analysis on the controlled experimental test bench demonstrated an accurate correlation between the HuMOVE system and data from a reference displacement sensor. Experimental tests in the human model during simulated intercourse conditions confirmed the accuracy of the sexual performance evaluation platform and the effectiveness of the selected and derived parameters. The obtained outcomes also established the project expectations in terms of usability and comfort, evidenced by the questionnaires that highlighted the low invasiveness and acceptance of the device. To the best of our knowledge, HuMOVE platform is the first device for human sexual performance analysis compatible with sexual intercourse; the system has the potential to be a helpful tool for physicians to accurately classify sexual disorders, such as premature or delayed ejaculation.

Quantitative Assessment of Altered Rectal Mucosal Permeability Due to Rectally Applied Nonoxynol-9, Biopsy, and Simulated Intercourse

Microbicide toxicity may reduce the efficacy of topical preexposure prophylaxis for human immunodeficiency virus (HIV) transmission. Noninvasive quantitative measures of microbicide toxicity would usefully inform microbicide development. Ten subjects received 3 one-time interventions: 5 mL of Normosol-R fluid alone (negative control), 5 mL of 2% nonoxynol-9 (N-9) gel, and 5 mL of Normosol-R with coital simulation and sigmoidoscopic biopsy (CS + BX). Each dose of N-9 and Normosol-R contained 500 µCi of (99m)technetium-diethylene triamine pentaacetic acid. Plasma and urine radioactivity was assessed over 24 hours. The plasma radioisotope concentration peaked 1 hour after N-9 dosing. The mean maximum radioisotope concentration after N-9 receipt was 12.0 times (95% confidence interval [CI], 6.8-21.0) and 8.4 times (95% CI, 5.2-13.5) the mean concentration after Normosol-R control receipt and CS + BX receipt, respectively; paired differences persisted for 24 hours. After N-9 dosing, the urine isotope level was 3.6 times (95% CI, 1.1-11.4) the level observed 8 hours after Normosol-R control receipt and 4.0 times (95% CI, 1.4-11.4) the level observed 4 hours after CS + BX receipt. Permeability after CS + BX receipt was greater than that after Normosol-R control receipt in 0-2-hour urine specimens only (mean permeability, 2.4; 95% CI, 1.0-5.8) but was not greater in blood. Plasma sampling after rectal radioisotope administration provided quantitative estimates of altered mucosal permeability after chemical and mechanical stresses. Permeability testing may provide a useful noninvasive adjunct to assess the mucosal effects of candidate microbicides. Clinical Trials Registration. NCT00389311.

An exploratory, randomized, crossover MRI study of microbicide delivery with the SILCS diaphragm compared to a vaginal applicator

BackgroundMicrobicide gels studied for HIV prevention often are delivered via a single-use vaginal applicator. Using a contraceptive diaphragm such as the SILCS diaphragm for gel delivery could have advantages, including lower cost and additional pregnancy prevention. Study DesignWe performed an exploratory, nonblinded, randomized, crossover study among healthy, sexually active, nonpregnant women. Using BufferGel®, we evaluated three microbicide delivery methods for gel distribution and retention: SILCS single-sided gel delivery, SILCS double-sided gel delivery and a vaginal applicator (without SILCS). Magnetic resonance images were taken at baseline, after gel insertion, and immediately and 6 h after simulated intercourse. Three women completed all gel delivery methods described in this article. ResultsMagnetic resonance imaging analysis indicated similar gel spread in the vagina among all three methods. SILCS single-sided gel application resulted in the most consistent longitudinal coverage; SILCS double-sided gel application was the most consistent in the transverse dimension. ConclusionsGel coverage was similar with all three methods. These results suggest that the SILCS microbicide delivery system is comparable to vaginal applicators for delivery of gel products intravaginally.

Distribution of Cell-Free and Cell-Associated HIV Surrogates in the Female Genital Tract After Simulated Vaginal Intercourse

Rational development of drugs to prevent human immunodeficiency virus (HIV) transmission benefits from an understanding HIV distribution in the female genital tract after intercourse. This study describes HIV distribution using surrogates of cell-free and cell-associated HIV and semen. Apheresis-derived, autologous, lymphocyte-rich cells radiolabeled with 3.7-MBq (100-μCi) indium 111 ((111)In)-oxine (cell-associated HIV surrogate) and 18.5-MBq (500-μCi) technetium 99m ((99m)Tc)-sulfur colloid (HIV-sized 100-nm particle, cell-free HIV surrogate) were resuspended in 3 mL of hydroxyethylcellulose gel (semen simulant) with gadoteridol and dosed via artificial phallus after simulated intercourse. Postdosing dual-isotope single photon emission computed tomography with computed tomography (SPECT/CT) and magnetic resonance (MR) images were acquired to determine the surrogates' distribution. Seven hours after dosing, vaginal biopsy and luminal samples were collected at discrete locations in 8 subjects. SPECT/CT and MR analysis showed HIV and semen surrogate distribution with highest signal intensity in the vaginal pericervical area, without detectable signal in the uterus. One-third of the administered dose was retained in the female genital tract after 4 hours. Cell-free and cell-associated surrogate distribution coincided. We demonstrate the feasibility of dual-isotope SPECT/CT and MR imaging to determine the distribution of HIV and semen surrogates after simulated intercourse without disrupting vaginal contents. Surrogate distribution suggests topical microbicides do not need to reach the uterus for efficacy.

Distribution of Cell-Free and Cell-Associated HIV Surrogates in the Colon After Simulated Receptive Anal Intercourse in Men Who Have Sex With Men

Describing the distribution and clearance of HIV surrogates within the gastrointestinal tract to inform rectal microbicide development. Radiolabeled simulated HIV-infected semen was administered, imaged, and biopsied to simulate and measure colonic HIV distribution after anal intercourse. Healthy male subjects with a history of receptive anal intercourse and experience with the use of anal sex toys were recruited to this study. Apheresis isolated leukocytes were collected before simulated intercourse. These autologous leukocytes, radiolabeled with 9.25 MBq (111)Indium-oxine (cell-associated HIV surrogate), and sulfur colloid particles, labeled with 37 MBq (99m)Technectium (cell-free HIV surrogate), were mixed in 3 mL autologous seminal plasma. This simulated HIV-infected semen was administered to subjects via an artificial phallus with urethra after 5 minutes of simulated intercourse. Postdosing dual isotope Single photon emission computed tomography coupled with traditional computed tomography (SPECT/CT) images were acquired at 1, 4, 8, and 24 hours. At 5 hours postdosing, colon biopsies were collected, CD4 cells were extracted, and samples analyzed for radioactivity. SPECT/CT images showed similar luminal distribution for both surrogates, with migration limited to the rectosigmoid colon in all subjects. SPECT showed at least 75% overlap in distribution of both surrogates up to 4 hours after dosing. Biopsies indicate that 2.4% of CD4 cells extracted from rectosigmoid colon tissue were exogenously administered. Our HIV surrogates stayed within the rectosigmoid colon for 24 hours. Exogenously dosed autologous lymphocytes and HIV-sized particles migrate to similar locations and associate with the colonic tissue in the lumen.

Sex and the Salt Road: Interpretation of a West Texas Pictograph

In the pictograph assemblage in the Black Mountains of west Texas, one image is a naked man who appears to be copulating with a crack in the bedrock. This pictograph, one at Hueco Tanks, and a similar petroglyph at Alamo Canyon may record an increase rite associated with the acquisition of salt. Anovice taking part in the 1912 Hopi expedition to the Grand Canyon for salt described simulated intercourse with a landmark boulder that was said to be Salt Woman, one of the primary deities in the creation myth of several Puebloan societies, thus establishing a context for the images of men copulating with rock. The Black Mountains are one of the few sources of water and food on the barren plain that separated the settled communities on the Rio Grande, near what is now EI Paso, from the Salt Flats. This image is but one element in the larger Mogollon iconographic repertoire adopted by Puebloan people and perpetuated in myth.

A randomized trial to determine the distribution of four topical gel formulations in the human vagina

Background There is an urgent need for the development of a topical microbicide to protect against sexually transmitted infections. We compared distribution and acceptability of four different gel formulations to be used as a vehicle for a microbicide. Study Design This is a randomized, double-blind comparative study. Six women tested each of the four gels at two different time points. Magnetic resonance imaging (MRI) scans were taken both within 10–15 min following intravaginal gel insertion and 4 h following gel insertion, before and after simulated intercourse at both time points. Results Vaginal surface contact immediately after insertion ranged from 68% to 92%. Simulated intercourse increased surface contact for all gels (range, 90–106%). After 4 h, surface contact ranged from 86% to 102%. Simulated intercourse at that time resulted in decreased coverage for two gels and increased coverage for two gels. One gel was noted to have consistent broad coverage of the vagina both immediately and 4 h after insertion, increased coverage with simulated intercourse at both time points and the lowest standard deviation of disruption at all time points. Conclusion MRI used in combination with qualitative assessments of acceptability can be used to select optimal gels for use as vehicles for potential spermicides or microbicides. We conclude that a gel consisting of 3% hydroxypropyl methylcellulose and 1.5% of methyl cellulose is the most promising candidate gel.

Distribution of a vaginal gel (Invisible Condom®) before, during and after simulated sexual intercourse and its persistence when delivered by two different vaginal applicators: a magnetic resonance imaging study

ObjectiveThe objective of this study was to evaluate the vaginal distribution of a microbicidal gel (Invisible Condom®) before, during and after simulated intercourse using an artificial phallus. The gel was delivered using either a new proprietary vaginal applicator (PVA), which has multiple lateral and apical holes, or a commercial applicator (CA), which has a single apical hole. The persistence of the gel was evaluated up to 24 h after its administration. Study DesignNine women (five women using the PVA and four women using the CA) applied the vaginal gel once, and pelvic images were taken immediately after application. An artificial phallus was inserted and the women had 30 vaginal thrusts, then another set of images was taken while the phallus was still inside the vagina. On exit of the phallus, one more set of images was taken. Images were subsequently taken at 30 min, 2 h, 6 h and 24 h after gel application. ResultsImmediately after gel application, the PVA distributed the gel throughout the vaginal/cervical mucosae, while the CA delivered the gel only to the cervical area. During simulated intercourse, the phallus further pushed the gel delivered with the CA into the fornix, whereas it spread the gel delivered with the PVA more evenly throughout the mucosal surface. After simulated intercourse, both applicators gave similar gel distributions between 30 min and 6 h after application. However, at 24 h, using the PVA, only 5% of the gel persisted in the vagina, compared to 40% of the gel using the CA. Discussion and ConclusionUsing the new PVA, the Invisible Condom® covered the vaginal/cervical mucosae before and during simulated intercourse, offering immediate protection, whereas only the cervical mucosa was covered using the CA. Forty percent of the gel persisted mostly in the upper vaginal/cervical area at 24 h following its administration with the CA, while only 5% of the gel was left using the PVA. The new applicator, with its unique design, ensures an even and immediate coating lasting throughout the first 6 h and could prevent potential microbicide vaginal toxicity at 24 h.

The search for a candidate vaginal gel: an imaging trial of the distribution of four topical gel formulations in the human vagina

There is urgent need for a vaginal microbicide, a product that women can self-administer and use to protect themselves against sexually transmitted diseases or undesired pregnancies. Recently some microbicides have failed to demonstrate clinical efficacy in phase II trials. Reasons for failure are unknown, but may include distribution of product. We compared distribution and acceptability of four different gel formulations to be used as a vehicle for a microbicide (nonionic gels [Gels A and B], and anionic gels [Gels B and C]). Randomized, double-blind comparative study. Six women inserted each of the four gels at two different time points and had a series of MRI scans taken. MRI scans were taken 10–15 minutes following intravaginal gel insertion and, at a separate visit, 4 hours following gel insertion. At each time point, scans were taken before and after simulated intercourse. All MRI scans were batch-read by a single radiologist blinded to gel allocation. Subjects reported gel leakage and other adverse events. Statistical analysis was performed using the Wilcoxon-signed-rank test for testing the continuous outcomes and the McNemar test for testing the discrete outcomes. Vaginal surface contact immediately after insertion ranged from 68% for Gel B to 92% for Gel A. Simulated intercourse increased surface contact for all gels (range 90%; Gel B: to 106%; Gel A). After four hours, surface contact was high for all four gels, (range 86% for Gel C to 102% for Gel D). Simulated intercourse at that time resulted in slightly decreased coverage for Gels C and D, and slightly increased coverage for Gels A and B (range 82% for Gel C to 99% for Gel A). All gels were noted to have some leakage within four hours of use with Gel D having the most leakage. One subject experienced mild itching/burning on two occasions using Gel D. Gel A had consistent excellent coverage of the vagina both immediately and four hours after insertion, increased coverage with simulated intercourse at both time points and the lowest standard deviation of disruption at all time points. MRI used in combination with qualitative assessments of acceptability, including leakage and adverse events, can be used to select optimal gels to be used as vehicles for potential spermicides or microbicides. We conclude that the optimal gel tested was a nonionic gel, Gel A consisting of 3% HPMC and 1.5% of Methyl Cellulose.

Magnetic resonance imaging of SILCS diaphragm: anatomical considerations and corroboration with clinical fit

Background We performed a pilot study to evaluate in vivo the fit of the new SILCS diaphragm, a single-size cervical barrier, using magnetic resonance imaging (MRI) in a group of women varying in body mass and parity. Study Design Two healthy premenopausal women were recruited for each of the following groups: body mass index (BMI)<25, BMI=25–30 and BMI>30. One woman in each group was nulliparous and one was multiparous. Subjects were instructed on the placement of the SILCS diaphragm. Each subject underwent three MRI scans: baseline, with the SILCS diaphragm in place and after placement of intravaginal contrast and simulated intercourse. Results The SILCS diaphragm was easily identified on MRI. In all subjects, the diaphragm covered the cervix. The position of the diaphragm did not change after simulated intercourse. The appropriate position of the diaphragm, as assessed by the subjects and the practitioner, was corroborated by the MR images. The intravaginal contrast was not readily visible on the images, precluding assessment of the diaphragm's barrier properties. Conclusion MRI confirms the anatomic position of the SILCS diaphragm in vivo, among a sample of women varying in body mass and parity.

Distribution of a 3.5-mL (1.0%) C31G vaginal gel using magnetic resonance imaging

C31G (Savvy™) has been developed as a topical vaginal microbicide with broad-spectrum antibacterial and antiviral properties. The objective of this study was to evaluate the distribution of a 1.0% concentration of (3.5 mL) C31G vaginal gel in the human pelvis using magnetic resonance imaging (MRI). Gel delivery with a standard applicator was primarily to the upper vagina and was well tolerated. Vaginal mucosal coverage at 18 min was excellent with 92% linear coverage and 75% surface contact coverage of the vagina. The upper vagina was almost completely covered and gel was also noted in the lower vagina. Coverage 6 h after application was substantially decreased, with 60% of maximal linear coverage and 41% surface contact. There was a very minimal coverage of the vaginal mucosa noted 24 h following insertion. Simulated intercourse resulted in relatively little change in overall distribution at all three time points. Repeat application of the gel may be necessary if intercourse has not occurred within the first few hours after initial insertion.

In vivo distribution of a vaginal gel: MRI evaluation of the effects of gel volume, time and simulated intercourse

A microbicide is designed to coat the vaginal epithelium and prevent transmission of HIV. Complete coverage is desired for optimal protection. In vivo factors affecting coverage have not yet been studied. This randomized crossover trial evaluates the effect of gel volume and patient activity upon vaginal epithelial coating. Gynol II gel was mixed with a magnetic resonance imaging (MRI) contrast agent. Ten women self-inserted, on separate visits, 3 or 5 mL of gel and underwent serial MRI scanning both before and after simulated intercourse. Gel spread was dependent upon time and volume. There was modest spread during the first hour and greater spread 6 h after insertion. Five milliliters of gel resulted in statistically significantly greater coverage immediately following insertion, within the first 30 min and at 6 h after insertion. Simulated intercourse greatly enhances gel spread. After simulated intercourse, the distribution of the gel at each volume was similar. Less leakage of gel was reported with the smaller volume.

The distribution of a 3.5 mL (1.0%) C31G vaginal gel (SAVVY) using magnetic resonence imaging

Objective: The objective of this study was to evaluate the distribution and retention of a 1.0% concentration (3.5ml) of Savvy vaginal gel in the human pelvis using Magnetic Resonance Imaging (MRI). Design: Open label phase I clinical trial Materials and Methods: Savvy was mixed with gadolinium at a concentration of 100:1. The mixture was placed in standard vaginal applicators to be self inserted in a normal clinical fashion. Six eligible subjects underwent a series of MRI scans. Baseline MRI was performed before insertion of the gel. MRI was performed, on separate visits, before and immediately after simulated intercourse with a synthetic phallic device within the first hour of insertion, 6 hours after insertion, and 24 hours after insertion of the gel. Results: Delivery of 3.5 ml of Savvy in the upper vagina with a standard applicator was easily accomplished and well tolerated. Coverage at 18 minutes was excellent with 92% linear coverage of the vagina and 75% surface contact coverage. The upper vagina was almost completely covered and gel was also noted in the lower vagina. Simulated intercourse after application of the gel resulted in relatively little change in overall distribution. There was a minimal increase in coverage, especially in the lateral aspects of the vagina. Simulated intercourse resulted in a decrease in the size and number of bare spots. Coverage six hours after application was substantially decreased from that of one hour. Overall coverage was approximately 60% of maximal linear coverage and 41% of surface contact. Simulated intercourse had little effect on distribution at these time periods. There was modest little coverage of the vaginal mucosa noted 24 hours after insertion. Gel covered the external os in all subjects after initial insertion at 18 minutes. Only half of the subjects had gel at the external cervical os 6 hours after administration. There was no coverage at the external os at 24 hours. Gel was noted in the endocervical canal in 4/6 subjects. The prevalence of gel in the endocervical canal was not increased after simulated intercourse. Gel was not visualized in the uterus at any time point. The applicator delivered the desired amount of gel. All women noted leakage of the product within one hour of insertion. There were few complaints of undesired symptoms and no serious adverse events. Conclusion: Savvy provided nearly complete coverage of the vaginal mucosa within one hour of insertion. Coverage was not greatly altered by simulated intercourse. Coverage diminished at 6 hours and 24 hours. Repeat administration may be necessary for coverage of this promising microbicide if it is not used with in the first few hours of application.

Magnetic resonance imaging to determine the distribution of a vaginal gel: before, during, and after both simulated and real intercourse

To provide effective contraception and protection against sexually transmitted disease, vaginal gels should maximally cover the cervical os and the vaginal epithelium before, during and after intercourse. To non-invasively monitor the intravaginal distribution of an applied intravaginal gel, we performed high-resolution magnetic resonance imaging (MRI) of the female pelvis before, during and after both real and simulated sexual intercourse. We sought to determine whether simulated intercourse with a plastic phallus could be used as a surrogate for real intercourse for such experiments. Dilute gadolinium chelate solution was mixed with Gynol-II gel and introduced intravaginally to volunteer female human subjects using a conventional applicator. MRI was performed at 1.5 Tesla with a surface coil. Imaging of the female pelvis was performed: (1) immediately after insertion of the gel; (2) during real intercourse with a male partner (2 subjects) or simulated intercourse with a plastic phallus (4 subjects); and (3) after completion of real or simulated intercourse. Subjects were studied after application of both 3 mL and 5 mL of vaginal gel. Measurements of gel thickness covering the vaginal mucosa were made digitally using electronic calipers. The bolus of gel is initially located in the upper vaginal canal, superior to the urogenital diaphragm. Both real and simulated intercourse dramatically increases the spread of gel to the lower vagina. The cervix appears to be adequately covered with gel both before and after intercourse. Increasing the volume of the gel increases initial vaginal mucosal coverage but also increases leakage from the introitus. No statistically significant differences in vaginal mucosal coverage were found between patients having undergone real vs. simulated intercourse, or on post-intercourse scans of 3 mL versus 5 mL. MRI is a sensitive, reproducible means of tracking the spread of intravaginal medications.

Efficacy of thermoplastic elastomer and latex condoms as viral barriers

The barrier efficacy of a thermoplastic elastomer (TPE) and three brands of latex condoms was compared in a passiveleak test and in a dynamic model of simulated intercourse. Fifteen replicates of each of the condoms were challenged with bacteriophage T7 (100 nm) and the polio virus Type 1 (PV-1, 27 nm). In the passive test, no condom leaked either virus. In the dynamic model, no TPE condoms leaked either virus and no latex condoms leaked T7. Two samples of one commercially available latex condom leaked T7 but not PV-1. These data support that intact latex condoms are effective in vivo viral barriers and extend the finding to TPE condoms as well. Given its substantial equivalence to latex as a viral barrier, TPE condoms are an alternative choice for individuals with latex allergies. The TPE material is also more resistant to common environmental conditions that affect latex adversely and should therefore be a superior choice if condoms must be stored for extended periods in suboptimal conditions.

Bladder perforation caused by cucumis sativus repaired per vagina

A case of bladder perforation secondary to simulated intercourse with a cucumber is presented. Treatment by primary vaginal repair was successful.