Early Intervention after Rape to prevent post-traumatic stress symptoms (the EIR-study): an internal pilot study of a randomized controlled trial.

BACKGROUND: Rape is one of the trauma incidents with the highest risk of subsequent post-traumatic stress disorder. Early interventions, such as prolonged exposure therapy (PE), have shown promise in preventing PTSD following a sexual assault. The primary objective of this internal pilot trial was to examine the feasibility of the EIR study protocol, which used modified prolonged exposure therapy (mPE) as a preventive intervention after rape. METHODS: This parallel two-arm clinical pilot study involved three sexual assault centers (SACs) in Trondheim, Oslo, and Vestfold, with data collected between June 2022 and March 2023. Women seeking assistance at one of these three SACs within 72 h after rape or attempted rape received acute medical treatment and forensic examinations. Women who wanted further psychosocial treatment were, if eligible and consenting, recruited to complete baseline assessments and a clinical interview before being randomized to one of two study arms. The intervention group prescribed up to five sessions of modified PE (mPE) in addition to treatment as usual (TAU), starting within the first 14 days after the rape incident, followed by weekly sessions. The other group received TAU. The present pilot evaluation is based on 22 participants, i.e., nine mPE + TAU and 13 TAU alone. Primary outcomes were predefined progression criteria regarding recruitment, retention, intervention implementation, a harm reporting system, and applying biological measurements and actigraphy. RESULTS: During the 6-month recruitment period, 235 women visited the three SACs. After eligibility screening and consent, 22 (9.4%) women were randomized. Three months later, 14 (63.6%) participants completed the final assessments. Intervention implementation was successful using trained SAC personnel to deliver mPE. The harm reporting system was used according to the study's plan, and adverse and serious adverse events were detected during the trial. The biological measurements and actigraphy had substantial missing data but were still considered usable for statistical analyses. CONCLUSION: It may be feasible to conduct a full-scale RCT of early intervention after rape by comparing mPE + TAU to TAU alone. Minor design refinements were made to the protocol to enhance the main study outcome. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05489133. Registered on 15 July 2022, retrospectively.

Amsterdam complex pelvic pain symptom scale with subscales: Based on a Norwegian translation, psychometric assessment and modification of the Amsterdam hyperactive pelvic floor scale.

INTRODUCTION: Women with an abnormally high pelvic floor muscle tone may have a clinical presentation that is complex, involving urinary, anorectal and/or sexual dysfunction, genital/pelvic pain and psychological distress. The Amsterdam Hyperactive Pelvic Floor Scale (AHPFS) is a Dutch 30-item condition-specific self-report questionnaire developed to measure these complex pelvic pain symptoms. The aim of this study was to translate the Dutch version into Norwegian, to assess the psychometric properties, and to present a valid factor structure. MATERIAL AND METHODS: Translation, back-translation and a review of the back-translated version were performed. Thereafter, a pilot test including feedback from six clinical experts and cognitive interviews with 11 patients from the target group was conducted. Next, a field test was performed among women who were (1) patients at the gynecological outpatient clinic/pelvic floor physiotherapist at St. Olav's Hospital, (2) members of the Vulvodynia or the Endometriosis Patient Associations or (3) female students and employees from the Faculty of Medicine and Health Science, the Norwegian University of Science and Technology, in a web-based survey. To ensure a sample with symptomatic women, only women who scored ≥11 according to the Dutch prespecified factor structure were included in the statistical analyses (n = 232). RESULTS: Content/face validity demonstrated that the questionnaire was perceived as relevant, comprehensive and understandable. Some adjustments in the instructions of the questionnaire and the response categories were made, which lead to the Norwegian translation ACPPS-30. Assessment of the questionnaire's dimensionality revealed a five-factor structure similar to the original Dutch Amsterdam Hyperactive Pelvic Floor Scale (AHPFS) but without the Urinary tract infection factor and seven other items. The translated and modified ACPPS-16 total score and subscales correlated as expected with scales measuring similar conditions. Test-retest reliability demonstrated good stability for scales (intraclass correlation coefficient 0.85-0.93) and single items (weighted kappa values from 0.34 to 0.90). CONCLUSIONS: A modified Norwegian version ACPPS-30 was presented, in addition to a shorter version with only 16 of the translated items distributed among five factors similar to the original Dutch version (ACPPS-16). Both versions proved to be valid, stable and reliable tools to investigate complex pelvic pain symptoms possibly due to an abnormally high-toned pelvic floor muscle.

Symptoms of complex pelvic pain: A survey in three cohorts of women.

INTRODUCTION: There has been increased interest in addressing chronic pelvic pain and its complexity in women. The often multifactorial etiology of chronic pelvic pain and its heterogeneous presentation, however, make the condition challenging to manage. Overlap with other pain-related conditions is frequently reported, and chronic pelvic pain may impact sexual function. Nevertheless, little is known about the symptom burden of chronic pelvic pain and more complex pelvic pain in different groups of women. Thus, the aim of our study was to use a newly validated Norwegian version of the Amsterdam Complex Pelvic Pain Symptom Scale (ACPPS) to describe and compare the symptom severity of complex pelvic pain in three cohorts of women and to assess associations between demographic and gynecological characteristics and the severity of the condition. MATERIAL AND METHODS: In our cross-sectional study, we collected self-reported data from patients referred to gynecological outpatient clinics, members of vulvodynia or endometriosis patient associations, and healthy volunteers. The 397 participants (47% response rate) completed an online survey about their demographic and gynecological characteristics and symptoms related to complex pelvic pain, including the Norwegian ACPPS. Score means on questionnaires, with standard deviations and 95% confidence intervals, were recorded. We used Pearson's chi-square test, Analysis of variance and multivariable linear regression were used to assess associations of demographic and gynecological characteristics with ACPPS scores. RESULTS: Members of the patient associations had significantly higher self-reported symptom burden than patients and volunteers. Symptom burden was lower among older and postmenopausal women, and unemployed women scored higher than employed ones. Especially high scores on the ACPPS were found among women with complaints of chronic pelvic pain, at least moderate pelvic pain intensity, and/or chronic vulvar pain. Women who had experienced sexual assault and/or reported low sexual function also reported high scores. In multivariable regression, fibromyalgia, low mental health and past sexual assault were found to be associated with high scores on the ACPPS. CONCLUSION: Many women in our study reported complex pelvic pain, and overlap with other pain-related conditions, low mental health and past sexual assault was associated with high symptom burden. Those findings support taking a biopsychosocial approach to treating women who present with such complaints.

Modified prolonged exposure therapy as Early Intervention after Rape (The EIR-study): study protocol for a multicenter randomized add-on superiority trial.

BACKGROUND: Sexual assault and rape are the traumatic life events with the highest probability for posttraumatic stress disorder (PTSD), which can have devastating consequences for those afflicted by the condition. Studies indicate that modified prolonged exposure (mPE) therapy may be effective in preventing the development of PTSD in recently traumatized individuals, and especially for people who have experienced sexual assault. If a brief, manualized early intervention can prevent or reduce post-traumatic symptoms in women who have recently experienced rape, healthcare services targeted for these populations (i.e., sexual assault centers, SACs) should consider implementing such interventions as part of routine care. METHODS/DESIGN: This is a multicenter randomized controlled add-on superiority trial that enrolls patients attending sexual assault centers within 72 h after rape or attempted rape. The objective is to assess whether mPE shortly after rape can prevent the development of post-traumatic stress symptoms. Patients will be randomized to either mPE plus treatment as usual (TAU) or TAU alone. The primary outcome is the development of post-traumatic stress symptoms 3 months after trauma. Secondary outcomes will be symptoms of depression, sleep difficulties, pelvic floor hyperactivity, and sexual dysfunction. The first 22 subjects will constitute an internal pilot trial to test acceptance of the intervention and feasibility of the assessment battery. DISCUSSION: This study will guide further research and clinical initiatives for implementing strategies for preventing post-traumatic stress symptoms after rape and provide new knowledge about which women may benefit the most from such initiatives and for revising existing treatment guidelines within this area. TRIAL REGISTRATION: ClinicalTrials.gov NCT05489133. Registered on 3 August 2022.

Chronic vulvar pain in gynecological outpatients.

OBJECTIVES: Chronic vulvar pain (CVP) is pain in the vulvar area exceeding three months of duration. Previous studies have reported a prevalence of 7-8% in the general population and observed an association between CVP and other chronic pain, affective disorders and early life stressors. The aim of this study was to estimate the prevalence of CVP among gynecological outpatients and to explore its association with child sexual abuse, comorbid fibromyalgia and mental health. METHODS: We conducted a questionnaire-based cross-sectional study among consecutive women attending an unselected general gynecological outpatient clinic at St Olav's University Hospital, Trondheim, Norway, during the period August 1st, 2017, to June 30th, 2018. CVP was defined as having experienced either vulvar burning, sharp pain or allodynia for three months or more within the previous year. Fibromyalgia was defined as widespread pain in the past six months in conjunction with a symptom severity score ≥5 on the fibromyalgia symptom severity score inventory, an ordinal scale from zero to 12. We collected information on sexual coercion experience and assessed mental health with the mental health inventory (MHI-5) of the SF-36 health survey, which yields a zero to five scale. RESULTS: Of 1,125 questionnaires distributed, 810 (72%) were returned, and 762 (68%) included in final analyses. Among these, 130 (17.1%) reported CVP within the previous year and 92 (16.7%) were classified as suffering from fibromyalgia. Fibromyalgia was associated with CVP (adjusted OR of 1.8, 95% CI 1.1-3.1). Child sexual abuse was reported by 96 (13.1%) and was associated with CVP (adjusted OR 2.0, 95% CI 1.2-3.3). CVP and fibromyalgia were both associated with lower mental health scores; 0.51 and 0.58 points on the MHI-5 scale, respectively. CONCLUSIONS: Chronic vulvar pain is common among women in a gynecological outpatient clinic and associated with child sexual abuse, comorbid fibromyalgia and worse mental health. Ethical committee number: REK Midt No. 2016/2150.

Female genital cutting in women living in Norway - consequences and treatment. / Omskjæring hos kvinner bosatt i Norge ­ konsekvenser og behandling.

BACKGROUND: Seven Norwegian hospitals offer an outpatient service for women who have undergone female genital cutting (FGC). This study presents symptoms, findings and treatment in women who were examined at the outpatient clinics in the period 2004-2015. MATERIAL AND METHOD: Each hospital identified patients by searching for relevant diagnostic and procedure codes. All those who had been examined at the outpatient clinics were included. Data were retrieved from patient records. RESULTS: A total of 913 women were included. The median age at the time of undergoing FGC was seven years, and at the time of consultation, 26 years. Almost half of the women were pregnant. The majority (81 %) had FGC type III (infibulation). Of these, 87 % had gynaecological problems. Of women with types I and II FGC, 55 % and 70 %, respectively, reported gynaecological problems. Altogether 64 % received surgical treatment, primarily deinfibulation (98 %). Few complications were recorded. INTERPRETATION: In many young, non-pregnant infibulated women, FGC-related problems that can be treated with deinfibulation may have been present since childhood and adolescence. There is probably an unmet need for treatment, irrespective of the type of FGM.

Is police investigation of rape biased by characteristics of victims?

AIM: To explore differences in police investigations between cases of rape against women with and without vulnerability factors. METHODS: Retrospective, descriptive study of cases of rape against women ≥16 years of age. Cases involving victims with and without vulnerability factors were compared regarding the quality of police investigation. RESULTS: Vulnerability was present among 68% of the victims. Cases with vulnerable victims had an adjusted odds ratio for a low-quality police investigation of 2.1 (95% CI [1.0-4.4]) compared to cases where victims were non-vulnerable. CONCLUSIONS: Our results do not prove that rape myths existed among police officers. Our findings show a trend indicating that vulnerable victims may have been less prioritized compared to non-vulnerable victims. More studies are needed regarding how the police respond to rape complaints and to what degree police investigations are influenced by different characteristics of victims.

Three groups of suspects in police reported rape cases: First-time suspects, recidivists and unidentified suspects. A comparative study.

BACKGROUND: Previous studies show that reported suspects in adult rape cases often have a criminal record, and that many are rape recidivists. Annual numbers of police reported rapes have dramatically increased but the proportion of rapes being prosecuted and numbers of convictions are low. To increase knowledge about the suspects in cases of police reported rapes; whether they have committed the crime before or not may inform preventive measures. AIMS: To compare suspect, victim, and assault related characteristics among different groups of police-reported rape suspects (first-time suspects, recidivist suspects and unidentified suspects). METHODS: Retrospective, descriptive study of suspects in cases of rape or attempted rape reported by women ≥16 years of age in the Sør-Trøndelag police district, Norway, from 2003 to 2010. RESULTS: Among the 356 suspects included, 207 (58%) were first-time suspects, 75 (21%) were recidivists and 74 (21%) were unidentified. Being a first-time suspect was significantly associated with victim being <18 years, recidivist suspect was significantly associated with victim being a partner, both suspect- and victim unemployment, and suspect reporting intake of other drugs than alcohol. When suspects were unidentified, victims were more likely to have consumed alcohol prior to assault, and reporting the suspect being of non-Western origin. Also, the reporting of a public venue was more frequent when unidentified suspect. CONCLUSIONS: The study shows different patterns in groups of suspects as to victim and assault characteristics. Detection and description of such differences can provide valuable information for future prevention programs, police investigation methods and health care guidelines.

Psychosocial Vulnerability Among Patients Contacting a Norwegian Sexual Assault Center.

In this study, the objective was to assess the occurrence of specific vulnerability factors among adult and adolescent females attending a Norwegian sexual assault center (SAC). We also explored assault characteristics and investigated whether these characteristics differed between the group of patients with vulnerability factors compared with the group without such factors. We conducted a retrospective descriptive study of 573 women ≥ 12 years of age attending the SAC at St. Olavs Hospital, Trondheim, Norway, between July 1, 2003 and December 31, 2010. A patient was considered vulnerable if at least one of the following features was present: intellectual or physical disability; history of present/former mental health problems; history of present/former alcohol/substance abuse; or former sexual assault. At least one vulnerability factor was present in 59% of the cases. More than one vulnerability factor was present in 29%. Reporting at least one vulnerability factor was associated with a higher patient age, unemployment, a higher frequency of reported light/moderate physical violence, and the documentation of minor body injury. In contrast, those without vulnerability more often were students assaulted during night time, by a casual or stranger assailant and reporting a higher intake of alcohol prior to the assault. There are obvious patterns of differences in the nature of sexual assaults reported among victims with specific vulnerability factors compared with victims without these factors. Future research should address these differences and possible solutions for better protection of especially vulnerable individuals against sexual offenses, such as those with mental health and substance abuse difficulties.

Factors associated with trace evidence analyses and DNA findings among police reported cases of rape.

OBJECTIVE: The aim of this study was to examine the association between victim, suspect and assault characteristics and (1) forensic analysis of trace evidence, (2) detection of spermatozoa and (3) DNA match in police-reported cases of rape/attempted rape. In addition, we explored whether DNA findings were associated with legal outcome. METHODS: We conducted a retrospective, descriptive study based on police-reported rapes and attempted rapes of women ≥16 years of age in Sør-Trøndelag Police District throughout 1997-2010. Police data were merged with information from the Sexual Assault Centre (SAC) at St. Olavs University Hospital, Trondheim, Norway. We used binary and multivariable logistic regression for the comparisons. RESULTS: We identified 324 victims (mean age 24 years). The police requested analysis in 135 (45%) of the 299 collected victim samples. The police decision to analyze was after adjustment associated with the victim being employed or under education, and a public venue, but not with interval from assault to sampling. Spermatozoa were detected in 79 (61%) of the analyzed cases, of which 71 were collected from victims within 24h. Interval from assault being <24h and reporting a penetrative assault remained associated with the findings of spermatozoa after adjustments. Forensic analyses of trace evidence collected from victim, suspect and/or venue disclosed matching DNA profiles in 57 (40%) of a total of 143 analyzed cases. Matching DNA profiles were associated with suspect being known to the victim and with the venue being private. A higher proportion of cases with a DNA match were prosecuted in court: 20 of the 29 cases prosecuted. However, despite a DNA match 35 cases were anyway dismissed because of insufficient evidence. CONCLUSIONS: Although many of the associations in our study were expected, it is still important to report the actual numbers to gain insight into the importance of a DNA match in legal proceedings. A substantial proportion of cases with DNA match was dismissed because of insufficient evidence. To strengthen the justice response to sexual assault, it is essential to generate knowledge about the role of medico-legal evidence in such cases, and there are obviously other non-medical factors influencing the legal decisions.

EtG/EtS in Serum by UHPLC-MS-MS in Suspected Sexual Assault Cases.

A method including semi-automated extraction of ethyl glucuronide (EtG) and ethyl sulfate (EtS) from serum followed by ultra-performance liquid chromatography-tandem mass spectrometry (UHPLC-MS-MS) has been developed and validated. Sample preparation prior to UHPLC-MS-MS analysis consisted of protein precipitation and filtration through a phospholipid removal plate. Chromatography was achieved using an HSS T3 column and gradient elution with formic acid in water in combination with methanol. The mass spectrometer was monitored in the negative mode with multiple reaction monitoring. Two transitions were monitored for the analytes and one for the deuterated internal standards (ISs). The limits of quantification were 0.025 mg/L for EtG and 0.009 mg/L for EtS. The between-assay relative standard deviations were in the range of 3.8-9.1%, the recovery was 66-102% and matrix effects ranged from 88 to 97% (corrected with IS). Compared to previously published studies, the method presented is semi-automated, uses a simple method for phospholipid removal and has short run times and low limit of quantifications. We analyzed serum samples from 49 female patients presenting to the Sexual Assault Centre at St. Olav University Hospital in Trondheim, Norway, for ethanol, EtG and EtS. EtG and EtS were detected longer than ethanol itself after intake of ethanol, with estimated maximum detection times of >24 h. The ethanol, EtG and EtS concentrations were highly correlated (P < 0.001), but with large inter-individual variations. This study suggests that analysis of EtG and EtS in serum or blood may complement ethanol analysis and shed light on the patient's recent ethanol intake after ethanol itself is no longer detectable.

Sexually transmitted infections among women attending a Norwegian Sexual Assault Centre.

OBJECTIVES: The objective was to describe the prevalence of sexually transmitted infections (STI) and blood-borne viruses (BBV), and prophylactic treatment offered to female postpubertal patients attending a Norwegian Sexual Assault Centre (SAC). We wanted to evaluate whether STIs diagnosed at the initial visit could have been assault-transmitted, and to explore whether background and assault characteristics were associated with diagnosed STI/BBV. METHODS: We included postpubertal females ≥12 years of age attending the SAC within 1 week of the assault. Data were collected from records. We conducted a retrospective, descriptive study, and used logistic regression analysis. RESULTS: Among 412 patients with a median age of 21 years, 35 patients had an STI (8.5%), two of which probably were assault-transmitted. Chlamydia trachomatis was the dominating agent, detected in 25 patients (6.4%). At serology screening, 3.7% tested positive for hepatitis C and/or hepatitis B core antibody. Patient age 16-19 years was associated with STI, while BBV positives were older. Non-Western assailant was associated with STI, while substance abuse was associated with STI and BBV. In order to prevent potential transmission of STI not identified at the initial visit, 91% accepted prophylaxis against bacterial STI, while antiviral prophylaxis was offered to less than one-fifth of the patients. CONCLUSIONS: The C trachomatis prevalence among the sexual assault patients was lower than in a comparable clinical population. The STI was suspected to be assault-transmitted in only two cases.

Ethanol and drug findings in women consulting a Sexual Assault Center--associations with clinical characteristics and suspicions of drug-facilitated sexual assault.

The purpose of the study was to describe toxicological findings among women seeking health care after sexual assault, and to assess the relationship with so-called proactive DFSA (drug facilitated sexual assault). We also explored associations between ethanol in blood/urine and background data, assault characteristics, and clinical findings. We conducted a retrospective, descriptive study of female patients ≥ 12 years of age consulting the Sexual Assault Center at St. Olavs University Hospital, Trondheim, Norway. They were examined between July 1, 2003 and December 31, 2010, and urine and/or blood were analyzed for ethanol and selected medicinal/recreational drugs. Among the 264 patients included, ethanol and/or drugs were detected in 155 (59%). Of the 50 patients (19%) testing positive for drugs other than ethanol, benzodiazepines/benzodiazepine-like drugs were found in 31, central stimulants in 14, cannabinoids in 13 and opioids in nine. None tested positive for gamma-hydroxybutyrate (GHB). In total, 57 patients (22%) suspected proactive DFSA, but only five had findings of sedative drugs that were not accounted for by self-reported voluntary intake. No cases could unequivocally be attributed to proactive DFSA. Among the 120 patients tested for ethanol within 12 h after the assault, 102 were positive. The median estimated blood alcohol concentration (BAC) at the time of assault was 1.87 g/L. Patients testing positive for ethanol more often reported a public place of assault and a stranger assailant. Higher estimated BAC at the time of assault was associated with higher frequency of suspecting proactive DFSA. Ethanol was the most prevalent toxicological finding in urine/blood from victims of sexual assault, and high ethanol concentrations were often detected. Among the patients suspecting proactive DFSA, very few had sedative drug findings not explained by voluntary intake. It seems like opportunistic DFSA, rather than proactive DFSA dominate among the sexually assaulted attending our SAC.

EtG/EtS in Urine from sexual assault victims determined by UPLC-MS-MS.

In cases of sexual assault, victims often present too late for the detection of ethanol in biological samples. An ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS-MS) method was developed and validated for the determination of ethyl glucuronide (EtG) and ethyl sulfate (EtS) in urine. Sample preparation prior to UPLC-MS-MS analysis was a simple sample dilution. The calibration ranges were 0.2-20 mg/L, and between-assay relative standard deviations were in the range of 0.7-7.0% at concentrations of 0.3, 3.0 and 7.0 mg/L. Urine samples were analyzed from 59 female patients presenting to the Sexual Assault Centre at St. Olav University Hospital in Trondheim, Norway between November 2010 and October 2011. EtG and EtS results were fully concordant, and positive in 45 of the 48 cases with self-reported alcohol intake. In contrast, ethanol was detectable in only 20 of these cases, corresponding to sensitivities of 94 and 42%, respectively. Of the patients reporting no alcohol intake, none had positive EtG/EtS findings. These data show that analysis of EtG and EtS greatly increases the detection window of alcohol ingestion in cases of sexual assault, and may shed additional light on the involvement of ethanol in such cases. The victims' self-reported intake of alcohol seems to be reliable in this study, according to the EtG/EtS findings.

Impact of medico-legal findings on charge filing in cases of rape in adult women.

OBJECTIVE: To assess the impact of the medical documentation and biological trace evidence in rape cases on the legal process. DESIGN: Retrospective descriptive study. SETTING AND SAMPLE: Police-reported cases of rape of women ≥16 years old in the Norwegian county of Sør-Trøndelag from January 1997 to June 2003. METHODS: Police data were merged with data from the Sexual Assault Center at St Olav's Hospital. Charged and non-charged cases were compared. MAIN OUTCOME MEASURES: Medico-legal findings and legal outcome. RESULTS: A total of 185 police-reported cases were identified. Of the 101 cases examined at Sexual Assault Center, charges were filed in 18 cases. Extragenital injuries were documented in 49 women; five were life threatening. Anogenital injuries were documented in 14 women; eight had multiple anogenital injuries. Documentation of injuries was not associated with charge filing. In only 33% of the cases were swabs collected from women's genitals used as trace evidence by the police. When used, this increased the likelihood for charge filing. A DNA profile matching the suspect was identified in four of the 18 charged cases and in only one among the 54 non-charged cases. CONCLUSIONS: Half of the women had one or more documented injury. Only one-third of the trace evidence kits collected from the women's anogenital area were analyzed. The analysis of swabs was associated with charge filing, regardless of test results. Increased use of such medical evidence, especially in cases of stranger rape, may ensure women's rights and increase available information to the legal system.