Identification of Etiopathological and Clinical Factors in Persistent Genital Arousal Disorder: The iPGAD-Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Questionnaires: Psychological/Psychiatric, neurological and gynecological/urological assessments
研究概览
简要总结
Investigation of (possible etiological) factors associated with PGAD symptomatology as well as description of comorbid disorders subjects with PGAD.
Persistent genital arousal disorder (PGAD) is a presumably rare, although debilitating condition, which was first defined at the beginning of this century and has not yet found consideration by any of the international classification systems of diseases. PGAD is commonly characterized by persistent and unwanted sensations of genital arousal which are not related to subjective feelings of sexual desire or arousal. Affected patients which are predominantly women can suffer tremendously. The lack of basic research on the etiology of PGAD leads to insufficient therapeutical approaches.
详细描述
The entire approach is of multimodal and explorative nature as only very limited information on this disease is available so far (hypotheses generating). Moreover, the aim of the study is to characterize PGAD patients in terms of their biography (e.g. trauma), comorbidities and life quality.
Clinical assessment:
- Psychological/psychiatric examination
- Neurological examination
- Gynecological/urological examination
- Laboratory assessment
- Structural and Functional Magnetic Resonance Imaging
General Hypotheses:
- There is a morphological correlate of PGAD that affects or represents a neuronal structure leading to altered perception of genital sensation (e.g. Tarlov cysts, varices, ...).
- There is a functional correlate of PGAD in the central nervous system (CNS) indicating a hyperfunction (excitation or disinhibition) or hypofunction (inhibition) of specific brain areas including hypothalamus, sensory cortex of the genitals and secondary brain areas, brain stem centers (e.g. raphe nuclei) and others.
- Patients with PGAD show an elevated rate of previous pharmacological treatment with drugs that may alter the central processing of sexual/genital perception or reveal a specific pattern of comorbid diseases (e.g. affective or somatoform disorders) that may predispose other disorders such as PGAD, pain disorders etc.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •female and male subjects
- •must be between 18-65 years of age
- •must fulfill the diagnostic criteria of persistent genital arousal disorder (PGAD) according to Leiblum & Nathan (2001)
- •controls must be healthy and matched in accordance with age and education.
排除标准
- •any exclusion criteria for magnetic resonance imaging
- •mental retardation
- •severe somatic or mental disease such as acute psychosis, brain damage, Alzheimer disease
- •severe bacterial infection requiring immediate medical treatment.
结局指标
主要结局
Questionnaires: Psychological/Psychiatric, neurological and gynecological/urological assessments
时间窗: Data collection and avaluation through study completion. Data collection (examinations) will take 1 day (max 2) per subject. Data evaluation of all collected data will take about 1 year.
Assessing sexual function (e.g. SIS/SES), depression and anxiety (HADS), childhood trauma (CTQ) and life quality (WHOQOL-BREF). In a semi-structured interview sociodemographic data, drug history and sexual characteristics are captured.
Laboratory assessments (blood samples)
时间窗: Data collection and avaluation through study completion. Data collection (examinations) will take 1 day (max 2) per subject. Data evaluation of all collected data will take about 1 year.
Blood sample will be analyzed to evaluate (epi-)genetic markers of increased central excitability or decreased inhibition including specific parameters of the serotonin-, dopamine- and endocannabinoid system
General outcome and target: Identification of clinical and neurobiological correlates of persistent genital arousal (PGAD)
时间窗: Data collection and avaluation through study completion. Data collection (examinations) will take 1 day (max 2) per subject. Data evaluation of all collected data will take about 1 year. Publication of findings will be an ongoing process afterwards.
1. gather a deeper clinical, (neuro)psychological and (neuro)biological understanding of PGAD 2. help to identify related etiopathological mechanisms of PGAD 3. inform clinicians and (sex) therapists on diagnostic issues and promising treatment targets in PGAD derived from comprehensive clinical and experimental measures 4. stimulate further neurobiological and clinical research in the field of PGAD, leading to further national and international cooperation and applications 5. publish a considerable number of publications in leading scientific journals and raise awareness of a rare disease not only among all clinicians dealing with sexual problems but also general practioners and others.
Clinical examinations: Psychological/Psychiatric, neurological and gynecological/urological assessments
时间窗: Data collection and avaluation through study completion. Data collection (examinations) will take 1 day (max 2) per subject. Data evaluation of all collected data will take about 1 year.
1. Neuro)psychological assessment using standardized clinical interviews (e.g. MINI, SOMS). 2. Neurological examination: Standardized clinical neurological examination as well as neurophysiological measurements will be conducted (Pudenus-SEP, ENoG, clinical EEG). 3. Gynecological/urological examination: Standard clinical investigation including ultrasound of the genital organs will be conducted to look for any somatic pathology (e.g. varices, tumors).
Clinical and experimental imaging (MRI, fMRI)
时间窗: Data collection and avaluation through study completion. Data collection (examinations) will take 1 day (max 2) per subject. Data evaluation of all collected data will take about 1 year.
1. Structural MRI of the pelvis is conducted to rule out any anatomical pathologies underlying PGAD (e.g. varices). 2. Structural MRI of the lumbosacral spinal cord to look for any pathologies on the spinal level (esp. spinal level S2-4 (e.g. Tarlov cysts)). 3. High-resolution structural MRI (T1) including brain stem will be applied to all participants in order to explore alterations in gray matter volume or density. 4. Structural differences in white matter will be assessed using a high-resolution DTI sequence. In addition to standard voxel-wise comparison of DTI derived parameters for white matter microstructural integrity, a tractography-based analysis will test for alterations in structural connectivity. 5. Resting-state functional MRI including brain stem scans will evaluate abnormal brain circuitry at rest (resting-state functional connectivity, RSFC). 6. Functional MRI to assess brain response towards sexual cue reactivity.
次要结局
未报告次要终点