Restless Genital SyndromeiPGADNCT04566783
Identification of Etiopathological and Clinical Factors in Persistent Genital Arousal Disorder
An observational study of Restless Genital Syndrome and Sexual Arousal Disorder, run by Hannover Medical School at 1 site in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Restless Genital Syndrome, Sexual Arousal Disorder, Orgasmic Disorder
- What is being tested?
- Psychological/psychiatric examination, Neurological examination and Gynecological/urological examination
- How many people
- 52 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2020to 1 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * female and male patients or subjects between 18-65 years of age fulfilling the diagnostic criteria of persistent genital arousal disorder (PGAD) according to Leiblum \& Nathan (2001). * additionally, age and education matched healthy controls.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of Etiopathological and Clinical Factors in Persistent Genital Arousal Disorder: The iPGAD-Study
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.
Read the detailed description
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.
Expected results and exploitation:
The proposed project will help to identify clinical and neurobiological correlates of persistent genital arousal (PGAD) and will provide
- a deeper clinical, (neuro)psychological and (neuro)biological understanding of PGAD
- help to identify related etiopathological mechanisms of PGAD
- inform clinicians and (sex) therapists on diagnostic issues and promising treatment targets in PGAD derived from comprehensive clinical and experimental measures
- stimulate further neurobiological and clinical research in the field of PGAD, leading to further national and international cooperation and applications
- 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 practitioners and others.
Objective(s):
Investigation of (possible etiological) factors associated with PGAD symptomatology as well as description of comorbid disorders subjects with PGAD.
Statistical Analysis:
Clinical (psychological, neurological and gynecological/urological) data is analyzed using a descriptive approach of frequencies and mean values of diverse clinical findings as well as a group comparison (patients versus healthy controls) using respective statistical analyses such as ttests, chi-square test and others after having tested for normal distribution where necessary. MRT data is analyzed using state-of-the-art special software (SPM) including group comparisons.
Sample Size Justification:
This is a cross-sectional study of a rare disease. At MHH usually 10 new patients occur per year. The investigator tries to include as many patients as possible and will probably achieve higher numbers by advertising the study and using data banks of already existing cases. Due to the presumably rare number of people affected with PGAD and the very few existing publications which are mostly case reports and the even fewer PGAD related MRI data a statistically neat sample size computing is not simple. The investigator cannot refer to prior carried out PGAD related MRI studies and to publications mentioning PGAD sample sizes. However, for MRI studies methodological work investigating the reliability of statistical effect in fMRI studies exist. An article by Thirion in 2007 shows that a sample size between 20 and 30 subjects per group is sufficient to detect statistical effects. This is also in accordance with common practice in fMRI aiming at at least 20 subject per group at which results become quite stable (Murphy \& Garavan 2004) Thus, the investigator aims at a sample size of 25 subjects per group. To account for potential dropouts (~10%, mainly due to excessive head movement in the MRI scanner) it is planned to include approximately 30 subjects per group.
Discussion of Perceived / Expected Risks and Benefits:
When considering all exclusion criteria for MRI there are no risks known for using a magnetic resonance imaging system. Clinical and (neuro)psychological testing might be perceived stressful by some participants and therefore may lead to a temporary increase in blood pressure and/or heart rate that will normally end after testing. Clinical examination (neurological and gynecological/urological) might lead to discomfort in some participants. Besides the neurological examination which can result in uncomfortable feelings (e.g. minor pain) during the ENoG-testing and Pudendus-SEP and that will normally end immediately after testing the clinical examination is pain-free. Blood Sampling might be painful and lead to hematoma. The amount of blood is low (approx. 30ml). Any serious damage to the organism during clinical examination and blood sampling is very unlikely.
- Conditions
- Restless Genital Syndrome, Sexual Arousal Disorder, Orgasmic Disorder, Psychosexual Disorder
- Being tested
- Psychological/psychiatric examination, Neurological examination, Gynecological/urological examination, Laboratory assessment, Structural and Functional Magnetic Resonance Imaging
- Keywords
- Persistant Genital Arousal Disorder, PGAD
- Medical subject headings
- Sexual Dysfunctions, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological/psychiatric examinationDiagnostic test
Thorough diagnostic and (neuro)psychological assessment using standardized clinical interviews (e.g. MINI, SOMS) as well as questionnaires 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.
Neurological examinationDiagnostic test
Standardized clinical neurological examination as well as neurophysiological measurements (Pudenus-SEP, ENoG, clinical EEG).
Gynecological/urological examinationDiagnostic test
Standard clinical investigation including ultrasound of the genital organs will be conducted to look for any somatic pathology (e.g. varices, tumors).
Laboratory assessmentDiagnostic test
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.
Structural and Functional Magnetic Resonance ImagingDiagnostic test
- Structural MRI of the pelvis is conducted to rule out any anatomical pathologies underlying PGAD (e.g. varices).
- Structural MRI of the lumbosacral spinal cord to look for any pathologies on the spinal level, especially spinal level S2-4 (e.g. Tarlov cysts).
- 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.
- 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.
- Resting-state functional MRI including brain stem scans will evaluate abnormal brain circuitry at rest (resting-state functional connectivity, RSFC).
- Functional MRI to assess brain response towards sexual cue reactivity.
| Study group | Role | What they receive |
|---|---|---|
| Women and men fulfilling PGAD-criteria | Inclusion criteria:
- Female and male patients or subjects between 18-65 years of age fulfilling the diagnostic criteria of persistent genital arousal disorder (PGAD) according to Leiblum \& Nathan (2001).
Exclusion criteria:
- Any exclusion criteria for magnetic resonance imaging (MRI), mental retardation, severe and acute somatic or mental disease such as acute psychosis, brain damage, Alzheimer's disease, severe bacterial infection requiring immediate medical treatment.
Age:
- 18 - 65 years of age
Gender:
- Female and male subjects Receives: Diagnostic Test: Psychological/psychiatric examination; Diagnostic Test: Neurological examination; Diagnostic Test: Gynecological/urological examination; Diagnostic Test: Laboratory assessment; Diagnostic Test: Structural and Functional Magnetic Resonance Imaging | |
| Controls | Inclusion criteria:
- Age and education matched healthy controls. Receives: Diagnostic Test: Psychological/psychiatric examination; Diagnostic Test: Neurological examination; Diagnostic Test: Gynecological/urological examination; Diagnostic Test: Laboratory assessment; Diagnostic Test: Structural and Functional Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
General outcome and target: Identification of clinical and neurobiological correlates of persistent genital arousal (PGAD)
- gather a deeper clinical, (neuro)psychological and (neuro)biological understanding of PGAD
- help to identify related etiopathological mechanisms of PGAD
- inform clinicians and (sex) therapists on diagnostic issues and promising treatment targets in PGAD derived from comprehensive clinical and experimental measures
- stimulate further neurobiological and clinical research in the field of PGAD, leading to further national and international cooperation and applications
- 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.
Measured: 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.
Questionnaires: Psychological/Psychiatric, neurological and gynecological/urological assessments
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.
Measured: 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.
Clinical examinations: Psychological/Psychiatric, neurological and gynecological/urological assessments
- Neuro)psychological assessment using standardized clinical interviews (e.g. MINI, SOMS).
- Neurological examination: Standardized clinical neurological examination as well as neurophysiological measurements will be conducted (Pudenus-SEP, ENoG, clinical EEG).
- 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).
Measured: 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.
Clinical and experimental imaging (MRI, fMRI)
- Structural MRI of the pelvis is conducted to rule out any anatomical pathologies underlying PGAD (e.g. varices).
- 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)).
- 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.
- 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.
- Resting-state functional MRI including brain stem scans will evaluate abnormal brain circuitry at rest (resting-state functional connectivity, RSFC).
- Functional MRI to assess brain response towards sexual cue reactivity.
Measured: 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.
Laboratory assessments (blood samples)
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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start1 Jun 2020
- Primary completion30 Aug 2021
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Restless Genital SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tillmann Prof. Krüger, MD, Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04566783
- Sponsor's protocol ID
- 8589_BO_S_2019
- Acronym
- iPGAD
- Status last verified
- Mar 2023
- First submitted
- 9 Jun 2020
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Leiblum SR, Nathan SG. Persistent sexual arousal syndrome: a newly discovered pattern of female sexuality. J Sex Marital Ther. 2001 Jul-Sep;27(4):365-80. doi: 10.1080/009262301317081115.
PubMed 11441520
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Etiopathological and Clinical Factors in Persistent Genital Arousal Disorder: The iPGAD-Study
- ClinicalTrials.gov ID
- NCT04566783
- Acronym / sponsor ID
- iPGAD / 8589_BO_S_2019
- Conditions
- Restless Genital Syndrome, Sexual Arousal Disorder, Orgasmic Disorder, Psychosexual Disorder
- Keywords
- Persistant Genital Arousal Disorder, PGAD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 28 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Expected results and exploitation:
The proposed project will help to identify clinical and neurobiological correlates of persistent genital arousal (PGAD) and will provide
- a deeper clinical, (neuro)psychological and (neuro)biological understanding of PGAD
- help to identify related etiopathological mechanisms of PGAD
- inform clinicians and (sex) therapists on diagnostic issues and promising treatment targets in PGAD derived from comprehensive clinical and experimental measures
- stimulate further neurobiological and clinical research in the field of PGAD, leading to further national and international cooperation and applications
- 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 practitioners and others.
Objective(s):
Investigation of (possible etiological) factors associated with PGAD symptomatology as well as description of comorbid disorders subjects with PGAD.
Statistical Analysis:
Clinical (psychological, neurological and gynecological/urological) data is analyzed using a descriptive approach of frequencies and mean values of diverse clinical findings as well as a group comparison (patients versus healthy controls) using respective statistical analyses such as ttests, chi-square test and others after having tested for normal distribution where necessary. MRT data is analyzed using state-of-the-art special software (SPM) including group comparisons.
Sample Size Justification:
This is a cross-sectional study of a rare disease. At MHH usually 10 new patients occur per year. The investigator tries to include as many patients as possible and will probably achieve higher numbers by advertising the study and using data banks of already existing cases. Due to the presumably rare number of people affected with PGAD and the very few existing publications which are mostly case reports and the even fewer PGAD related MRI data a statistically neat sample size computing is not simple. The investigator cannot refer to prior carried out PGAD related MRI studies and to publications mentioning PGAD sample sizes. However, for MRI studies methodological work investigating the reliability of statistical effect in fMRI studies exist. An article by Thirion in 2007 shows that a sample size between 20 and 30 subjects per group is sufficient to detect statistical effects. This is also in accordance with common practice in fMRI aiming at at least 20 subject per group at which results become quite stable (Murphy \& Garavan 2004) Thus, the investigator aims at a sample size of 25 subjects per group. To account for potential dropouts (~10%, mainly due to excessive head movement in the MRI scanner) it is planned to include approximately 30 subjects per group.
Discussion of Perceived / Expected Risks and Benefits:
When considering all exclusion criteria for MRI there are no risks known for using a magnetic resonance imaging system. Clinical and (neuro)psychological testing might be perceived stressful by some participants and therefore may lead to a temporary increase in blood pressure and/or heart rate that will normally end after testing. Clinical examination (neurological and gynecological/urological) might lead to discomfort in some participants. Besides the neurological examination which can result in uncomfortable feelings (e.g. minor pain) during the ENoG-testing and Pudendus-SEP and that will normally end immediately after testing the clinical examination is pain-free. Blood Sampling might be painful and lead to hematoma. The amount of blood is low (approx. 30ml). Any serious damage to the organism during clinical examination and blood sampling is very unlikely.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women and men fulfilling PGAD-criteria | – | Diagnostic Test: Psychological/psychiatric examination, Diagnostic Test: Neurological examination, Diagnostic Test: Gynecological/urological examination, Diagnostic Test: Laboratory assessment, Diagnostic Test: Structural and Functional Magnetic Resonance ImagingInclusion criteria: - Female and male patients or subjects between 18-65 years of age fulfilling the diagnostic criteria of persistent genital arousal disorder (PGAD) according to Leiblum \& Nathan (2001). Exclusion criteria: - Any exclusion criteria for magnetic resonance imaging (MRI), mental retardation, severe and acute somatic or mental disease such as acute psychosis, brain damage, Alzheimer's disease, severe bacterial infection requiring immediate medical treatment. Age: - 18 - 65 years of age Gender: - Female and male subjects |
| Controls | – | Diagnostic Test: Psychological/psychiatric examination, Diagnostic Test: Neurological examination, Diagnostic Test: Gynecological/urological examination, Diagnostic Test: Laboratory assessment, Diagnostic Test: Structural and Functional Magnetic Resonance ImagingInclusion criteria: - Age and education matched healthy controls. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * female and male patients or subjects between 18-65 years of age fulfilling the diagnostic criteria of persistent genital arousal disorder (PGAD) according to Leiblum \& Nathan (2001). * additionally, age and education matched healthy controls.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological/psychiatric examinationThorough diagnostic and (neuro)psychological assessment using standardized clinical interviews (e.g. MINI, SOMS) as well as questionnaires 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. | Diagnostic test | Controls, Women and men fulfilling PGAD-criteria |
| Neurological examinationStandardized clinical neurological examination as well as neurophysiological measurements (Pudenus-SEP, ENoG, clinical EEG). | Diagnostic test | Controls, Women and men fulfilling PGAD-criteria |
| Gynecological/urological examinationStandard clinical investigation including ultrasound of the genital organs will be conducted to look for any somatic pathology (e.g. varices, tumors). | Diagnostic test | Controls, Women and men fulfilling PGAD-criteria |
| Laboratory assessmentBlood 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. | Diagnostic test | Controls, Women and men fulfilling PGAD-criteria |
| Structural and Functional Magnetic Resonance Imaging1. 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, especially 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. | Diagnostic test | Controls, Women and men fulfilling PGAD-criteria |
Primary outcome
General outcome and target: Identification of clinical and neurobiological correlates of persistent genital arousal (PGAD)
Time frame: 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.
Questionnaires: Psychological/Psychiatric, neurological and gynecological/urological assessments
Time frame: 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.
Clinical examinations: Psychological/Psychiatric, neurological and gynecological/urological assessments
Time frame: 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)
Time frame: 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.
Laboratory assessments (blood samples)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Background: PubMed 11441520Leiblum SR, Nathan SG. Persistent sexual arousal syndrome: a newly discovered pattern of female sexuality. J Sex Marital Ther. 2001 Jul-Sep;27(4):365-80. doi: 10.1080/009262301317081115.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tillmann Prof. Krüger, MD principal investigator
Hannover Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Restless Genital Syndrome and Sexual Arousal Disorder, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General outcome and target: Identification of clinical and neurobiological correlates of persistent genital arousal (PGAD) (time frame: 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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04566783, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.