VirginityNCT04858919
Transrectal and 3D Transabdominal Ultrasound Compared to Vaginoscopy in Diagnosing Virgins With Genital Lesions
A study testing 3D transabdominal ultrasound, transrectal ultrasound and vaginoscopy in people with Virginity and Genital Diseases, Female, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study is to compare the feasibility and test performance of different 3D pelvic ultrasound and Transrectal ultrasound in the detection of local lesions in the uterus , cervix and vagina compared to the final diagnosis confirmed by vaginoscopy as a golden standard modality of diagnosis in Virgin Patients Read more about this study
- Who is it for?
- Ages 5 to 55 years, women only
- Conditions the study is for
- Virginity, Genital Diseases, Female, Diagnoses Disease
- What is being tested?
- 3D transabdominal ultrasound, transrectal ultrasound and vaginoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2019to 1 Apr 2021
- Phase
- Interventional
- 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 5 to 55 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Virgins complaining of Abnormal vaginal bleeding, abnormal discharge , pelvic pain
- Virgins with Suspected genital tract lesion by examination
- Virgins with Suspected genital tract lesion by pelvic ultrasound
Who cannot join
- Sexually Active Patients
- Suspected or documented Pregnancy
- Virgin patients with no suspected uterine, cervical or vaginal lesion by pelvic ultrasound
- Patients unable to communicate effectively
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transrectal Ultrasound and 3D Transabdominal Ultrasound in Comparison to Vaginoscopy in Virgins With Suspected Genital Tract Lesions
This study is to compare the feasibility and test performance of different 3D pelvic ultrasound and Transrectal ultrasound in the detection of local lesions in the uterus , cervix and vagina compared to the final diagnosis confirmed by vaginoscopy as a golden standard modality of diagnosis in Virgin Patients
Read the detailed description
Virginity is a very private issue; saving or losing it is a matter of choice depending on age, ethnicity, religion, or simply personal decision. Post-pubertal teenage girls, religious women such as nuns, and women in some countries tend to be virgin. This situation must be respected by medical professionals. But when a vaginal examination is necessary, virginity might be a limiting factor for the gynecologist in diagnosis and treatment.
Vaginal discharge or bleeding is the symptom most commonly reported by adolescent girls that are referred for gynecologic problems. The most common cause of vaginal discharge at these ages is infection due to a hypo-estrogenized vagina, although other potential causes, such as congenital anomalies of the genitalia, trauma, foreign bodies, sexual abuse, and malignant disease, must also be excluded. With regard to virginity and childbearing possibility in the future, a careful approach is of paramount importance.
Hymenal tissue does not easily tolerate vigorous manipulation and wide movements. When needed, potential hymeneal disruption may be discussed with mature women or with the parents of adolescent girls for the sake of correct diagnosis and treatment; but in general, they are highly resistant to that.
When a reproductive tract examination or transvaginal operation must be arranged for a virgin, the operator faces a challenge and may hesitate to utilize hysteroscopy, which can result in a delayed diagnosis or improper treatment.
The most common indication for hysteroscopy is abnormal vaginal bleeding in virginal patients and has been widely used for uterine cavity examination and management. Although the possibility of hymen preservation is high, virgins are highly resistant to this procedure. This may be due to a belief that the procedure causes disruption of virginity and worries associated with their future partners.
The approach by vaginoscopy and hysteroscopy via a hysteroscope provides a safe and non-traumatic method in assessing the reproductive organs because the scope of the hysteroscope is advanced into the vagina without a speculum or tenaculum. Distension of the vaginal wall by distension medium can in turn provide a clear endoscopic view.
These considerations have made clinicians opt for these procedures in assessing pathologies of the vagina, the surface of the cervix, the cervical canal, and the intrauterine cavity and other developmental anomalies of the sex organs in patients. Furthermore, the entire procedure can be undertaken without disrupting integrity of the hymen, whereas the traditional method requires the use of retractors and, therefore, disrupts this integrity.
Although hysteroscopy can improve diagnosis and thereby improve quality of life, virgins may decline this procedure. Patients with delayed diagnosis and management in some uncommon but serious situations, such as endometrial malignancy, are life-threatening.
So far, only a few reports have discussed the protection of hymen integrity in hysteroscopy, and the physical and psychological impacts of this surgery in virgins are not conclusive .This is an important issue that gynecologists encounter, but which has seldom been discussed. Intravenous sedation is recommended to reduce the patient's anxiety and pain, avoid vasovagal reaction, relax the buttock muscles and reduce the risk of hymenal trauma . Unlike operative hysteroscope, loop electrode cannot be employed in mini-hysteroscope; therefore, for some diseases like submucous leiomyoma or uterine septum, mini-hysteroscopy is not therapeutically beneficial, and this should be explained to the patients in advance. Adequate preoperative counseling is also necessary to emphasize the importance of the procedure and to lessen their anxiety.
In virgin patients when vaginal examination cannot be done ultrasonography is a useful adjunct to inspection of the external genital organs.
Currently there are three accepted and more or less widely used modalities to image the contents of the female pelvis. Transabdominal sonography (TAS) was the first to be used and is still the most widespread.
By using a full urinary bladder as an acoustic window, ovaries, uterus, and superior vagina can be clearly examined using transabdominal (TA) ultrasonography.
Transvaginal sonography provides clear images of the region of interest, provided that the targeted organ is within the focal range of the probe, and that the probe is placed in proximity to the organ in question .
Agenesis of the vagina, a virginal introitus and the fear of introducing infection such as in the case of premature rupture of the membranes are some of the more common situations in which Transvaginal ultrasound is not possible or is relatively contraindicated.
In such cases introducing a commercially available vaginal probe through the anal sphincter into the rectum seems to be a reasonable alternative to image the female pelvic structures within 'reach' of the probe. We present a study to compare TAS and transrectal sonography (TRS) in a group of patients in whom Transvaginal ultrasound was not possible.
Transrectal sonography (TRUS) has been widely used in men as a diagnostic tool for prostate cancer. Its value in the management of disorders of the lower urinary tract in women and as an alternative to intraoperative gynecologic sonography has also been documented . Case reports in the radiological literature attest to the fact that it has been used to guide drainage of inflammatory pelvic collections.
- Conditions
- Virginity, Genital Diseases, Female, Diagnoses Disease
- Being tested
- 3D transabdominal ultrasound, transrectal ultrasound, vaginoscopy
- Medical subject headings
- Sexual Abstinence, Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D transabdominal ultrasoundDiagnostic test
Initially 3D pelvic ultrasound will be performed on all patients. The transabdominal probes used will be those of the ultrasound scanner using a convex probe (multiple frequency 1-6 MHz).
transrectal ultrasoundDiagnostic test
The vaginal probe will be covered with the customary plastic sheath and richly lubricated with lubricating gel. The probe will then be slowly advanced into the rectum. The transvaginal probes used will be those of the ultrasound scanner using a vaginal probe (multiple frequency 1-8 MHz). The scanning technique will be similar to that of Transvaginal ultrasound.
vaginoscopyDiagnostic test
It is the final procedure in the study to reach the accurate diagnosis. A rigid hysteroscope will be used. The sheath has a 5-mm outer diameter, with 2.9 mm rod lens. A high intensity light source and fiberoptic cable will be used to illuminate the uterine cavity. A solution of 0.9% normal saline will be used as the distention medium. The pressure will be kept at 100-120 mmHg using a pressure adjustable cuff system with the aim of maintaining the lowest pressure required to distend the uterine cavity.
| Study group | Role | What they receive |
|---|---|---|
| study group | Other | virgins with genital tract lesion Receives: Diagnostic Test: 3D transabdominal ultrasound; Diagnostic Test: transrectal ultrasound; Diagnostic Test: vaginoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of different diagnostic modalities in Virgins.
By questionnaire to asses the acceptance of patient to undergo different modalities as 3D pelvic ultrasound, Transrectal ultrasound and vaginoscopy is assessed.
Measured: 1 to 2 hours
Test performance of different diagnostic modalities in Virgins
diagnostic accuracy of 3D pelvic ultrasound and Transrectal ultrasound in the detection of local lesions in the uterus, cervix and vagina compared to the final diagnosis confirmed by vaginoscopy as a golden standard modality of diagnosis in Virgins.
Measured: 24 hours to 1 week
Secondary outcomes (2)
Patients' satisfaction
Visual Analogue Scale will be used for grading levels of patients' overall satisfaction by giving a range of potential scores (0-10) with a score 0 reflecting greatest satisfaction
Measured: 1-2 hours
patients' pain
Visual Analogue Scale will be used for grading levels of patients' pain by giving a range of potential scores (0-10) with a score 0 reflecting least discomfort
Measured: 1-2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start1 Jun 2019
- Primary completion1 Mar 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VirginityStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A diagnostic test accuracy study that will be conducted at Ain-Shams University Maternity Hospital ,the patients will be recruited from women admitted from gynecologic clinic or from emergency room and from patients following up in outpatient clinic patients will be recruited to this study All Patients recruited must have suspected uterine, cervical or vaginal lesion by history, examination and Pelvic ultrasound
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04858919
- Sponsor's protocol ID
- vaginoscope
- Status last verified
- Apr 2021
- First submitted
- 13 Apr 2021
- Last updated
- 26 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transrectal Ultrasound and 3D Transabdominal Ultrasound in Comparison to Vaginoscopy in Virgins With Suspected Genital Tract Lesions
- ClinicalTrials.gov ID
- NCT04858919
- Acronym / sponsor ID
- vaginoscope
- Conditions
- Virginity, Genital Diseases, Female, Diagnoses Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 26 Apr 2021 (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.
This study is to compare the feasibility and test performance of different 3D pelvic ultrasound and Transrectal ultrasound in the detection of local lesions in the uterus , cervix and vagina compared to the final diagnosis confirmed by vaginoscopy as a golden standard modality of diagnosis in Virgin Patients
Detailed description
Virginity is a very private issue; saving or losing it is a matter of choice depending on age, ethnicity, religion, or simply personal decision. Post-pubertal teenage girls, religious women such as nuns, and women in some countries tend to be virgin. This situation must be respected by medical professionals. But when a vaginal examination is necessary, virginity might be a limiting factor for the gynecologist in diagnosis and treatment.
Vaginal discharge or bleeding is the symptom most commonly reported by adolescent girls that are referred for gynecologic problems. The most common cause of vaginal discharge at these ages is infection due to a hypo-estrogenized vagina, although other potential causes, such as congenital anomalies of the genitalia, trauma, foreign bodies, sexual abuse, and malignant disease, must also be excluded. With regard to virginity and childbearing possibility in the future, a careful approach is of paramount importance.
Hymenal tissue does not easily tolerate vigorous manipulation and wide movements. When needed, potential hymeneal disruption may be discussed with mature women or with the parents of adolescent girls for the sake of correct diagnosis and treatment; but in general, they are highly resistant to that.
When a reproductive tract examination or transvaginal operation must be arranged for a virgin, the operator faces a challenge and may hesitate to utilize hysteroscopy, which can result in a delayed diagnosis or improper treatment.
The most common indication for hysteroscopy is abnormal vaginal bleeding in virginal patients and has been widely used for uterine cavity examination and management. Although the possibility of hymen preservation is high, virgins are highly resistant to this procedure. This may be due to a belief that the procedure causes disruption of virginity and worries associated with their future partners.
The approach by vaginoscopy and hysteroscopy via a hysteroscope provides a safe and non-traumatic method in assessing the reproductive organs because the scope of the hysteroscope is advanced into the vagina without a speculum or tenaculum. Distension of the vaginal wall by distension medium can in turn provide a clear endoscopic view.
These considerations have made clinicians opt for these procedures in assessing pathologies of the vagina, the surface of the cervix, the cervical canal, and the intrauterine cavity and other developmental anomalies of the sex organs in patients. Furthermore, the entire procedure can be undertaken without disrupting integrity of the hymen, whereas the traditional method requires the use of retractors and, therefore, disrupts this integrity.
Although hysteroscopy can improve diagnosis and thereby improve quality of life, virgins may decline this procedure. Patients with delayed diagnosis and management in some uncommon but serious situations, such as endometrial malignancy, are life-threatening.
So far, only a few reports have discussed the protection of hymen integrity in hysteroscopy, and the physical and psychological impacts of this surgery in virgins are not conclusive .This is an important issue that gynecologists encounter, but which has seldom been discussed. Intravenous sedation is recommended to reduce the patient's anxiety and pain, avoid vasovagal reaction, relax the buttock muscles and reduce the risk of hymenal trauma . Unlike operative hysteroscope, loop electrode cannot be employed in mini-hysteroscope; therefore, for some diseases like submucous leiomyoma or uterine septum, mini-hysteroscopy is not therapeutically beneficial, and this should be explained to the patients in advance. Adequate preoperative counseling is also necessary to emphasize the importance of the procedure and to lessen their anxiety.
In virgin patients when vaginal examination cannot be done ultrasonography is a useful adjunct to inspection of the external genital organs.
Currently there are three accepted and more or less widely used modalities to image the contents of the female pelvis. Transabdominal sonography (TAS) was the first to be used and is still the most widespread.
By using a full urinary bladder as an acoustic window, ovaries, uterus, and superior vagina can be clearly examined using transabdominal (TA) ultrasonography.
Transvaginal sonography provides clear images of the region of interest, provided that the targeted organ is within the focal range of the probe, and that the probe is placed in proximity to the organ in question .
Agenesis of the vagina, a virginal introitus and the fear of introducing infection such as in the case of premature rupture of the membranes are some of the more common situations in which Transvaginal ultrasound is not possible or is relatively contraindicated.
In such cases introducing a commercially available vaginal probe through the anal sphincter into the rectum seems to be a reasonable alternative to image the female pelvic structures within 'reach' of the probe. We present a study to compare TAS and transrectal sonography (TRS) in a group of patients in whom Transvaginal ultrasound was not possible.
Transrectal sonography (TRUS) has been widely used in men as a diagnostic tool for prostate cancer. Its value in the management of disorders of the lower urinary tract in women and as an alternative to intraoperative gynecologic sonography has also been documented . Case reports in the radiological literature attest to the fact that it has been used to guide drainage of inflammatory pelvic collections.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A diagnostic test accuracy study that will be conducted at Ain-Shams University Maternity Hospital ,the patients will be recruited from women admitted from gynecologic clinic or from emergency room and from patients following up in outpatient clinic patients will be recruited to this study All Patients recruited must have suspected uterine, cervical or vaginal lesion by history, examination and Pelvic ultrasound
| Arm | Type | Receives |
|---|---|---|
| study group | Other | Diagnostic Test: 3D transabdominal ultrasound, Diagnostic Test: transrectal ultrasound, Diagnostic Test: vaginoscopyvirgins with genital tract lesion |
Who may qualify
- Ages
- 5 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Virgins complaining of Abnormal vaginal bleeding, abnormal discharge , pelvic pain
- Virgins with Suspected genital tract lesion by examination
- Virgins with Suspected genital tract lesion by pelvic ultrasound
Key exclusion criteria (4 listed)
- Sexually Active Patients
- Suspected or documented Pregnancy
- Virgin patients with no suspected uterine, cervical or vaginal lesion by pelvic ultrasound
- Patients unable to communicate effectively
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 |
|---|---|---|
| 3D transabdominal ultrasoundInitially 3D pelvic ultrasound will be performed on all patients. The transabdominal probes used will be those of the ultrasound scanner using a convex probe (multiple frequency 1-6 MHz). | Diagnostic test | study group |
| transrectal ultrasoundThe vaginal probe will be covered with the customary plastic sheath and richly lubricated with lubricating gel. The probe will then be slowly advanced into the rectum. The transvaginal probes used will be those of the ultrasound scanner using a vaginal probe (multiple frequency 1-8 MHz). The scanning technique will be similar to that of Transvaginal ultrasound. | Diagnostic test | study group |
| vaginoscopyIt is the final procedure in the study to reach the accurate diagnosis. A rigid hysteroscope will be used. The sheath has a 5-mm outer diameter, with 2.9 mm rod lens. A high intensity light source and fiberoptic cable will be used to illuminate the uterine cavity. A solution of 0.9% normal saline will be used as the distention medium. The pressure will be kept at 100-120 mmHg using a pressure adjustable cuff system with the aim of maintaining the lowest pressure required to distend the uterine cavity. | Diagnostic test | study group |
Primary outcome
Feasibility of different diagnostic modalities in Virgins.
Time frame: 1 to 2 hours
By questionnaire to asses the acceptance of patient to undergo different modalities as 3D pelvic ultrasound, Transrectal ultrasound and vaginoscopy is assessed.
Test performance of different diagnostic modalities in Virgins
Time frame: 24 hours to 1 week
diagnostic accuracy of 3D pelvic ultrasound and Transrectal ultrasound in the detection of local lesions in the uterus, cervix and vagina compared to the final diagnosis confirmed by vaginoscopy as a golden standard modality of diagnosis in Virgins.
2 secondary outcomes
Patients' satisfaction
Time frame: 1-2 hours
patients' pain
Time frame: 1-2 hours
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 26 Apr 2021.
- Individual participant dataSharing planned: Yes
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D transabdominal ultrasound, transrectal ultrasound and vaginoscopy in people with Virginity and Genital Diseases, Female, run by Ain Shams University at 1 site in Egypt.
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 3 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 26 Apr 2021. 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 Egypt. 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?
Feasibility of different diagnostic modalities in Virgins. (time frame: 1 to 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Apr 2021.