Data CollectionNCT03267472
Pattern of Genitourinary Fistula in Upper Egypt
An observational study of Data Collection, run by Assiut University.
Trial summary
the pattern of genitourinary fistula in upper egypt Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Data Collection
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2017to 20 Oct 2017
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: A genitourinary fistula is defined as an abnormal communication between the urinary (ureters, bladder, urethra) and the genital (uterus, cervix, vagina) systems. The true incidence of genitourinary fistula is unknown. Uro-genital fistulas are a great challenge for women in developing countries. The new classification of genitourinary fistula divides genitourinary fistulae into four main types, depending on the distance of the distal edge of the fistula from the external urinary meatus.
Who may be able to join
- any female with genitourinary fistula
Who cannot join
- no
About this study
Official title: the Genitourinary Fistula Experience in Upper Egypt
the pattern of genitourinary fistula in upper egypt
Read the detailed description
A genitourinary fistula is defined as an abnormal communication between the urinary (ureters, bladder, urethra) and the genital (uterus, cervix, vagina) systems.
The true incidence of genitourinary fistula is unknown. Uro-genital fistulas are a great challenge for women in developing countries.
The new classification of genitourinary fistula divides genitourinary fistulae into four main types, depending on the distance of the distal edge of the fistula from the external urinary meatus. These four types are further subclassified by the size of the fistula, extent of associated scarring, vaginal length or special considerations:
Type 1: Distal edge of fistula > 3.5 cm from external urinary meatus Type 2: Distal edge of fistula 2.5-3.5 cm from external urinary meatus Type 3: Distal edge of fistula 1.5 - < 2.5 cm from external urinary meatus
- Conditions
- Data Collection
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of genitourinary fistula in upper egypt
to detect how many numbers of cases of genitourinary fistula in upper egypt .
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start20 Oct 2017 (estimated)
- Primary completion20 Oct 2017 (estimated)
- Study completion20 Oct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Data CollectionStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AHMED FARAHAT HASSAN, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03267472
- Sponsor's protocol ID
- genitourinary fistula
- Status last verified
- Aug 2017
- First submitted
- 29 Aug 2017
- Last updated
- 8 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Genitourinary Fistula Experience in Upper Egypt
- ClinicalTrials.gov ID
- NCT03267472
- Acronym / sponsor ID
- genitourinary fistula
- Conditions
- Data Collection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Oct 2017 (estimated)
- Primary completion
- 20 Oct 2017 (estimated)
- Study completion
- 20 Oct 2017 (estimated)
- First posted
- 30 Aug 2017 (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.
the pattern of genitourinary fistula in upper egypt
Detailed description
A genitourinary fistula is defined as an abnormal communication between the urinary (ureters, bladder, urethra) and the genital (uterus, cervix, vagina) systems.
The true incidence of genitourinary fistula is unknown. Uro-genital fistulas are a great challenge for women in developing countries.
The new classification of genitourinary fistula divides genitourinary fistulae into four main types, depending on the distance of the distal edge of the fistula from the external urinary meatus. These four types are further subclassified by the size of the fistula, extent of associated scarring, vaginal length or special considerations:
Type 1: Distal edge of fistula > 3.5 cm from external urinary meatus Type 2: Distal edge of fistula 2.5-3.5 cm from external urinary meatus Type 3: Distal edge of fistula 1.5 - < 2.5 cm from external urinary meatus
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A genitourinary fistula is defined as an abnormal communication between the urinary (ureters, bladder, urethra) and the genital (uterus, cervix, vagina) systems. The true incidence of genitourinary fistula is unknown. Uro-genital fistulas are a great challenge for women in developing countries. The new classification of genitourinary fistula divides genitourinary fistulae into four main types, depending on the distance of the distal edge of the fistula from the external urinary meatus.
Key inclusion criteria (1 listed)
- any female with genitourinary fistula
Key exclusion criteria (1 listed)
- no
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prevalence of genitourinary fistula in upper egypt
Time frame: 5 years
to detect how many numbers of cases of genitourinary fistula in upper egypt .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2017.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Data Collection, run by Assiut University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
prevalence of genitourinary fistula in upper egypt (time frame: 5 years). 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 8 Sep 2017; AzTrials last refreshed its copy on 30 Oct 2026.