Genitovesical FistulaNCT07043062
Laparoscopic Versus Open Surgical Repair of Genitovesical Fistula in Females
A study testing Open surgical Interference in people with Genitovesical Fistula, run by South Valley University at 1 site in Egypt.
Trial summary
Fistula is an abnormal passway that connects two organs or vessels that do not connect normally. Genitourinary fistula refers to a fistula that occurs between reproductive tract organs (vagina, cervix, and uterus), and lower urinary tract (bladder, urethra, and pelvic ureters). Read more about this study
- Who is it for?
- Ages 25 to 70 years, women only
- Conditions the study is for
- Genitovesical Fistula
- What is being tested?
- Open surgical Interference
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2024to 1 Aug 2025
- 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 25 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females with Vesicovaginal fistula or Vesicouterine fistula.
- Timing of repair after 2-6 months of beginning of symptoms and signs of fistula.
Who cannot join
- Malignant , Recurrant or Post Radiation Genitovesical fistula.
- Females with congenital disease in Bladder ,Uterus or Vagina.
- Females with Vaginal or Uterine prolapse.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
South Valley University Hospital
Qina
Mostafa AbdelRazek Ahmed, Assist.Prof, +201004116386, mostafa_uro@med.svu.edu.eg
About this study
Official title: Laparoscopic Versus Open Surgical Repair of Genitovesical Fistula in Females :ِ A Prospective Comparative Non Randomized Study
Fistula is an abnormal passway that connects two organs or vessels that do not connect normally.
Genitourinary fistula refers to a fistula that occurs between reproductive tract organs (vagina, cervix, and uterus), and lower urinary tract (bladder, urethra, and pelvic ureters).
It is a serious condition which can significantly influence the biological and psychological condition of women, with a negative impact on the quality of life.
Read the detailed description
Fistula is an abnormal passway that connects two organs or vessels that do not connect normally.
Genitourinary fistula refers to a fistula that occurs between reproductive tract organs (vagina, cervix, and uterus), and lower urinary tract (bladder, urethra, and pelvic ureters).
It is a serious condition which can significantly influence the biological and psychological condition of women, with a negative impact on the quality of life.
In developed countries, iatrogenic injury during hysterectomy or pelvic surgery is the primary cause of fistulae . However, the etiology differs in developing countries, being secondary to prolonged, obstructed, complicated labor.
Genitovesical fistulae are one of the most devastating complications in the urogynecology setting. The commonest type of these fistulae is the vesicovaginal fistula (VVF);the patients Suffering from continuous urinary leakage through the vagina and urinary smell, patients with VVF face hygienic, social, infectious, psychological, and sexual problems.
Vesicouterine fistulae (VUF) are not as common as VVF. In 1908, the first case was reported by Knipe , and later in 1957, Youssef reported on the classic symptoms of VUF. These symptoms included amenorrhea and cyclic hematuria, or menouria; known afterward as Youssef's syndrome. The prevalence of these fistulae is estimated to be 1-4% of all genitourinary fistulae.
Several options for the management of such fistulae have been discussed; these include conservative treatment with prolonged catheterization , open surgery, cysto-fulguration, endourology, and laparoscopy/robotic surgery. The decision-making is guided by the patient characteristics, etiology, and the experience of the treating surgeon.
Laparoscopy is of great advantage when compared to open surgery, including safe, effective, minimally invasive procedure, less postoperative pain, smaller incisions, lower blood loss, a shorter hospital stay, and faster recovery. It is associated with a lower incidence of postoperative complications, including infections and improper wound healing
- Conditions
- Genitovesical Fistula
- Being tested
- Open surgical Interference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open surgical InterferenceProcedure or surgery
Also called Laparoscopic Repair
to compare the outcomes of Laparoscopic repair versus Open surgical repair of Genitovesical fistula in females.
| Study group | Role | What they receive |
|---|---|---|
| Group of Laparoscopic Repair | Active comparator | About 25 female patients suffering from Vesicovaginal fistula or Vesicouterine fistula and will be subjected to Laparoscopic repair of the fistula Receives: Procedure: Open surgical Interference |
| Group of Open Surgical Repair | Active comparator | About 25 female patients suffering from Vesicovaginal fistula or Vesicouterine fistula and will be subjected to surgical repair of the fistula. Receives: Procedure: Open surgical Interference |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment of Genitourinary fistula
To examine the female patients whom suffering fromGenitourinary fistula, either by surgical interference or Laparoscopy
Measured: From base line to 2 Months from the starting of the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start1 Aug 2024
- Primary completion30 Jul 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genitovesical FistulaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hassan Elshazly Khodary, South Valley University
- Investigators
- Ahmed Aboalyosr Mohamed, Professor, Study chair, Urology Department, Faculty of Medicine, South Valley University, Qena, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07043062
- Sponsor's protocol ID
- Female Genitovesical fistula
- Status last verified
- Aug 2024
- First submitted
- 21 May 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Versus Open Surgical Repair of Genitovesical Fistula in Females :ِ A Prospective Comparative Non Randomized Study
- ClinicalTrials.gov ID
- NCT07043062
- Acronym / sponsor ID
- Female Genitovesical fistula
- Conditions
- Genitovesical Fistula
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 29 Jun 2025 (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.
Fistula is an abnormal passway that connects two organs or vessels that do not connect normally.
Genitourinary fistula refers to a fistula that occurs between reproductive tract organs (vagina, cervix, and uterus), and lower urinary tract (bladder, urethra, and pelvic ureters).
It is a serious condition which can significantly influence the biological and psychological condition of women, with a negative impact on the quality of life.
Detailed description
Fistula is an abnormal passway that connects two organs or vessels that do not connect normally.
Genitourinary fistula refers to a fistula that occurs between reproductive tract organs (vagina, cervix, and uterus), and lower urinary tract (bladder, urethra, and pelvic ureters).
It is a serious condition which can significantly influence the biological and psychological condition of women, with a negative impact on the quality of life.
In developed countries, iatrogenic injury during hysterectomy or pelvic surgery is the primary cause of fistulae . However, the etiology differs in developing countries, being secondary to prolonged, obstructed, complicated labor.
Genitovesical fistulae are one of the most devastating complications in the urogynecology setting. The commonest type of these fistulae is the vesicovaginal fistula (VVF);the patients Suffering from continuous urinary leakage through the vagina and urinary smell, patients with VVF face hygienic, social, infectious, psychological, and sexual problems.
Vesicouterine fistulae (VUF) are not as common as VVF. In 1908, the first case was reported by Knipe , and later in 1957, Youssef reported on the classic symptoms of VUF. These symptoms included amenorrhea and cyclic hematuria, or menouria; known afterward as Youssef's syndrome. The prevalence of these fistulae is estimated to be 1-4% of all genitourinary fistulae.
Several options for the management of such fistulae have been discussed; these include conservative treatment with prolonged catheterization , open surgery, cysto-fulguration, endourology, and laparoscopy/robotic surgery. The decision-making is guided by the patient characteristics, etiology, and the experience of the treating surgeon.
Laparoscopy is of great advantage when compared to open surgery, including safe, effective, minimally invasive procedure, less postoperative pain, smaller incisions, lower blood loss, a shorter hospital stay, and faster recovery. It is associated with a lower incidence of postoperative complications, including infections and improper wound healing
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group of Laparoscopic Repair | Active comparator | Procedure: Open surgical InterferenceAbout 25 female patients suffering from Vesicovaginal fistula or Vesicouterine fistula and will be subjected to Laparoscopic repair of the fistula |
| Group of Open Surgical Repair | Active comparator | Procedure: Open surgical InterferenceAbout 25 female patients suffering from Vesicovaginal fistula or Vesicouterine fistula and will be subjected to surgical repair of the fistula. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Females with Vesicovaginal fistula or Vesicouterine fistula.
- Timing of repair after 2-6 months of beginning of symptoms and signs of fistula.
Key exclusion criteria (3 listed)
- Malignant , Recurrant or Post Radiation Genitovesical fistula.
- Females with congenital disease in Bladder ,Uterus or Vagina.
- Females with Vaginal or Uterine prolapse.
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 |
|---|---|---|
| Open surgical InterferenceAlso: Laparoscopic Repairto compare the outcomes of Laparoscopic repair versus Open surgical repair of Genitovesical fistula in females. | Procedure or surgery | Group of Laparoscopic Repair, Group of Open Surgical Repair |
Primary outcome
Treatment of Genitourinary fistula
Time frame: From base line to 2 Months from the starting of the operation
To examine the female patients whom suffering fromGenitourinary fistula, either by surgical interference or Laparoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- 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.
Ahmed Aboalyosr Mohamed, Professor study chair
Urology Department, Faculty of Medicine, South Valley University, Qena, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open surgical Interference in people with Genitovesical Fistula, run by South Valley 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 2 inclusion and 3 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 29 Jun 2025. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hassan Elshazly Khodary Hassanein, MSC (+201006769357, hassanelshazly67@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment of Genitourinary fistula (time frame: From base line to 2 Months from the starting of the operation). 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 29 Jun 2025.