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NCT Number: NCT07043062

Laparoscopic Versus Open Surgical Repair of Genitovesical Fistula in Females

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.

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Key information

Age range

25 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

South Valley University Hospital

Qina, Egypt

Location status: Recruiting

Location contact

Mostafa AbdelRazek Ahmed, Assist.Prof

CONTACT

[email protected]

+201004116386

About this 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.

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Females with Vesicovaginal fistula or Vesicouterine fistula.
  • Timing of repair after 2-6 months of beginning of symptoms and signs of fistula.

Exclusion criteria

  • Malignant , Recurrant or Post Radiation Genitovesical fistula.
  • Females with congenital disease in Bladder ,Uterus or Vagina.
  • Females with Vaginal or Uterine prolapse.

Treatment and study plan

Open surgical Interference

Procedure

to compare the outcomes of Laparoscopic repair versus Open surgical repair of Genitovesical fistula in females.

Other names: Laparoscopic Repair

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Mahmoud Hassan, Assist.prof

CONTACT

[email protected]

+201069611961

Hassan Elshazly Khodary Hassanein, MSC

CONTACT

[email protected]

+201006769357

Sponsors and collaborators

Lead sponsor

South Valley University

Other

Registry information

Official study title

Laparoscopic Versus Open Surgical Repair of Genitovesical Fistula in Females :ِ A Prospective Comparative Non Randomized Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 29, 2025
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.