Cystoinflation to Prevent Bladder Injury in Cases of Placenta Accreta Spectrum

NCT ID: NCT07050082

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2025-01-01

Brief Summary

Placenta accreta spectrum (PAS) disorders are associated with a high risk of bladder injury .leading to increased morbidity. Cystoinflation, involving controlled retrograde bladder filling, has been proposed as a technique to improve intraoperative visualization and reduce bladder injuries.

Objective To evaluate the efficacy and safety of cystoinflation in preventing bladder injuries in cases of PAS.

Methods This randomized controlled trial included 84 women diagnosed with PAS, allocated equally into cystoinflation and control groups. The cystoinflation group underwent bladder filling with 200 mL saline to facilitate dissection, while the control group did not. Primary outcome measures included the incidence of bladder injury, operative time. Data were analyzed using appropriate statistical tests with significance set at p<0.05.

Detailed Description

The global incidence of placenta accreta spectrum (PAS) disorders are rising in parallel with the increasing rates of cesarean delivery, posing significant challenges in obstetric practice due to its association with severe maternal morbidity and mortality . PAS encompasses a spectrum of abnormal placental adherence, which can lead to life-threatening hemorrhage during delivery.

In response to the limitations of traditional terminology (placenta accreta, increta, percreta), the International Federation of Gynecology and Obstetrics introduced a standardized classification under the umbrella of PAS disorders, aiming to improve diagnostic clarity and clinical management.

Surgical management recognized as the standard of care for invasive placentation .However, this procedure carries a substantial risk, with severe maternal morbidity rates reaching 40-50%, primarily due to hemorrhage and injury to adjacent organs. In extreme cases, maternal mortality may reach up to 7% .The complexity of the surgery is heightened by the high risk of adjacent organ injury, with an adjusted odds ratio of 8.2 for damage to nearby structures .

Among these complications, urinary tract injury is notably prevalent. Risk factors include the depth and lateral extension of placental invasion, the extent of intraoperative blood loss, and the number of prior cesarean sections . Urinary tract trauma occurs in approximately 29% of PAS-related surgeries, with bladder lacerations accounting for 76%, ureteral injuries for 17%, and genitourinary fistulas for 5% . Although injuries to the bowel, pelvic vasculature, and nerves are less common, they remain clinically significant .

Bladder injury, in particular, has profound implications, contributing to prolonged operative time, urinary tract infections, voiding dysfunction, and extended catheterization, all of which adversely affect a patient's physical and psychological well-being .While routine preoperative bladder catheterization aids in visualizing the surgical field, it often fails to prevent bladder injury in cases with dense adhesions.

This study aims to assess the efficacy and safety of bladder filling with 200 cc saline during bladder dissection in women diagnosed with PAS.

Conditions

Bladder Injury; Accreta, Placenta

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Bladder filling

42 case of PAS , bladder dissection done after filling bladder with 200 cc saline

Group Type: EXPERIMENTAL

Bladder dissection after filling with 200 cc saline solution

Intervention Type: PROCEDURE

Bladder filling after entering peritoneal cavity, then bladder dissection done to avoid bladder injury

Non bladder filling

42 case of PAS , bladder dissection done with empty bladder

Group Type: ACTIVE_COMPARATOR

Bladder dissection with empty bladder

Intervention Type: OTHER

After entering peritoneal cavity, bladder dissection done with empty bladder

Interventions

Bladder dissection after filling with 200 cc saline solution

Bladder filling after entering peritoneal cavity, then bladder dissection done to avoid bladder injury

Intervention Type: PROCEDURE

Bladder dissection with empty bladder

After entering peritoneal cavity, bladder dissection done with empty bladder

Intervention Type: OTHER

Other Intervention Names

Bladder filling; Cystoinflation; Bladder dissection; Classic bladder dissection

Eligibility Criteria

Inclusion Criteria

• Gestational age 34 weeks or more
• BMI 18.5-29.9
• Placcenta accreta diagnosed by ultrasound
• Previous caesarian section
• General anaesthetia

Exclusion Criteria

• medical disorders
• History of bladder injury or previous bladder surgery

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Islam Sharawy Abdelrahman

Assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of medicine Cairo university

Cairo, , Egypt

Countries

Egypt

Other Identifiers

Cystoinflation in PAS cases

Identifier Type: -

Identifier Source: org_study_id