Bladder InjuryNCT07050082
Cystoinflation to Prevent Bladder Injury in Cases of Placenta Accreta Spectrum
A study testing Bladder dissection after filling with 200 cc saline solution and Bladder dissection with empty bladder in people with Bladder Injury and Accreta, Placenta, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Bladder Injury, Accreta, Placenta
- What is being tested?
- Bladder dissection after filling with 200 cc saline solution and Bladder dissection with empty bladder
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 1 Jan 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Gestational age 34 weeks or more
- BMI 18.5-29.9
- Placcenta accreta diagnosed by ultrasound
- Previous caesarian section
- General anaesthetia
Who cannot join
- medical disorders
- History of bladder injury or previous bladder surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cystoinflation to Prevent Bladder Injury in Cases of Placenta Accreta Spectrum , a Randomized Controlled Trial
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.
Read the 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
- Being tested
- Bladder dissection after filling with 200 cc saline solution, Bladder dissection with empty bladder
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bladder dissection after filling with 200 cc saline solutionProcedure or surgery
Also called Bladder filling, Cystoinflation, Bladder dissection
Bladder filling after entering peritoneal cavity, then bladder dissection done to avoid bladder injury
Bladder dissection with empty bladderOther
Also called Classic bladder dissection
After entering peritoneal cavity, bladder dissection done with empty bladder
| Study group | Role | What they receive |
|---|---|---|
| Bladder filling | Experimental | 42 case of PAS , bladder dissection done after filling bladder with 200 cc saline Receives: Procedure: Bladder dissection after filling with 200 cc saline solution |
| Non bladder filling | Active comparator | 42 case of PAS , bladder dissection done with empty bladder Receives: Other: Bladder dissection with empty bladder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of bladder injury in two groups
Comparing incidence of bladder injury in cases of PAS with and without bladder filling
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start1 Jun 2023
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder InjuryStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Sharawy Abdelrahman, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07050082
- Sponsor's protocol ID
- Cystoinflation in PAS cases
- Status last verified
- Jun 2023
- First submitted
- 25 Jun 2025
- Last updated
- 10 Sep 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 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cystoinflation to Prevent Bladder Injury in Cases of Placenta Accreta Spectrum , a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07050082
- Acronym / sponsor ID
- Cystoinflation in PAS cases
- Conditions
- Bladder Injury, Accreta, Placenta
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 3 Jul 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bladder filling | Experimental | Procedure: Bladder dissection after filling with 200 cc saline solution42 case of PAS , bladder dissection done after filling bladder with 200 cc saline |
| Non bladder filling | Active comparator | Other: Bladder dissection with empty bladder42 case of PAS , bladder dissection done with empty bladder |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Gestational age 34 weeks or more
- BMI 18.5-29.9
- Placcenta accreta diagnosed by ultrasound
- Previous caesarian section
- General anaesthetia
Key exclusion criteria (2 listed)
- medical disorders
- History of bladder injury or previous bladder surgery
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 |
|---|---|---|
| Bladder dissection after filling with 200 cc saline solutionAlso: Bladder filling, Cystoinflation, Bladder dissectionBladder filling after entering peritoneal cavity, then bladder dissection done to avoid bladder injury | Procedure or surgery | Bladder filling |
| Bladder dissection with empty bladderAlso: Classic bladder dissectionAfter entering peritoneal cavity, bladder dissection done with empty bladder | Other | Non bladder filling |
Primary outcome
Incidence of bladder injury in two groups
Time frame: 18 months
Comparing incidence of bladder injury in cases of PAS with and without bladder filling
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 10 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bladder dissection after filling with 200 cc saline solution and Bladder dissection with empty bladder in people with Bladder Injury and Accreta, Placenta, run by Cairo 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 5 inclusion and 2 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 10 Sep 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?
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?
Incidence of bladder injury in two groups (time frame: 18 months). 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 10 Sep 2025.