Urinary Tract InjuryNCT03668535
Filling of the Urinary Bladder During Difficult Cesarean Section
A study testing Bladder Filling and Bladder deflation in people with Urinary Tract Injury and Cesarean Section Complications, run by South Valley University at 1 site in Egypt.
Trial summary
Risk factors for bladder injury during Cesarean Section are well known. Most of cases of bladder injury occur in presence of previous Cesarean Sections, morbidly adherent placenta, or previous bladder injury. limited evidence suggest that bladder filling may decrease the incidence of bladder injury. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Urinary Tract Injury, Cesarean Section Complications
- What is being tested?
- Bladder Filling and Bladder deflation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2017to 30 Nov 2018
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Previous Cesarean Section 3 times or more
- Previous history of bladder injury during Cesarean Section
- Operative report of extensive adhesions in the last Cesarean Section
- Cesarean Section for placenta accreta spectrum
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Egypt1 site
South Valley University, Qena Faculty of Medicine, Obstetrics and Gynecology Department
Qina, Qena Governorate
About this study
Risk factors for bladder injury during Cesarean Section are well known. Most of cases of bladder injury occur in presence of previous Cesarean Sections, morbidly adherent placenta, or previous bladder injury. limited evidence suggest that bladder filling may decrease the incidence of bladder injury. n our study, we compared the outcome of urinary bladder filling during Cesarean Section in cases at high risk of bladder injury.
Read the detailed description
In women at risk of bladder injury, such as in presence of previous Cesarean Section(s), there may tough adhesions between the bladder and the lower uterine segment. Trial of separation of the bladder in such circumstances may result in bladder injury. Filling of the bladder will delineate the contour of the bladder and clarify the proper plane of dissection. In a recent randomized clinical trial lower bladder filling resulted in non-significant decrease in the rate of bladder injury in women with placenta percreta. In our study, we compared the outcome of urinary bladder filling during Cesarean Section in cases at high risk of bladder injury.
Patients and Methods Inclusion criteria: Pregnant women at gestation from 20- 41 weeks who have any of the following risk factors
- Previous Cesarean Section 3 times or more
- Previous history of bladder injury during Cesarean Section
- Operative report of extensive adhesions in the last Cesarean Section
- Cesarean Section for placenta accreta spectrum Methods This is a randomized controlled trial done at the department of Obstetrics \& Gynaecology unit, South Valley University from August 1st, 2017until the 30th of August 2018. The research is approved by the Committee of Ethics for Biomedical Researches, South Valley University at June 2017. All cases have informed consent before inclusion in the research. Closed envelop is used to randomized patients to either group. Group A: are cases of Cesarean section who have the intervention. Group: are cases of Cesarean section who do not have the intervention.
The intervention:
Triple-way urethral catheter insertion before establishment of anaesthesia. Evaluation of the drained urine is done (including: amount, character, and simple for culture and sensitivity). Instillation of 200 ml sterile saline is done by 50 ml syringe through the irrigation way. The irrigation way is closed temporarily by artery forceps. After laparotomy the bladder may be deflated by 50 ml or further inflated by 50 ml if needed to allow comfortable dissection. All Cesarean sections in both groups are done by the same surgeon supported by the same team in the same hospital. The Cesarean sections are done under spinal or general anaesthesia through pfannenstiel's incision. The catheter is removed 12 hours after Cesarean section. Postoperative follow up is maintained until 3 months from the time of the Cesarean section.
- Being tested
- Bladder Filling, Bladder deflation
- Keywords
- Urinary, Bladder, Injury, Cesarean
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bladder FillingProcedure or surgery
Group A have a triple-way urethral catheter insertion before establishment of anaesthesia. Evaluation of the drained urine is done (including: amount, character, and simple for culture and sensitivity). Instillation of 200 ml sterile saline is done by 50 ml syringe through the irrigation way. The irrigation way is closed temporarily by artery forceps. After laparotomy the bladder may be deflated by 50 ml or further inflated by 50 ml if needed to allow comfortable dissection.
Bladder deflationProcedure or surgery
Group B have Foley's catheter is inserted as usual. The catheter is connected freely to urinary bag.
| Study group | Role | What they receive |
|---|---|---|
| Bladder Filling arm | Active comparator | Group A have triple-way urethral catheter insertion before establishment of anaesthesia. Evaluation of the drained urine is done (including: amount, character, and simple for culture and sensitivity). Instillation of 200 ml sterile saline is done by 50 ml syringe through the irrigation way. The irrigation way is closed temporarily by artery forceps. After laparotomy the bladder may be deflated by 50 ml or further inflated by 50 ml if needed to allow comfortable dissection. Receives: Procedure: Bladder Filling |
| Bladder deflation arm | Active comparator | Group B have Foley's catheter is inserted as usual. The catheter is connected freely to urinary bag. Receives: Procedure: Bladder deflation |
What is being measured
The primary outcome is the main question the study is designed to answer.
bladder injury
the intra-operative rate of urinary bladder injury
Measured: 3 months
Secondary outcomes (4)
Operative time
Operative time in minutes
Measured: 3 months
post-operative voiding dysfunction
post-operative voiding dysfunction in the form of dysuria or retention
Measured: 3 months
operative blood loss
estimated blood loss in mL
Measured: 3 months
Urinary bladder fistulae
development of bladder fistulae
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start1 Aug 2017
- Primary completion30 Aug 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InjuryStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups of women with difficult Cesarean Section at risk of urinary bladder injury. Group A will receive the intervention. Group B will not receive the intervention.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Abdel-Rahman Mohammad Ahmed, South Valley University
- Investigators
- Mohammad AM Ahmed, MD, Principal investigator, South Valley University, Qena Faculty of Medicine, Obstetrics and Gynecology Department, Qena, Qena, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03668535
- Sponsor's protocol ID
- OBGYN 004
- Status last verified
- Feb 2019
- First submitted
- 9 Sep 2018
- Last updated
- 7 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared in unanonomous manner with the predetermined group of researchers
Publications
Salman L, Aharony S, Shmueli A, Wiznitzer A, Chen R, Gabbay-Benziv R. Urinary bladder injury during cesarean delivery: Maternal outcome from a contemporary large case series. Eur J Obstet Gynecol Reprod Biol. 2017 Jun;213:26-30. doi: 10.1016/j.ejogrb.2017.04.007. Epub 2017 Apr 5.
PubMed 28411456Alanwar A, Al-Sayed HM, Ibrahim AM, Elkotb AM, Abdelshafy A, Abdelhadi R, Abbas AM, Abdelmenam HS, Fares T, Nossair W, Abdallah AA, Sabaa H, Nawara M. Urinary tract injuries during cesarean section in patients with morbid placental adherence: retrospective cohort study. J Matern Fetal Neonatal Med. 2019 May;32(9):1461-1467. doi: 10.1080/14767058.2017.1408069. Epub 2017 Dec 3.
PubMed 29157027Pandey D, Mehta S, Grover A, Goel N. Indwelling Catheterization in Caesarean Section: Time To Retire It! J Clin Diagn Res. 2015 Sep;9(9):QC01-4. doi: 10.7860/JCDR/2015/13495.6415. Epub 2015 Sep 1.
PubMed 26500959Senanayake H. Elective cesarean section without urethral catheterization. J Obstet Gynaecol Res. 2005 Feb;31(1):32-7. doi: 10.1111/j.1447-0756.2005.00237.x.
PubMed 15669989Acharya S, Uprety DK, Pokharel HP, Amatya R, Rai R. Cesarean section without urethral catheterization: a randomized control trial. Kathmandu Univ Med J (KUMJ). 2012 Apr-Jun;10(38):18-22. doi: 10.3126/kumj.v10i2.7337.
PubMed 23132469Abdel-Aleem H, Aboelnasr MF, Jayousi TM, Habib FA. Indwelling bladder catheterisation as part of intraoperative and postoperative care for caesarean section. Cochrane Database Syst Rev. 2014 Apr 11;2014(4):CD010322. doi: 10.1002/14651858.CD010322.pub2.
PubMed 24729285Ozcan HC, Balat O, Ugur MG, Sucu S, Tepe NB, Kazaz TG. Use of Bladder Filling to Prevent Urinary System Complications in the Management of Placenta Percreta: a Randomized Prospective Study. Geburtshilfe Frauenheilkd. 2018 Feb;78(2):173-178. doi: 10.1055/s-0044-100039. Epub 2018 Feb 19.
PubMed 29479114Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.
PubMed 34184246
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Filling of the Urinary Bladder During Difficult Cesarean Section
- ClinicalTrials.gov ID
- NCT03668535
- Acronym / sponsor ID
- OBGYN 004
- Keywords
- Urinary, Bladder, Injury, Cesarean
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 12 Sep 2018 (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.
Risk factors for bladder injury during Cesarean Section are well known. Most of cases of bladder injury occur in presence of previous Cesarean Sections, morbidly adherent placenta, or previous bladder injury. limited evidence suggest that bladder filling may decrease the incidence of bladder injury. n our study, we compared the outcome of urinary bladder filling during Cesarean Section in cases at high risk of bladder injury.
Detailed description
In women at risk of bladder injury, such as in presence of previous Cesarean Section(s), there may tough adhesions between the bladder and the lower uterine segment. Trial of separation of the bladder in such circumstances may result in bladder injury. Filling of the bladder will delineate the contour of the bladder and clarify the proper plane of dissection. In a recent randomized clinical trial lower bladder filling resulted in non-significant decrease in the rate of bladder injury in women with placenta percreta. In our study, we compared the outcome of urinary bladder filling during Cesarean Section in cases at high risk of bladder injury.
Patients and Methods Inclusion criteria: Pregnant women at gestation from 20- 41 weeks who have any of the following risk factors
- Previous Cesarean Section 3 times or more
- Previous history of bladder injury during Cesarean Section
- Operative report of extensive adhesions in the last Cesarean Section
- Cesarean Section for placenta accreta spectrum Methods This is a randomized controlled trial done at the department of Obstetrics \& Gynaecology unit, South Valley University from August 1st, 2017until the 30th of August 2018. The research is approved by the Committee of Ethics for Biomedical Researches, South Valley University at June 2017. All cases have informed consent before inclusion in the research. Closed envelop is used to randomized patients to either group. Group A: are cases of Cesarean section who have the intervention. Group: are cases of Cesarean section who do not have the intervention.
The intervention:
Triple-way urethral catheter insertion before establishment of anaesthesia. Evaluation of the drained urine is done (including: amount, character, and simple for culture and sensitivity). Instillation of 200 ml sterile saline is done by 50 ml syringe through the irrigation way. The irrigation way is closed temporarily by artery forceps. After laparotomy the bladder may be deflated by 50 ml or further inflated by 50 ml if needed to allow comfortable dissection. All Cesarean sections in both groups are done by the same surgeon supported by the same team in the same hospital. The Cesarean sections are done under spinal or general anaesthesia through pfannenstiel's incision. The catheter is removed 12 hours after Cesarean section. Postoperative follow up is maintained until 3 months from the time of the Cesarean section.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Two groups of women with difficult Cesarean Section at risk of urinary bladder injury. Group A will receive the intervention. Group B will not receive the intervention.
| Arm | Type | Receives |
|---|---|---|
| Bladder Filling arm | Active comparator | Procedure: Bladder FillingGroup A have triple-way urethral catheter insertion before establishment of anaesthesia. Evaluation of the drained urine is done (including: amount, character, and simple for culture and sensitivity). Instillation of 200 ml sterile saline is done by 50 ml syringe through the irrigation way. The irrigation way is closed temporarily by artery forceps. After laparotomy the bladder may be deflated by 50 ml or further inflated by 50 ml if needed to allow comfortable dissection. |
| Bladder deflation arm | Active comparator | Procedure: Bladder deflationGroup B have Foley's catheter is inserted as usual. The catheter is connected freely to urinary bag. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Previous Cesarean Section 3 times or more
- Previous history of bladder injury during Cesarean Section
- Operative report of extensive adhesions in the last Cesarean Section
- Cesarean Section for placenta accreta spectrum
Key exclusion criteria (1 listed)
- -
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 FillingGroup A have a triple-way urethral catheter insertion before establishment of anaesthesia. Evaluation of the drained urine is done (including: amount, character, and simple for culture and sensitivity). Instillation of 200 ml sterile saline is done by 50 ml syringe through the irrigation way. The irrigation way is closed temporarily by artery forceps. After laparotomy the bladder may be deflated by 50 ml or further inflated by 50 ml if needed to allow comfortable dissection. | Procedure or surgery | Bladder Filling arm |
| Bladder deflationGroup B have Foley's catheter is inserted as usual. The catheter is connected freely to urinary bag. | Procedure or surgery | Bladder deflation arm |
Primary outcome
bladder injury
Time frame: 3 months
the intra-operative rate of urinary bladder injury
4 secondary outcomes
Operative time
Time frame: 3 months
post-operative voiding dysfunction
Time frame: 3 months
operative blood loss
Time frame: 3 months
Urinary bladder fistulae
Time frame: 3 months
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 7 Feb 2019.
- Background: PubMed 28411456Salman L, Aharony S, Shmueli A, Wiznitzer A, Chen R, Gabbay-Benziv R. Urinary bladder injury during cesarean delivery: Maternal outcome from a contemporary large case series. Eur J Obstet Gynecol Reprod Biol. 2017 Jun;213:26-30. doi: 10.1016/j.ejogrb.2017.04.007. Epub 2017 Apr 5.
- Background: PubMed 29157027Alanwar A, Al-Sayed HM, Ibrahim AM, Elkotb AM, Abdelshafy A, Abdelhadi R, Abbas AM, Abdelmenam HS, Fares T, Nossair W, Abdallah AA, Sabaa H, Nawara M. Urinary tract injuries during cesarean section in patients with morbid placental adherence: retrospective cohort study. J Matern Fetal Neonatal Med. 2019 May;32(9):1461-1467. doi: 10.1080/14767058.2017.1408069. Epub 2017 Dec 3.
- Background: PubMed 26500959Pandey D, Mehta S, Grover A, Goel N. Indwelling Catheterization in Caesarean Section: Time To Retire It! J Clin Diagn Res. 2015 Sep;9(9):QC01-4. doi: 10.7860/JCDR/2015/13495.6415. Epub 2015 Sep 1.
- Background: PubMed 15669989Senanayake H. Elective cesarean section without urethral catheterization. J Obstet Gynaecol Res. 2005 Feb;31(1):32-7. doi: 10.1111/j.1447-0756.2005.00237.x.
- Background: PubMed 23132469Acharya S, Uprety DK, Pokharel HP, Amatya R, Rai R. Cesarean section without urethral catheterization: a randomized control trial. Kathmandu Univ Med J (KUMJ). 2012 Apr-Jun;10(38):18-22. doi: 10.3126/kumj.v10i2.7337.
- Background: PubMed 24729285Abdel-Aleem H, Aboelnasr MF, Jayousi TM, Habib FA. Indwelling bladder catheterisation as part of intraoperative and postoperative care for caesarean section. Cochrane Database Syst Rev. 2014 Apr 11;2014(4):CD010322. doi: 10.1002/14651858.CD010322.pub2.
- Background: PubMed 29479114Ozcan HC, Balat O, Ugur MG, Sucu S, Tepe NB, Kazaz TG. Use of Bladder Filling to Prevent Urinary System Complications in the Management of Placenta Percreta: a Randomized Prospective Study. Geburtshilfe Frauenheilkd. 2018 Feb;78(2):173-178. doi: 10.1055/s-0044-100039. Epub 2018 Feb 19.
- Derived from this study: PubMed 34184246Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.
- Individual participant dataSharing planned: Yes. IPD will be shared in unanonomous manner with the predetermined group of researchers
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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.
Mohammad AM Ahmed, MD principal investigator
South Valley University, Qena Faculty of Medicine, Obstetrics and Gynecology Department, Qena, 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 Bladder Filling and Bladder deflation in people with Urinary Tract Injury and Cesarean Section Complications, 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 4 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: finished, as of the sponsor's last update on 7 Feb 2019. 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?
bladder injury (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03668535, which also lists 8 linked publications.
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 7 Feb 2019; AzTrials last refreshed its copy on 6 Nov 2026.