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AzTrials

Bladder InjuryNCT04302545

Cystoinflation to Prevent Bladder Injury in Obstetrics and Gynaecology Surgery

A study testing Cystoinflation in people with Bladder Injury and Complications; Cesarean Section, run by Shazia Saaqib at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Part1:The healthy pregnant women with previous operative deliveries admitted for elective C-section will be counselled and conditioned informed consent will be taken to be included in either study group if dense pelvic adhesions will be found during their operation. Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
What is being tested?
Cystoinflation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
564 participants
Where
1 sitePakistan
Study dates
1 Aug 2017to 30 Apr 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • :• Patients with medical disorders
  • Bladder injury before group assignment
  • Placenta previa
  • Subjects experiencing micturition problems (dysuria, frequency, urgency, urinary retention, incontinence) before the study.
  • Eligibility criteria of part 2\&3 will be provided after publication -

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Lady Willingdon Hospital

    Lahore, Punjab Province, 042

Other trials in Pakistan

About this study

Official title: Cystoinflation to Prevent Bladder Injury in Obstetrics and Gynaecology Surgery Part 1-Cystoinflation in Repeat C-section Part 2- Cystoinflation in Abdominal Hysterectomy Part3- Cystoinflation in Placenta Accreta Spectrum Management

Part1:The healthy pregnant women with previous operative deliveries admitted for elective C-section will be counselled and conditioned informed consent will be taken to be included in either study group if dense pelvic adhesions will be found during their operation. Adhesiolysis will be performed using bladder retro-fill with 300cc saline in the cystoinflation group, and without retro-fill in control.Both groups will be observed for bladder injury rate,bloodloss,operativetime,urinary tract infection,micturition problems and fistula formation.

Part2\&3:Summary of Part 2 and 3 will be provided after publication

Read the detailed description

Part1:Investigators will conduct this study to find the effectiveness of cystoinflation to prevent bladder injury in women with adhesions of previous C-sections. This prospective analytic longitudinal study will be conducted in Lady Willingdon Hospital, a tertiary care teaching hospital affiliated with King Edward Medical University Pakistan, from August 2017 to July 2019, after approval by the institutional review board of King Edward Medical University, Pakistan. The subjects will be randomly allocated to cystoinflation and control groups. The healthy pregnant women with previous operative deliveries admitted for elective C-section will be counselled and conditioned informed consent will be taken to be included in either study group if dense pelvic adhesions will be found during their operation. Adhesiolysis will be performed using bladder retro-fill with 300cc saline in the cystoinflation group, and without retro-fill in control. We will assess primary outcome by observing bladder injury rate, blood loss and operative time. The secondary outcome will be assessed by Urinary tract infection, micturition problems and fistula formation during 3month follow up period. The cystoinflation will be considered effective if the proportion of bladder injury in the study group will be less than 50% of the control group.

Part2\&3:Details of part2\&3 will be provided after publication

Being tested
Cystoinflation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CystoinflationProcedure or surgery

    Also called Bladder retrofill

    Bladder retrofill with 300cc saline to distend the bladder to recognize bladder outline

Study groups in NCT04302545
Study groupRoleWhat they receive
Cystoinflation groupExperimentalBladder will be recognized by observing its gradual distension during bladder retro-fill with 300cc saline to perform adhesiolysis.
Receives: Procedure: Cystoinflation
Control groupNo interventionPelvic adhesiolysis will be performed without bladder retrofill.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bladder Injury Rate

    The bladder injury will be detected by direct visualization in the cesarean section before delivery of the baby during adhesiolysis of dense adhesions of the lower uterine segment, which cover and obscure the bladder. The bladder injury outcome will be measured as the number(percentage) of subjects with injury.

    Measured: From the confirmation of adhesions to adhesiolysis and separation of bladder flap from uterus, before delivery of the baby during cesarean section.This time frame can range between 10-20 minutes.

  2. Blood Loss

    Amount of blood loss during C-section will be increase in weight of sponges used during operation, taking 1gram equal to 1cc.

    Measured: From the confirmation of adhesions to adhesiolysis and separation of bladder flap from uterus, before delivery of the baby during cesarean section.This time frame can range between 10-20 minutes.

  3. Operative Time

    Time from incision till closure of skin

    Measured: During Caesarean section

Secondary outcomes (9)

  1. White Blood Cells Count Per High Power Feild

    The normal white cell count ranges between 4000-11000 per microlitre. The raised count is an indication of postoperative infection.

    Measured: 3rd postoperative day

  2. Urine Culture Report for Micro-organisms

    The outcome measure was the number(percentage) of subjects in which urine culture reports showed the growth of micro-organisms in the urine of the subjects sent for test on the second postoperative day.

    Measured: 2nd postoperative day

  3. Fever

    Number of patients who presented with fever during hospital stay

    Measured: upto 3months

  4. Postmicturition Bladder Volume After C-section

    Volume of urine retained in bladder after evacuation. Bladder distension will be diagnosed if volume retained in the bladder will be greater than 50cc measured on 4th postoperative day

    Measured: upto 3months

  5. Composite Micturition Problems During Hospital Stay

    The micturition problems during the hospital stay investigated in this study were dysuria, feeling of incomplete evacuation, frequency, urgency, urethral and extra-urethral incontinence), Dysuria was expressed by the subject as painful micturition using an 11point visual analogue Scale from zero to ten and converted into severity scores from 0-3.

    Score 0 or no point= 0 point on scale Score1 or mild pain=1-3point Score2 or Moderate Pain=4-6points; Score 3 or Severe Pain=.7-10 Other micturition problems (feeling of incomplete evacuation, frequency, urgency, urethral and extra-urethral incontinence) were measured subjectively on a 4point Likert scale questionnaire according to severity ranging from 0-3 (0-never, 1-rarely, 2-sometimes, and 3-often). The micturition problems of each subject were summed up as composite variables and both groups were compared for the mean value of the composite variable and standard deviation in spss20 statistical software.

    Measured: Complaint recorded during hospital stay (range between 4-21 days)

  6. Duration of Urinary Catheterization

    The time interval for which subject will be kept catheterized postoperatively.

    Measured: upto 3months

  7. Duration of Hospital Stay

    The time interval in days from the date of operation till discharge from the hospital.

    Measured: upto 3months

  8. Number of Subjects With Urinary Fistula Formation

    abnormal communication between genital tract nd urinary tract

    Measured: upto 3months

  9. Composite Micturition Problems After Discharge

    IT is composit Likert score(range from 0-3) of micturition problems recorded by patient after discharge from the hospital to the completion of 3months postoperative(follow up period).The lower value of the score is associated with good outcome while higher value shows a poor outcome.

    Measured: upto 3months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2020
  2. Study start1 Aug 2017
  3. Primary completion30 Apr 2021
  4. Study completion30 Apr 2022

Resources

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
Subjects will be assigned into cystoinflation group and control group after parallel assignment. In the cystoinflation group, the intervention will be retro-fill of the bladder with 300cc saline and clamping the drainage port of the catheter till the completion of adhesiolysis. In contrast, the urinary catheter of control group patients will be put on free drainage.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
564 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04302545
Sponsor's protocol ID
ERB#216/RC/KEMU
Other IDs
NCT#04302545
Status last verified
Aug 2024
First submitted
6 Mar 2020
Last updated
4 Sep 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No: There is no plan to make individual participant data available. The data will be made available to individual researchers on request after publication.

Publications

  • O'Hanlan KA. Cystosufflation to prevent bladder injury. J Minim Invasive Gynecol. 2009 Mar-Apr;16(2):195-7. doi: 10.1016/j.jmig.2008.11.011. Epub 2009 Jan 9.

    PubMed 19138575

  • Pandey 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 26500959

  • Abdel-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 24729285

  • Joelsson-Alm E, Nyman CR, Svensen C, Ulfvarson J. Micturition problems after bladder distension during hospitalization in Sweden: "I'm not ill, just damaged for the rest of my life". Nurs Res. 2014 Nov-Dec;63(6):418-25. doi: 10.1097/NNR.0000000000000057.

    PubMed 25350541

  • Saaqib S, Naheed M, Iqbal A, Rehman RMAU, Khalid M. Evaluating a novel approach to placenta accreta spectrum management: the modified Triple-P technique with cystoinflation (a randomized controlled trial). Sci Rep. 2025 Jul 16;15(1):25870. doi: 10.1038/s41598-025-07582-6.

    PubMed 40670452

Questions about this trial

What is this clinical trial studying?

A study testing Cystoinflation in people with Bladder Injury and Complications; Cesarean Section, run by Shazia Saaqib at 1 site in Pakistan.

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 0 inclusion and 5 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 4 Sep 2024. 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 Pakistan. 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?

Yes. Results are posted in the registry (first posted 28 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Rate (time frame: From the confirmation of adhesions to adhesiolysis and separation of bladder flap from uterus, before delivery of the baby during cesarean section.This time frame can range between 10-20 minutes.). The study lists 3 primary outcomes in all. 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 NCT04302545, which also lists 5 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 4 Sep 2024.

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