Cystoinflation to Prevent Bladder Injury in Obstetrics and Gynaecology Surgery

NCT04302545 | Completed Results DMC

• 2 other identifiers: ERB#216/RC/KEMUNCT#04302545
• Study Type: interventional
• Target: 564
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Bladder Injury; Complications; Cesarean Section; Adhesions Pelvic

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

• Blood Loss

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

  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.

• Operative Time

  Time from incision till closure of skin

  During Caesarean section

Secondary Outcomes (9)

• White Blood Cells Count Per High Power Feild

  3rd postoperative day

• Urine Culture Report for Micro-organisms

  2nd postoperative day

• Fever

  upto 3months

• Postmicturition Bladder Volume After C-section

  upto 3months

• Composite Micturition Problems During Hospital Stay

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

Study Arms (2)

Cystoinflation group

EXPERIMENTAL

Bladder will be recognized by observing its gradual distension during bladder retro-fill with 300cc saline to perform adhesiolysis.

Procedure: Cystoinflation

Control group

NO INTERVENTION

Pelvic adhesiolysis will be performed without bladder retrofill.

Interventions

Cystoinflation PROCEDURE

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

Also known as: Bladder retrofill

Cystoinflation group

Eligibility Criteria

• Gender Eligibility Details: part1:Pregnant women Part2:Assigned to abdominal hysterectomy Part3:pregnant women with placenta accreta spectrum
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy pregnant women of any age
• Two or more previous C-sections
• Gestational age between 38-40 weeks (confirmed by dating scan)
• Dense Adhesions of Tulandi scores four or more.
• women who give informed consent to participate in the study

You may not qualify if:

• :• 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 -

Sponsors & Collaborators

• Shazia Saaqib: lead
• King Edward Medical University: collaborator
• Institute of Public Health, Pakistan: collaborator

Study Sites (1)

Lady Willingdon Hospital

Lahore, Punjab Province, 042, Pakistan

Location

Related Publications (5)

• 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.

  PMID: 19138575 RESULT

• 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.

  PMID: 26500959 RESULT

• 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.

  PMID: 24729285 RESULT

• 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.

  PMID: 25350541 RESULT

• 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.

  PMID: 40670452 DERIVED

Results Point of Contact

• Title: Shazia Saaqib
• Organization: King Edward Medical University, Lahore, Pakistan

shaziasaaqib@gmail.com

+92-3214708583

Study Officials

• Munazza Naheed, MBBS

  King Edward Medical University

  STUDY DIRECTOR

• Tayyaba Saeed, MBBS

  King Edward Medical University

  STUDY DIRECTOR

• Mohammad Khalid, MBBS, MHM

  Institute of Public Health, Pakistan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants and outcome assessors are kept blind by just entering the random number assigned to the subject on the papers and notes are written without details of adhesiolysis. The completed outcome performas are sent to the assessors with the only random number entered and without the assigned group. The random number file is opened only after receiving results from the statistician. The care providers in theatre and principle surgeon cannot be blinded in this study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor Gynecology and Obstetrics

Model Details: 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.

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: March 10, 2020
• Study Start: August 1, 2017
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2022
• Last Updated: September 4, 2024
• Results First Posted: September 28, 2021

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)