N/A N=214 Randomized Double-blind Prevention

Cystoinflation to Prevent Bladder Injury in Obstetrics and Gynaecology Surgery

Bladder Injury · Complications; Cesarean Section · Adhesions Pelvic

Bottom Line

View on ClinicalTrials.gov: NCT04302545 ↗

Enrolled (actual)

214

Serious AEs

11.7%

Results posted

Sep 2021

Primary outcome: Primary: Bladder Injury Rate — 3; 22 Participants — p=<.0001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Cystoinflation (Procedure)
Age: Pediatric, Adult, Older Adult
Sex: Female
Sponsor: Shazia Saaqib
Primary completion: Apr 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Bladder Injury Rate	3; 22	<.0001 sig
PRIMARY Blood Loss	585.32; 797.10	<0.0001 sig
PRIMARY Operative Time	45; 45	1
SECONDARY White Blood Cells Count Per High Power Feild	6.26; 7.36	.001 sig
SECONDARY Urine Culture Report for Micro-organisms	2; 18	<0.0001 sig
SECONDARY Fever	2; 13	0.003 sig
SECONDARY Postmicturition Bladder Volume After C-section	15.56; 14.91	.336
SECONDARY Composite Micturition Problems During Hospital Stay	.077; .47	.021 sig
SECONDARY Duration of Urinary Catheterization	1.25; 3.14	<0.0001 sig
SECONDARY Duration of Hospital Stay	4.18; 5.50	<.0001 sig
SECONDARY Number of Subjects With Urinary Fistula Formation	0; 1	—
SECONDARY Composite Micturition Problems After Discharge	.0047; .0701	.003 sig

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

Eligibility Criteria

Part1:Inclusion Criteria:

• 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

Exclusion Criteria

:• 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 -

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04302545). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.