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Comparison of 1 Versus 2 Days Post-Operative Catheterization After Anterior Colporrhaphy

S

San Donato Group (GSD)

Status

Completed

Conditions

Anterior Vaginal Wall Prolapse
Catheter Related Complication

Treatments

Procedure: Catheter removal after surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT06429228
CAT_273219

Details and patient eligibility

About

Patients who undergo anterior vaginal wall plastic surgery and place the bladder catheter during surgery are selected. The purpose of the study is to evaluate the presence of statistically significant differences in bladder catheter repositioning within 12 hours after bladder catheter removal in the group of patients in whom the bladder catheter is removed on postoperative day I or II.

Secondary outcomes include evaluation of the incidence of urinary tract infections, number of hospitalization days and total hospitalization costs for patients undergoing anterior vaginal wall surgery in patients in whom the bladder catheter is removed on postoperative day I or II.

Enrollment

100 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Women 18 years of age or older
  • Patients who are candidates for cystopexy surgery
  • Patients who have consented to the signing of the Informed Consent

Exclusion criteria

  • Micturition dysfunction with preoperative bladder stagnation > 200 cc at pessary evaluation
  • History of recurrent cystitis
  • Positive preoperative urine culture
  • Azotemia > 40 mg/dL or creatininemia > 1 mg/dL
  • Not collected signed consent endorsed
  • Diabetes mellitus
  • Contraindications to transurethral bladder catheterization
  • Major protocol violations due to unforeseen intraoperative complications (bladder and/or rectal damage, severe bleeding with need for urinary monitoring)

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Catheter removal in postoperative day I
Experimental group
Treatment:
Procedure: Catheter removal after surgery
Catheter removal in postoperative day II
Experimental group
Treatment:
Procedure: Catheter removal after surgery

Trial contacts and locations

1

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Central trial contact

Vittoria Benini; Stefano Salvatore

Data sourced from clinicaltrials.gov

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