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Completed

NCT Number: NCT06429228

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS San Raffaele Hospital

Milan, 20132, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Catheter removal after surgery

Procedure

Removal of catheter placed during the procedure in first or second post-surgical days.

Primary outcomes

  1. differences in bladder catheter repositioning within 12 hours after bladder catheter removal

    Time frame: 12 hours

    After removal of the bladder catheter, on postoperative day I or II, the appearance of urinary urge will be assessed and, in case of spontaneous urination, the quantity of urine will be measured. In the event that after the waiting time of 6 hours an adequate urination stimulus does not arise, we will proceed with an ultrasound evaluation of bladder stagnation (RV) and the application of the department protocol, as follows:

    • if the sum of diuresis and RV is between 500 and 1000 cc, extemporaneous catheterization and re-evaluation after 4 hours are indicated
    • if the sum of diuresis and RV is > 1000cc, positioning of a bladder catheter and maintenance of the same for 5-7 days with subsequent evaluation is indicated.

Secondary outcomes

  1. incidence of urinary tract infections for patients undergoing cystopexy surgery in patients in whom the bladder catheter is removed on postoperative day I or II.

    Time frame: During hospital stay

    Before removing the catheter, a chemical-physical examination will be carried out; if this is positive, urine culture will be carried out. The diagnosis of urinary tract infection will be made with leukocyturia greater than 25 cells per field, positivity for urinary nitrite, presence of at least 20 bacteria per field, bacteriuria and/or more than 100,000 colony forming units associated with at least one of the following signs (fever, dysuria, increased urinary frequency, suprapubic pain, burning on urination or worsening of urinary incontinence). Patients with a positive culture and/or who show symptoms attributable to urinary tract infection will be subjected to antibiotic therapy.

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
May 24, 2024
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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