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

Catheter Related Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06429228
• Other study ID #: CAT_273219
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2020
• Est. completion date: September 2024

Study information

• Verified date: May 2024
• Source: IRCCS San Raffaele
• Contact: Stefano Salvatore
• Phone: 0226434930
• Email: salvatore.stefano[@]hsr.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anterior Vaginal Wall Prolapse
• Catheter Related Complication
• Prolapse

Intervention

Procedure:
• Catheter removal after surgery
Removal of catheter placed during the procedure in first or second post-surgical days.

Locations

Country	Name	City	State
Italy	IRCCS San Raffaele Hospital	Milan

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	differences in bladder catheter repositioning within 12 hours after bladder catheter removal	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.	12 hours
Secondary	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.	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.	During hospital stay