CompletedNot Applicable

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

Italy100 participantsStarted 2020-04-20

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 12 hours

Trial details

NCT IDNCT06429228

SponsorIRCCS San Raffaele

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04-18

View on ClinicalTrials.gov More Catheter Related Complication trials