Gabapentin Versus Trospium Chloride for Prevention of a Catheter-related Bladder Discomfort Insid… (NCT06346522) | Clinical Trial Compass
CompletedPhase 4
Gabapentin Versus Trospium Chloride for Prevention of a Catheter-related Bladder Discomfort Inside the ICU
Egypt120 participantsStarted 2024-04-10
Plain-language summary
Catheter-related bladder discomfort (CRBD) is a frequent complaint after urinary bladder catheterization which is commonly done in the perioperative period. CRBD shows similar symptoms to overactive bladder (OAB); so, drugs used for the management of OAB could influence symptoms of CRBD. Trospium chloride and gabapentin are effective in managing patient with OAB even the resistant cases. We will evaluate and compare the efficacy of both oral trospium and gabapentin on prevention of CRBD in the postoperative period in the ICU in in patients undergoing spinal surgery and requiring intraoperative catheterization of the urinary bladder.
Who can participate
Age range
20 Years – 65 Years
Sex
ALL
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:
* Both males and females with age 20-65 years
* American Society of Anesthesiologists (ASA) physical status class I, II or III.
* Patients will undergoing elective spinal surgery and will require catheterization of the urinary bladder.
Exclusion Criteria:
* known allergy to the study drugs or patient refusal.
* Urinary bladder pathology as overactive bladder (frequency more than 3 times in the night or more than 8 times in 24 h), bladder outflow obstruction, urinary tract infection or malignancy
* Preoperative neurological bladder and/or bowel involvement secondary to spinal cord compression.
* Chronic opioids use for chronic pain, drugs or alcohol abuse
* Moderate to severe hepatic disease, renal impairment with creatinine clearance (CrCl) less than 30 ml/minute
* Narrow angle glaucoma
* Psychiatric diseases
* Gastrointestinal obstructive conditions as severe chronic constipation or ileus
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
1
The incidence (yes/no) and severity of catheter-related bladder discomfort (CRBD) in 1,2,6,12,24 hours after the study drugs intake
Timeframe: First 24 hours after the study drugs intake