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NCT06346522
Gabapentin Versus Trospium Chloride for Prevention of a Catheter-related Bladder Discomfort Inside the ICU
Phase 4 trial testing Gabapentin (Gaptin ®) 400mg oral capsule once in Catheter-related Bladder Discomfort (CRBD) in 120 participants. Completed in 20 September 2024.
1 September 2024
Quick facts
| Lead sponsor | Ain Shams University |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | prevention |
| Enrollment | 120 |
| Start date | 10 April 2024 |
| Primary completion | 1 September 2024 |
| Estimated completion | 20 September 2024 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Gabapentin (Gaptin ®) 400mg oral capsule once — full drug profile →
- Trospium chloride slow release (Trospikan ® SR) 60mg oral capsule — full drug profile →
Conditions studied
- Catheter-related Bladder Discomfort (CRBD) — all drugs for Catheter-related Bladder Discomfort (CRBD) →
Sponsor
Ain Shams University
Who can join
Adults 20 to 65, any sex, with Catheter-related Bladder Discomfort (CRBD). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06346522
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06346522 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ain Shams University
- Last refreshed: 28 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06346522.
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