Catheter-related Bladder Discomfort (CRBD)Phase 4NCT06346522
Gabapentin Versus Trospium Chloride for Prevention of a Catheter-related Bladder Discomfort Inside the ICU
A Phase 4 study testing Gabapentin (Gaptin ®) 400mg oral capsule once and Trospium chloride slow release (Trospikan ® SR) 60mg oral capsule in people with Catheter-related Bladder Discomfort (CRBD), run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Catheter-related Bladder Discomfort (CRBD)
- What is being tested?
- Gabapentin (Gaptin ®) 400mg oral capsule once and Trospium chloride slow release (Trospikan ® SR) 60mg oral capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2024to 20 Sep 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Gabapentin Versus Trospium Chloride for Prevention of Catheter-related Bladder Discomfort (CRBD) Inside the Intensive Care Unit (ICU): a Prospective, Randomized,Comparative Clinical Study
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.
Read the detailed description
- Study will be conducted in the intensive care units (ICU) of Ain Shams University Hospitals, Cairo, Egypt
- After satisfactory pain control and full recovery in the postanesthesia care unit (PACU), the patient will be transferred to the ICU as a case of postoperative care after elective spinal diskectomy surgeries (cervical, dorsal or lumber) with removal of the damaged portion of the herniated or degenerated disks. Admission to ICU will be for medical, surgical or anesthesia related causes.
- Standard monitoring devices via GE monitor will be connected to the patient as electrocardiogram (ECG) for heart rate (beats/min), pulse oximetry for (SPO2 as a percentage) and non-invasive blood pressure (NIBP) (mmHg).Temperature of the patient in Celsius (◦C), random blood sugar (mg/dl) and urine output (ml/hour) will be monitored also. Follow-up by standard postoperative laboratory tests will be done too.
- After the patient will regain feeding according to the European Society for Clinical Nutrition and Metabolism (ESPEN) guidelines [1],the consented and enrolled 120 patients will be randomly assigned to one of the following groups and oral drug will be taken with sips of water:
- Group G (40 patients): Gabapentin (GaptinR) 400mg oral capsule
- Group T (40 patients): Trospium chloride slow release (TrospikanR SR) 60mg oral capsule
- Group C (40 patients): Non-pharmacological standard of care control group who administered nothing
- Incidence and severity of CRBD will be assessed by 4-point severity scale developed by Agarwal in1,2,6,12,24 hours after the study drugs intake . Assessment of pain severity and control will be done by using Numerical Pain Rating Scale (NPRS) and measuring total fentanyl requirements in the 1st 24h in micrograms (µg/day). Side effects of the study drugs will be recorded and managed accordingly with the use of Ramsay sedation score to assess sedation level one hour after the study drugs intake .
- Patients will continue their monitored care in the ICU till the control of the causes of their ICU admission or their end.
- Demographic data, causes for postoperative care in the ICU (Medical, surgical or anesthesia related) and spine surgery site and number for each (cervical, dorsal, lumber) will be collected and recorded.The collected study data results will be revised, electronically recorded in datasheet, coded, tabulated, analyzed, and processed using the proper computerized statistical package program. Suitable statistical analysis will be done according to the type of data obtained for each parameter with comparison between groups to identify any significant differences between them
- Being tested
- Gabapentin (Gaptin ®) 400mg oral capsule once, Trospium chloride slow release (Trospikan ® SR) 60mg oral capsule
- Keywords
- Catheter-related bladder discomfort (CRBD), Gabapentin, Trospium chloride, Intensive Care Unit (ICU), Postoperative care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gabapentin (Gaptin ®) 400mg oral capsule onceDrug
Also called Gaptin ®
After the patient will regain feeding, the patients will take with sips of water Gabapentin (Gaptin ®) 400mg oral capsule once in the first 24 hour after icu admission
Trospium chloride slow release (Trospikan ® SR) 60mg oral capsuleDrug
Also called Trospikan ® SR
After the patient will regain feeding, the patients will take with sips of water Trospium chloride slow release (Trospikan ® SR) 60mg oral capsule once in the first 24 hour after icu admission
| Study group | Role | What they receive |
|---|---|---|
| -Group G (40 patients): Gabapentin | Active comparator | After the patient will regain feeding, the patients will take with sips of water Gabapentin (Gaptin ®) 400mg oral capsule once in the first 24 hour after icu admission Receives: Drug: Gabapentin (Gaptin ®) 400mg oral capsule once |
| -Group T (40 patients): Trospium chloride slow release | Active comparator | After the patient will regain feeding, the patients will take with sips of water Trospium chloride slow release (Trospikan ® SR) 60mg oral capsule once in the first 24 hour after icu admission Receives: Drug: Trospium chloride slow release (Trospikan ® SR) 60mg oral capsule |
| Group C (40 patients): Non-pharmacological standard of care control group | No intervention | Non-pharmacological standard of care control group who administered nothing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence (yes/no) and severity of catheter-related bladder discomfort (CRBD) in 1,2,6,12,24 hours after the study drugs intake
Severity of CRBD will be assessed and recorded by a CRBD 4-point severity scale developed by Agarwal et al as following:
- No discomfort
- Mild: urinary urgency or suprapubic discomfort reported by the patient on questioning only
- Moderate: urinary urgency or suprapubic discomfort reported by the patient themselves without being questioned and not accompanied by behavioral changes
- Severe: urinary urgency or suprapubic discomfort reported by the patient themselves and accompanied by behavioral changes such as attempts to remove the catheter, verbal responses, and restless movements of extremities) [2]
Measured: First 24 hours after the study drugs intake
Secondary outcomes (4)
Total fentanyl requirements in micrograms (µg)
Total fentanyl requirements in the 1st 24h after study drugs intake in micrograms (µg/day)
Measured: First 24 hours after the study drugs intake
Numerical Pain Rating Scale (NPRS) (0-10)
NPRS for measurement of surgical pain intensity. It consists of a 10 cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').NPRS will be assessed at 1,2,6,12,24 hours after the study drugs intake.
Measured: First 24 hours after the study drugs intake
Side effects of the study drugs
They includes:
- Nausea and vomiting
- Dry mouth
- Light headedness or confusion
- Headache
- Tachycardia
- Blurred vision
- Facial flushing
- Agitation
- Constipation
Measured: First 24 hours after the study drugs intake
Ramsay sedation score
Ramsay sedation score [3].It will be assessed after one hour of the study drugs intake
Score Sedation level
- Awake; agitated or restless or both
- Awake; cooperative, oriented, and tranquil
- Awake but responds to commands only
- Asleep; brisk response to light glabellar tap or loud auditory stimulus
- Asleep; sluggish response to light glabellar tap or loud auditory stimulus
- Asleep; no response to glabellar tap or loud auditory stimulus
Measured: After one hour of the study drugs intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start10 Apr 2024
- Primary completion1 Sep 2024
- Study completion20 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Catheter-related Bladder Discomfort (CRBD)Studies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, randomized, comparative, clinical trial study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed M Mohamed, MD, Principal investigator, Ain Shames University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06346522
- Sponsor's protocol ID
- FMASU R37/2024
- Status last verified
- Mar 2024
- First submitted
- 29 Mar 2024
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The datasets used and analyzed during the current study are available from the corresponding author on reasonable request, with hiding of identities of participants or any personal information.
Publications
Weimann A, Braga M, Carli F, Higashiguchi T, Hubner M, Klek S, Laviano A, Ljungqvist O, Lobo DN, Martindale RG, Waitzberg D, Bischoff SC, Singer P. ESPEN practical guideline: Clinical nutrition in surgery. Clin Nutr. 2021 Jul;40(7):4745-4761. doi: 10.1016/j.clnu.2021.03.031. Epub 2021 Apr 19.
PubMed 34242915Agarwal A, Dhiraaj S, Singhal V, Kapoor R, Tandon M. Comparison of efficacy of oxybutynin and tolterodine for prevention of catheter related bladder discomfort: a prospective, randomized, placebo-controlled, double-blind study. Br J Anaesth. 2006 Mar;96(3):377-80. doi: 10.1093/bja/ael003. Epub 2006 Jan 16.
PubMed 16415311Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J. 1974 Jun 22;2(5920):656-9. doi: 10.1136/bmj.2.5920.656.
PubMed 4835444
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Gabapentin Versus Trospium Chloride for Prevention of Catheter-related Bladder Discomfort (CRBD) Inside the Intensive Care Unit (ICU): a Prospective, Randomized,Comparative Clinical Study
- ClinicalTrials.gov ID
- NCT06346522
- Acronym / sponsor ID
- FMASU R37/2024
- Keywords
- Catheter-related bladder discomfort (CRBD), Gabapentin, Trospium chloride, Intensive Care Unit (ICU), Postoperative care
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 20 Sep 2024 (actual)
- First posted
- 4 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Study will be conducted in the intensive care units (ICU) of Ain Shams University Hospitals, Cairo, Egypt
- After satisfactory pain control and full recovery in the postanesthesia care unit (PACU), the patient will be transferred to the ICU as a case of postoperative care after elective spinal diskectomy surgeries (cervical, dorsal or lumber) with removal of the damaged portion of the herniated or degenerated disks. Admission to ICU will be for medical, surgical or anesthesia related causes.
- Standard monitoring devices via GE monitor will be connected to the patient as electrocardiogram (ECG) for heart rate (beats/min), pulse oximetry for (SPO2 as a percentage) and non-invasive blood pressure (NIBP) (mmHg).Temperature of the patient in Celsius (◦C), random blood sugar (mg/dl) and urine output (ml/hour) will be monitored also. Follow-up by standard postoperative laboratory tests will be done too.
- After the patient will regain feeding according to the European Society for Clinical Nutrition and Metabolism (ESPEN) guidelines [1],the consented and enrolled 120 patients will be randomly assigned to one of the following groups and oral drug will be taken with sips of water:
- Group G (40 patients): Gabapentin (GaptinR) 400mg oral capsule
- Group T (40 patients): Trospium chloride slow release (TrospikanR SR) 60mg oral capsule
- Group C (40 patients): Non-pharmacological standard of care control group who administered nothing
- Incidence and severity of CRBD will be assessed by 4-point severity scale developed by Agarwal in1,2,6,12,24 hours after the study drugs intake . Assessment of pain severity and control will be done by using Numerical Pain Rating Scale (NPRS) and measuring total fentanyl requirements in the 1st 24h in micrograms (µg/day). Side effects of the study drugs will be recorded and managed accordingly with the use of Ramsay sedation score to assess sedation level one hour after the study drugs intake .
- Patients will continue their monitored care in the ICU till the control of the causes of their ICU admission or their end.
- Demographic data, causes for postoperative care in the ICU (Medical, surgical or anesthesia related) and spine surgery site and number for each (cervical, dorsal, lumber) will be collected and recorded.The collected study data results will be revised, electronically recorded in datasheet, coded, tabulated, analyzed, and processed using the proper computerized statistical package program. Suitable statistical analysis will be done according to the type of data obtained for each parameter with comparison between groups to identify any significant differences between them
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A prospective, randomized, comparative, clinical trial study
| Arm | Type | Receives |
|---|---|---|
| -Group G (40 patients): Gabapentin | Active comparator | Drug: Gabapentin (Gaptin ®) 400mg oral capsule onceAfter the patient will regain feeding, the patients will take with sips of water Gabapentin (Gaptin ®) 400mg oral capsule once in the first 24 hour after icu admission |
| -Group T (40 patients): Trospium chloride slow release | Active comparator | Drug: Trospium chloride slow release (Trospikan ® SR) 60mg oral capsuleAfter the patient will regain feeding, the patients will take with sips of water Trospium chloride slow release (Trospikan ® SR) 60mg oral capsule once in the first 24 hour after icu admission |
| Group C (40 patients): Non-pharmacological standard of care control group | No intervention | –Non-pharmacological standard of care control group who administered nothing |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gabapentin (Gaptin ®) 400mg oral capsule onceAlso: Gaptin ®After the patient will regain feeding, the patients will take with sips of water Gabapentin (Gaptin ®) 400mg oral capsule once in the first 24 hour after icu admission | Drug | -Group G (40 patients): Gabapentin |
| Trospium chloride slow release (Trospikan ® SR) 60mg oral capsuleAlso: Trospikan ® SRAfter the patient will regain feeding, the patients will take with sips of water Trospium chloride slow release (Trospikan ® SR) 60mg oral capsule once in the first 24 hour after icu admission | Drug | -Group T (40 patients): Trospium chloride slow release |
Primary outcome
The incidence (yes/no) and severity of catheter-related bladder discomfort (CRBD) in 1,2,6,12,24 hours after the study drugs intake
Time frame: First 24 hours after the study drugs intake
Severity of CRBD will be assessed and recorded by a CRBD 4-point severity scale developed by Agarwal et al as following: 1. No discomfort 2. Mild: urinary urgency or suprapubic discomfort reported by the patient on questioning only 3. Moderate: urinary urgency or suprapubic discomfort reported by the patient themselves without being questioned and not accompanied by behavioral changes 4. Severe: urinary urgency or suprapubic discomfort reported by the patient themselves and accompanied by behavioral changes such as attempts to remove the catheter, verbal responses, and restless movements of extremities) [2]
4 secondary outcomes
Total fentanyl requirements in micrograms (µg)
Time frame: First 24 hours after the study drugs intake
Numerical Pain Rating Scale (NPRS) (0-10)
Time frame: First 24 hours after the study drugs intake
Side effects of the study drugs
Time frame: First 24 hours after the study drugs intake
Ramsay sedation score
Time frame: After one hour of the study drugs intake
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Background: PubMed 34242915Weimann A, Braga M, Carli F, Higashiguchi T, Hubner M, Klek S, Laviano A, Ljungqvist O, Lobo DN, Martindale RG, Waitzberg D, Bischoff SC, Singer P. ESPEN practical guideline: Clinical nutrition in surgery. Clin Nutr. 2021 Jul;40(7):4745-4761. doi: 10.1016/j.clnu.2021.03.031. Epub 2021 Apr 19.
- Results publication: PubMed 16415311Agarwal A, Dhiraaj S, Singhal V, Kapoor R, Tandon M. Comparison of efficacy of oxybutynin and tolterodine for prevention of catheter related bladder discomfort: a prospective, randomized, placebo-controlled, double-blind study. Br J Anaesth. 2006 Mar;96(3):377-80. doi: 10.1093/bja/ael003. Epub 2006 Jan 16.
- Results publication: PubMed 4835444Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J. 1974 Jun 22;2(5920):656-9. doi: 10.1136/bmj.2.5920.656.
- Individual participant dataSharing planned: Undecided. The datasets used and analyzed during the current study are available from the corresponding author on reasonable request, with hiding of identities of participants or any personal information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed M Mohamed, MD principal investigator
Ain Shames University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gabapentin (Gaptin ®) 400mg oral capsule once and Trospium chloride slow release (Trospikan ® SR) 60mg oral capsule in people with Catheter-related Bladder Discomfort (CRBD), run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence (yes/no) and severity of catheter-related bladder discomfort (CRBD) in 1,2,6,12,24 hours after the study drugs intake (time frame: First 24 hours after the study drugs intake). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06346522, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.