Post Operative Urinary RetentionDEX-PURNCT07077850
Effect of IV Dexamethasone on Post-op Urinary Retention After Spinal Anesthesia
A study testing Dexamethasone (IV) and Normal Saline (0.9% NaCl) in people with Post Operative Urinary Retention and Spinal Aneshtesia, run by Al-Quds University at 1 site in Palestinian Territories.
Trial summary
What is this study about? This study is testing whether a common medication called dexamethasone, given through a vein (IV) before surgery, can help prevent a problem called postoperative urinary retention (POUR). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Operative Urinary Retention, Spinal Aneshtesia
- What is being tested?
- Dexamethasone (IV) and Normal Saline (0.9% NaCl)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,084 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 20 Aug 2025to 20 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients at Al-Makassed Hospital undergoing spinal anesthesia for surgery
Who cannot join
- Chronic steroid use
- Individuals who should not be administered dexamethasone
- Have a history of urological issues or procedures
- Have neurological disorders
- Using an intraoperative Foley's catheter
- Operations for possible nerve damage
Trial locations and contacts
1 site in 1 country.
Palestinian Territories1 site
Al-Makassed Islamic Charitable Society Hospital
East Jerusalem, Al-Makassed Islamic Charitable Society Hospital, 9710000
About this study
Official title: The Effectiveness of Intravenous Dexamethasone Prophylaxis in Preventing Post-operative Urinary Retention in Spinal Anesthesia at Al-Makassed Hospital
What is this study about? This study is testing whether a common medication called dexamethasone, given through a vein (IV) before surgery, can help prevent a problem called postoperative urinary retention (POUR). POUR means having trouble urinating after surgery, which can cause discomfort and sometimes requires using a catheter.
Who can join the study? The study includes adult People who are having surgery with spinal anesthesia at Al-Makassed Hospital. People who have certain medical conditions, use steroids regularly, or need a catheter during surgery cannot join.
Read more
What will happen in the study?
Participants will be randomly assigned to one of two groups:
- One group will get 8 mg of IV dexamethasone before surgery.
- The other group will get a saltwater (placebo) injection. Neither the participants nor the doctors will know which treatment they receive.
After surgery, the researchers will check how soon each participant can urinate and whether they need a catheter.
Why is this study important? POUR can slow recovery and cause complications. Dexamethasone is already used for other reasons like nausea and swelling. This study will help find out if it also lowers the risk of POUR in people getting spinal anesthesia.
Read the detailed description
Postoperative urinary retention (POUR) is a common complication following spinal anesthesia, affecting patient comfort, recovery, and sometimes requiring catheterization. While dexamethasone is routinely used to prevent nausea and inflammation in surgical patients, its potential role in preventing POUR has not been fully explored, especially in the context of spinal anesthesia.
This study is a prospective, randomized, double-blind, placebo-controlled clinical trial conducted at Al-Makassed Hospital. It aims to evaluate whether a single preoperative intravenous dose of 8 mg dexamethasone reduces the incidence of POUR in adult patients undergoing elective surgery under spinal anesthesia.
Eligible participants are randomized into two equal groups using block randomization. One group receives 8 mg of IV dexamethasone, and the other receives a placebo (0.9% saline). Both patients and assessors are blinded to group assignment. Data will be collected on age, BMI, comorbidities (including history of BPH or prior POUR), current anticholinergic drug use, anesthetic agent and dose, which level of spinal anesthesia (e.g. L3-L4), type of surgery, IV fluid volume, and duration of operation.
The primary outcome is the incidence of POUR, defined as failure to void within 6 hours after surgery and requiring catheterization. Secondary outcomes include time to first void and the overall need for urinary catheterization. Safety data will also be recorded, and any adverse events related to dexamethasone will be reported.
The study has been approved by the Al-Quds University Research Ethics Committee. All participants will provide informed consent prior to enrollment.
- Being tested
- Dexamethasone (IV), Normal Saline (0.9% NaCl)
- Keywords
- POUR, Spinal Anesthesia, Dexamethasone, Intravenous Corticosteriods, Urinary Complications, Perioperative Complications, Placebo-Controlled Trial, Randomized Controlled Trial, Al-Makassed Hospital, Postoperative Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone (IV)Drug
Also called Dexamethasone Sodium Phosphate
Intravenous administration of 8 mg dexamethasone sodium phosphate given as a single dose before surgery under spinal anesthesia. This corticosteroid is being evaluated for its potential to prevent postoperative urinary retention (POUR) by reducing inflammation and other perioperative effects.
Normal Saline (0.9% NaCl)Drug
Also called Isotonic Saline
Intravenous administration of 0.9% normal saline (placebo) given as a single dose before surgery under spinal anesthesia. This inert solution is used to compare against the active drug dexamethasone to determine its effect on postoperative urinary retention (POUR).
| Study group | Role | What they receive |
|---|---|---|
| Arm 2: Placebo Group (Participants receiving intravenous 0.9% saline as placebo) | Placebo comparator | Participants in this arm will receive an intravenous injection of 0.9% normal saline (placebo) before undergoing surgery under spinal anesthesia. This group is used to compare the effect of dexamethasone on the incidence of postoperative urinary retention (POUR). Receives: Drug: Normal Saline (0.9% NaCl) |
| Arm 1: Dexamethasone group | Experimental | Participants in this arm will receive a single 8 mg dose of intravenous dexamethasone before undergoing surgery under spinal anesthesia. The intervention is administered preoperatively to evaluate its effectiveness in reducing the risk of postoperative urinary retention (POUR). Receives: Drug: Dexamethasone (IV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative Urinary Retention (POUR)
The percentage of participants who fail to void within 6 hours after surgery and require urinary catheterization.
Measured: Measured within 6 hours postoperatively.
Secondary outcomes (3)
Time to First Urination
Time elapsed from the end of surgery until the participant first voids spontaneously.
Measured: Recorded within the first 24 hours after surgery.
Need for Urinary Catheterization
Number and percentage of participants who require catheterization at any time during postoperative monitoring.
Measured: During hospital stay post-surgery (up to 24 hours)
Adverse Events Related to Dexamethasone
Incidence and type of adverse events possibly related to dexamethasone administration (e.g., allergic reactions).
Measured: From drug administration to 24 hours postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start20 Aug 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Post Operative Urinary RetentionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned in a 1:1 ratio to receive either a single 8 mg dose of intravenous dexamethasone or a placebo (0.9% normal saline) prior to surgery under spinal anesthesia. Each participant remains in their assigned group throughout the study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,084 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Quds University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abeer Hasan, Al-Quds University
- Investigators
- Abeer J Dar Hasan, MD, Principal investigator, Al-Makassed Islamic Charitable Society Hospital and Al-Quds UniversityMohammed M Maree, MD, Study director, Al-Makassed Islamic Charitable Society Hospital and Al-Quds University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07077850
- Sponsor's protocol ID
- DEX-PUR Trial
- Acronym
- DEX-PUR
- Status last verified
- Jul 2026
- First submitted
- 12 Jul 2025
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because this study is conducted at a single center with limited infrastructure for data sharing. Additionally, the current ethical approval and informed consent do not include provisions for sharing de-identified participant-level data with external researchers.
Publications
Neff SP, Stapelberg F, Warmington A. Excruciating perineal pain after intravenous dexamethasone. Anaesth Intensive Care. 2002 Jun;30(3):370-1. doi: 10.1177/0310057X0203000319.
PubMed 12075649Toftegaard M, Knudsen F. Massive vasopressin-resistant polyuria induced by dexamethasone. Intensive Care Med. 1995 Mar;21(3):238-40. doi: 10.1007/BF01701480.
PubMed 7790612Primack A, Kajubi S. Insulin and growth hormone response to an oral glucose load in Ugandan hepatocellular carcinoma patients. East Afr Med J. 1974 Aug;51(8):574-8. No abstract available.
PubMed 4371198Denham M, Donovan K, Wetoska N, Kuchta K, Carbray J, Linn JG, Denham W, Haggerty SP, Joehl R, Ujiki M. Effects of dexamethasone on postoperative urinary retention after laparoscopic inguinal hernia repair. Surg Endosc. 2019 Sep;33(9):3008-3013. doi: 10.1007/s00464-018-6572-7. Epub 2018 Nov 7.
PubMed 30406386Splinter WM, Roberts DJ. Dexamethasone decreases vomiting by children after tonsillectomy. Anesth Analg. 1996 Nov;83(5):913-6. doi: 10.1097/00000539-199611000-00004.
PubMed 8895262Levin RM, Longhurst PA, Monson FC, Kato K, Wein AJ. Effect of bladder outlet obstruction on the morphology, physiology, and pharmacology of the bladder. Prostate Suppl. 1990;3:9-26. doi: 10.1002/pros.2990170503.
PubMed 1689174Kamphuis ET, Ionescu TI, Kuipers PW, de Gier J, van Venrooij GE, Boon TA. Recovery of storage and emptying functions of the urinary bladder after spinal anesthesia with lidocaine and with bupivacaine in men. Anesthesiology. 1998 Feb;88(2):310-6. doi: 10.1097/00000542-199802000-00007.
PubMed 9477049
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Intravenous Dexamethasone Prophylaxis in Preventing Post-operative Urinary Retention in Spinal Anesthesia at Al-Makassed Hospital
- ClinicalTrials.gov ID
- NCT07077850
- Acronym / sponsor ID
- DEX-PUR / DEX-PUR Trial
- Keywords
- POUR, Spinal Anesthesia, Dexamethasone, Intravenous Corticosteriods, Urinary Complications, Perioperative Complications, Placebo-Controlled Trial, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,084 participants (actual)
- Lead sponsor
- Al-Quds UniversityUniversity, hospital or other
- Study start
- 20 Aug 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 22 Jul 2025 (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.
What is this study about? This study is testing whether a common medication called dexamethasone, given through a vein (IV) before surgery, can help prevent a problem called postoperative urinary retention (POUR). POUR means having trouble urinating after surgery, which can cause discomfort and sometimes requires using a catheter.
Who can join the study? The study includes adult People who are having surgery with spinal anesthesia at Al-Makassed Hospital. People who have certain medical conditions, use steroids regularly, or need a catheter during surgery cannot join.
What will happen in the study?
Participants will be randomly assigned to one of two groups:
- One group will get 8 mg of IV dexamethasone before surgery.
- The other group will get a saltwater (placebo) injection. Neither the participants nor the doctors will know which treatment they receive.
After surgery, the researchers will check how soon each participant can urinate and whether they need a catheter.
Why is this study important? POUR can slow recovery and cause complications. Dexamethasone is already used for other reasons like nausea and swelling. This study will help find out if it also lowers the risk of POUR in people getting spinal anesthesia.
Detailed description
Postoperative urinary retention (POUR) is a common complication following spinal anesthesia, affecting patient comfort, recovery, and sometimes requiring catheterization. While dexamethasone is routinely used to prevent nausea and inflammation in surgical patients, its potential role in preventing POUR has not been fully explored, especially in the context of spinal anesthesia.
This study is a prospective, randomized, double-blind, placebo-controlled clinical trial conducted at Al-Makassed Hospital. It aims to evaluate whether a single preoperative intravenous dose of 8 mg dexamethasone reduces the incidence of POUR in adult patients undergoing elective surgery under spinal anesthesia.
Eligible participants are randomized into two equal groups using block randomization. One group receives 8 mg of IV dexamethasone, and the other receives a placebo (0.9% saline). Both patients and assessors are blinded to group assignment. Data will be collected on age, BMI, comorbidities (including history of BPH or prior POUR), current anticholinergic drug use, anesthetic agent and dose, which level of spinal anesthesia (e.g. L3-L4), type of surgery, IV fluid volume, and duration of operation.
The primary outcome is the incidence of POUR, defined as failure to void within 6 hours after surgery and requiring catheterization. Secondary outcomes include time to first void and the overall need for urinary catheterization. Safety data will also be recorded, and any adverse events related to dexamethasone will be reported.
The study has been approved by the Al-Quds University Research Ethics Committee. All participants will provide informed consent prior to enrollment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned in a 1:1 ratio to receive either a single 8 mg dose of intravenous dexamethasone or a placebo (0.9% normal saline) prior to surgery under spinal anesthesia. Each participant remains in their assigned group throughout the study.
| Arm | Type | Receives |
|---|---|---|
| Arm 2: Placebo Group (Participants receiving intravenous 0.9% saline as placebo) | Placebo comparator | Drug: Normal Saline (0.9% NaCl)Participants in this arm will receive an intravenous injection of 0.9% normal saline (placebo) before undergoing surgery under spinal anesthesia. This group is used to compare the effect of dexamethasone on the incidence of postoperative urinary retention (POUR). |
| Arm 1: Dexamethasone group | Experimental | Drug: Dexamethasone (IV)Participants in this arm will receive a single 8 mg dose of intravenous dexamethasone before undergoing surgery under spinal anesthesia. The intervention is administered preoperatively to evaluate its effectiveness in reducing the risk of postoperative urinary retention (POUR). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients at Al-Makassed Hospital undergoing spinal anesthesia for surgery
Key exclusion criteria (6 listed)
- Chronic steroid use
- Individuals who should not be administered dexamethasone
- Have a history of urological issues or procedures
- Have neurological disorders
- Using an intraoperative Foley's catheter
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 |
|---|---|---|
| Dexamethasone (IV)Also: Dexamethasone Sodium PhosphateIntravenous administration of 8 mg dexamethasone sodium phosphate given as a single dose before surgery under spinal anesthesia. This corticosteroid is being evaluated for its potential to prevent postoperative urinary retention (POUR) by reducing inflammation and other perioperative effects. | Drug | Arm 1: Dexamethasone group |
| Normal Saline (0.9% NaCl)Also: Isotonic SalineIntravenous administration of 0.9% normal saline (placebo) given as a single dose before surgery under spinal anesthesia. This inert solution is used to compare against the active drug dexamethasone to determine its effect on postoperative urinary retention (POUR). | Drug | Arm 2: Placebo Group (Participants receiving intravenous 0.9% saline as placebo) |
Primary outcome
Incidence of Postoperative Urinary Retention (POUR)
Time frame: Measured within 6 hours postoperatively.
The percentage of participants who fail to void within 6 hours after surgery and require urinary catheterization.
3 secondary outcomes
Time to First Urination
Time frame: Recorded within the first 24 hours after surgery.
Need for Urinary Catheterization
Time frame: During hospital stay post-surgery (up to 24 hours)
Adverse Events Related to Dexamethasone
Time frame: From drug administration to 24 hours postoperative.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Background: PubMed 12075649Neff SP, Stapelberg F, Warmington A. Excruciating perineal pain after intravenous dexamethasone. Anaesth Intensive Care. 2002 Jun;30(3):370-1. doi: 10.1177/0310057X0203000319.
- Background: PubMed 7790612Toftegaard M, Knudsen F. Massive vasopressin-resistant polyuria induced by dexamethasone. Intensive Care Med. 1995 Mar;21(3):238-40. doi: 10.1007/BF01701480.
- Background: PubMed 4371198Primack A, Kajubi S. Insulin and growth hormone response to an oral glucose load in Ugandan hepatocellular carcinoma patients. East Afr Med J. 1974 Aug;51(8):574-8. No abstract available.
- Background: PubMed 30406386Denham M, Donovan K, Wetoska N, Kuchta K, Carbray J, Linn JG, Denham W, Haggerty SP, Joehl R, Ujiki M. Effects of dexamethasone on postoperative urinary retention after laparoscopic inguinal hernia repair. Surg Endosc. 2019 Sep;33(9):3008-3013. doi: 10.1007/s00464-018-6572-7. Epub 2018 Nov 7.
- Background: PubMed 8895262Splinter WM, Roberts DJ. Dexamethasone decreases vomiting by children after tonsillectomy. Anesth Analg. 1996 Nov;83(5):913-6. doi: 10.1097/00000539-199611000-00004.
- Background: PubMed 1689174Levin RM, Longhurst PA, Monson FC, Kato K, Wein AJ. Effect of bladder outlet obstruction on the morphology, physiology, and pharmacology of the bladder. Prostate Suppl. 1990;3:9-26. doi: 10.1002/pros.2990170503.
- Background: PubMed 9477049Kamphuis ET, Ionescu TI, Kuipers PW, de Gier J, van Venrooij GE, Boon TA. Recovery of storage and emptying functions of the urinary bladder after spinal anesthesia with lidocaine and with bupivacaine in men. Anesthesiology. 1998 Feb;88(2):310-6. doi: 10.1097/00000542-199802000-00007.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because this study is conducted at a single center with limited infrastructure for data sharing. Additionally, the current ethical approval and informed consent do not include provisions for sharing de-identified participant-level data with external researchers.
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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.
Abeer J Dar Hasan, MD principal investigator
Al-Makassed Islamic Charitable Society Hospital and Al-Quds University
Mohammed M Maree, MD study director
Al-Makassed Islamic Charitable Society Hospital and Al-Quds University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone (IV) and Normal Saline (0.9% NaCl) in people with Post Operative Urinary Retention and Spinal Aneshtesia, run by Al-Quds University at 1 site in Palestinian Territories.
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 1 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2026. 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 Palestinian Territories. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of Postoperative Urinary Retention (POUR) (time frame: Measured within 6 hours postoperatively.). 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 NCT07077850, which also lists 7 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 14 Jul 2026.