HerniaPhase 4NCT03027115
Hernia Surgery Urinary Retention
A Phase 4 study testing Tamsulosin in people with Hernia and Urinary Retention, run by Memorial Health University Medical Center at 1 site in United States.
Trial summary
Investigating whether pre-operative treatment with a selective alpha1-adrenoceptor antagonist affects the likelihood of male patients developing post-operative urinary retention following hernia repair. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hernia, Urinary Retention
- What is being tested?
- Tamsulosin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2017to 27 Jan 2020
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male
- 18 years of age
- Presenting with hernia requiring surgical intervention
Who cannot join
- Intolerability of tamsulosin or related drugs
- Investigator discretion
- Unwillingness or inability to comply with protocol procedures and assessments
Trial locations and contacts
1 site in 1 country.
Andrew Schwemmer, M.D. contact
United States1 site, 1 recruiting
- Recruiting
Memorial Health University Medical Center
Savannah, Georgia, 31404
Vishu Danthuluri, M.D., 256-665-5214, vishwanathdanthuluri@memorialhealth.com
Andrew Schwemmer, M.D., SchweAn2@memorialhealth.com
About this study
Official title: Post-operative Urinary Retention: A Prospective Randomized Study Identifying Patients at Risk and Reducing the Incidence Using Tamsulosin Pretreatment
Investigating whether pre-operative treatment with a selective alpha1-adrenoceptor antagonist affects the likelihood of male patients developing post-operative urinary retention following hernia repair.
Read the detailed description
The purpose of this study will be to investigate whether pre-operative treatment with a selective alpha1-adrenoceptor antagonist affects the likelihood of male patients developing post-operative urinary retention following hernia repair surgery. It is also of interest to determine whether or not a well-known urological screening tool, the IPSS, can identify patients at risk for urinary retention following elective laparoscopic or open hernia repair surgery. We will investigate if it is possible to pre-treat patients with a selective alpha1-adrenoceptor antagonist which we think can reduce the incidence of post-operative urinary retention and the associated adverse consequences, especially in those patients at higher risk.
- Conditions
- Hernia, Urinary Retention
- Being tested
- Tamsulosin
- Medical subject headings
- Hernia, Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamsulosinDrug
Also called Flomax
Tamsulosin treatment for 7 days pre-operatively
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | treatment with a selective alpha1-adrenoceptor antagonist Receives: Drug: Tamsulosin |
| Control | No intervention | no treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative urinary retention
Incidence of post-operative urinary retention in patients undergoing hernia repair
Measured: 2 weeks
Secondary outcomes (1)
Effect of IPSS
the variance in the relationship between treatment arm and incidence of post-operative urinary retention in patients undergoing hernia repair that is attributable to International Prostate Symptom Score (IPSS)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2017 (estimated)
- Study start13 Jan 2017
- Primary completion13 Jan 2020 (estimated)
- Study completion27 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HerniaStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization to 1 of 2 possible arms, control and treatment
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Health University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03027115
- Sponsor's protocol ID
- MHUMC 2016.10.05
- Status last verified
- Mar 2018
- First submitted
- 18 Jan 2017
- Last updated
- 23 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Urinary Retention: A Prospective Randomized Study Identifying Patients at Risk and Reducing the Incidence Using Tamsulosin Pretreatment
- ClinicalTrials.gov ID
- NCT03027115
- Acronym / sponsor ID
- MHUMC 2016.10.05
- Conditions
- Hernia, Urinary Retention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Memorial Health University Medical CenterUniversity, hospital or other
- Study start
- 13 Jan 2017 (actual)
- Primary completion
- 13 Jan 2020 (estimated)
- Study completion
- 27 Jan 2020 (estimated)
- First posted
- 20 Jan 2017 (estimated)
- 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.
Investigating whether pre-operative treatment with a selective alpha1-adrenoceptor antagonist affects the likelihood of male patients developing post-operative urinary retention following hernia repair.
Detailed description
The purpose of this study will be to investigate whether pre-operative treatment with a selective alpha1-adrenoceptor antagonist affects the likelihood of male patients developing post-operative urinary retention following hernia repair surgery. It is also of interest to determine whether or not a well-known urological screening tool, the IPSS, can identify patients at risk for urinary retention following elective laparoscopic or open hernia repair surgery. We will investigate if it is possible to pre-treat patients with a selective alpha1-adrenoceptor antagonist which we think can reduce the incidence of post-operative urinary retention and the associated adverse consequences, especially in those patients at higher risk.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization to 1 of 2 possible arms, control and treatment
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Tamsulosintreatment with a selective alpha1-adrenoceptor antagonist |
| Control | No intervention | –no treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male
- 18 years of age
- Presenting with hernia requiring surgical intervention
Key exclusion criteria (3 listed)
- Intolerability of tamsulosin or related drugs
- Investigator discretion
- Unwillingness or inability to comply with protocol procedures and assessments
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 |
|---|---|---|
| TamsulosinAlso: FlomaxTamsulosin treatment for 7 days pre-operatively | Drug | Treatment |
Primary outcome
Post-operative urinary retention
Time frame: 2 weeks
Incidence of post-operative urinary retention in patients undergoing hernia repair
1 secondary outcome
Effect of IPSS
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2018.
- Individual participant dataSharing planned: No. There is no plan to share IPD.
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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.
Andrew Schwemmer, M.D. contact
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 Tamsulosin in people with Hernia and Urinary Retention, run by Memorial Health University Medical Center at 1 site in United States.
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 3 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: status not confirmed, as of the sponsor's last update on 23 Mar 2018. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vishu Danthuluri, M.D. (256.665-6214, vishwanathdanthuluri@memorialhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative urinary retention (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2018.