Urinary RetentionPhase 4STOP-POURNCT04491526
Study to Prevent Postoperative Urinary Retention
A Phase 4 study testing TAMSULOSIN Mepha Ret Depocaps 0.4 mg in people with Urinary Retention and Inguinal Hernia, run by Antonio Nocito, MD at 1 site in Switzerland.
Trial summary
Post-operative urinary retention (POUR) is a common complication after inguinal hernia repair with a reported incidence up 34%. It can be described as the inability to initiate urination or properly empty one's bladder following surgery. Read more about this study
- Who is it for?
- Ages 60 years and older, men only
- Conditions the study is for
- Urinary Retention, Inguinal Hernia
- What is being tested?
- TAMSULOSIN Mepha Ret Depocaps 0.4 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 312 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2020to 9 Feb 2026
- 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 60 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males
- ≥60 years old
- Planned uni- or bilateral endoscopic total extraperitoneal inguinal hernia repair
- Surgery scheduled more than 6 days from the time of consent
- Informed Consent as documented by signature (Appendix Informed Consent Form)
Who cannot join
- Orthostatic hypotension (feeling of dizziness after getting up from a sitting or lying position)
- Severe liver disease (Child Pugh C)
- Taking strong inhibitors of CYP3A4 (ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir/ritonavir, lopinavir, or conivaptan)
- Being on alpha-blockers (alfuzosin, doxazosin, prazosin, terazosin, tamsulosin, phenoxybenzamine, or silodosin) or a combination product containing alpha-blocker (duodart)
- History of allergy or sensitivity to tamsulosin or other alpha-blockers (alfuzosin, doxazosin, prazosin, terazosin, or phenoxybenzamine)
- Long term Indwelling urinary or suprapubic catheter
Show all 12Show fewer
- Status post cystectomy
- Inability to provide informed consent
- Known or suspected non-compliance, drug or alcohol abuse,
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- Participation in another study with investigational drug within the 30 days preceding and during the present study,
- Previous enrolment into the current study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Quadruple Blinded, Placebo Controlled, Multi-centered Trial Investigating Prophylactic Tamsulosin in Prevention of Postoperative Urinary Retention in Men After Endoscopic Total Extraperitoneal Inguinal Hernia Repair
Post-operative urinary retention (POUR) is a common complication after inguinal hernia repair with a reported incidence up 34%. It can be described as the inability to initiate urination or properly empty one's bladder following surgery. It is usually self-limited, but it requires the use of catheterization to empty the bladder in order to prevent further injury to the bladder or kidneys and to relief the discomfort of a full bladder. Tamsulosin is a medication that is commonly used in men with urinary symptoms related to an enlarged prostate. There is some evidence to suggest that it may also potentially be beneficial for preventing post-operative urinary retention.
The purpose of this study is to determine if tamsulosin ("TAMSULOSIN Mepha Ret Depocaps 0.4 mg") is effective in preventing post-operative urinary retention following endoscopic total extraperitoneal inguinal hernia repair and its impact on hospital length of stay.
Read the detailed description
In this RCT subjects are randomly and parallel assigned to one of two groups: one (the experimental group) receiving "Tamsulosin 0.4 mg"/ day, 5 days prior to the day of laparoscopic inguinal hernia repair surgery, at the day of surgery and for 1 day following surgery. (5+1+1), and the other (the control group) receiving one placebo capsule matching the active study drug per day from 5 days prior to the day of surgery, at the day of surgery and for 1 day following surgery. (5+1+1). There will be effective (concealed) randomization of the subjects to the intervention/control groups (to eliminate selection bias and minimize confounding variables). Both groups will be treated identically in all respects except for the intervention being tested and to this end patients, investigators, care providers and outcomes assessors will be blinded to which group an individual is assigned. Group assignment will be performed using a covariate-adaptive allocation procedure to provide a balance for selected covariates (Site, IPSS-Score, Age, "uni- or bilateral surgery" and "history of prostate or bladder surgery". To achieve that; Minimization, first described by Taves [and expanded by Pocock and Simon [the most commonly used covariate-adaptive randomization method will be applied. It achieves the balance in treatment assignments across factor levels by choosing the allocation for the new subject that would lead to the smallest degree of imbalance possible across the set of his baseline characteristics. The two groups are then followed up to 3 days after surgery to see if there are any differences between them in primary and secondary outcomes. Patients are analyzed within the group to which they were allocated, irrespective of whether they experienced the intended intervention (intention to treat analysis). This RCT is designed as a superiority trial and aims to demonstrate the superiority of Tamsulosin in prevention of POUR compared to placebo. We anticipate the detection of a 65% relative risk reduction of POUR in the experimental group in comparison with the placebo group. To detect a 65% reduction of POUR in the experimental group (2.9% anticipated) in comparison with the placebo group (8.3% anticipated) and to assure a study power of 80% with a Fisher's Exact Test and a significance level of 5% and adjusting for a drop-out rate of 2% we need 634 patients in total; 317 in each group. Our target population consists of male patients ≥ 60 yrs, scheduled for elective endoscopic inguinal hernia repair. The studied sample is appropriate to the hypothesis being tested so that any results will be appropriately generalizable.
- Conditions
- Urinary Retention, Inguinal Hernia
- Being tested
- TAMSULOSIN Mepha Ret Depocaps 0.4 mg, Control Intervention
- Keywords
- Urinary Retention, Inguinal Hernia Repair, alpha-1 adrenergic receptor antagonists, IPSS
- Medical subject headings
- Urinary Retention, Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAMSULOSIN Mepha Ret Depocaps 0.4 mgDrug
Also called Verum
0.4mg/day Tamsulosin hydrochloride ("TAMSULOSIN Mepha Ret Depocaps 0.4 mg") from 5 days prior to the day of surgery, at the day of surgery and for 1 day following surgery. (5+1+1)
Control InterventionDrug
Also called Placebo
One placebo capsule matching the active study drug per day from 5 days prior to the day of surgery, at the day of surgery and for 1 day following surgery. (5+1+1)
| Study group | Role | What they receive |
|---|---|---|
| Tamsulosin Arm | Experimental | p.o. Receives: Drug: TAMSULOSIN Mepha Ret Depocaps 0.4 mg |
| Placebo Arm | Placebo comparator | p.o. Receives: Drug: Control Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative urinary retention (Need for any catheterization postoperatively)
Need for any catheterization postoperatively (Yes/No)
Measured: up to 3 days after surgery
Secondary outcomes (23)
Time to first voiding after surgery
secondary outcomes in Non-POUR Patients
Measured: up to 3 days after surgery
Urinary Volume measurement at defined points in time (n)
secondary outcomes in all Patients
Measured: up to 12 hours after surgery
Volume of first micturition after surgery
secondary outcomes in Non-POUR Patients
Measured: up to 12 hours after surgery
Post-operative Pain (Quantity of Pain / VAS-Score)
Quantity of pain is verified at arrival in the PACU and at every 6 hours by the nursing staff, using the standardised numeric rating scale. The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older.
Measured: up to 3 days after surgery
Need for opioid analgesics post operatively
secondary outcomes in all Patients
Measured: up to 3 days after surgery
Quantity of post-operative opioid use (opioid dosage will be converted to oral morphine equivalence dose)
opioid use is documented in the patient's record, opioid dosage will be converted to oral morphine equivalence dose
Measured: up to 3 days after surgery
Intraoperative applications of opioid analgesics (Yes/No)
Opioid use during surgery is documented in the patient's record, this is a binary endpoint opioid use; (yes/ no)
Measured: intra-operative period
Quantity of intra-operative opioid use opioid dosage will be converted to oral morphine equivalence dose)
Opioid use during surgery is documented in the patient's record, opioid dosage will be converted to oral morphine equivalence dose
Measured: intra-operative period
Amount of intraoperative fluid administration
Intraoperative fluid administration (in milliliter) is documented in the patient's record
Measured: intra-operative period
International Prostate Symptom Score (IPSS score) pre-surgery (-5d)
0-7 Mildly symptomatic / 8-19 Moderately symptomatic / 20-35 Severely symptomatic
Measured: min. 5 days prior to surgery
International Prostate Symptom Score (IPSS score) post-surgery (3d)
0-7 Mildly symptomatic / 8-19 Moderately symptomatic / 20-35 Severely symptomatic
Measured: 3 days post surgery
Change in International Prostate Symptom Score (IPSS score) from baseline prior to surgery (-5d) to day 3(+3d) after surgery
0-7 Mildly symptomatic / 8-19 Moderately symptomatic / 20-35 Severely symptomatic
Measured: 3 days post surgery
Side-effects of study medication (orthostatic hypotension, retrograde ejaculation, Floppy-Iris-Syndrom)
Will be documented in the patient record by the study personnel, binary endpoint (Yes/No)
Measured: 5 days prior to surgery (-5d) to day 3(+3d) after surgery
In hospital complications (using the evaluated standard classification for complication in surgery (Classification Grade I-V) )
secondary outcomes in all Patients
Measured: as long as the patient is labeled inpatient, on average 1-3 days
Length of hospital stay in days (Inpatients)
secondary outcomes in all Patients
Measured: as long as the patient is labeled inpatient, on average 1-3 days
Time to discharge after surgery in hours (outpatients)
secondary outcomes in all Patients
Measured: up to 12 hours after surgery
Residual urinary volume after catherization
secondary outcomes in POUR Patients
Measured: up to 12 hours after surgery
Macrohematuria
secondary outcomes in POUR Patients
Measured: 3 days post surgery
Relevant injury to the urethra (Presence of a Via falsa diagnosed by a urologist)
secondary outcomes in POUR Patients
Measured: 3 days post surgery
Catheter-related infections
secondary outcomes in POUR Patients
Measured: 3 days post surgery
Catheter-related bladder discomfort ( (Ggrading according to the 3three Ggrades (mild, moderate, severe)
secondary outcomes in POUR Patients
Measured: 3 days post surgery
Prostatitis
secondary outcomes in POUR Patients
Measured: 3 days post surgery
Failed first trial without catheter (TWOC: need for a second catheter insertion due to insufficient voiding after TWOC).
secondary outcomes in POUR Patients
Measured: 1 day post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start1 Nov 2020
- Primary completion9 Feb 2026
- Study completion9 Feb 2026
Why it stopped: The study was terminated prematurely following a pre-planned interim analysis demonstrating futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antonio Nocito, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Antonio Nocito, MD, Kantonsspital Baden
- Investigators
- Antonio Nocito, Prof, Principal investigator, Kantonsspital Baden AG, Im Ergel 1, 5404 Baden, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04491526
- Sponsor's protocol ID
- 2020-00569
- Acronym
- STOP-POUR
- Status last verified
- Feb 2026
- First submitted
- 23 Jul 2020
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified participant data are available upon reasonable request from https://orcid.org/0000-0002-7339-1458.
Publications
Bieri U, Slieker J, Hefermehl LJ, Soppe S, Teufelberger G, Tedaldi R, Graf N, Bieri M, Nocito A. Randomised, quadruple blinded, placebo controlled, multicentre trial investigating prophylactic tamsulosin in prevention of postoperative urinary retention in men after endoscopic total extraperitoneal inguinal hernia repair (STOP-POUR trial): a study protocol. BMJ Open. 2021 Dec 7;11(12):e048911. doi: 10.1136/bmjopen-2021-048911.
PubMed 34876420
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Quadruple Blinded, Placebo Controlled, Multi-centered Trial Investigating Prophylactic Tamsulosin in Prevention of Postoperative Urinary Retention in Men After Endoscopic Total Extraperitoneal Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT04491526
- Acronym / sponsor ID
- STOP-POUR / 2020-00569
- Conditions
- Urinary Retention, Inguinal Hernia
- Keywords
- Urinary Retention, Inguinal Hernia Repair, alpha-1 adrenergic receptor antagonists, IPSS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated prematurely following a pre-planned interim analysis demonstrating futility
- Enrolment
- 312 participants (actual)
- Lead sponsor
- Antonio Nocito, MDUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 9 Feb 2026 (actual)
- Study completion
- 9 Feb 2026 (actual)
- First posted
- 29 Jul 2020 (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.
Post-operative urinary retention (POUR) is a common complication after inguinal hernia repair with a reported incidence up 34%. It can be described as the inability to initiate urination or properly empty one's bladder following surgery. It is usually self-limited, but it requires the use of catheterization to empty the bladder in order to prevent further injury to the bladder or kidneys and to relief the discomfort of a full bladder. Tamsulosin is a medication that is commonly used in men with urinary symptoms related to an enlarged prostate. There is some evidence to suggest that it may also potentially be beneficial for preventing post-operative urinary retention.
The purpose of this study is to determine if tamsulosin ("TAMSULOSIN Mepha Ret Depocaps 0.4 mg") is effective in preventing post-operative urinary retention following endoscopic total extraperitoneal inguinal hernia repair and its impact on hospital length of stay.
Detailed description
In this RCT subjects are randomly and parallel assigned to one of two groups: one (the experimental group) receiving "Tamsulosin 0.4 mg"/ day, 5 days prior to the day of laparoscopic inguinal hernia repair surgery, at the day of surgery and for 1 day following surgery. (5+1+1), and the other (the control group) receiving one placebo capsule matching the active study drug per day from 5 days prior to the day of surgery, at the day of surgery and for 1 day following surgery. (5+1+1). There will be effective (concealed) randomization of the subjects to the intervention/control groups (to eliminate selection bias and minimize confounding variables). Both groups will be treated identically in all respects except for the intervention being tested and to this end patients, investigators, care providers and outcomes assessors will be blinded to which group an individual is assigned. Group assignment will be performed using a covariate-adaptive allocation procedure to provide a balance for selected covariates (Site, IPSS-Score, Age, "uni- or bilateral surgery" and "history of prostate or bladder surgery". To achieve that; Minimization, first described by Taves [and expanded by Pocock and Simon [the most commonly used covariate-adaptive randomization method will be applied. It achieves the balance in treatment assignments across factor levels by choosing the allocation for the new subject that would lead to the smallest degree of imbalance possible across the set of his baseline characteristics. The two groups are then followed up to 3 days after surgery to see if there are any differences between them in primary and secondary outcomes. Patients are analyzed within the group to which they were allocated, irrespective of whether they experienced the intended intervention (intention to treat analysis). This RCT is designed as a superiority trial and aims to demonstrate the superiority of Tamsulosin in prevention of POUR compared to placebo. We anticipate the detection of a 65% relative risk reduction of POUR in the experimental group in comparison with the placebo group. To detect a 65% reduction of POUR in the experimental group (2.9% anticipated) in comparison with the placebo group (8.3% anticipated) and to assure a study power of 80% with a Fisher's Exact Test and a significance level of 5% and adjusting for a drop-out rate of 2% we need 634 patients in total; 317 in each group. Our target population consists of male patients ≥ 60 yrs, scheduled for elective endoscopic inguinal hernia repair. The studied sample is appropriate to the hypothesis being tested so that any results will be appropriately generalizable.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tamsulosin Arm | Experimental | Drug: TAMSULOSIN Mepha Ret Depocaps 0.4 mgp.o. |
| Placebo Arm | Placebo comparator | Drug: Control Interventionp.o. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males
- ≥60 years old
- Planned uni- or bilateral endoscopic total extraperitoneal inguinal hernia repair
- Surgery scheduled more than 6 days from the time of consent
- Informed Consent as documented by signature (Appendix Informed Consent Form)
Key exclusion criteria (12 listed)
- Orthostatic hypotension (feeling of dizziness after getting up from a sitting or lying position)
- Severe liver disease (Child Pugh C)
- Taking strong inhibitors of CYP3A4 (ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir/ritonavir, lopinavir, or conivaptan)
- Being on alpha-blockers (alfuzosin, doxazosin, prazosin, terazosin, tamsulosin, phenoxybenzamine, or silodosin) or a combination product containing alpha-blocker (duodart)
- History of allergy or sensitivity to tamsulosin or other alpha-blockers (alfuzosin, doxazosin, prazosin, terazosin, or phenoxybenzamine)
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 |
|---|---|---|
| TAMSULOSIN Mepha Ret Depocaps 0.4 mgAlso: Verum0.4mg/day Tamsulosin hydrochloride ("TAMSULOSIN Mepha Ret Depocaps 0.4 mg") from 5 days prior to the day of surgery, at the day of surgery and for 1 day following surgery. (5+1+1) | Drug | Tamsulosin Arm |
| Control InterventionAlso: PlaceboOne placebo capsule matching the active study drug per day from 5 days prior to the day of surgery, at the day of surgery and for 1 day following surgery. (5+1+1) | Drug | Placebo Arm |
Primary outcome
Post operative urinary retention (Need for any catheterization postoperatively)
Time frame: up to 3 days after surgery
Need for any catheterization postoperatively (Yes/No)
23 secondary outcomes
Time to first voiding after surgery
Time frame: up to 3 days after surgery
Urinary Volume measurement at defined points in time (n)
Time frame: up to 12 hours after surgery
Volume of first micturition after surgery
Time frame: up to 12 hours after surgery
Post-operative Pain (Quantity of Pain / VAS-Score)
Time frame: up to 3 days after surgery
Need for opioid analgesics post operatively
Time frame: up to 3 days after surgery
Quantity of post-operative opioid use (opioid dosage will be converted to oral morphine equivalence dose)
Time frame: up to 3 days after surgery
Intraoperative applications of opioid analgesics (Yes/No)
Time frame: intra-operative period
Quantity of intra-operative opioid use opioid dosage will be converted to oral morphine equivalence dose)
Time frame: intra-operative period
Amount of intraoperative fluid administration
Time frame: intra-operative period
International Prostate Symptom Score (IPSS score) pre-surgery (-5d)
Time frame: min. 5 days prior to surgery
International Prostate Symptom Score (IPSS score) post-surgery (3d)
Time frame: 3 days post surgery
Change in International Prostate Symptom Score (IPSS score) from baseline prior to surgery (-5d) to day 3(+3d) after surgery
Time frame: 3 days post surgery
Side-effects of study medication (orthostatic hypotension, retrograde ejaculation, Floppy-Iris-Syndrom)
Time frame: 5 days prior to surgery (-5d) to day 3(+3d) after surgery
In hospital complications (using the evaluated standard classification for complication in surgery (Classification Grade I-V) )
Time frame: as long as the patient is labeled inpatient, on average 1-3 days
Length of hospital stay in days (Inpatients)
Time frame: as long as the patient is labeled inpatient, on average 1-3 days
Time to discharge after surgery in hours (outpatients)
Time frame: up to 12 hours after surgery
Residual urinary volume after catherization
Time frame: up to 12 hours after surgery
Macrohematuria
Time frame: 3 days post surgery
Relevant injury to the urethra (Presence of a Via falsa diagnosed by a urologist)
Time frame: 3 days post surgery
Catheter-related infections
Time frame: 3 days post surgery
Catheter-related bladder discomfort ( (Ggrading according to the 3three Ggrades (mild, moderate, severe)
Time frame: 3 days post surgery
Prostatitis
Time frame: 3 days post surgery
Failed first trial without catheter (TWOC: need for a second catheter insertion due to insufficient voiding after TWOC).
Time frame: 1 day post surgery
Results and safety
The study was stopped early (reason given: The study was terminated prematurely following a pre-planned interim analysis demonstrating futility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Derived from this study: PubMed 34876420Bieri U, Slieker J, Hefermehl LJ, Soppe S, Teufelberger G, Tedaldi R, Graf N, Bieri M, Nocito A. Randomised, quadruple blinded, placebo controlled, multicentre trial investigating prophylactic tamsulosin in prevention of postoperative urinary retention in men after endoscopic total extraperitoneal inguinal hernia repair (STOP-POUR trial): a study protocol. BMJ Open. 2021 Dec 7;11(12):e048911. doi: 10.1136/bmjopen-2021-048911.
- Individual participant dataSharing planned: Yes. Deidentified participant data are available upon reasonable request from https://orcid.org/0000-0002-7339-1458.
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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.
Antonio Nocito, Prof principal investigator
Kantonsspital Baden AG, Im Ergel 1, 5404 Baden, Switzerland
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 Mepha Ret Depocaps 0.4 mg in people with Urinary Retention and Inguinal Hernia, run by Antonio Nocito, MD at 1 site in Switzerland.
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 5 inclusion and 12 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: stopped early, as of the sponsor's last update on 17 Feb 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 Switzerland. 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.
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 was stopped early (reason given: The study was terminated prematurely following a pre-planned interim analysis demonstrating futility). Results are not available in the source record.
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?
Post operative urinary retention (Need for any catheterization postoperatively) (time frame: up to 3 days after surgery). 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 NCT04491526, which also lists 1 linked publication.
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 17 Feb 2026.