Urinary RetentionPhase 4NCT04682366

The Effect of Tamsulosin on Postoperative Urinary Retention

A Phase 4 study testing Tamsulosin in people with Urinary Retention, run by Wake Forest University Health Sciences at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

This is a double-blinded randomized controlled trial of perioperative use of tamsulosin to prevent postoperative urinary retention in female pelvic reconstructive surgery undergoing same-day discharge with an enhanced recovery after surgery protocol. Read more about this study

Who is it for?: Ages 21 to 99 years, women only
Conditions the study is for: Urinary Retention
What is being tested?: Tamsulosin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 4 participants
Where: 1 siteUnited States
Study dates: 19 Oct 2021to 10 Nov 2022
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 21 to 99 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Stage II or greater pelvic organ prolapse in > 1 vaginal compartment
Plan for multicompartment native tissue vaginal repair (which would include any combination of uterosacral ligament suspension, sacrospinous ligament suspension, cystocele and/or rectocele repair, with or without hysterectomy and with or without concomitant mid-urethral sling) or vaginal closure with female pelvic medicine and reconstructive surgery (FPMRS) - trained surgeons at Wake Forest Baptist Health
Participation in Enhanced-Recovery-After-Surgery protocol with plan for same-day hospital discharge
Willing to remain compliant with Investigation Product (IP)

Who cannot join

Intraoperative complication necessitating prolonged bladder drainage or placement of a vaginal pack x 24 hours (patients would exit study after randomization and will be excluded from the per-protocol analysis)
Patients whose surgical plan would necessitate a voiding trial on postop day >0
Less than 21 years of age
Unable to understand English
Patients who are scheduled to undergo combined colorectal procedures such as rectopexy, sphincteroplasty
Patient with known allergy to Tamsulosin or sulfa drugs

Show all 13Show fewer

Patients with upcoming cataract surgery
Patient with orthostatic hypotension
History of postvoid residual (PVR>150) prior to surgery with prolapse reduction
Patients with hypertension on alpha-blockers
Single compartment prolapse repair (anterior or posterior repair only)
Use of mesh for prolapse repair
High tone pelvic floor dysfunction

Trial locations and contacts

1 site in 1 country.

United States1 site

Wake Forest Health Sciences
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: Evaluating the Effect of Tamsulosin on Postoperative Urinary Retention in Women Undergoing Same Day Hospital Discharge Following Pelvic Reconstructive Surgery: A Randomized Trial

Read the detailed description

The primary objective is to determine the effect of Tamsulosin on same-day active voiding trial in women undergoing female pelvic reconstructive surgery with vaginal native tissue repair with same-day discharge planned.

Duration of catheterization, postoperative urinary tract infection rates, patient level of satisfaction, Emergency Department (ED) visits and adverse events postoperatively will also be compared between women receiving Tamsulosin versus placebo.

Patients will be offered participation in the study at their postoperative visit if they meet study criteria. Once consent is obtained, patients will be randomized to receive Tamsulosin 0.4 mg orally once daily or matching placebo capsules for a total of 10 days starting 5 days pre-operatively.

Conditions: Urinary Retention
Being tested: Tamsulosin, Placebo
Keywords: Postoperative care, Urinary tract infection, Female pelvic reconstructive surgery, Enhanced recovery after surgery, Tamsulosin, Flomax
Medical subject headings: Urinary Retention, Urinary Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TamsulosinDrug
Oral drug: 10 days of 0.4 mg of oral Tamsulosin
PlaceboDrug
Oral drug: 10 days of identical-appearing placebo

Study groups in NCT04682366
Study group	Role	What they receive
Tamsulosin	Experimental	Patients in this arm will receive 10 days of 0.4 mg of oral tamsulosin once daily starting 5 days pre-operatively and continuing until all pills are completed. Receives: Drug: Tamsulosin
Placebo	Placebo comparator	Patients in this arm will receive 10 days of identical-appearing placebo once daily starting 5 days pre-operatively and continuing until all pills are completed. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Postoperative (Day 0) Urinary Retention
Urinary retention can be defined as >150cc residual volume during an active voiding trial
Measured: Up to 6 weeks postoperatively

Secondary outcomes (5)

Urinary Tract Infection Rate
Urinary tract infection rate
Measured: Week 6
Incidence of Delayed Urinary Retention
Delayed urinary retention will be defined as post-void residual > 150 cc
Measured: Week 6
Number Emergency Department (ED) Visits
Measured: Up to 30 days postoperatively
Total Number of Days of Bladder Catheterization
Measured: Week 6
Patient Level of Satisfaction With Voiding Function
Patient satisfaction questionnaire: Patient Global Impression of Improvement (PGI-I) - Patient level of satisfaction (scale of 1 -7) - very dissatisfied, moderately dissatisfied, slightly dissatisfied, neutral, slightly satisfied, moderately satisfied, very satisfied - the lower the score denotes the more satisfaction)
Measured: Day 0 and 1 week postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Oct 202110 Nov 2022

First posted23 Dec 2020
Study start19 Oct 2021
Primary completion10 Nov 2022
Study completion10 Nov 2022

Why it stopped: Challenges in enrollment led to decission for termination

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (28)Papers the sponsor has linked to this study.
Other trials for Urinary RetentionStudies of the same condition, open and under way.
More trials run by Wake Forest University Health SciencesThe 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04682366
Sponsor's protocol ID: IRB00070462
Status last verified: Oct 2022
First submitted: 18 Dec 2020
Last updated: 31 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Committee Opinion No 701: Choosing the Route of Hysterectomy for Benign Disease. Obstet Gynecol. 2017 Jun;129(6):e155-e159. doi: 10.1097/AOG.0000000000002112.
PubMed 28538495
Akkoc A, Aydin C, Topaktas R, Kartalmis M, Altin S, Isen K, Metin A. Prophylactic effects of alpha-blockers, Tamsulosin and Alfuzosin, on postoperative urinary retention in male patients undergoing urologic surgery under spinal anaesthesia. Int Braz J Urol. 2016 May-Jun;42(3):578-84. doi: 10.1590/S1677-5538.IBJU.2015.0256.
PubMed 27286124
Carter-Brooks CM, Du AL, Ruppert KM, Romanova AL, Zyczynski HM. Implementation of a urogynecology-specific enhanced recovery after surgery (ERAS) pathway. Am J Obstet Gynecol. 2018 Nov;219(5):495.e1-495.e10. doi: 10.1016/j.ajog.2018.06.009. Epub 2018 Jun 18.
PubMed 29913175
Chapman GC, Sheyn D, Petrikovets A, Mahajan ST, El-Nashar S, Pollard R, Mangel JM. Tamsulosin to Prevent Postoperative Urinary Retention After Female Pelvic Reconstructive Surgery. Female Pelvic Med Reconstr Surg. 2020 Nov;26(11):682-687. doi: 10.1097/SPV.0000000000000650.
PubMed 30418263
Chong C, Kim HS, Suh DH, Jee BC. Risk factors for urinary retention after vaginal hysterectomy for pelvic organ prolapse. Obstet Gynecol Sci. 2016 Mar;59(2):137-43. doi: 10.5468/ogs.2016.59.2.137. Epub 2016 Mar 16.
PubMed 27004205
Clancy C, Coffey JC, O'Riordain MG, Burke JP. A meta-analysis of the efficacy of prophylactic alpha-blockade for the prevention of urinary retention following primary unilateral inguinal hernia repair. Am J Surg. 2018 Aug;216(2):337-341. doi: 10.1016/j.amjsurg.2017.02.017. Epub 2017 Mar 14.
PubMed 28341140
Costantini E, Lazzeri M, Bini V, Zucchi A, Fioretti F, Frumenzio E, Porena M. Open-label, longitudinal study of tamsulosin for functional bladder outlet obstruction in women. Urol Int. 2009;83(3):311-5. doi: 10.1159/000241674. Epub 2009 Oct 13.
PubMed 19829032
Doll KM, Dusetzina SB, Robinson W. Trends in Inpatient and Outpatient Hysterectomy and Oophorectomy Rates Among Commercially Insured Women in the United States, 2000-2014. JAMA Surg. 2016 Sep 1;151(9):876-7. doi: 10.1001/jamasurg.2016.0804. No abstract available.
PubMed 27168235
FitzGerald MP, Brubaker L. The etiology of urinary retention after surgery for genuine stress incontinence. Neurourol Urodyn. 2001;20(1):13-21. doi: 10.1002/1520-6777(2001)20:13.0.co;2-r.
PubMed 11135378
Geynisman-Tan J, Dave-Heliker B, Bochenska K, Collins S, Lewicky-Gaupp C, Mueller M, Kenton K. Duration of Catheterization After Retropubic Midurethral Sling. Female Pelvic Med Reconstr Surg. 2019 Sep-Oct;25(5):369-371. doi: 10.1097/SPV.0000000000000569.
PubMed 29509646
Hooton TM, Bradley SF, Cardenas DD, Colgan R, Geerlings SE, Rice JC, Saint S, Schaeffer AJ, Tambayh PA, Tenke P, Nicolle LE; Infectious Diseases Society of America. Diagnosis, prevention, and treatment of catheter-associated urinary tract infection in adults: 2009 International Clinical Practice Guidelines from the Infectious Diseases Society of America. Clin Infect Dis. 2010 Mar 1;50(5):625-63. doi: 10.1086/650482.
PubMed 20175247
Jackson J, Davies P, Leggett N, Nugawela MD, Scott LJ, Leach V, Richards A, Blacker A, Abrams P, Sharma J, Donovan J, Whiting P. Systematic review of interventions for the prevention and treatment of postoperative urinary retention. BJS Open. 2018 Nov 19;3(1):11-23. doi: 10.1002/bjs5.50114. eCollection 2019 Feb.
PubMed 30734011
Jennings AJ, Spencer RJ, Medlin E, Rice LW, Uppal S. Predictors of 30-day readmission and impact of same-day discharge in laparoscopic hysterectomy. Am J Obstet Gynecol. 2015 Sep;213(3):344.e1-7. doi: 10.1016/j.ajog.2015.05.014. Epub 2015 May 14.
PubMed 25981843
Kenton K, Pham T, Mueller E, Brubaker L. Patient preparedness: an important predictor of surgical outcome. Am J Obstet Gynecol. 2007 Dec;197(6):654.e1-6. doi: 10.1016/j.ajog.2007.08.059.
PubMed 18060968
Kowalik U, Plante MK. Urinary Retention in Surgical Patients. Surg Clin North Am. 2016 Jun;96(3):453-67. doi: 10.1016/j.suc.2016.02.004.
PubMed 27261788

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effect of Voiding Position (Standing in the Shower vs. Sitting) on Post- Void Residual Urine Volume (PVR) After Removal of Urinary Catheter in Women Following Vaginal Delivery With Epidural Analgesia: A Double- Blind Randomized Controlled Trial
Postpartum Urinary Retention
Recruiting
Pelvic Health Electrically Evoked Recording (PEER) 2 Study
Overactive Bladder, Fecal Incontinence
Not yet recruitingObservational study
Long-Term Effectiveness and Safety of Sacral Neuromodulation With InterStim for Lower Urinary Tract Dysfunction
Overactive Bladder (OAB), Urgency Urinary Incontinence
Recruiting
Evaluating the Clinical Efficacy of Thulio vs. Holmium Laser Enucleation of the Prostate
BPH With Symptomatic Lower Urinary Tract Symptoms, BPH With Urinary Obstruction
Active, not recruiting
Preoperative Pelvic Floor Physical Therapy to Minimize Stress Urinary Incontinence After Holmium Laser Enucleation of the Prostate
Benign Prostatic Hyperplasia With Outflow Obstruction, Urinary Retention

All Urinary Retention trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluating the Effect of Tamsulosin on Postoperative Urinary Retention in Women Undergoing Same Day Hospital Discharge Following Pelvic Reconstructive Surgery: A Randomized Trial
ClinicalTrials.gov ID: NCT04682366
Acronym / sponsor ID: IRB00070462
Conditions: Urinary Retention
Keywords: Postoperative care, Urinary tract infection, Female pelvic reconstructive surgery, Enhanced recovery after surgery, Tamsulosin, Flomax
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Challenges in enrollment led to decission for termination
Enrolment: 4 participants (actual)
Lead sponsor: Wake Forest University Health SciencesUniversity, hospital or other
Study start: 19 Oct 2021 (actual)
Primary completion: 10 Nov 2022 (actual)
Study completion: 10 Nov 2022 (actual)
First posted: 23 Dec 2020 (actual)
Results: Posted 31 Jan 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Tamsulosin	Experimental	Drug: TamsulosinPatients in this arm will receive 10 days of 0.4 mg of oral tamsulosin once daily starting 5 days pre-operatively and continuing until all pills are completed.
Placebo	Placebo comparator	Drug: PlaceboPatients in this arm will receive 10 days of identical-appearing placebo once daily starting 5 days pre-operatively and continuing until all pills are completed.

Who may qualify

Ages: 21 to 99 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Stage II or greater pelvic organ prolapse in > 1 vaginal compartment
Plan for multicompartment native tissue vaginal repair (which would include any combination of uterosacral ligament suspension, sacrospinous ligament suspension, cystocele and/or rectocele repair, with or without hysterectomy and with or without concomitant mid-urethral sling) or vaginal closure with female pelvic medicine and reconstructive surgery (FPMRS) - trained surgeons at Wake Forest Baptist Health
Participation in Enhanced-Recovery-After-Surgery protocol with plan for same-day hospital discharge
Willing to remain compliant with Investigation Product (IP)

Key exclusion criteria (13 listed)

Intraoperative complication necessitating prolonged bladder drainage or placement of a vaginal pack x 24 hours (patients would exit study after randomization and will be excluded from the per-protocol analysis)
Patients whose surgical plan would necessitate a voiding trial on postop day >0
Less than 21 years of age
Unable to understand English
Patients who are scheduled to undergo combined colorectal procedures such as rectopexy, sphincteroplasty

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
TamsulosinOral drug: 10 days of 0.4 mg of oral Tamsulosin	Drug	Tamsulosin
PlaceboOral drug: 10 days of identical-appearing placebo	Drug	Placebo

Primary outcome

Number of Participants With Postoperative (Day 0) Urinary Retention
Time frame: Up to 6 weeks postoperatively
Urinary retention can be defined as >150cc residual volume during an active voiding trial

5 secondary outcomes

Urinary Tract Infection Rate
Time frame: Week 6
Incidence of Delayed Urinary Retention
Time frame: Week 6
Number Emergency Department (ED) Visits
Time frame: Up to 30 days postoperatively
Total Number of Days of Bladder Catheterization
Time frame: Week 6
Patient Level of Satisfaction With Voiding Function
Time frame: Day 0 and 1 week postoperatively

Results and safety

Results posted to the registry on 31 Jan 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tamsulosin	2	1
Placebo	2	1

Primary outcome: Number of Participants With Postoperative (Day 0) Urinary Retention

Time frame: Up to 6 weeks postoperatively. Count of participants. Unit: Participants

Measure	Tamsulosin n = 1	Placebo n = 1
Value	1	1

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tamsulosin	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Placebo	0 of 1 (0%)	0 of 1 (0%)	0 of 1

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 28538495Committee Opinion No 701: Choosing the Route of Hysterectomy for Benign Disease. Obstet Gynecol. 2017 Jun;129(6):e155-e159. doi: 10.1097/AOG.0000000000002112.
Background: PubMed 27286124Akkoc A, Aydin C, Topaktas R, Kartalmis M, Altin S, Isen K, Metin A. Prophylactic effects of alpha-blockers, Tamsulosin and Alfuzosin, on postoperative urinary retention in male patients undergoing urologic surgery under spinal anaesthesia. Int Braz J Urol. 2016 May-Jun;42(3):578-84. doi: 10.1590/S1677-5538.IBJU.2015.0256.
Background: PubMed 29913175Carter-Brooks CM, Du AL, Ruppert KM, Romanova AL, Zyczynski HM. Implementation of a urogynecology-specific enhanced recovery after surgery (ERAS) pathway. Am J Obstet Gynecol. 2018 Nov;219(5):495.e1-495.e10. doi: 10.1016/j.ajog.2018.06.009. Epub 2018 Jun 18.
Background: PubMed 30418263Chapman GC, Sheyn D, Petrikovets A, Mahajan ST, El-Nashar S, Pollard R, Mangel JM. Tamsulosin to Prevent Postoperative Urinary Retention After Female Pelvic Reconstructive Surgery. Female Pelvic Med Reconstr Surg. 2020 Nov;26(11):682-687. doi: 10.1097/SPV.0000000000000650.
Background: PubMed 27004205Chong C, Kim HS, Suh DH, Jee BC. Risk factors for urinary retention after vaginal hysterectomy for pelvic organ prolapse. Obstet Gynecol Sci. 2016 Mar;59(2):137-43. doi: 10.5468/ogs.2016.59.2.137. Epub 2016 Mar 16.
Background: PubMed 28341140Clancy C, Coffey JC, O'Riordain MG, Burke JP. A meta-analysis of the efficacy of prophylactic alpha-blockade for the prevention of urinary retention following primary unilateral inguinal hernia repair. Am J Surg. 2018 Aug;216(2):337-341. doi: 10.1016/j.amjsurg.2017.02.017. Epub 2017 Mar 14.
Background: PubMed 19829032Costantini E, Lazzeri M, Bini V, Zucchi A, Fioretti F, Frumenzio E, Porena M. Open-label, longitudinal study of tamsulosin for functional bladder outlet obstruction in women. Urol Int. 2009;83(3):311-5. doi: 10.1159/000241674. Epub 2009 Oct 13.
Background: PubMed 27168235Doll KM, Dusetzina SB, Robinson W. Trends in Inpatient and Outpatient Hysterectomy and Oophorectomy Rates Among Commercially Insured Women in the United States, 2000-2014. JAMA Surg. 2016 Sep 1;151(9):876-7. doi: 10.1001/jamasurg.2016.0804. No abstract available.
Background: PubMed 11135378FitzGerald MP, Brubaker L. The etiology of urinary retention after surgery for genuine stress incontinence. Neurourol Urodyn. 2001;20(1):13-21. doi: 10.1002/1520-6777(2001)20:13.0.co;2-r.
Background: PubMed 29509646Geynisman-Tan J, Dave-Heliker B, Bochenska K, Collins S, Lewicky-Gaupp C, Mueller M, Kenton K. Duration of Catheterization After Retropubic Midurethral Sling. Female Pelvic Med Reconstr Surg. 2019 Sep-Oct;25(5):369-371. doi: 10.1097/SPV.0000000000000569.
Background: PubMed 20175247Hooton TM, Bradley SF, Cardenas DD, Colgan R, Geerlings SE, Rice JC, Saint S, Schaeffer AJ, Tambayh PA, Tenke P, Nicolle LE; Infectious Diseases Society of America. Diagnosis, prevention, and treatment of catheter-associated urinary tract infection in adults: 2009 International Clinical Practice Guidelines from the Infectious Diseases Society of America. Clin Infect Dis. 2010 Mar 1;50(5):625-63. doi: 10.1086/650482.
Background: PubMed 30734011Jackson J, Davies P, Leggett N, Nugawela MD, Scott LJ, Leach V, Richards A, Blacker A, Abrams P, Sharma J, Donovan J, Whiting P. Systematic review of interventions for the prevention and treatment of postoperative urinary retention. BJS Open. 2018 Nov 19;3(1):11-23. doi: 10.1002/bjs5.50114. eCollection 2019 Feb.
Individual participant dataSharing planned: No

Related trials for Urinary Retention

Not yet recruiting
Effect of Voiding Position (Standing in the Shower vs. Sitting) on Post- Void Residual Urine Volume (PVR) After Removal of Urinary Catheter in Women Following Vaginal Delivery With Epidural Analgesia: A Double- Blind Randomized Controlled Trial
Postpartum Urinary Retention
Recruiting
Pelvic Health Electrically Evoked Recording (PEER) 2 Study
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Not yet recruitingObservational study
Long-Term Effectiveness and Safety of Sacral Neuromodulation With InterStim for Lower Urinary Tract Dysfunction
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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.

Majid Mirzazadeh, MD principal investigator

Wake Forest Health Sciences

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 Urinary Retention, run by Wake Forest University Health Sciences 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 4 inclusion and 13 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 31 Jan 2024. 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. 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?

Yes. Results are posted in the registry (first posted 31 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Postoperative (Day 0) Urinary Retention (time frame: Up to 6 weeks 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 NCT04682366, which also lists 28 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 31 Jan 2024.