Urinary Retention PostoperativePhase 2NCT04597372
Impact of Tamsulosin on Post-Operative Urinary Retention Following Pelvic Reconstructive Surgery
A Phase 2 study testing Tamsulosin in people with Urinary Retention Postoperative, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 1 site in United States.
Trial summary
The objective of the study is to determine the effectiveness of postoperative Tamsulosin in reducing the duration of acute postoperative urinary retention (POUR) following pelvic reconstructive surgery through a double blind, randomized placebo-controlled trial. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Retention Postoperative
- 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
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2021to Dec 2026
- Phase
- Phase 2
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- willing and able to provide informed consent
- postoperative urinary retention as defined by a failed RGVT prior to hospital discharge
- Ability to speak and read English
- Tolerate pill ingestion
Who cannot join
- allergy/intolerance to Tamsulosin or sulfa drugs
- preoperative history of urinary retention as defined by preoperative post void residual of >150mL
- current use of alpha antagonist medication for hypertension
- severe dementia
- end stage renal or liver disease
- history of severe heart failure or major cardiovascular event in the last 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
West Penn Hospital
Pittsburgh, Pennsylvania, 15224
AHN Clinical Trials Contact, (412)-330-6151, clinicaltrials@ahn.org
Lindsay Turner, MD
About this study
Official title: The Impact of Tamsulosin on Duration of Post-Operative Urinary Retention in Women Undergoing Pelvic Reconstructive Surgery- A Double Blind, Randomized, Placebo-Controlled Study
The objective of the study is to determine the effectiveness of postoperative Tamsulosin in reducing the duration of acute postoperative urinary retention (POUR) following pelvic reconstructive surgery through a double blind, randomized placebo-controlled trial.
Read the detailed description
The primary objective is to determine the impact of Tamsulosin on duration of urinary retention following pelvic reconstructive surgery in women. Duration of catheterization via indwelling foley or clean intermittent self-catheterization (CISC), measured in days, will be compared between women receiving Tamsulosin versus placebo after diagnosis of postoperative urinary retention via standardized voiding trial. It is hypothesized that women receiving Tamsulosin will have a shorter duration of urinary retention, fewer urinary tract infections, and improved quality of life as compared with placebo. The Euroqol-5D (EQ-5D) will be used to compare physical, emotional, functional, and social/family well-being between women receiving Tamsulosin and placebo.
Upon diagnosis of POUR, women will be offered participation in the study. Once consent is obtained, women will be randomized to tamsulosin 0.4 mg or matching placebo capsules to be used daily until resolution of POUR or a 10 day course, whichever occurs first.
- Conditions
- Urinary Retention Postoperative
- Being tested
- Tamsulosin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamsulosinDrug
Study drug will contain 0.4 mg of Tamsulosin. Subjects will be provided with 10 capsules to be taken daily.
PlaceboDrug
Placebo will be prepared by the IDS pharmacist (or contracted pharmacy) and encapsulated in identical appearing wraps. Subjects will be provided with 10 capsules to be taken daily.
| Study group | Role | What they receive |
|---|---|---|
| Tamsulosin | Experimental | 10 capsules will be distributed to subjects to be taken daily. Each capsule contains 0.4mg of Tamsulosin. Subjects will take the capsule once daily until the end of the 10 day course or until the resolution of acute postoperative urinary retention.
Both study drug and placebo will appear identical and will be prepared by the pharmacy. Receives: Drug: Tamsulosin |
| Placebo | Placebo comparator | 10 capsules will be distributed to subjects to be taken daily. Subjects will take the capsule once daily until the end of the 10 day course or until the resolution of acute postoperative urinary retention.
Both study drug and placebo will appear identical and will be prepared by the pharmacy. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the impact of Tamsulosin on duration of urinary retention
The primary outcome is duration of postoperative urinary retention measured in days following failed retrograde voiding trial.
Measured: Date of failed retrograde voiding trial until resolution of post-operative urinary retention or a 10-day course
Secondary outcomes (2)
To assess the impact of Tamsulosin on rates of urinary tract infection (UTI).
The electronic medical record (EMR) will be reviewed to determine if subjects were treated for a urinary tract infection (UTI). UTIs will be diagnosed by a urine culture confirming bacteriuria of at least 10 ^5 CFU/mL. UTIs treated presumptively and without culture will also be included as positive cultures.
Measured: Date of failed the retrograde voiding trial and up to 6 weeks.
To quantify the effect of Tamsulosin on patient quality of life.
Patients will be asked to complete the Euroqol-5D (EQ-5D) questionnaire to assess quality of life. The EQ-5D is scored with a 5-digit code of index values which reflect how good or bad a health state is (Level 1 indicates no problem where is Level 5 indicates extreme problems).
Measured: Prior to discharge and again at 2 weeks follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start3 Nov 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Urinary Retention PostoperativeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University
- Responsible party
- Principal investigator, Lindsay Turner, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Investigators
- Lindsay Turner, MD, Principal investigator, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597372
- Sponsor's protocol ID
- IRB00264995
- Status last verified
- Mar 2026
- First submitted
- 5 Oct 2020
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Results will be published; patient identifiers will not be used in the research publications.
Publications
Willis-Gray MG, Wu JM, Field C, Pulliam S, Husk KE, Brueseke TJ, Geller EJ, Connolly A, Dieter AA. Is a Postvoid Residual Necessary? A Randomized Trial of Two Postoperative Voiding Protocols. Female Pelvic Med Reconstr Surg. 2021 Feb 1;27(2):e256-e260. doi: 10.1097/SPV.0000000000000743.
PubMed 31157716Geller EJ, Hankins KJ, Parnell BA, Robinson BL, Dunivan GC. Diagnostic accuracy of retrograde and spontaneous voiding trials for postoperative voiding dysfunction: a randomized controlled trial. Obstet Gynecol. 2011 Sep;118(3):637-642. doi: 10.1097/AOG.0b013e318229e8dd.
PubMed 21860294Oliphant SS, Lowder JL, Ghetti C, Zyczynski HM. Effect of a preoperative self-catheterization video on anxiety: a randomized controlled trial. Int Urogynecol J. 2013 Mar;24(3):419-24. doi: 10.1007/s00192-012-1868-y. Epub 2012 Jul 3.
PubMed 22752014Hooton 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 20175247K Ramakrishnan, J Mold. Urinary Catheters: A Review. The Internet Journal of Family Practice. 2004 Volume 3 Number 2.
Baldini G, Bagry H, Aprikian A, Carli F. Postoperative urinary retention: anesthetic and perioperative considerations. Anesthesiology. 2009 May;110(5):1139-57. doi: 10.1097/ALN.0b013e31819f7aea.
PubMed 19352147Kuipers PW, Kamphuis ET, van Venrooij GE, van Roy JP, Ionescu TI, Knape JT, Kalkman CJ. Intrathecal opioids and lower urinary tract function: a urodynamic evaluation. Anesthesiology. 2004 Jun;100(6):1497-503. doi: 10.1097/00000542-200406000-00023.
PubMed 15166570Darrah DM, Griebling TL, Silverstein JH. Postoperative urinary retention. Anesthesiol Clin. 2009 Sep;27(3):465-84, table of contents. doi: 10.1016/j.anclin.2009.07.010.
PubMed 19825487Lose G, Lindholm P. Prophylactic phenoxybenzamine in the prevention of postoperative retention of urine after vaginal repair: a prospective randomized double-blind trial. Int J Gynaecol Obstet. 1985 Sep;23(4):315-20. doi: 10.1016/0020-7292(85)90026-8.
PubMed 2866119Livne PM, Kaplan B, Ovadia Y, Servadio C. Prevention of post-hysterectomy urinary retention by alpha-adrenergic blocker. Acta Obstet Gynecol Scand. 1983;62(4):337-40. doi: 10.3109/00016348309156234.
PubMed 6138916Roehrborn CG, Siami P, Barkin J, Damiao R, Major-Walker K, Morrill B, Montorsi F; CombAT Study Group. The effects of dutasteride, tamsulosin and combination therapy on lower urinary tract symptoms in men with benign prostatic hyperplasia and prostatic enlargement: 2-year results from the CombAT study. J Urol. 2008 Feb;179(2):616-21; discussion 621. doi: 10.1016/j.juro.2007.09.084. Epub 2007 Dec 21.
PubMed 18082216Lepor H. Phase III multicenter placebo-controlled study of tamsulosin in benign prostatic hyperplasia. Tamsulosin Investigator Group. Urology. 1998 Jun;51(6):892-900. doi: 10.1016/s0090-4295(98)00126-5.
PubMed 9609623FDA Prescription Drug Advisory Rule for Tamsulosin. NDA 020579.C.F.R. Accessed 4/3/20. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=020579
Mohammadi-Fallah M, Hamedanchi S, Tayyebi-Azar A. Preventive effect of tamsulosin on postoperative urinary retention. Korean J Urol. 2012 Jun;53(6):419-23. doi: 10.4111/kju.2012.53.6.419. Epub 2012 Jun 19.
PubMed 22741052Narayan P, Tewari A. A second phase III multicenter placebo controlled study of 2 dosages of modified release tamsulosin in patients with symptoms of benign prostatic hyperplasia. United States 93-01 Study Group. J Urol. 1998 Nov;160(5):1701-6.
PubMed 9783935
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Tamsulosin on Duration of Post-Operative Urinary Retention in Women Undergoing Pelvic Reconstructive Surgery- A Double Blind, Randomized, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT04597372
- Acronym / sponsor ID
- IRB00264995
- Conditions
- Urinary Retention Postoperative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)University, hospital or other
- Collaborators
- Johns Hopkins University
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Oct 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.
The objective of the study is to determine the effectiveness of postoperative Tamsulosin in reducing the duration of acute postoperative urinary retention (POUR) following pelvic reconstructive surgery through a double blind, randomized placebo-controlled trial.
Detailed description
The primary objective is to determine the impact of Tamsulosin on duration of urinary retention following pelvic reconstructive surgery in women. Duration of catheterization via indwelling foley or clean intermittent self-catheterization (CISC), measured in days, will be compared between women receiving Tamsulosin versus placebo after diagnosis of postoperative urinary retention via standardized voiding trial. It is hypothesized that women receiving Tamsulosin will have a shorter duration of urinary retention, fewer urinary tract infections, and improved quality of life as compared with placebo. The Euroqol-5D (EQ-5D) will be used to compare physical, emotional, functional, and social/family well-being between women receiving Tamsulosin and placebo.
Upon diagnosis of POUR, women will be offered participation in the study. Once consent is obtained, women will be randomized to tamsulosin 0.4 mg or matching placebo capsules to be used daily until resolution of POUR or a 10 day course, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tamsulosin | Experimental | Drug: Tamsulosin10 capsules will be distributed to subjects to be taken daily. Each capsule contains 0.4mg of Tamsulosin. Subjects will take the capsule once daily until the end of the 10 day course or until the resolution of acute postoperative urinary retention. Both study drug and placebo will appear identical and will be prepared by the pharmacy. |
| Placebo | Placebo comparator | Drug: Placebo10 capsules will be distributed to subjects to be taken daily. Subjects will take the capsule once daily until the end of the 10 day course or until the resolution of acute postoperative urinary retention. Both study drug and placebo will appear identical and will be prepared by the pharmacy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years or older
- willing and able to provide informed consent
- postoperative urinary retention as defined by a failed RGVT prior to hospital discharge
- Ability to speak and read English
- Tolerate pill ingestion
Key exclusion criteria (6 listed)
- allergy/intolerance to Tamsulosin or sulfa drugs
- preoperative history of urinary retention as defined by preoperative post void residual of >150mL
- current use of alpha antagonist medication for hypertension
- severe dementia
- end stage renal or liver disease
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 |
|---|---|---|
| TamsulosinStudy drug will contain 0.4 mg of Tamsulosin. Subjects will be provided with 10 capsules to be taken daily. | Drug | Tamsulosin |
| PlaceboPlacebo will be prepared by the IDS pharmacist (or contracted pharmacy) and encapsulated in identical appearing wraps. Subjects will be provided with 10 capsules to be taken daily. | Drug | Placebo |
Primary outcome
To determine the impact of Tamsulosin on duration of urinary retention
Time frame: Date of failed retrograde voiding trial until resolution of post-operative urinary retention or a 10-day course
The primary outcome is duration of postoperative urinary retention measured in days following failed retrograde voiding trial.
2 secondary outcomes
To assess the impact of Tamsulosin on rates of urinary tract infection (UTI).
Time frame: Date of failed the retrograde voiding trial and up to 6 weeks.
To quantify the effect of Tamsulosin on patient quality of life.
Time frame: Prior to discharge and again at 2 weeks follow up
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 20 Mar 2026.
- Background: PubMed 31157716Willis-Gray MG, Wu JM, Field C, Pulliam S, Husk KE, Brueseke TJ, Geller EJ, Connolly A, Dieter AA. Is a Postvoid Residual Necessary? A Randomized Trial of Two Postoperative Voiding Protocols. Female Pelvic Med Reconstr Surg. 2021 Feb 1;27(2):e256-e260. doi: 10.1097/SPV.0000000000000743.
- Background: PubMed 21860294Geller EJ, Hankins KJ, Parnell BA, Robinson BL, Dunivan GC. Diagnostic accuracy of retrograde and spontaneous voiding trials for postoperative voiding dysfunction: a randomized controlled trial. Obstet Gynecol. 2011 Sep;118(3):637-642. doi: 10.1097/AOG.0b013e318229e8dd.
- Background: PubMed 22752014Oliphant SS, Lowder JL, Ghetti C, Zyczynski HM. Effect of a preoperative self-catheterization video on anxiety: a randomized controlled trial. Int Urogynecol J. 2013 Mar;24(3):419-24. doi: 10.1007/s00192-012-1868-y. Epub 2012 Jul 3.
- 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.
- BackgroundK Ramakrishnan, J Mold. Urinary Catheters: A Review. The Internet Journal of Family Practice. 2004 Volume 3 Number 2.
- Background: PubMed 19352147Baldini G, Bagry H, Aprikian A, Carli F. Postoperative urinary retention: anesthetic and perioperative considerations. Anesthesiology. 2009 May;110(5):1139-57. doi: 10.1097/ALN.0b013e31819f7aea.
- Background: PubMed 15166570Kuipers PW, Kamphuis ET, van Venrooij GE, van Roy JP, Ionescu TI, Knape JT, Kalkman CJ. Intrathecal opioids and lower urinary tract function: a urodynamic evaluation. Anesthesiology. 2004 Jun;100(6):1497-503. doi: 10.1097/00000542-200406000-00023.
- Background: PubMed 19825487Darrah DM, Griebling TL, Silverstein JH. Postoperative urinary retention. Anesthesiol Clin. 2009 Sep;27(3):465-84, table of contents. doi: 10.1016/j.anclin.2009.07.010.
- Background: PubMed 2866119Lose G, Lindholm P. Prophylactic phenoxybenzamine in the prevention of postoperative retention of urine after vaginal repair: a prospective randomized double-blind trial. Int J Gynaecol Obstet. 1985 Sep;23(4):315-20. doi: 10.1016/0020-7292(85)90026-8.
- Background: PubMed 6138916Livne PM, Kaplan B, Ovadia Y, Servadio C. Prevention of post-hysterectomy urinary retention by alpha-adrenergic blocker. Acta Obstet Gynecol Scand. 1983;62(4):337-40. doi: 10.3109/00016348309156234.
- Background: PubMed 18082216Roehrborn CG, Siami P, Barkin J, Damiao R, Major-Walker K, Morrill B, Montorsi F; CombAT Study Group. The effects of dutasteride, tamsulosin and combination therapy on lower urinary tract symptoms in men with benign prostatic hyperplasia and prostatic enlargement: 2-year results from the CombAT study. J Urol. 2008 Feb;179(2):616-21; discussion 621. doi: 10.1016/j.juro.2007.09.084. Epub 2007 Dec 21.
- Background: PubMed 9609623Lepor H. Phase III multicenter placebo-controlled study of tamsulosin in benign prostatic hyperplasia. Tamsulosin Investigator Group. Urology. 1998 Jun;51(6):892-900. doi: 10.1016/s0090-4295(98)00126-5.
- Individual participant dataSharing planned: No. Results will be published; patient identifiers will not be used in the research publications.
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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.
Lindsay Turner, MD principal investigator
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tamsulosin in people with Urinary Retention Postoperative, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) 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 5 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: looking for participants now, as of the sponsor's last update on 20 Mar 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Lindsay Turner ((412)-330-4567, lindsay.turner@AHN.ORG), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the impact of Tamsulosin on duration of urinary retention (time frame: Date of failed retrograde voiding trial until resolution of post-operative urinary retention or a 10-day course). 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 NCT04597372, which also lists 21 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 20 Mar 2026.