Urinary RetentionPhase 2/3NCT03524339
Tamsulosin vs Placebo to Prevent Postoperative Urinary Retention in Female Pelvic Reconstructive Surgery
A Phase 2/3 study testing Tamsulosin in people with Urinary Retention and Lower Urinary Tract Symptoms, run by University Hospitals Cleveland Medical Center at 2 sites in United States.
Trial summary
This is a placebo controlled randomized controlled trial of perioperative use of tamsulosin to prevent postoperative urinary retention in female pelvic reconstructive surgery. 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, Lower Urinary Tract Symptoms, Stress Urinary Incontinence
- What is being tested?
- Tamsulosin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2018to 9 Jun 2020
- Phase
- Phase 2/3
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients must be 18 years or older as well as willing and able to provide informed consent
- Patients must be undergoing a scheduled surgery for pelvic organ prolapse or urinary incontinence
- Standard postoperative plan must include admission to the hospital with foley catheterization overnight the night after surgery, and planned removal of foley catheter and active voiding trial on postoperative day 1.
Who cannot join
- Patient unable or unwilling to provide informed consent
- Severe allergy to sulfa drugs
- Known allergy to tamsulosin or another alpha antagonist medication
- History of urinary retention
- Planned bladder catheterization greater than 24 hours after surgery
- Current use of alpha antagonist medication for hypertension
- End stage renal or liver disease
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
University Hospitals
Cleveland, Ohio, 44106
About this study
Official title: Perioperative Administration of Tamsulosin vs Placebo to Prevent Postoperative Urinary Retention in Female Pelvic Reconstructive Surgery
This is a placebo controlled randomized controlled trial of perioperative use of tamsulosin to prevent postoperative urinary retention in female pelvic reconstructive surgery.
- Conditions
- Urinary Retention, Lower Urinary Tract Symptoms, Stress Urinary Incontinence, Pelvic Organ Prolapse
- Being tested
- Placebo oral capsule, Tamsulosin
- Medical subject headings
- Urinary Retention, Lower Urinary Tract Symptoms, Urinary Incontinence, Stress, Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo oral capsuleDrug
Tamsulosin or placebo will be given for 3 days prior to surgery and one week after surgery to determine its effects on postoperative urinary retention.
TamsulosinDrug
Tamsulosin or placebo will be given for 3 days prior to surgery and one week after surgery to determine its effects on postoperative urinary retention.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo oral capsule |
| Tamsulosin | Experimental | Not described Receives: Drug: Tamsulosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Urinary Retention
Failed voiding trial upon removal of catheter
Measured: Within 72 hours of surgery
Secondary outcomes (3)
International Prostate Symptom Score
Total and subscale scores reported. Total score range 0-35, with 0 being less symptomatic and 35 being more symptomatic. Total score is sum of individual questions. Seven subgroups address incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining, nocturia. Each subgroup is scored 0-5 with 5 being most symptomatic. The last question is independent, rates quality of life from 0 (best) to 6 (worst)
Measured: Within 1 week of surgery
Postoperative Urinary Tract Infection
Treated for urinary tract infection with antibiotics or urinalysis or urine culture suggests infection.
Measured: Within 6 weeks after surgery
Sent Home With Catheterization
Urinary retention that required homegoing catheterization
Measured: within 6 weeks of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start1 Aug 2018
- Primary completion9 Jun 2020
- Study completion9 Jun 2020
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 (11)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 University Hospitals Cleveland Medical CenterThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Graham Chapman, University Hospitals Cleveland Medical Center
- Investigators
- Graham Chapman, Principal investigator, University Hospitals Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03524339
- Sponsor's protocol ID
- Tamsulosin for POUR
- Status last verified
- Oct 2021
- First submitted
- 10 Apr 2018
- Last updated
- 8 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hakvoort RA, Dijkgraaf MG, Burger MP, Emanuel MH, Roovers JP. Predicting short-term urinary retention after vaginal prolapse surgery. Neurourol Urodyn. 2009;28(3):225-8. doi: 10.1002/nau.20636.
PubMed 19130599Chong 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 27004205Espaillat-Rijo L, Siff L, Alas AN, Chadi SA, Zimberg S, Vaish S, Davila GW, Barber M, Hurtado EA. Intraoperative Cystoscopic Evaluation of Ureteral Patency: A Randomized Controlled Trial. Obstet Gynecol. 2016 Dec;128(6):1378-1383. doi: 10.1097/AOG.0000000000001750.
PubMed 27824741FitzGerald 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 11135378Reitz A, Haferkamp A, Kyburz T, Knapp PA, Wefer B, Schurch B. The effect of tamsulosin on the resting tone and the contractile behaviour of the female urethra: a functional urodynamic study in healthy women. Eur Urol. 2004 Aug;46(2):235-40; discussion 240. doi: 10.1016/j.eururo.2004.04.009.
PubMed 15245819Pummangura N, Kochakarn W. Efficacy of tamsulosin in the treatment of lower urinary tract symptoms (LUTS) in women. Asian J Surg. 2007 Apr;30(2):131-7. doi: 10.1016/S1015-9584(09)60146-9.
PubMed 17475584Zhang HL, Huang ZG, Qiu Y, Cheng X, Zou XQ, Liu TT. Tamsulosin for treatment of lower urinary tract symptoms in women: a systematic review and meta-analysis. Int J Impot Res. 2017 Jul;29(4):148-156. doi: 10.1038/ijir.2017.12. Epub 2017 Apr 20.
PubMed 28424499Madani AH, Aval HB, Mokhtari G, Nasseh H, Esmaeili S, Shakiba M, Shakiba RS, Seyed Damavand SM. Effectiveness of tamsulosin in prevention of post-operative urinary retention: a randomized double-blind placebo-controlled study. Int Braz J Urol. 2014 Jan-Feb;40(1):30-6. doi: 10.1590/S1677-5538.IBJU.2014.01.05.
PubMed 24642148Akkoc 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 27286124Poylin V, Curran T, Cataldo T, Nagle D. Perioperative use of tamsulosin significantly decreases rates of urinary retention in men undergoing pelvic surgery. Int J Colorectal Dis. 2015 Sep;30(9):1223-8. doi: 10.1007/s00384-015-2294-7. Epub 2015 Jun 23.
PubMed 26099320Chapman GC, Sheyn D, Slopnick EA, Roberts K, El-Nashar SA, Henderson JW, Mangel J, Hijaz AK, Pollard RR, Mahajan ST. Tamsulosin vs placebo to prevent postoperative urinary retention following female pelvic reconstructive surgery: a multicenter randomized controlled trial. Am J Obstet Gynecol. 2021 Sep;225(3):274.e1-274.e11. doi: 10.1016/j.ajog.2021.04.236. Epub 2021 Apr 21.
PubMed 33894146
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Administration of Tamsulosin vs Placebo to Prevent Postoperative Urinary Retention in Female Pelvic Reconstructive Surgery
- ClinicalTrials.gov ID
- NCT03524339
- Acronym / sponsor ID
- Tamsulosin for POUR
- Conditions
- Urinary Retention, Lower Urinary Tract Symptoms, Stress Urinary Incontinence, Pelvic Organ Prolapse
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 9 Jun 2020 (actual)
- Study completion
- 9 Jun 2020 (actual)
- First posted
- 14 May 2018 (actual)
- Results
- Posted 8 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a placebo controlled randomized controlled trial of perioperative use of tamsulosin to prevent postoperative urinary retention in female pelvic reconstructive surgery.
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 |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo oral capsule |
| Tamsulosin | Experimental | Drug: Tamsulosin |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must be 18 years or older as well as willing and able to provide informed consent
- Patients must be undergoing a scheduled surgery for pelvic organ prolapse or urinary incontinence
- Standard postoperative plan must include admission to the hospital with foley catheterization overnight the night after surgery, and planned removal of foley catheter and active voiding trial on postoperative day 1.
Key exclusion criteria (7 listed)
- Patient unable or unwilling to provide informed consent
- Severe allergy to sulfa drugs
- Known allergy to tamsulosin or another alpha antagonist medication
- History of urinary retention
- Planned bladder catheterization greater than 24 hours after surgery
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 |
|---|---|---|
| Placebo oral capsuleTamsulosin or placebo will be given for 3 days prior to surgery and one week after surgery to determine its effects on postoperative urinary retention. | Drug | Placebo |
| TamsulosinTamsulosin or placebo will be given for 3 days prior to surgery and one week after surgery to determine its effects on postoperative urinary retention. | Drug | Tamsulosin |
Primary outcome
Postoperative Urinary Retention
Time frame: Within 72 hours of surgery
Failed voiding trial upon removal of catheter
3 secondary outcomes
International Prostate Symptom Score
Time frame: Within 1 week of surgery
Postoperative Urinary Tract Infection
Time frame: Within 6 weeks after surgery
Sent Home With Catheterization
Time frame: within 6 weeks of surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19130599Hakvoort RA, Dijkgraaf MG, Burger MP, Emanuel MH, Roovers JP. Predicting short-term urinary retention after vaginal prolapse surgery. Neurourol Urodyn. 2009;28(3):225-8. doi: 10.1002/nau.20636.
- 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 27824741Espaillat-Rijo L, Siff L, Alas AN, Chadi SA, Zimberg S, Vaish S, Davila GW, Barber M, Hurtado EA. Intraoperative Cystoscopic Evaluation of Ureteral Patency: A Randomized Controlled Trial. Obstet Gynecol. 2016 Dec;128(6):1378-1383. doi: 10.1097/AOG.0000000000001750.
- 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 15245819Reitz A, Haferkamp A, Kyburz T, Knapp PA, Wefer B, Schurch B. The effect of tamsulosin on the resting tone and the contractile behaviour of the female urethra: a functional urodynamic study in healthy women. Eur Urol. 2004 Aug;46(2):235-40; discussion 240. doi: 10.1016/j.eururo.2004.04.009.
- Background: PubMed 17475584Pummangura N, Kochakarn W. Efficacy of tamsulosin in the treatment of lower urinary tract symptoms (LUTS) in women. Asian J Surg. 2007 Apr;30(2):131-7. doi: 10.1016/S1015-9584(09)60146-9.
- Background: PubMed 28424499Zhang HL, Huang ZG, Qiu Y, Cheng X, Zou XQ, Liu TT. Tamsulosin for treatment of lower urinary tract symptoms in women: a systematic review and meta-analysis. Int J Impot Res. 2017 Jul;29(4):148-156. doi: 10.1038/ijir.2017.12. Epub 2017 Apr 20.
- Background: PubMed 24642148Madani AH, Aval HB, Mokhtari G, Nasseh H, Esmaeili S, Shakiba M, Shakiba RS, Seyed Damavand SM. Effectiveness of tamsulosin in prevention of post-operative urinary retention: a randomized double-blind placebo-controlled study. Int Braz J Urol. 2014 Jan-Feb;40(1):30-6. doi: 10.1590/S1677-5538.IBJU.2014.01.05.
- 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 26099320Poylin V, Curran T, Cataldo T, Nagle D. Perioperative use of tamsulosin significantly decreases rates of urinary retention in men undergoing pelvic surgery. Int J Colorectal Dis. 2015 Sep;30(9):1223-8. doi: 10.1007/s00384-015-2294-7. Epub 2015 Jun 23.
- Derived from this study: PubMed 33894146Chapman GC, Sheyn D, Slopnick EA, Roberts K, El-Nashar SA, Henderson JW, Mangel J, Hijaz AK, Pollard RR, Mahajan ST. Tamsulosin vs placebo to prevent postoperative urinary retention following female pelvic reconstructive surgery: a multicenter randomized controlled trial. Am J Obstet Gynecol. 2021 Sep;225(3):274.e1-274.e11. doi: 10.1016/j.ajog.2021.04.236. Epub 2021 Apr 21.
- Individual participant dataSharing planned: No
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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.
Graham Chapman principal investigator
University Hospitals Case Western Reserve University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tamsulosin in people with Urinary Retention and Lower Urinary Tract Symptoms, run by University Hospitals Cleveland Medical Center at 2 sites 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 7 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: finished, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 8 Nov 2021). 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?
Postoperative Urinary Retention (time frame: Within 72 hours of 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 NCT03524339, which also lists 11 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 8 Nov 2021.