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This is a placebo controlled randomized controlled trial of perioperative use of tamsulosin to prevent postoperative urinary retention in female pelvic reconstructive surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Tamsulosin | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo oral capsule | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Urinary Retention | Failed voiding trial upon removal of catheter | Within 72 hours of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Graham Chapman | University Hospitals Case Western Reserve University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States | ||
| University Hospitals |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19130599 | Background | 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. | |
| 27004205 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo oral capsule: 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. |
| FG001 | Tamsulosin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 1, 2019 |
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| Tamsulosin | Drug | 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. |
|
| Within 1 week of surgery |
| Postoperative Urinary Tract Infection | Treated for urinary tract infection with antibiotics or urinalysis or urine culture suggests infection. | Within 6 weeks after surgery |
| Sent Home With Catheterization | Urinary retention that required homegoing catheterization | within 6 weeks of surgery |
| Cleveland |
| Ohio |
| 44106 |
| United States |
| 27824741 | Background | Espaillat-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. |
| 11135378 | Background | 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. |
| 15245819 | Background | Reitz 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. |
| 17475584 | Background | Pummangura 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. |
| 28424499 | Background | Zhang 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. |
| 24642148 | Background | Madani 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. |
| 27286124 | Background | 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. |
| 26099320 | Background | Poylin 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. |
| 33894146 | Derived | Chapman 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. |
Tamsulosin: 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.
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo oral capsule: 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. |
| BG001 | Tamsulosin | Tamsulosin: 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Postoperative Urinary Retention | Failed voiding trial upon removal of catheter | Posted | Count of Participants | Participants | Within 72 hours of surgery |
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| Secondary | 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) | Posted | Median | Inter-Quartile Range | Points | Within 1 week of surgery |
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| ||||||||||||||||||||||||||||||
| Secondary | Postoperative Urinary Tract Infection | Treated for urinary tract infection with antibiotics or urinalysis or urine culture suggests infection. | Posted | Count of Participants | Participants | Within 6 weeks after surgery |
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| Secondary | Sent Home With Catheterization | Urinary retention that required homegoing catheterization | Posted | Count of Participants | Participants | within 6 weeks of surgery |
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Three days prior to surgery through five days after surgery (10d total)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo oral capsule: 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. | 0 | 62 | 2 | 62 | 3 | 62 |
| EG001 | Tamsulosin | Tamsulosin: 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. | 0 | 57 | 1 | 57 | 3 | 57 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Development of atrial fibrillation | Cardiac disorders | Non-systematic Assessment | Postoperative |
| |
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Postoperative |
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| Congestive heart failure | Cardiac disorders | Non-systematic Assessment | Postoperative |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness/lightheadedness | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Graham Chapman | Cleveland Clinic | 440-312-2229 | gchapman5@gmail.com |
| Oct 8, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D016055 | Urinary Retention |
| D059411 | Lower Urinary Tract Symptoms |
| D014550 | Urinary Incontinence, Stress |
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014549 | Urinary Incontinence |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
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| ID | Term |
|---|---|
| D000077409 | Tamsulosin |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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