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Challenges in enrollment led to decission for termination
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamsulosin | Drug | Oral drug: 10 days of 0.4 mg of oral Tamsulosin |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Postoperative (Day 0) Urinary Retention | Urinary retention can be defined as >150cc residual volume during an active voiding trial | Up to 6 weeks postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary Tract Infection Rate | Urinary tract infection rate | Week 6 |
| Incidence of Delayed Urinary Retention | Delayed urinary retention will be defined as post-void residual > 150 cc |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Majid Mirzazadeh, MD | Wake Forest Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28538495 | Background | 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. | |
| 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tamsulosin | 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. Tamsulosin: Oral drug: 10 days of 0.4 mg of oral Tamsulosin |
| FG001 | Placebo | 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. Placebo: Oral drug: 10 days of identical-appearing placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
2 Subjects were Lost To Follow - 1 in each Group
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| ID | Title | Description |
|---|---|---|
| BG000 | Tamsulosin | 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. Tamsulosin: Oral drug: 10 days of 0.4 mg of oral Tamsulosin |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 1 Subject was Lost-to-Follow |
| 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 | Number of Participants With Postoperative (Day 0) Urinary Retention | Urinary retention can be defined as >150cc residual volume during an active voiding trial | Posted | Count of Participants | Participants | Up to 6 weeks postoperatively |
|
6 weeks
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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 | Tamsulosin | 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. Tamsulosin: Oral drug: 10 days of 0.4 mg of oral Tamsulosin |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Majid Mirzazadeh | Wake Forest | 336-716-4131 | mmirzaza@wakehealth.edu |
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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 | Aug 19, 2021 | Jan 29, 2024 | Prot_SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 12, 2022 | Dec 4, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D016055 | Urinary Retention |
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D000077409 | Tamsulosin |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Placebo |
| Drug |
Oral drug: 10 days of identical-appearing placebo |
|
| Week 6 |
| Number Emergency Department (ED) Visits | Up to 30 days postoperatively |
| Total Number of Days of Bladder Catheterization | 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) | Day 0 and 1 week postoperatively |
| 29913175 | Background | 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. |
| 30418263 | Background | 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. |
| 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. |
| 28341140 | Background | 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. |
| 19829032 | Background | 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. |
| 27168235 | Background | 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. |
| 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. |
| 29509646 | Background | 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. |
| 20175247 | Background | 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. |
| 30734011 | Background | 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. |
| 25981843 | Background | 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. |
| 18060968 | Background | 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. |
| 27261788 | Background | 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. |
| 2850917 | Background | Koyanagi T, Morita H, Taniguchi K, Kubota M, Shinno Y, Takamatsu T. Neurogenic urethra: clinical relevance of isolated neuropathic dysfunction of the urethra, and the denervation supersensitivity of the urethra revisited. Eur Urol. 1988;15(1-2):77-83. doi: 10.1159/000473401. |
| 6138916 | Background | Livne 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. |
| 2866119 | Background | Lose 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. |
| 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. |
| 21508753 | Background | Perron-Burdick M, Yamamoto M, Zaritsky E. Same-day discharge after laparoscopic hysterectomy. Obstet Gynecol. 2011 May;117(5):1136-1141. doi: 10.1097/AOG.0b013e318215dd4e. |
| 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. |
| 27399998 | Background | Propst K, Tunitsky-Bitton E, O'Sullivan DM, Steinberg AC, LaSala C. Phenazopyridine for Evaluation of Ureteral Patency: A Randomized Controlled Trial. Obstet Gynecol. 2016 Aug;128(2):348-355. doi: 10.1097/AOG.0000000000001472. |
| 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. |
| 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. |
| 27319367 | Background | Ripperda CM, Kowalski JT, Chaudhry ZQ, Mahal AS, Lanzer J, Noor N, Good MM, Hynan LS, Jeppson PC, Rahn DD. Predictors of early postoperative voiding dysfunction and other complications following a midurethral sling. Am J Obstet Gynecol. 2016 Nov;215(5):656.e1-656.e6. doi: 10.1016/j.ajog.2016.06.010. Epub 2016 Jun 16. |
| 23107080 | Background | Schiavone MB, Herzog TJ, Ananth CV, Wilde ET, Lewin SN, Burke WM, Lu YS, Neugut AI, Hershman DL, Wright JD. Feasibility and economic impact of same-day discharge for women who undergo laparoscopic hysterectomy. Am J Obstet Gynecol. 2012 Nov;207(5):382.e1-9. doi: 10.1016/j.ajog.2012.09.014. Epub 2012 Sep 17. |
| 25434837 | Background | Tunitsky-Bitton E, Murphy A, Barber MD, Goldman HB, Vasavada S, Jelovsek JE. Assessment of voiding after sling: a randomized trial of 2 methods of postoperative catheter management after midurethral sling surgery for stress urinary incontinence in women. Am J Obstet Gynecol. 2015 May;212(5):597.e1-9. doi: 10.1016/j.ajog.2014.11.033. Epub 2014 Nov 27. |
| 25185611 | Background | Turner LC, Kantartzis K, Shepherd JP. Predictors of postoperative acute urinary retention in women undergoing minimally invasive sacral colpopexy. Female Pelvic Med Reconstr Surg. 2015 Jan-Feb;21(1):39-42. doi: 10.1097/SPV.0000000000000110. |
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. Placebo: Oral drug: 10 days of identical-appearing placebo |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | 1 Subject in each group was LTF | Count of Participants | Participants |
|
| Race (NIH/OMB) | 1 Subject in each group was LTF | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Lost to follow-up | Count of Participants | Participants |
|
|
|
| Secondary | Urinary Tract Infection Rate | Urinary tract infection rate | No Data was collected | Posted | Week 6 |
|
|
| Secondary | Incidence of Delayed Urinary Retention | Delayed urinary retention will be defined as post-void residual > 150 cc | No Data was collected | Posted | Week 6 |
|
|
| Secondary | Number Emergency Department (ED) Visits | No Data was collected | Posted | Up to 30 days postoperatively |
|
|
| Secondary | Total Number of Days of Bladder Catheterization | No Data was collected | Posted | Week 6 |
|
|
| Secondary | 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) | No Data was collected | Posted | Day 0 and 1 week postoperatively |
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 1 |
| 1 |
| EG001 | Placebo | 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. Placebo: Oral drug: 10 days of identical-appearing placebo | 0 | 1 | 0 | 1 | 0 | 1 |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D007239 | Infections |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|