The Effect of Tamsulosin on Postoperative Urinary Retention
NCT ID: NCT04682366
Last Updated: 2024-01-31
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
TERMINATED
Clinical Phase
PHASE4
Total Enrollment
4 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-10-19
Study Completion Date
2022-11-10
Brief Summary
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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.
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Detailed Description
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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.
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
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Urinary Retention
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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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.
Group Type
EXPERIMENTAL
Tamsulosin
Intervention Type
DRUG
Oral drug: 10 days of 0.4 mg of oral Tamsulosin
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.
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Oral drug: 10 days of identical-appearing placebo
Interventions
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Tamsulosin
Oral drug: 10 days of 0.4 mg of oral Tamsulosin
Intervention Type
DRUG
Placebo
Oral drug: 10 days of identical-appearing placebo
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* 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)
* 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)
Exclusion Criteria
* 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
* 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
* 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
* 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
Minimum Eligible Age
21 Years
Maximum Eligible Age
99 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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Wake Forest University Health Sciences
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Majid Mirzazadeh, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest Health Sciences
Locations
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Wake Forest Health Sciences
Winston-Salem, North Carolina, United States
Site Status
Countries
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United States
References
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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.
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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.
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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.
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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.
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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.
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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.
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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IRB00070462
Identifier Type: -
Identifier Source: org_study_id
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