Tamsulosin vs Placebo to Prevent Postoperative Urinary Retention in Female Pelvic Reconstructive Surgery

NCT03524339 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: Tamsulosin for POUR
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 2

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• Postoperative Urinary Retention

  Failed voiding trial upon removal of catheter

  Within 72 hours of surgery

Secondary Outcomes (3)

• International Prostate Symptom Score

  Within 1 week of surgery

• Postoperative Urinary Tract Infection

  Within 6 weeks after surgery

• Sent Home With Catheterization

  within 6 weeks of surgery

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo oral capsule

Tamsulosin

EXPERIMENTAL

Drug: Tamsulosin

Interventions

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.

Placebo

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.

Tamsulosin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (2)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

University Hospitals

Cleveland, Ohio, 44106, United States

Location

Related Publications (11)

• 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.

  PMID: 19130599 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.

  PMID: 27004205 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.

  PMID: 27824741 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.

  PMID: 11135378 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.

  PMID: 15245819 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.

  PMID: 17475584 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.

  PMID: 28424499 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.

  PMID: 24642148 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.

  PMID: 27286124 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.

  PMID: 26099320 BACKGROUND

• 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.

  PMID: 33894146 DERIVED

MeSH Terms

Conditions

Urinary Retention; Lower Urinary Tract Symptoms; Urinary Incontinence, Stress; Pelvic Organ Prolapse

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Prolapse; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Results Point of Contact

• Title: Graham Chapman
• Organization: Cleveland Clinic

gchapman5@gmail.com

440-312-2229

Study Officials

• Graham Chapman

  University Hospitals Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: May 14, 2018
• Study Start: August 1, 2018
• Primary Completion: June 9, 2020
• Study Completion: June 9, 2020
• Last Updated: November 8, 2021
• Results First Posted: November 8, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)