Does Post-Operative Prophylaxis With Macrobid Reduce the Incidence of Post-Operative Urinary Tract Infection in Patients Undergoing Placement of a Sub-Urethral Sling for the Treatment of Stress Urinary Incontinence - Full Text View

Sponsor:	University of Missouri-Columbia
Collaborator:	Texas A&M University
Information provided by:	University of Missouri-Columbia
ClinicalTrials.gov Identifier:	NCT00734968

Purpose

This project will be a randomized, double blinded, placebo controlled clinical trial. The aim of the trial is to determine whether or not post-operative prophylaxis with macrobid will decrease the incidence of postoperative urinary tract infection in women receiving sub-urethral slings for the treatment of urinary incontinence.

Condition	Intervention	Phase
Post-Operative Urinary Tract Infection in Patients Undergoing Placement of a Sub-Urethral Sling for the Treatment of Stress Urinary Incontinence	Drug: Nitrofurantoin Other: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Does Post-Operative Prophylaxis With Macrobid Reduce the Incidence of Post-Operative Urinary Tract Infection in Patients Undergoing Placement of a Sub-Urethral Sling for the Treatment of Stress Urinary Incontinence: A Randomized, Double Blinded Placebo Controlled Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Pelvic Support Problems Urinary Incontinence Urinary Tract Infections

Drug Information available for: Nitrofurantoin Nitrofurantoin monohydrate

U.S. FDA Resources

Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:

Incidence of post-operative UTI following the placement of sub-urethral sling for the treatment of stress urinary incontinence [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	160
Study Start Date:	August 2008
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively	Drug: Nitrofurantoin Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence
2: Placebo Comparator Arm randomly assigned to receive placebo 1 tablet PO BID x 3 days post-operatively.The incidence of UTI in this group will be compared with group one (1)	Other: Placebo 6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Women over the age of 18 who will undergo the placement of a sub-urethral sling for the treatment of stress urinary incontinence

Exclusion Criteria:

Exclusion criteria are those with a known allergy to macrobid, those with glucose-6-phosphate deficiency, renal impairment, women breast feeding or with a known pregnancy, patients taking medications for gout, and those with known risk factors for complicated UTI (polycystic renal disease, nephrolithiasis, neurogenic bladder, diabetes, immuno-suppression, etc).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00734968

Contacts

Contact: Daniel L Jackson, M.D.	573-499-6084	Jacksondl@health.missouri.edu
Contact: Raymond T Foster, M.D., M.S., M.H.Sc.	573-875-9258	FosterRT@health.missouri.edu

Locations

United States, Texas
Scott and White Hosptial, Texas A&M University	Recruiting
Temple, Texas, United States, 76508
Contact: Ed Higgins, M.D. 257-724-2677 ehiggins@swmail.sw.org
Principal Investigator: Ed Higgins, M.D.

Sponsors and Collaborators

University of Missouri-Columbia

Texas A&M University

Investigators

Principal Investigator:	Daniel L Jackson, M.D.	University of Missouri-Columbia
Study Director:	Raymond T Foster, M.D., M.S., M.H.Sc.	University of Missouri-Columbia

More Information

Publications:

Anger JT, Litwin MS, Wang Q, Pashos CL, Rodríguez LV. Complications of sling surgery among female Medicare beneficiaries. Obstet Gynecol. 2007 Mar;109(3):707-14.

Bent S, Nallamothu BK, Simel DL, Fihn SD, Saint S. Does this woman have an acute uncomplicated urinary tract infection? JAMA. 2002 May 22-29;287(20):2701-10. Review.

[No authors listed] Evidence-based emergency medicine/rational clinical examination abstract. Does this woman have an acute uncomplicated urinary tract infection? Ann Emerg Med. 2007 Jan;49(1):106-8. No abstract available.

Bodelsson G, Henriksson L, Osser S, Stjernquist M. Short term complications of the tension free vaginal tape operation for stress urinary incontinence in women. BJOG. 2002 May;109(5):566-9.

Ferro A, Byck D, Gallup D. Intraoperative and postoperative morbidity associated with cystoscopy performed in patients undergoing gynecologic surgery. Am J Obstet Gynecol. 2003 Aug;189(2):354-7; discussion 357.

Grover ML, Bracamonte JD, Kanodia AK, Bryan MJ, Donahue SP, Warner AM, Edwards FD, Weaver AL. Assessing adherence to evidence-based guidelines for the diagnosis and management of uncomplicated urinary tract infection. Mayo Clin Proc. 2007 Feb;82(2):181-5.

Gupta K, Hooton TM, Roberts PL, Stamm WE. Patient-initiated treatment of uncomplicated recurrent urinary tract infections in young women. Ann Intern Med. 2001 Jul 3;135(1):9-16.

Karram MM, Segal JL, Vassallo BJ, Kleeman SD. Complications and untoward effects of the tension-free vaginal tape procedure. Obstet Gynecol. 2003 May;101(5 Pt 1):929-32.

Kuuva N, Nilsson CG. A nationwide analysis of complications associated with the tension-free vaginal tape (TVT) procedure. Acta Obstet Gynecol Scand. 2002 Jan;81(1):72-7.

LaSala CA, Schimpf MO, Udoh E, O'Sullivan DM, Tulikangas P. Outcome of tension-free vaginal tape procedure when complicated by intraoperative cystotomy. Am J Obstet Gynecol. 2006 Dec;195(6):1857-61.

Lim JL, Quinlan DJ. Safety of a new transobturator suburethral synthetic sling (TVT-O) procedure during the training phase. J Obstet Gynaecol Can. 2006 Mar;28(3):214-7.

Pugsley H, Barbrook C, Mayne CJ, Tincello DG. Morbidity of incontinence surgery in women over 70 years old: a retrospective cohort study. BJOG. 2005 Jun;112(6):786-90.

Schraffordt Koops SE, Bisseling TM, Heintz AP, Vervest HA. Prospective analysis of complications of tension-free vaginal tape from The Netherlands Tension-free Vaginal Tape study. Am J Obstet Gynecol. 2005 Jul;193(1):45-52.

Sokol AI, Jelovsek JE, Walters MD, Paraiso MF, Barber MD. Incidence and predictors of prolonged urinary retention after TVT with and without concurrent prolapse surgery. Am J Obstet Gynecol. 2005 May;192(5):1537-43.

Tamussino KF, Hanzal E, Kolle D, Ralph G, Riss PA; Austrian Urogynecology Working Group. Tension-free vaginal tape operation: results of the Austrian registry. Obstet Gynecol. 2001 Nov;98(5 Pt 1):732-6.

Tsivian A, Mogutin B, Kessler O, Korczak D, Levin S, Sidi AA. Tension-free vaginal tape procedure for the treatment of female stress urinary incontinence: long-term results. J Urol. 2004 Sep;172(3):998-1000.

Valpas A, Kivelä A, Penttinen J, Kauko M, Kujansuu E, Tomas E, Haarala M, Meltomaa S, Nilsson CK. Tension-free vaginal tape and laparoscopic mesh colposuspension in the treatment of stress urinary incontinence: immediate outcome and complications--a randomized clinical trial. Acta Obstet Gynecol Scand. 2003 Jul;82(7):665-71.

Ward K, Hilton P; United Kingdom and Ireland Tension-free Vaginal Tape Trial Group. Prospective multicentre randomised trial of tension-free vaginal tape and colposuspension as primary treatment for stress incontinence. BMJ. 2002 Jul 13;325(7355):67.

Responsible Party:	University of Missouri-Columbia School of Medicine. Department of OB/GYN and Women's Health ( Daniel Jackson, M.D. )
Study ID Numbers:	1108717
Study First Received:	August 12, 2008
Last Updated:	February 24, 2009
ClinicalTrials.gov Identifier:	NCT00734968 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Missouri-Columbia:

UTI
Urinary tract infection
suburethral sling

Prevention
Nitrofurantoin
Prophylaxis

Additional relevant MeSH terms:

Anti-Infective Agents
Communicable Diseases
Urination Disorders
Urinary Tract Infections
Stress
Anti-Infective Agents, Urinary
Renal Agents
Infection
Pharmacologic Actions

Urological Manifestations
Signs and Symptoms
Urinary Incontinence, Stress
Pathologic Processes
Urologic Diseases
Nitrofurantoin
Therapeutic Uses
Urinary Incontinence

ClinicalTrials.gov processed this record on February 08, 2010