Does Treatment With Macrobid Reduce Urinary Tract Infections in Patients Receiving a Sub-Urethral Sling for Incontinence

NCT00734968 | Completed Phase 4 Results DMC

• 1 other identifier: 1108717
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

Brief Summary

This project will determine whether 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.

Conditions

Stress Incontinence

Keywords

Urinary tract infection (UTI); suburethral sling; Prevention; Nitrofurantoin; Prophylaxis

Outcome Measures

Primary Outcomes (3)

• Incidence of Post-operative UTI Following the Placement of Sub-urethral Sling for the Treatment of Stress Urinary Incontinence

  The overall rate of UTI following the placement of sub-urethral sling for the treatment of stress urinary incontinence in our study was 24.8% (n = 37)

  6 weeks

• Incidence of Post-operative UTI in Placebo Group

  The incidence of UTI in the placebo group was 32%.

  6 weeks

• Incidence of Post-operative UTI in Treatment Group

  The incidence of UTI in the nitrofurantoin group was 17.6%.

  6 weeks

Study Arms (2)

Treatment

EXPERIMENTAL

Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively

Drug: Nitrofurantoin

Placebo

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

Interventions

Nitrofurantoin DRUG

Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence

Also known as: Macrobid

Treatment

Placebo OTHER

6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets.

Placebo

Eligibility Criteria

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

You may qualify if:

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

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• Texas A&M University: collaborator

Study Sites (1)

Scott and White Hosptial, Texas A&M University

Temple, Texas, 76508, United States

Location

Related Publications (20)

• Anger JT, Litwin MS, Wang Q, Pashos CL, Rodriguez LV. Complications of sling surgery among female Medicare beneficiaries. Obstet Gynecol. 2007 Mar;109(3):707-14. doi: 10.1097/01.AOG.0000255975.24668.f2.

  PMID: 17329524 BACKGROUND

• 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. doi: 10.1001/jama.287.20.2701.

  PMID: 12020306 BACKGROUND

• Aubin C. 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. doi: 10.1016/j.annemergmed.2006.09.022. No abstract available.

  PMID: 17203544 BACKGROUND

• 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. doi: 10.1111/j.1471-0528.2002.01195.x.

  PMID: 12066948 BACKGROUND

• 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. doi: 10.1067/s0002-9378(03)00677-x.

  PMID: 14520192 BACKGROUND

• 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. doi: 10.4065/82.2.181.

  PMID: 17290725 BACKGROUND

• 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. doi: 10.7326/0003-4819-135-1-200107030-00004.

  PMID: 11434727 BACKGROUND

• 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. doi: 10.1016/s0029-7844(03)00122-4.

  PMID: 12738152 BACKGROUND

• 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. doi: 10.1034/j.1600-0412.2002.810113.x.

  PMID: 11942891 BACKGROUND

• 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. doi: 10.1016/j.ajog.2006.06.060.

  PMID: 17132487 BACKGROUND

• 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):214-217. doi: 10.1016/S1701-2163(16)32111-9.

  PMID: 16650360 BACKGROUND

• 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. doi: 10.1111/j.1471-0528.2004.00522.x.

  PMID: 15924538 BACKGROUND

• 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. doi: 10.1016/j.ajog.2004.11.004.

  PMID: 16021057 BACKGROUND

• 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. doi: 10.1016/j.ajog.2004.10.623.

  PMID: 15902154 BACKGROUND

• 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. doi: 10.1016/s0029-7844(01)01565-4.

  PMID: 11704161 BACKGROUND

• 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. doi: 10.1097/01.ju.0000135072.27734.4a.

  PMID: 15311022 BACKGROUND

• Valpas A, Kivela 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.

  PMID: 12790850 BACKGROUND

• 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. doi: 10.1136/bmj.325.7355.67.

  PMID: 12114234 BACKGROUND

• Temtanakitpaisan T, Buppasiri P, Lumbiganon P, Laopaiboon M, Rattanakanokchai S. Prophylactic antibiotics for preventing infection after continence surgery in women with stress urinary incontinence. Cochrane Database Syst Rev. 2022 Mar 29;3(3):CD012457. doi: 10.1002/14651858.CD012457.pub2.

  PMID: 35349162 DERIVED

• Jackson D, Higgins E, Bracken J, Yandell PM, Shull B, Foster RT Sr. Antibiotic prophylaxis for urinary tract infection after midurethral sling: a randomized controlled trial. Female Pelvic Med Reconstr Surg. 2013 May-Jun;19(3):137-41. doi: 10.1097/SPV.0b013e318285ba53.

  PMID: 23611930 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress; Urinary Tract Infections

Interventions

Nitrofurantoin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nitrofurans; Nitro Compounds; Organic Chemicals; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Daniel Jackson MD
• Organization: University of Missouri

jacksondl@health.missouri.edu

573 499 6041

Study Officials

• Daniel L Jackson, M.D.

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

• Raymond T Foster, MD, MS, MHSc

  University of Missouri-Columbia

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2008
• First Posted: August 14, 2008
• Study Start: May 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: October 11, 2016
• Results First Posted: October 11, 2016

Record last verified: 2016-08

Locations

US (1)