Suppressive Therapy With Oral Antibiotics for Prevention of Postoperative Urinary Tract Infection (UTI) (STOPP UTI)

• ClinicalTrials.gov Identifier: NCT01450800
• Recruitment Status: Completed
• First Posted: October 12, 2011
• Results First Posted: May 1, 2014
• Last Update Posted: February 13, 2017
• Sponsor: Duke University
• Information provided by (Responsible Party): Duke University

Study Description

Brief Summary:

This is a study of patients undergoing gynecologic surgery who require post-operative catheterization to determine if prophylactic antibiotic treatment decreases the risk of post-operative urinary tract infection in these patients.

Condition or disease	Intervention/treatment	Phase
Urinary Tract Infection	Drug: Nitrofurantoin; Drug: Placebo	Phase 4

Detailed Description:

Study Population Participants will be recruited from all patients who are planning to undergo gynecologic surgery by an attending surgeon in the Division of Urogynecology at Duke University Medical Center (DUMC). After enrollment and randomization, the participants will take the study drug once daily to start on post-operative day one and continue until the participant has stopped catheterizing for up to one week after surgery. The participant will also complete a daily diary for one week after surgery to record any catheterization and any study drug or additional antibiotic medication taken. We will then follow patients for a total of three weeks after surgery to monitor for treatment for UTI. At three weeks after surgery the observation period for the participant is complete.

Sample Size Under the assumption of 80% power and an alpha error of 0.05, we would need 156 subjects to demonstrate a 66% reduction in risk of UTI (i.e. from 28% to 10%) in those undergoing prophylactic antibiotic treatment. Therefore, we aim to recruit a total of 175 participants to account for participant dropout.

Study Definitions For our study purposes, post-operative catheterization will be defined to include patients who are hospitalized post-operatively with an indwelling Foley catheter as well as patients discharged with either intermittent self-catheterization (ISC) or indwelling Foley catheter. The decision to catheterize will be determined by type of surgical procedure, need for inpatient stay and void trial results. Void trials will be conducted as follows: the bladder is backfilled with 300cc normal saline, the catheter is removed and the patient is prompted to void immediately and, after voiding is complete, a (PVR) post-void residual volume is measured. The patient passes the void trial if she voids over 200cc in total volume or if her PVR is less than 100cc.

Our primary outcome of treatment for UTI within the first three weeks after surgery is to be defined clinically. A patient will be considered to have received treatment for UTI if she receives any antibiotic therapy for clinically suspected or culture-proven urinary tract infection (i.e. empirically given upon development of urinary symptoms or prescribed based on urinalysis or urine culture results) within the first three weeks after surgery.

Data Collection Demographic characteristics, operative data and post-operative data will be collected. Prior to discharge after surgery all patients will undergo a void trial per standard procedure unless they receive an indwelling Foley catheter for overnight hospitalization. Post-operatively all subjects will be given a catheterization diary to record days of catheterization and days of antibiotic therapy. All subjects will be instructed to call our clinical office to report any urinary complaints and/or treatment for UTI. Information will be collected from electronic medical records regarding any office visits, urine cultures performed or treatment for UTI during this post-operative period. Data will be entered into a de-identified study database for analysis by the PI and study coordinator who will be blinded to participant randomization.

Subject Randomization and Blinding Study participants will be randomized to prophylactic treatment versus no treatment via a computerized randomization scheme by the IDS at the time of enrollment. Patients will be blinded to treatment by the utilization of placebo tablets.

Adverse Events Nitrofurantoin is FDA approved for the treatment of UTI. We will be using a prophylactic dose and will monitor for any adverse events. Adverse events will be reported per protocol. A safety monitoring designee will perform reviews on a designated basis throughout the study.

Study Costs There will be no additional cost to the patient for their participation in this study. No additional laboratory testing will be performed as a result of participation.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 163 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Antibiotic Prophylaxis for Urinary Tract Infection in Patients Requiring Catheterization After Urogynecologic Surgery
• Study Start Date: August 2011
• Actual Primary Completion Date: March 2013
• Actual Study Completion Date: September 2013

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Nitrofurantoin; Nitrofurantoin 100mg by mouth daily starting on postoperative day 1 for up to 7 days during catheterization	Drug: Nitrofurantoin; Nitrofurantoin 100mg po daily to be taken every day the patient uses a catheter for up to one week post-operatively; Other Names: Macrobid; Macrodantin
Placebo Comparator: Placebo; Placebo drug 1 tablet by mouth daily starting on postoperative day 1 for up to 7 days during catheterization	Drug: Placebo; Participants randomized to placebo will be instructed to take placebo one tablet by mouth daily starting on postoperative day 1 for up to 7 days during catheterization; Other Names: Placebo medication; Inactive medication

Outcome Measures

Primary Outcome Measures :

1. Urinary Tract Infections [ Time Frame: three weeks post-operative ]
   The primary outcome was treatment for UTI within the first 3 weeks after surgery. Treatment for UTI was defined to include any treatment received for clinically suspected or culture-proven urinary tract infection within 3 weeks of surgery. Clinically suspected treatment was defined to include treatment given empirically upon development of urinary symptoms or prescribed based on urine test results. Culture-proven UTI was defined as a urine culture with greater than 100,000 colony-forming units of a single organism.

Secondary Outcome Measures :

1. Other Risk Factors for UTI [ Time Frame: 3 weeks following surgery ]
   We examined risk of UTI as related to vaginal estrogen therapy
2. Other Risk Factors for UTI [ Time Frame: 3 weeks following surgery ]
   We examined risk of UTI as related to history of recurrent UTIs
3. Other Risk Factors for UTI [ Time Frame: 3 weeks following surgery ]
   We examined risk of UTI as related to preoperative UTI treatment
4. Other Risk Factors for UTI [ Time Frame: 3 weeks following surgery ]
   We examined risk of UTI as related to Creatinine Clearance
5. Other Risk Factors for UTI [ Time Frame: 3 weeks following surgery ]
   We examined risk of UTI as related to sling as part of surgery
6. Other Risk Factors for UTI [ Time Frame: 3 weeks following surgery ]
   We examined risk of UTI as related to total postoperative catheter days
7. Other Risk Factors for UTI [ Time Frame: 3 weeks following surgery ]
   We examined risk of UTI as related to postoperative catheter type

Other Outcome Measures:

1. Antibiotic Resistance to Macrobid [ Time Frame: 6 weeks after surgery ]
   We examined for macrobid resistance on urine culture results within 3 weeks of surgery

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Undergoing urogynecologic surgery
• Receive postoperative catheterization

Exclusion Criteria:

• Age less than 21 years old
• Pregnancy
• Allergy, contraindication or intolerance to Nitrofurantoin
• Do not speak English
• Dependent on trans-urethral catheter to accomplish voiding preoperatively
• Undergoing interstim device placement, urethral diverticulum surgery or fistula surgery
• Sustain intraoperative urinary tract injury requiring postoperative catheterization

Contacts and Locations

Locations

United States, North Carolina

Duke University Medical Center

Durham, North Carolina, United States, 27705

Sponsors and Collaborators

Duke University

Investigators

• Principal Investigator: Cindy Amundsen, MD; Duke University

More Information

Publications:

Brown JS, Grady D, Ouslander JG, Herzog AR, Varner RE, Posner SF. Prevalence of urinary incontinence and associated risk factors in postmenopausal women. Heart & Estrogen/Progestin Replacement Study (HERS) Research Group. Obstet Gynecol. 1999 Jul;94(1):66-70. doi: 10.1016/s0029-7844(99)00263-x.

Hannestad YS, Rortveit G, Sandvik H, Hunskaar S; Norwegian EPINCONT study. Epidemiology of Incontinence in the County of Nord-Trondelag. A community-based epidemiological survey of female urinary incontinence: the Norwegian EPINCONT study. Epidemiology of Incontinence in the County of Nord-Trondelag. J Clin Epidemiol. 2000 Nov;53(11):1150-7. doi: 10.1016/s0895-4356(00)00232-8.

Irwin DE, Milsom I, Hunskaar S, Reilly K, Kopp Z, Herschorn S, Coyne K, Kelleher C, Hampel C, Artibani W, Abrams P. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol. 2006 Dec;50(6):1306-14; discussion 1314-5. doi: 10.1016/j.eururo.2006.09.019. Epub 2006 Oct 2.

Thomas TM, Plymat KR, Blannin J, Meade TW. Prevalence of urinary incontinence. Br Med J. 1980 Nov 8;281(6250):1243-5. doi: 10.1136/bmj.281.6250.1243.

Wu JM, Hundley AF, Fulton RG, Myers ER. Forecasting the prevalence of pelvic floor disorders in U.S. Women: 2010 to 2050. Obstet Gynecol. 2009 Dec;114(6):1278-1283. doi: 10.1097/AOG.0b013e3181c2ce96.

Levin I, Groutz A, Gold R, Pauzner D, Lessing JB, Gordon D. Surgical complications and medium-term outcome results of tension-free vaginal tape: a prospective study of 313 consecutive patients. Neurourol Urodyn. 2004;23(1):7-9. doi: 10.1002/nau.10164.

Nilsson CG, Kuuva N, Falconer C, Rezapour M, Ulmsten U. Long-term results of the tension-free vaginal tape (TVT) procedure for surgical treatment of female stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2001;12 Suppl 2:S5-8. doi: 10.1007/s001920170003.

Falagas ME, Athanasiou S, Iavazzo C, Tokas T, Antsaklis A. Urinary tract infections after pelvic floor gynecological surgery: prevalence and effect of antimicrobial prophylaxis. A systematic review. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Aug;19(8):1165-72. doi: 10.1007/s00192-008-0584-0. Epub 2008 Apr 10.

Sutkin G, Lowder JL, Smith KJ. Prophylactic antibiotics to prevent urinary tract infection during clean intermittent self-catheterization (CISC) for management of voiding dysfunction after prolapse and incontinence surgery: a decision analysis. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Aug;20(8):933-8. doi: 10.1007/s00192-009-0885-y. Epub 2009 Apr 10.

Macy E, Poon K-Y T. Self-reported antibiotic allergy incidence and prevalence: age and sex effects. Am J Med. 2009 Aug;122(8):778.e1-7. doi: 10.1016/j.amjmed.2009.01.034.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Dieter AA, Amundsen CL, Edenfield AL, Kawasaki A, Levin PJ, Visco AG, Siddiqui NY. Oral antibiotics to prevent postoperative urinary tract infection: a randomized controlled trial. Obstet Gynecol. 2014 Jan;123(1):96-103. doi: 10.1097/AOG.0000000000000024. Erratum In: Obstet Gynecol. 2014 Mar;123(3):669.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT01450800
• Other Study ID Numbers: Pro00025269; 3913577 ( Other Grant/Funding Number: Charles B Hammond Research Fund )
• First Posted: October 12, 2011
• Results First Posted: May 1, 2014
• Last Update Posted: February 13, 2017
• Last Verified: December 2016

Keywords provided by Duke University:

urinary tract infection; gynecologic surgery; post-operative complications; nitrofurantoin

Additional relevant MeSH terms:

Infections; Communicable Diseases; Urinary Tract Infections; Disease Attributes; Pathologic Processes; Urologic Diseases; Nitrofurantoin; Anti-Infective Agents, Urinary; Anti-Infective Agents; Renal Agents; Anti-Bacterial Agents