Non-inferiority of short-term urethral catheterization following fistula repair surgery: Study protocol for a randomized controlled trial

BMC Women's Health

Volumn 12, Issue , 2012, Pages

  Barone, Mark A ^a   Frajzyngier, Vera ^a   Arrowsmith, Steven ^a,b   Ruminjo, Joseph ^a   Seuc, Armando ^c   Landry, Evelyn ^a   Beattie, Karen ^a   Barry, Thierno H ^d   Lewis, Alyona ^e   Muleta, Mulu ^f   Nembunzu, Dolorès ^g   Olupot, Robert ^h   Sunday Adeoye, Ileogben ⁱ   Wakasiaka, Weston K ^j   Widmer, Mariana ^c   Gülmezoglu, A Metin ^c  

^a Fistula Care Project   (United States)

^b Fistula Consulting LLC   (United States)

^c WORLD HEALTH ORGANIZATION   (Switzerland)

^d L'Hôpital Préfectoral de Kissidougou ^*  (Guinea)

^e Aberdeen Women's Centre   (Sierra Leone)

^f UNIVERSITY OF GONDAR   (Ethiopia)

^g Boulevard Lumumba   (Congo)

^h Kagando Hospital   (Uganda)

ⁱ National Obstetric Fistula Centre Abakaliki   (Nigeria)

^j KENYATTA NATIONAL HOSPITAL   (Kenya)

more..

Author keywords

Catheter; Non inferiority randomized controlled trial; Surgery; Vaginal fistula

Indexed keywords

ARTICLE; HOSPITALIZATION; HUMAN; INTERMITTENT CATHETERIZATION; MULTICENTER STUDY (TOPIC); OUTCOME ASSESSMENT; RANDOMIZED CONTROLLED TRIAL (TOPIC); SAMPLE SIZE; STUDY DESIGN; URETHRA FISTULA; URETHRA SURGERY; URETHRAL CATHETERIZATION; URINE INCONTINENCE; URINE RETENTION; AFRICA SOUTH OF THE SAHARA; BLADDER CATHETERIZATION; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; FEMALE; INSTRUMENTATION; MULTICENTER STUDY; POSTOPERATIVE COMPLICATION; RANDOMIZED CONTROLLED TRIAL; STANDARD; TIME; VAGINA DISEASE;

AFRICA SOUTH OF THE SAHARA; FEMALE; HUMANS; OUTCOME ASSESSMENT (HEALTH CARE); POSTOPERATIVE COMPLICATIONS; TIME FACTORS; URINARY CATHETERIZATION; VAGINAL FISTULA;

EID: 84858382596     PISSN: None     EISSN: 14726874     Source Type: Journal    
DOI: 10.1186/1472-6874-12-5     Document Type: Article

References (13)

1. Wall LL, Arrowsmith SD, Briggs ND, Browning A, Lassey A. The obstetric vesicovaginal fistula in the developing world. Obstet Gynecol Surv 2005, 60(7 Suppl 1):S3-S51.
2. Lassey AT. Simple fistulas: diagnosis and management in low-resource settings-a descriptive report. Int J Gynaecol Obstet 2007, 99(Suppl 1):S47-S50.
3. Kelly J. Current methods of urinary fistulae repair. Curr Obstet Gynecol 1994, 4(2):104-106.
4. Wall LL. Obstetric vesicovaginal fistula as an international public-health problem. Lancet 2006, 368(9542):1201-1209. 10.1016/S0140-6736(06)69476-2, 17011947.
5. Schiotz HA, Tanbo TG. Postoperative voiding, bacteriuria and urinary tract infection with Foley catheterization after gynecological surgery. Acta Obstet Gynecol Scand 2006, 85(4):476-481. 10.1080/00016340500409877, 16612711.
6. Arrowsmith SD, Ruminjo J, Landry EG. Current practices in treatment of female genital fistula: a cross sectional study. BMC Pregnancy Childbirth 2010, 10:73. 10.1186/1471-2393-10-73, 2995487, 21067606.
7. Frajzyngier V. Toward a better understanding of urinary fistula repair prognosis: Results from a multi-country prospective cohort study 2011, Columbia University, Department of Epidemiology: Dissertation.
8. de Moya MA, Zacharias N, Osbourne A, Butt MU, Alam HB, King DR, McGovern F, Velmahos GC. Colovesical fistula repair: is early Foley catheter removal safe?. J Surg Res 2009, 156(2):274-277. 10.1016/j.jss.2009.03.094, 19665732.
9. Nardos R, Browning A, Member B. Duration of bladder catheterization after surgery for obstetric fistula. Int J Gynaecol Obstet 2008, 103(1):30-32. 10.1016/j.ijgo.2008.05.021, 18632103.
10. Boruch AV, Nieponice A, Qureshi IR, Gilbert TW, Badylak SF. Constructive remodeling of biologic scaffolds is dependent on early exposure to physiologic bladder filling in a canine partial cystectomy model. J Surg Res 2010, 161(2):217-225. 10.1016/j.jss.2009.02.014, 19577253.
11. Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJ. Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement. JAMA 2006, 295(10):1152-1160. 10.1001/jama.295.10.1152, 16522836.
12. Lewis J. The European regulatory experience. Stat Med 2002, 21:2931-2938. 10.1002/sim.1297, 12325109.
13. Phipps S, Lim YN, McClinton S, Barry C, Rane A, N'Dow JMO. Short term urinary catheter policies following urogenital surgery in adults (Review). The Cochrane Library 2009, 1:1-70.