Stacy M Lenger, Christine M Chu1, Chiara Ghetti1, Michael J Durkin2, Zoe Jennings3, Siobhan Sutcliffe, Jerry L Lowder1. 1. Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, Washington University School of Medicine. 2. Division of Infectious Diseases, Department of Internal Medicine. 3. Division of Clinical Research, Department of Obstetrics and Gynecology, Washington University School of Medicine.
Abstract
OBJECTIVE: The aim of the study was to inform feasibility parameters (eligibility, enrollment, and retention) for a recurrent urinary tract infection (rUTI) prevention randomized controlled trial (RCT). METHODS: We assessed feasibility parameters of an RCT of postmenopausal women with uncomplicated rUTIs using vaginal estrogen. Participants were randomized to either d-mannose or a control arm. All participants were required to be using vaginal estrogen and to have a negative urine culture before 90-day trial participation. An RCT exit survey and separate survey for UTI patients (N = 196) were added to inform feasibility parameters and patient preferences for rUTI prevention and study participation after slower enrollment than anticipated. RESULTS: At the time of interim and subsequent futility analyses, 545 patients had been evaluated for frequent/recurrent UTIs from March 1, 2018, to January 18, 2020. Of these, 213 (39.1%) had culture-proven rUTIs and 71 (33.3% of those with culture-proven rUTIs) were eligible for the RCT. Reasons for ineligibility included complicated UTIs, premenopausal/perimenopausal status, or existing UTI prevention regimen. Of the 71 eligible participants, 57 (80.3%) enrolled, and 44 began their planned 90-day study period (77.2%; 80.0% after excluding 2 participants awaiting negative urine cultures at the time of analysis). The study was halted before conclusion. Study retention (76.0%-83.7%) was slightly lower than expected. Urinary tract infection survey patients demonstrated significant interest in rUTI research participation. CONCLUSIONS: We learned several important lessons that can benefit future research. Many patients with frequent/recurrent UTIs are interested in research, but rigorous eligibility criteria and referral urine culture documentation made recruitment challenging.
OBJECTIVE: The aim of the study was to inform feasibility parameters (eligibility, enrollment, and retention) for a recurrent urinary tract infection (rUTI) prevention randomized controlled trial (RCT). METHODS: We assessed feasibility parameters of an RCT of postmenopausal women with uncomplicated rUTIs using vaginal estrogen. Participants were randomized to either d-mannose or a control arm. All participants were required to be using vaginal estrogen and to have a negative urine culture before 90-day trial participation. An RCT exit survey and separate survey for UTI patients (N = 196) were added to inform feasibility parameters and patient preferences for rUTI prevention and study participation after slower enrollment than anticipated. RESULTS: At the time of interim and subsequent futility analyses, 545 patients had been evaluated for frequent/recurrent UTIs from March 1, 2018, to January 18, 2020. Of these, 213 (39.1%) had culture-proven rUTIs and 71 (33.3% of those with culture-proven rUTIs) were eligible for the RCT. Reasons for ineligibility included complicated UTIs, premenopausal/perimenopausal status, or existing UTI prevention regimen. Of the 71 eligible participants, 57 (80.3%) enrolled, and 44 began their planned 90-day study period (77.2%; 80.0% after excluding 2 participants awaiting negative urine cultures at the time of analysis). The study was halted before conclusion. Study retention (76.0%-83.7%) was slightly lower than expected. Urinary tract infection survey patients demonstrated significant interest in rUTI research participation. CONCLUSIONS: We learned several important lessons that can benefit future research. Many patients with frequent/recurrent UTIs are interested in research, but rigorous eligibility criteria and referral urine culture documentation made recruitment challenging.
Authors: Stacy M Lenger; Megan S Bradley; Debbie A Thomas; Marnie H Bertolet; Jerry L Lowder; Siobhan Sutcliffe Journal: Am J Obstet Gynecol Date: 2020-06-01 Impact factor: 8.661
Authors: Mariëlle A J Beerepoot; Gerben ter Riet; Sita Nys; Willem M van der Wal; Corianne A J M de Borgie; Theo M de Reijke; Jan M Prins; Jeanne Koeijers; Annelies Verbon; Ellen Stobberingh; Suzanne E Geerlings Journal: Arch Intern Med Date: 2012-05-14
Authors: Jennifer Anger; Una Lee; A Lenore Ackerman; Roger Chou; Bilal Chughtai; J Quentin Clemens; Duane Hickling; Anil Kapoor; Kimberly S Kenton; Melissa R Kaufman; Mary Ann Rondanina; Ann Stapleton; Lynn Stothers; Toby C Chai Journal: J Urol Date: 2019-07-08 Impact factor: 7.600