Publications by authors named "Douglas van Drie"
Aims: Evaluate the Altis single-incision sling for treatment of female stress urinary incontinence through 24 months.
Methods: This was a prospective, multi-center, industry-sponsored (Coloplast Corp.), single-arm trial with primary efficacy defined as ≥50% reduction in 24 h pad weight from baseline at 6-months.
Characteristics Associated With Successful Fitting of a Vaginal Bowel Control System for Fecal Incontinence.
Female Pelvic Med Reconstr Surg
December 2017
Objectives: We previously showed that management with a novel vaginal bowel control system was efficacious in women with moderate to severe fecal incontinence. The objective of this secondary analysis was to evaluate the clinical characteristics associated with device-fitting success.
Methods: This is a secondary analysis of an institutional review board-approved, multicenter, prospective, open-label clinical study of women aged 19 to 75 years with 4 or more episodes of fecal incontinence recorded on a 2-week baseline bowel diary.
Background: Bowel dysfunction, including frequency, fecal urgency, stool consistency, and evacuation symptoms, contributes to fecal incontinence.
Objective: The purpose of this study was to examine the impact of a vaginal bowel control system on parameters of bowel function, including frequency, urgency, stool consistency, and evacuation.
Design: This was a secondary analysis of a multicenter, prospective clinical trial.
Objective: To evaluate efficacy of the Elevate Anterior and Apical (EAA) in the repair of pelvic organ prolapse (POP) when performed after previous hysterectomy and with or without uterine preservation during POP surgery.
Materials And Methods: One hundred forty-two women with anterior vaginal prolapse and/or apical descent ≥ stage II were enrolled. The primary outcome was treatment failure defined as > stage II POP-Q during follow-up using the Last observed Failure Carried Forward method.
Objective: To evaluate the effectiveness and safety of a vaginal bowel-control device and pump system for fecal incontinence treatment.
Methods: Women with a minimum of four fecal incontinence episodes over 2 weeks were fit with the intravaginal device. Treatment success, defined as a 50% or greater reduction of incontinent episodes, was assessed at 1 month.
Purpose: We describe the safety and efficacy of the Altis(®) Single Incision Sling System for the treatment of female stress urinary incontinence through 12 months.
Materials And Methods: In this study we collected a variety of safety and efficacy measures relevant to the assessment of urinary incontinence. The primary efficacy end point was improvement in 24-hour pad weight test.
Study Objective: To report MiniArc single-incision sling efficacy results in the office setting and the feasibility of performing the procedure in the office.
Design: Prospective, single-arm, nonrandomized, institutional review board-approved study (Canadian Task Force classification II-2).
Setting: Three in-office clinical sites in the United States.
Aims: An open-label, extension clinical study was conducted to assess the safety of a novel, oral formulation of tranexamic acid (TA) in women with cyclic heavy menstrual bleeding.
Patients & Methods: Eligible patients who completed either a three- or six-cycle double-blinded clinical trial of TA were offered enrollment into a study of nine cycles with TA (1.3 g orally three times/day for a maximum of 5 days per cycle).
Objective: We sought to assess the efficacy and safety of 2 dosing regimens of a novel, oral tranexamic acid formulation (Lysteda; Ferring Pharmaceuticals Inc, Parsippany, NJ) in women with cyclic heavy menstrual bleeding.
Study Design: This was a multicenter, double-blind, placebo-controlled, randomized, parallel-group trial for 3 menstrual cycles (n = 304). Women with mean menstrual blood loss (MBL) of ≥ 80 mL/cycle were randomized to receive either 1.
Objective: To evaluate anatomic and functional outcomes at 1-year following trocar-guided transvaginal prolapse repair using a partially absorbable mesh.
Study Design: Prospective multicentre cohort study at 11 international sites. One hundred twenty-seven patients with pelvic organ prolapse stage ≥ III had surgery and were evaluated at 3 months and 1-year postsurgery compared with baseline.
Objective: To compare outcomes of anterior colporrhaphy alone to that reinforced with bovine pericardium graft.
Methods: Women with anterior vaginal wall prolapse were enrolled in a randomized fashion in this grafted compared with nongrafted repair study. Outcome measures included pelvic organ prolapse quantification data, quality-of-life assessment, healing abnormalities, and complications.