30 closest matches · ranked by relevance
Pelvic Organ Prolapse
Primary: Number of Patients With a Composite Outcome : Bladder Wound, Rectum Wound, Abnormal Bleeding — 6 Participants
Pelvic Organ Prolapse
Primary: Percent of Subjects With an ICS (International Incontinence Society) POP-Q (Pelvic Organ Prolapse Quantification System) Stage of </= Stage I in the Posterior…
Pelvic Organ Prolapse
Primary: Prolapse by "Pelvic Organ Prolapse Quantification System" (POP-Q), at 12 Months — 8; 38; 75; 46 participants — p=<0.05
Pelvic Organ Prolapse
Primary: Number of Participants With Treatment Failure Defined as Subsequent Treatment for Urinary Incontinence, Signs or Symptoms of Bothersome Urinary Incontinence — 39; 85…
Pelvic Organ Prolapse (POP)
Primary: Surgical Success — 25; 30; 28; 27 Participants
Pelvic Organ Prolapse
Primary: Pain Score at 4 Hours — 3.16; 3.77 score on a scale
Pelvic Organ Prolapse · Prolapse
Primary: The Ability of the Study Device to be Retained During Valsalva Compared to the Ability of the Subject's Current Pessary to be Retained During Valsalva (Change in…
Pelvic Organ Prolapse (POP)
Primary: Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) — 30; 0; 0; 0 participants
Vaginal Vault Prolapse · Pelvic Organ Prolapse · Uterine Prolapse
Primary: Patient Global Impression of Improvement (PGI-I) Score — 39 Participants
Pelvic Organ Prolapse
Primary: Number of Participants With Recurrence of Pelvic Organ Prolapse — 0; 0 Participants
Pelvic Organ Prolapse
Primary: Pelvic Floor Distress Inventory-20 (PFDI-20) — 49.46; 62.75 score on a scale — p=.0021
Fecal Incontinence
Primary: Fecal Incontinence Incidence From Baseline (Pre-treatment) Through 24 Months Post-treatment — 6.9; 3.0; 3.7; 3.7 Number of FI episodes/14 day period
Pelvic Organ Prolapse
Primary: Proportion of Patients Having Concurrent Apical Suspension Performed — 66 Participants
Pelvic Organ Prolapse · Urogenital Prolapse · Vaginal Vault Prolapse
Primary: Surgical "Failure" Defined by (i) Anatomic Assessment of Prolapse, (ii) Presence of Bulge Symptoms, and/or (Iii) Retreatment of Prolapse — 18; 8 Participants
Uterovaginal Prolapse
Primary: Cumulative Failure — 78; 69; 9; 16 Participants
Pelvic Organ Prolapse · Menopause
Primary: Vaginal Wall Composition: Epithelium (Intention to Treat) — 413.9; 314.1 microns — p=0.21
Urinary Retention Postoperative
Primary: Number of Participants With Postoperative Urinary Retention After Pelvic Organ Prolapse Surgery (INTENT-TO-TREAT) — 30; 25 Participants
Pelvic Organ Prolapse
Primary: Number of Participants With Vaginal Mesh or Suture Exposure — 5; 8 Participants — p=0.30
Genital Diseases, Female · Pelvic Organ Prolapse
Primary: The Number of Participants With a Current Mesh Erosion or Treated for a Mesh Erosion Since Inserted — 5 Participants
Pelvic Organ Prolapse
Primary: Percentage of Participants With POP-Q Stage Improvement Assessed by POP-Q Stage Improvement Based Upon Grading of Prolapse of the Anterior, Posterior, or Combined…
Pelvic Organ Prolapse
Primary: Change From Baseline in Postoperative Pain — 20.5; 29.2; 20.7; 20.1 units on a scale — p=<0.05
Urinary Bladder, Overactive
Primary: Change in OAB Symptoms Post Pubovaginal Sling Operation — 63; 21; 4 participants — p=0.001
Pelvic Floor Disorders · Stress Urinary Incontinence · Pelvic Organ Prolapse
Primary: Prolapse and Incontinence Knowledge Questionnaire (PIKQ) — 17; 17; 21; 21 score on a scale
Pelvic Organ Prolapse
Primary: Surgical Failure — 17; 22; 20; 14 Participants
Pelvic Organ Prolapse
Primary: Primary Efficacy Endpoint - Number of Participants With Composite Anatomic and Symptomatic Success at 36 Months — 201; 389; 199; 384 Participants — p=0.056
Postoperative Pain
Primary: Visual Analog Scale (VAS) Score for Pain — 28.0; 24.5 millimeter (mm) — p=0.57
Obstetric; Injury Pelvic Floor
Primary: Change in Levator Hiatus Area at Rest Measured Via 3-dimensional Ultrasound at Gestational Week 21 and 37. — 2.0 cm
Anterior Vaginal Wall Prolapse · Cystocele · Pelvic Organ Prolapse
Primary: Prospective Randomized Trial of Anterior Colporrhaphy Vs. Cystocele Repair Using Polypropylene Mesh or Porcine Dermis — 5; 14; 12 Participants
Pelvic Organ Prolapse · Cystocele · Uterine Prolapse
Primary: Pelvic Organ Prolapse Quantification Exam (POP-Q) Point C — -7.25; -7 cm
Stress Urinary Incontinence · Pelvic Floor Disorders
Primary: Number of Participants With Subjectively Bothersome Stress Incontinence — 129; 126 Participants