30 closest matches · ranked by relevance
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 Recurrence of Pelvic Organ Prolapse — 0; 0 Participants
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 · 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
Primary: Number of Patients With a Composite Outcome : Bladder Wound, Rectum Wound, Abnormal Bleeding — 6 Participants
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…
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: Percent of Subjects With an ICS (International Incontinence Society) POP-Q (Pelvic Organ Prolapse Quantification System) Stage of </= Stage I in the Posterior…
Prolapse
Primary: Change in the Stage of Prolapse of the Anterior Vaginal Wall Before and One Year After Surgery
Pelvic Organ Prolapse
Primary: Pelvic Floor Distress Inventory-20 (PFDI-20) — 49.46; 62.75 score on a scale — p=.0021
Cystocele · Uterine Prolapse · Urinary Incontinence
Primary: Recurrent Stage II or Greater Anterior Vaginal Prolapse — 24; 11 participants — p=0.005
Pelvic Organ Prolapse · Menopause
Primary: Vaginal Wall Composition: Epithelium (Intention to Treat) — 413.9; 314.1 microns — p=0.21
Pelvic Organ Prolapse (POP)
Primary: Surgical Success — 25; 30; 28; 27 Participants
Pelvic Organ Prolapse (POP)
Primary: Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) — 30; 0; 0; 0 participants
Pelvic Organ Prolapse
Primary: Proportion of Patients Having Concurrent Apical Suspension Performed — 66 Participants
Vaginal Apical Prolapse
Primary: Number of Subjects Catheterized Within the Six-week Post-operative Period Following Surgical Repair of Prolapse, Among Those Discharged Without a Urinary Catheter. — 2…
Vaginal Prolapse · Uterine Prolapse · Cystocele
Primary: The Primary Outcome Measure for Objective Treatment Success is Anterior Prolapse, Point Ba at Stage 0 or 1 (Defined as Maximal Descent of the Anterior Wall to Greater…
Pelvic Organ Prolapse · Uterine Prolapse · Vaginal Prolapse
Primary: Number of Participants With Anatomic Cure at 3 Years — 20; 21; 8; 8 Participants — p=<0.05
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
Pelvic Organ Prolapse
Primary: Number of Participants With Success at 36 Months — 191; 390 Participants
Stress Urinary Incontinence
Primary: Treatment-emergent Serious Adverse Event — 0; 0 participants
Pelvic Organ Prolapse
Primary: Number of Participants With Vaginal Mesh or Suture Exposure — 5; 8 Participants — p=0.30
Vaginal Vault Prolapse
Primary: Number of Participants With Pelvic Organ Prolapse Recurrence — 2; 1 participants
Stress Urinary Incontinence · Pelvic Floor Disorders
Primary: Number of Participants With Subjectively Bothersome Stress Incontinence — 129; 126 Participants
Vaginal Vault Prolapse · Pelvic Organ Prolapse · Uterine Prolapse
Primary: Patient Global Impression of Improvement (PGI-I) Score — 39 Participants
Pelvic Organ Prolapse · Cystocele · Uterine Prolapse
Primary: Pelvic Organ Prolapse Quantification Exam (POP-Q) Point C — -7.25; -7 cm
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 · Perioperative/Postoperative Complications
Primary: Postoperative Opioid Use — 25; 20 MMEs
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