Clinical trials: Procidentia
Quality of Recovery, Same Day Surgery
Dexamethasone Administration To Improve Patient Recovery In Ambulatory Vaginal Prolapse Surgery: Is There A Role?
To the investigators knowledge there are no studies in the literature evaluating the effect of Dexamethasone administration on patients undergoing outpatient vaginal prolapse surgeries.
- Conditions
- Quality of Recovery, Same Day Surgery, Nausea and Vomiting, Postoperative, Vaginal Prolapse
- Trial name
- NCT03338400
- Testing
- Dexamethasone, Normal saline
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- The Cleveland Clinic
Mitral Valve Insufficiency, Mitral Valve Regurgitation
Feasibility Study of a Percutaneous Mitral Valve Repair System.
Prospective, multi-center, Phase I study of the Evalve Cardiovascular Valve Repair System (CVRS) in the treatment of mitral valve regurgitation. Patients will undergo 30-day, 6 month, 12 month, and 5 year clinical follow-up.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation
- Trial name
- EVEREST(I) (NCT00209339)
- Testing
- Percutaneous mitral valve repair (MitraClip Implant)
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- Abbott Medical Devices
Hemorrhoids
Comparison Study of Surgical Staplers for the Treatment of Hemorrhoids
The purpose of this study is to demonstrate that the Covidien EEA™ Hemorrhoid and Prolapse Stapling Set for the treatment of hemorrhoids is non-inferior to the competitor device based on the primary endpoint.
- Trial name
- HEMOSTASIS (NCT01306877)
- Testing
- EEA Hemorrhoid and Prolapse Stapling Set, Endosurgery Proximate PPH03 Stapling Set
- Where
- United States
- Volunteers
- 149 people
- Sponsor
- Medtronic - MITG
Uterovaginal Prolapse
Study of Uterine Prolapse Procedures - Randomized Trial
The primary purpose of this randomized clinical trial is to compare the effectiveness and safety of two transvaginal apical suspension strategies for uterovaginal prolapse: a mesh augmented hysteropexy versus vaginal hysterectomy…
- Trial name
- SUPeR (NCT01802281)
- Testing
- Uterosacral ligament suspension, Uphold® LITE
- Where
- 8 sites in United States
- Volunteers
- 183 people
- Sponsor
- NICHD Pelvic Floor Disorders Network
Pelvic Organ Prolapse, Prolapse
Early Feasibility Study of the Reia Vaginal Pessary
This is an early feasibility open-label non-randomized trial to obtain preliminary information about the function and effectiveness of a novel vaginal pessary for the use in women who suffer from symptoms of pelvic organ prolapse…
- Trial name
- NCT04275089
- Testing
- Reia Vaginal Pessary
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Reia, LLC
Ptosis, Eyelid
Phenylephrine Versus Eyelid Taping for Muller's Muscle-Conjunctival Resection (MMCR) Evaluation
This research study aims to compare whether Phenylephrine 2.5% ophthalmic eye drop solution can serve as a better indicator of the effect of a drooping upper eyelid (ptosis) by covering part of the upper portion of the field of…
- Trial name
- NCT05890027
- Testing
- Phenylephrine Ophthalmic, Eyelid Tape
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- University of Miami
Mitral Valve Regurgitation, Mitral Valve Prolapse
Safety and Performance Study of the Harpoon Mitral Valve Repair System
The primary objective of this study is to evaluate the safety and performance of the Harpoon Medical Device. It is anticipated, that the Harpoon Medical Device will provide advantages over current surgical interventions…
- Conditions
- Mitral Valve Regurgitation, Mitral Valve Prolapse, Mitral Valve Insufficiency
- Trial name
- NCT03285724
- Testing
- Harpoon Artificial ePTFE Chords
- Where
- 2 sites in Poland
- Volunteers
- 1 people
- Sponsor
- Edwards Lifesciences
Pelvic Organ Prolapse
Smartmesh Technology in Pelvic Floor Repair Procedures
Pelvic organ prolapse repair involves conservative treatments and surgical treatments. Conservative treatments are for patients with moderate prolapse. Treatment of symptomatic prolapse remains essentially surgical.
- Trial name
- Restorelle (NCT03098641)
- Testing
- pelvic organ prolapse repair
- Where
- 16 sites in France
- Volunteers
- 272 people
- Sponsor
- Groupe Hospitalier de la Rochelle Ré Aunis
Obstructed Defecation, Pelvic Organ Prolapse
Prospective Randomized Controlled Trial of Obstructed Defecation Surgery
Obstructive defecatory syndrome (ODS) or inability to completely empty bowel is characterized by a combination of straining, incomplete evacuation, and the use of digital manipulation with bowel movement.
- Trial name
- PROD (NCT05747027)
- Testing
- Laparoscopic abdominal ventral rectopexy, Transvaginal sacrospinous rectopexy
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Endeavor Health
Pelvic Organ Prolapse
Uphold LITE Post-Market Surveillance Study
The purpose of this study is to compare transvaginal mesh repair to traditional native tissue repair in women surgically treated for anterior and/or apical pelvic organ prolapse.
- Trial name
- Uphold LITE (NCT01917968)
- Testing
- Uphold Lightweight Vaginal Support System, Traditional native tissue repair
- Where
- 28 sites in United States
- Volunteers
- 289 people
- Sponsor
- Boston Scientific Corporation
Anterior Vaginal Wall Prolapse, Cystocele
Anterior Colporrhaphy Versus Cystocele Repair Using Polypropylene Mesh or Porcine Dermis
The purpose of this study is to evaluate the success rate of cystocele repair using polypropylene mesh or porcine dermis compared to that of anterior colporrhaphy in a prospective randomized fashion.
- Conditions
- Anterior Vaginal Wall Prolapse, Cystocele, Pelvic Organ Prolapse
- Trial name
- OARS (NCT01393171)
- Testing
- Polypropylene mesh (Polyform by Boston Scientific), Porcine Dermis (Pelvicol by CRBard), Anterior Colporrhaphy
- Where
- 2 sites in United States
- Volunteers
- 99 people, healthy volunteers welcome
- Sponsor
- Kaiser Permanente
Pelvic Organ Prolapse, Stress Urinary Incontinence
Impact of Decision Aids in Urogynecology
To evaluate how patient knowledge and confidence in decision making can be impacted by shared decision making in common urogynecology conditions.
- Conditions
- Pelvic Organ Prolapse, Stress Urinary Incontinence, Overactive Bladder
- Trial name
- NCT04369404
- Testing
- Pelvic organ prolapse decision aid, Stress urinary incontinence decision aid, Overactive bladder decision aid
- Where
- United States
- Volunteers
- 66 people
- Sponsor
- Massachusetts General Hospital
Urinary Tract Infections, Urinary Retention Postoperative
Urinary Track Infection Prevention After Urogynecological Surgery
This study is randomized double-blinded placebo-controlled trial to access oral Methenamine Hippurate (MH) in combination with cranberry capsules is superior to cranberry capsules alone in prevention of UTI in patients with…
- Conditions
- Urinary Tract Infections, Urinary Retention Postoperative, Pelvic Organ Prolapse
- Trial name
- NCT03818321
- Testing
- Methenamine Hippurate 1 g tablet
- Where
- United States
- Volunteers
- 185 people
- Sponsor
- TriHealth Inc.
Postoperative Pain, Opioid Use
STandard Versus No Opioid Prescription After Prolapse and Anti-INcontinence Surgery Trial
Overprescribing opioids is considered a major contributor to the opioid crisis. Hill et al. demonstrated that within a general surgery practice, over 70% of the prescribed opioid pills were never taken.
- Conditions
- Postoperative Pain, Opioid Use, Prolapse; Female, Incontinence
- Trial name
- STOP-PAIN (NCT04491617)
- Testing
- Standard opioid prescribing, Restrictive opioid prescribing
- Where
- United States
- Volunteers
- 129 people
- Sponsor
- The Cleveland Clinic
Pelvic Organ Prolapse, Uterine Prolapse
Efficacy Study of Vaginal Mesh for Prolapse
The primary aim of this double-blind, randomized clinical trial (RCT) is to test the hypothesis that the addition of a standardized technique of interpositional synthetic polypropylene mesh placement improves the one-year outcome…
- Conditions
- Pelvic Organ Prolapse, Uterine Prolapse, Vaginal Prolapse, Cystocele
- Trial name
- VAMP (NCT00475540)
- Testing
- synthetic monofilament polypropylene mesh
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Medstar Health Research Institute
Pelvic Organ Prolapse
Postoperative Virtual Clinical Encounters
Postoperative follow up is necessary following any surgical procedure and has been conducted in the same manner since the field of surgery began.
- Trial name
- NCT04138810
- Testing
- VCE, Survey
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- University of Pennsylvania
Urinary Tract Infections
Nitrofurantoin and Urinary Tract Infections (UTIs)
Urinary tract infection (UTI) is the most common complication after surgery for prolapse or urinary incontinence. UTIs are painful and have the potential to turn into kidney infections.
- Trial name
- APPIC (NCT00678041)
- Testing
- Nitrofurantoin
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- University of Pittsburgh
Pelvic Organ Prolapse
The ELEGANT Trial: Elevate Transvaginal Mesh vs. Anterior Colporrhaphy
This study is designed to compare the safety and efficacy of a commercially available mesh kit used for surgical repair of anterior vaginal wall prolapse with traditional suture repair surgery.
- Trial name
- NCT01497171
- Testing
- Elevate Mesh, Anterior Colporrhaphy
- Where
- 6 sites in United States, Germany
- Volunteers
- 5 people
- Sponsor
- Emanuel Trabuco
Volume Loss (Soft Tissue Ptosis or Atrophy )
Pan Facial Volume Restoration
The aim of this study is to assess performance and tolerance as well as investigator and subject satisfaction further to pan-facial volume restoration with a new cross-linked hyaluronic acid dermal filler containing lidocaine…
- Trial name
- EVE (NCT01545557)
- Testing
- Hyaluronic acid dermal filler gel
- Where
- 3 sites in Brazil
- Volunteers
- 60 people
- Sponsor
- Galderma R&D
Cystocele, Uterine Prolapse
Outcomes of Anterior Colporrhaphy Versus Graft Reinforced Anterior Prolapse Repair
The purpose of this study is determine whether grafted anterior vaginal prolapse repair is more effective and associated with less complications than prolapse repair with suture.
- Conditions
- Cystocele, Uterine Prolapse, Urinary Incontinence
- Trial name
- NCT00535301
- Testing
- grafted anterior prolapse repair, sutured anterior vaginal prolapse repair
- Where
- United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Kaiser Permanente