Clinical trials: Prolapse
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
Brow Ptosis, Surgical Wound
An Analysis of Dermabond vs. Non-Absorbable Sutures in Skin Closure for Brow Ptosis Procedures
The goal of this clinical trial is to compare Dermabond with non-absorbable sutures in skin closure after brow ptosis surgery. The main questions it aims to answer are: if Dermabond provides equivalent wound healing compared to…
- Trial name
- NCT05981443
- Testing
- Dermabond, Non-Absorbable Sutures
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Cody Blanchard
Pelvic Organ Prolapse
Sacro-Spinous Ligaments Anterior Apical Anchoring
Anterior-apical compartment mesh implants for pelvic floor reconstruction are anchored here to the Sacro-Spinous ligaments and evaluated being a feasible and effective method.
- Trial name
- NCT01842464
- Testing
- Anterior Sacro-Spinous
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Western Galilee Hospital-Nahariya
Pelvic Organ Prolapse
Nitrofurantoin Prophylaxis During Catheter-managed Acute Urinary Retention After Pelvic Reconstructive Surgery
The specific aim of this randomized double-blind placebo-controlled trial is to determine if extended release nitrofurantoin antibiotic prophylaxis decreases the incidence of symptomatic urinary tract infection (UTI) compared…
- Trial name
- NCT02727322
- Testing
- Nitrofurantoin
- Where
- 2 sites in United States
- Volunteers
- 154 people
- Sponsor
- Halina M Zyczynski, MD
Vaginal Vault Prolapse, Pelvic Organ Prolapse
Prediction of Postsurgical Symptomatic Outcomes With Preoperative Pessary Use
This is a single center, prospective trial of pessary use prior to reconstructive pelvic floor surgery for pelvic organ prolapse.
- Conditions
- Vaginal Vault Prolapse, Pelvic Organ Prolapse, Uterine Prolapse, Pelvic Floor Prolapse
- Trial name
- NCT02680145
- Testing
- Preoperative Pessary Use
- Where
- United States
- Volunteers
- 58 people
- Sponsor
- Mayo Clinic
Mitral Valve Regurgitation, Mitral Valve Prolapse
CE Mark Study for the Harpoon Medical Device
The purpose 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 including: 1) a…
- Conditions
- Mitral Valve Regurgitation, Mitral Valve Prolapse, Mitral Valve Insufficiency
- Trial name
- TRACER (NCT02768870)
- Testing
- Harpoon Artificial ePTFE Chords
- Where
- 4 sites in Italy, United Kingdom
- Volunteers
- 26 people
- Sponsor
- Edwards Lifesciences
Constipation, Surgical Procedure, Unspecified
Pre-operative Polyethylene Glycol 3350 for Minimally Invasive Urogynecologic Surgery
The goal of this clinical trial is to test the use of a laxative before surgery in women having surgery to fix pelvic prolapse that do not have constipation.
- Conditions
- Constipation, Surgical Procedure, Unspecified, Prolapse; Female
- Trial name
- NCT06159777
- Testing
- Polyethylene Glycol 3350
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- University Hospitals Cleveland Medical Center
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
Mitral Valve Regurgitation, Mitral Valve Prolapse
Safety and Early Feasibility Study of the Harpoon Medical Device (EFS)
The purpose of this study is to evaluate the safety and performance of the Harpoon Medical TSD-5. The Harpoon device will provide many significant advantages over current surgical interventions including: 1) a small minimally…
- Conditions
- Mitral Valve Regurgitation, Mitral Valve Prolapse, Mitral Valve Insufficiency
- Trial name
- EFS (NCT02771275)
- Testing
- Harpoon Medical Device
- Where
- 2 sites in Poland
- Volunteers
- 13 people
- Sponsor
- Edwards Lifesciences
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
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
Mitral Valve Insufficiency, Mitral Valve Regurgitation
Real World Expanded Multicenter Study of the MitraClip® System (REALISM)
Prospective, multicenter, continued access registry of the MitraClip® Cardiovascular Valve Repair System in the treatment of mitral valve regurgitation.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation
- Trial name
- REALISM (NCT01931956)
- Testing
- MitraClip® implant
- Where
- 38 sites in United States
- Volunteers
- 965 people
- Sponsor
- Abbott Medical Devices
Barlow's Disease, Prolapse; Mitral
Minimally Invasive or Conventional Edge-To-Edge Repair for Severe Mitral Regurgitation Due to Bileaflet Prolapse in Barlow's Disease: Does the Surgical Approach Have an Impact on the Long-term Results?
The study evaluates the long-term results of patients affected by bileaflet prolapse in Barlow's Disease, treated with edge-to-edge technique between 1997 and 2011.
- Trial name
- NCT04002648
- Testing
- Right minithoracotomy, Sternotomy
- Volunteers
- 208 people
- Sponsor
- Ospedale San Raffaele
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
Vaginal Prolapse, Uterine Prolapse
Efficacy Study of Vaginal Mesh for Anterior 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
- Vaginal Prolapse, Uterine Prolapse, Cystocele, Pelvic Organ Prolapse
- Trial name
- VAMP-A (NCT00557882)
- Testing
- synthetic polypropylene mesh
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Medstar Health Research Institute
Pelvic Organ Prolapse
Vaginally Assisted Laparoscopic Hysteropexy Versus Vaginal Hysterectomy
Utero-vaginal prolapse is a common, often disabling, condition experienced by women of varying ages. The traditional surgical treatment for utero-vaginal prolapse often includes vaginal hysterectomy and anterior or posterior…
- Trial name
- NCT03436147
- Testing
- POP-Q
- Where
- Turkey (Türkiye)
- Volunteers
- 49 people
- Sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Vaginal Apical Prolapse
Comparing Force of Stream to Retrograde Fill Voiding Trial After Vaginal Apex Suspension
Voiding difficulties are common after prolapse and incontinence surgeries. All patients after vaginal prolapse surgery must complete a voiding trial if they are to be discharged home without a catheter.
- Trial name
- NCT02753920
- Testing
- voiding trial, Foley catheter
- Where
- United States
- Volunteers
- 184 people, healthy volunteers welcome
- Sponsor
- Northwell Health
Pelvic Organ Prolapse
Outcomes Following Vaginal Prolapse Repair and Mid Urethral Sling Trial
Pelvic organ prolapse is common among women with a prevalence that has been estimated to be as high as 30%. Prolapse may be corrected by surgery using either a vaginal or abdominal incision.
- Trial name
- OPUS (NCT00460434)
- Testing
- TVT
- Where
- 8 sites in United States
- Volunteers
- 337 people, healthy volunteers welcome
- Sponsor
- NICHD Pelvic Floor Disorders Network
Pelvic Organ Prolapse, Urogenital Prolapse
Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen
This study randomizes postmenopausal women with symptomatic pelvic organ prolapse planning native tissue transvaginal surgical repair to 6-8 weeks of preoperative and 1-year continued postoperative vaginal estrogen cream compared…
- Conditions
- Pelvic Organ Prolapse, Urogenital Prolapse, Vaginal Vault Prolapse, Cystocele
- Trial name
- IMPROVE (NCT02431897)
- Testing
- Conjugated Estrogens Cream
- Where
- 3 sites in United States
- Volunteers
- 206 people
- Sponsor
- University of Texas Southwestern Medical Center
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