Clinical trials: Prolapse
Pelvic Organ Prolapse
Performance of Tension Free Vaginal Mesh (Prolift) Versus Conventional Vaginal Prolapse Surgery in Recurrent Prolapse.
Pelvic organ prolapse is a common problem. A lot of women have surgery for prolapse. The recurrence rate op pelvic organ prolapse after surgical treatment is high.
- Trial name
- NCT00372190
- Testing
- Tensionfree vaginal mesh kit (Prolift), classic vaginal prolapse surgery (fascia plication)
- Where
- 13 sites in Netherlands
- Volunteers
- 194 people
- Sponsor
- Radboud University Medical Center
Pelvic Organ Prolapse
Physical Therapy Intervention for Pelvic Organ Prolapses
Pelvic floor muscle training (PFMT) and pessaries are first-line non-surgical conservative treatments for pelvic organ prolapse (POP).
- Trial name
- NCT06532292
- Testing
- Biofeedback, HIFEM
- Where
- Taiwan
- Volunteers
- 28 people
- Sponsor
- National Taiwan University Hospital
Pelvic Floor Disorders, Stress Urinary Incontinence
Educating Women About Pelvic Floor Disorders During Pregnancy
The purpose of this study is to assess the increase in knowledge of pregnant patients regarding pelvic floor disorders when comparing two educational interventions: written handouts vs interactive workshops.
- Conditions
- Pelvic Floor Disorders, Stress Urinary Incontinence, Pelvic Organ Prolapse
- Trial name
- NCT05440539
- Testing
- Written Handouts, Interactive Workshop
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- The Methodist Hospital Research Institute
Pelvic Organ Prolapse, Urinary Incontinence
Chlorhexidine vs. Iodine for Vaginal Preparation in Urogynecologic Procedures
This is a randomized controlled trial to determine if there is a difference between chlorhexidine gluconate and povidone iodine vaginal preparations for urogynecological surgery post operative infections.
- Conditions
- Pelvic Organ Prolapse, Urinary Incontinence, Pelvic Floor Disorders, Gynecologic Disease
- Trial name
- CLNUP (NCT04048356)
- Testing
- Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
- Where
- United States
- Volunteers
- 137 people, healthy volunteers welcome
- Sponsor
- University of New Mexico
Visceral Prolapse
Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design
The study is a multi-center, randomized, surgical trial of women with symptomatic post-hysterectomy apical (cuff) prolapse desiring surgical treatment.
- Trial name
- ASPIRe (NCT02676973)
- Testing
- Open, Robotic, or Laparoscopic, Transvaginal Native Tissue Repair, Uphold™ LITE
- Where
- 10 sites in United States
- Volunteers
- 360 people
- Sponsor
- NICHD Pelvic Floor Disorders Network
Pelvic Organ Prolapse
Feasibility Study of the Reia Vaginal Pessary
The purpose of this study is to obtain preliminary data on the effectiveness, safety, function, comfort, and patient satisfaction with a novel vaginal pessary design for the use in women who suffer from symptoms of pelvic organ…
- Trial name
- NCT04508335
- Testing
- Reia Vaginal Pessary
- Where
- 7 sites in United States
- Volunteers
- 78 people
- Sponsor
- Reia, LLC
Breast Ptosis, Obesity
Evaluation of Dermal Closure With an Absorbable Barbed Suture as Compared to a Conventional Absorbable Suture
The objective of this study is to evaluate the use of an absorbable barbed suture as compared to a conventional absorbable suture when used for dermal closure during certain body contouring procedures.
- Trial name
- NCT00959374
- Testing
- V-Loc 180/90 Wound Closure Device, 3-0 Monocryl Absorbable Sutures
- Where
- 8 sites in United States, Germany
- Volunteers
- 229 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Pelvic Organ Prolapse
FINPOP 2015: Incidence, Methods, Complications and Quality of Life of Pelvic Organ Prolapse Operations in Finland 2015
The aim of this study is to investigate the safety and effectivity of pelvic organ prolapse (POP) surgery. In this multi center study the population consists of POP operations done in Finland year 2015.The study is prospective…
- Trial name
- NCT02716506
- Testing
- POP surgery
- Where
- Finland
- Volunteers
- 3,515 people, healthy volunteers welcome
- Sponsor
- Society for Gynecological Surgery in Finland
Pelvic Organ Prolapse, Perioperative/Postoperative Complications
Preoperative Gabapentin vs Placebo for Vaginal Prolapse Surgery
This study will recruit women scheduled to undergo vaginal apical suspension surgery (either uterosacral ligament suspension or sacrospinous ligament fixation) with or without other prolapse or anti-incontinence procedures.
- Trial name
- NCT05658887
- Testing
- Gabapentin
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Joseph Kowalski
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
Pelvic Organ Prolapse
Improvement of Pain Following Robotic Sacrocolpopexy and Rectocele Repair for Pelvic Organ Prolapse
To determine if the injection of liposomal bupivacaine to laparoscopic port sites and rectocele repair incisions at the completion of a robotic sacrocolpopexy with concomitant rectocele repair will result in decreased…
- Trial name
- NCT02449915
- Testing
- Bupivacaine
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- TriHealth Inc.
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
Blepharoptosis, Ptosis, Eyelid
Clinical Trial Comparing Two Non-Surgical Treatments for Severe Blepharoptosis
This clinical trial will evaluate two non-surgical devices designed to improve eye lid opening for patients with severe Blepharoptosis (incomplete opening of the eyelids).
- Conditions
- Blepharoptosis, Ptosis, Eyelid, Myasthenia Gravis, Stroke
- Trial name
- NCT04678115
- Testing
- Magnetic Levator Prosthesis (MLP), Kinesiotape Frontalis Sling (KTFS)
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Massachusetts Eye and Ear Infirmary
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
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
Rectocele
Barbed Suture Versus Non-Barbed Suture for Posterior Colporrhaphy
The aim of this randomized clinical trial is to compare barbed suture versus non-barbed suture at the time of posterior repair on postoperative pain scores as measured by a visual analog scale (VAS) at 6 weeks.
- Trial name
- NCT04658784
- Testing
- 2-0 dioxanone, glycolide and trimethylene carbonate, 2-0 polydioxanone
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- Wake Forest University Health Sciences
Ptosis, Eyelid, Conjunctiva Inflamed
The Effect of Upneeq (Oxymetazoline Hydrochloride 0.1%) on Eyelid Position, Eye Redness, and Eye Appearance
The purpose of the research is to see if Upneeq ( oxymetazoline 0.1% ophthalmic solution) has an effect on eyelid position, eye redness, or patient-perceived appearance of the eyes.
- Conditions
- Ptosis, Eyelid, Conjunctiva Inflamed, Eye Manifestations
- Trial name
- NCT04831047
- Testing
- Oxymetazoline hydrochloride 0.1% ophthalmic solution
- Where
- United States
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- University of Miami
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
Pelvic Floor Repair Systems for Prolapse Repair
1. This is a prospective, multi-center, post market study, which will be conducted under a common protocol. 2. The primary objective of the study is to evaluate long-term efficacy of the AMS Pelvic Floor Repair System devices for…
- Trial name
- PROPEL (NCT00638235)
- Testing
- AMS Apogee™ with IntePro, AMS Apogee™ with Intexen LP, AMS Perigee™ with IntePro
- Where
- 28 sites in United States, Belgium and 5 more
- Volunteers
- 725 people
- Sponsor
- ASTORA Women's Health
Pelvic Organ Prolapse (POP)
Operations and Pelvic Muscle Training in the Management of Apical Support Loss: The OPTIMAL Trial
Pelvic organ prolapse is common among women with a prevalence that has been estimated to be as high as 30%. Pelvic organ prolapse often involves a combination of support defects involving the anterior, posterior and/or apical…
- Trial name
- OPTIMAL (NCT00597935)
- Testing
- SSLF, ULS, PMT
- Where
- 9 sites in United States
- Volunteers
- 374 people
- Sponsor
- NICHD Pelvic Floor Disorders Network