Clinical trials: Reconstructive Pelvic Surgery
Pelvic Organ Prolapse
Restricted Convalescence: Outcomes Following Urogynecologic Procedures
The investigators are conducting a study to better understand the relationship between activity restrictions and women's satisfaction following urogynecologic surgery for prolapse.
- Trial name
- ReCOUP (NCT02138487)
- Testing
- liberal postoperative activity, Restricted postoperative activity
- Where
- 3 sites in United States
- Volunteers
- 105 people
- Sponsor
- Northwestern University
Pelvic Organ Prolapse Vaginal Surgery, Stress Urinary Incontinence in Women
The AMPER Study: Evaluation of the Efficacy of Human Amniotic Membrane Grafting in Preventing Mesh Exposure in Vaginal Reconstructive Surgery Using Polypropylene Mesh.
This study evaluates the efficacy of adding a human amniotic membrane graft to polypropylene mesh surgery for pelvic prolapse and stress urinary incontinence.
- Trial name
- AMPER (NCT07414849)
- Testing
- Sacrospinous Hysteropexy with Mesh, Retropubic Mid-urethral Sling (Bottom-Up), Transobturator Mid-urethral Sling (Out-In)
- Where
- Argentina
- Volunteers
- 330 people
- Sponsor
- Hospital General de Agudos J. M. Penna
Preoperative Anxiety
Music Listening on Preoperative Anxiety in Female Pelvic Medicine and Reconstructive Surgery
Can music listening decrease a patient's anxiety before surgery? The investigators hypothesize that music listening will decrease a patient's pre-operative anxiety significantly more than no music listening.
- Trial name
- NCT03651310
- Testing
- Music Listening Group
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Loyola University
Rectal Cancer, Defect of Floor of Lesser Pelvis
Collagen Implant (Biological Mesh) Versus GM Flap for Reconstruction of Pelvic Floor After ELAPE in Rectal Cancer
The trial compares two different techniques for reconstruction of the lesser pelvic floor after an extended abdominoperineal excision for locally advanced rectal cancer.
- Trial name
- NEAPE (NCT01347697)
- Testing
- Reconstruction with an acellular porcine dermal collagen implant (biological mesh), Reconstruction with a gluteus maximus myocutaneous flap
- Where
- 8 sites in Finland, Sweden
- Volunteers
- 91 people
- Sponsor
- Umeå University
Urinary Retention, Lower Urinary Tract Symptoms
Tamsulosin vs Placebo to Prevent Postoperative Urinary Retention in Female Pelvic Reconstructive Surgery
This is a placebo controlled randomized controlled trial of perioperative use of tamsulosin to prevent postoperative urinary retention in female pelvic reconstructive surgery.
- Conditions
- Urinary Retention, Lower Urinary Tract Symptoms, Stress Urinary Incontinence, Pelvic Organ Prolapse
- Trial name
- NCT03524339
- Testing
- Tamsulosin
- Where
- 2 sites in United States
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- University Hospitals Cleveland Medical Center
Pelvic Organ Prolapse
Tranexamic Acid in Vaginal Reconstructive Surgery
Tranexamic acid (TXA) has been demonstrated to reduce blood loss in trauma, orthopedic, cardiac, and plastic surgeries in numerous well-designed and adequately powered studies.
- Trial name
- TEXAS (NCT06419075)
- Testing
- Tranexamic acid, Vasopressin, NaCl 0.9%
- Volunteers
- healthy volunteers welcome
- Sponsor
- The University of Texas Medical Branch, Galveston
Postoperative Pain
Postoperative Environment on Pain Following Pelvic Reconstructive Surgery
This study is to determine if patients following prolapse repair including vaginal vault suspension have decreased pain measured via a visual analog scale (VAS) on postoperative day one and just prior to discharge when exposed to…
- Trial name
- NCT03379753
- Testing
- music and positive images
- Where
- United States
- Volunteers
- 132 people
- Sponsor
- TriHealth Inc.
Colon Cleansing
Will Cleaning the Bowel With an Enema Before Vaginal Prolapse Surgery Prevent Complications?
Traditionally, many gynecologic surgeons have asked patients to perform a cleansing enema the night before a vaginal surgery done to repair pelvic organ prolapse (dropped bladder, dropped uterus).
- Trial name
- NCT00981539
- Testing
- enema
- Where
- 2 sites in United States
- Volunteers
- 310 people, healthy volunteers welcome
- Sponsor
- Illinois Urogynecology, Ltd.
Gynecologic Surgery
A Study of Near-Infrared Fluorescence Imaging With ICG During Reconstructive Gynecologic Surgery
The objective of this study is to assess whether Near-Infrared Fluorescence/NIR Imaging perfusion alters intraoperative management of the flap or of the participant wound bed.
- Trial name
- NCT05071976
- Testing
- ICG-NIR angiography
- Where
- 7 sites in United States
- Volunteers
- 15 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Urinary Tract Infections, Catheter-Related Infections
Short-course Methenamine Hippurate for Prevention of Post-operative UTI
The investigators will determine the efficacy of an innovative short regimen of methenamine hippurate on prevention of post-operative UTI in patients requiring short-term catheterization after pelvic reconstructive surgery…
- Trial name
- NO-UTI (NCT02358993)
- Testing
- methenamine hippurate, Ciprofloxacin
- Where
- 4 sites in United States
- Volunteers
- 201 people
- Sponsor
- University of Pennsylvania
Voiding Disorders
Home vs. Office Foley Catheter Removal in Women With Voiding Difficulty Following Pelvic Reconstructive Surgery
The purpose of this study is to evaluate the patient satisfaction with voiding assessment remotely after removal of Foley catheter at home by the patient or her caregiver compared to removal at the office by a healthcare provider…
- Trial name
- NCT03373773
- Testing
- Foley catheter removal
- Where
- United States
- Volunteers
- 78 people
- Sponsor
- Yale University
Pelvic Organ Prolapse, Stress Urinary Incontinence
Outcomes of Pelvic Surgery With and Without Anti-incontinence Procedure in Occult Stress Urinary Incontinence Patients
1. To evaluate whether a standardized tension-free vaginal tape-obturator(TVT-O) procedure, when added to a planned improved reconstruction pelvic surgery, improves the rate of urinary stress continence in subjects with occult…
- Conditions
- Pelvic Organ Prolapse, Stress Urinary Incontinence, Other Specified Urinary Incontinence
- Trial name
- PTOS (NCT02193607)
- Testing
- TVT-O, Improved reconstruction pelvic surgery
- Where
- China
- Volunteers
- 196 people
- Sponsor
- Peking Union Medical College Hospital
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
Urinary Retention
The Effect of Tamsulosin on Postoperative Urinary Retention
This is a double-blinded randomized controlled trial of perioperative use of tamsulosin to prevent postoperative urinary retention in female pelvic reconstructive surgery undergoing same-day discharge with an enhanced recovery…
- Trial name
- NCT04682366
- Testing
- Tamsulosin
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Wake Forest University Health Sciences
Pelvic Organ Prolapse
Use of Pre-Emptive Pudendal Nerve Block for Pelvic Reconstructive Surgery
The purpose of this study is to determine the effectiveness of perineal pain control via injection of a local anesthetic to numb the pudendal nerve. The medication which is commonly used for this block is called marcaine.
- Trial name
- NCT02409498
- Testing
- pudendal block, no pudendal block
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Icahn School of Medicine at Mount Sinai
Uterine Prolapse, Stage III
GYNECARE PROSIMA* Procedure Versus Modified Total Pelvic Floor Reconstructive Surgery for Uterine Prolapse Stage III
Pelvic Organ prolapse (a feeling of bulge in the vagina) may cause some distressing symptoms such as loss of control of the bowel or bladder, and may also cause problems with patient's sex life.
- Trial name
- NCT01396109
- Testing
- Procedure: TVH and GYNECARE PROSIMA* Pelvic Floor Repair System, Procedure: TVH and Modified Pelvic Floor Reconstruction Surgery with mesh
- Where
- 10 sites in China
- Volunteers
- 200 people
- Sponsor
- Peking Union Medical College Hospital
Pelvic Organ Prolapse, Prolapse of Vaginal Vault After Hysterectomy
VITOM Study: A Randomized, Controlled Trial.
This is research in which students are queried by questionnaires on their satisfaction with and experience with certain educational practices (use of a camera image projecting during a live surgery) or with pre-recorded video.
- Conditions
- Pelvic Organ Prolapse, Prolapse of Vaginal Vault After Hysterectomy, Bulging of Vaginal Wall, Incontinence
- Trial name
- VITOM (NCT03120689)
- Testing
- Live Surgery using VITOM, Live Surgery without VITOM, Video viewing with VITOM
- Where
- United States
- Volunteers
- 145 people, healthy volunteers welcome
- Sponsor
- University of Louisville