Clinical trials: Pelvic Surgery
Catheter-Associated Urinary Tract Infection
Nitrofurantoin Administration for the Prevention of Short-Term Catheter Associated Urinary Tract Infection After Pelvic Surgery
The specific aim of this randomized double-blind placebo-controlled trial is to evaluate the efficacy of administration of nitrofurantoin prophylaxis after catheter discontinuation for the prevention of catheter-associated…
- Trial name
- NAUTICA (NCT03287089)
- Testing
- Nitrofurantoin 100 MG
- Where
- United States
- Volunteers
- 164 people
- Sponsor
- Wake Forest University Health Sciences
Non-Cardiac/ Non-Thoracic Surgery, Abdominal Surgery
Assisted Fluid Management IDE Study
The primary objective of this study is to evaluate the performance of the Acumen™ Assisted Fluid Management (AFM) Feature in its ability to predict a subject's fluid responsiveness.
- Conditions
- Non-Cardiac/ Non-Thoracic Surgery, Abdominal Surgery, Pelvic Surgery, Major Peripheral Vascular Surgery
- Trial name
- AFM (NCT03469570)
- Testing
- EV1000 Clinical Platform with Assisted Fluid Management (AFM) Feature
- Where
- 10 sites in United States
- Volunteers
- 330 people
- Sponsor
- Edwards Lifesciences
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
Nerve Block, Pain, Postoperative
Pudendal Nerve Block in Vaginal Surgery
The objective of this this randomized controlled study is to determine whether a pudendal nerve block at the time of vaginal surgery is associated with improved postoperative pain control and decrease opioid consumption compared…
- Conditions
- Nerve Block, Pain, Postoperative, Pelvic Floor Disorders, Pelvic Organ Prolapse
- Trial name
- NCT04198714
- Testing
- Pudendal block
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- MetroHealth Medical Center
Endometritis, Wound Infection
Study of Effectiveness and Safety of Azithromycin-based Extended-spectrum Prophylaxis to Prevent Post Cesarean Infection
The Cesarean Section Optimal Antibiotic Prophylaxis (C/SOAP) study is a large pragmatic multi-center randomized clinical trial designed to evaluate the comparative effectiveness and safety of azithromycin-based extended-spectrum…
- Conditions
- Endometritis, Wound Infection, Abscess, Surgical Site Infection
- Trial name
- C/SOAP (NCT01235546)
- Testing
- Azithromycin and standard of care
- Where
- 9 sites in United States
- Volunteers
- 2,013 people
- Sponsor
- Alan Tita
Hemorrhage, Soft Tissue Bleeding
EVARREST™ Fibrin Sealant Patch Post-Market Study
The objective of this study is to evaluate the clinical utility of EVARREST™ Fibrin Sealant Patch (Fibrin Pad) as an adjunct to hemostasis in soft tissue bleeding during intra-abdominal (stomach area), retroperitoneal (hip and…
- Trial name
- EVARREST (NCT01902459)
- Testing
- EVARREST™ Fibrin Sealant Patch, Standard of Care
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Ethicon, Inc.
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
Injury of Ureter
Evaluation of Ureteral Jets on Cystoscopy
This study evaluates 4 different methods to aid surgeons to visualize ureteral jets on cystoscopy.
- Trial name
- JET (NCT02476448)
- Testing
- Normal saline, Phenazopyridine, Dextrose 10%
- Where
- United States
- Volunteers
- 176 people, healthy volunteers welcome
- Sponsor
- Cecilia Calvo
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
Hemorrhage, Soft Tissue Bleeding
The Paediatric EVICEL® Soft Tissue and Parenchymal Organ Bleeding Study
To evaluate the safety and effectiveness of EVICEL® Fibrin Sealant (Human) as an adjunct to achieve haemostasis during surgery in paediatric patients.
- Trial name
- NCT02227706
- Testing
- EVICEL® Fibrin Sealant, SURGICEL® Absorbable Hemostat
- Where
- 13 sites in Belgium, Canada and 1 more
- Volunteers
- 40 people
- Sponsor
- Ethicon, Inc.
Pelvic Organ Prolapse
Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies
The purpose of this research is to determine if there is a difference in total costs of care and return to health in women who undergo a laparoscopic abdominal sacrocolpopexy (ASC) compared to those undergoing the same procedure…
- Trial name
- ACCESS (NCT01124916)
- Testing
- Robotic assisted laparoscopic abdominal sacrocolpopexy, Standard laparoscopic abdominal sacrocolpopexy
- Where
- 2 sites in United States
- Volunteers
- 84 people
- Sponsor
- Loyola University
Bladder Cancer
Robotic-Assisted Laparoscopic Extended Pelvic Lymph Node Dissection for Transitional Cell Carcinoma of the Bladder
The goal of this clinical research study is to evaluate how many lymph nodes are left behind after robotic-assisted removal and are then found after a wider incision is made, in patients who are having their bladder removed for…
- Trial name
- NCT00963859
- Testing
- Robotic-assisted laparoscopic surgery
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- M.D. Anderson Cancer Center
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
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
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
Vaginal Prolapse
Observational Data Collection of Surgical Outcomes in the Treatment of Vaginal Prolapse With AMS Products
This registry was observational (only collected information typically noted by the surgeon when their patients were routinely seen); there was no change to the care the patient received as a result of being part of the registry).
- Trial name
- POWER1012 (NCT00388947)
- Testing
- AMS Prolapse Product
- Where
- United States
- Volunteers
- 1,543 people
- Sponsor
- ASTORA Women's Health
Rectal Cancer
Sexual Function and Wellbeing in Males With Rectal Cancer
Preoperative radiotherapy and pelvic surgery is recommended to many patients with rectal cancer. For men there are theoretical reasons to believe that the treatment may effect hormone levels, spermatogenesis, sexual function and…
- Trial name
- NCT01216202
- Testing
- Preoperative radiotherapy
- Where
- 2 sites in Sweden
- Volunteers
- 178 people
- Sponsor
- Karolinska Institutet
Prostate Cancer
Prostate Radiation Therapy or Short-Term Androgen Deprivation Therapy and Pelvic Lymph Node Radiation Therapy With or Without Prostate Radiation Therapy in Treating Patients With a Rising Prostate Specific Antigen (PSA) After Surgery for Prostate Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause the growth of prostate cancer cells.
- Trial name
- NCT00567580
- Testing
- PBRT, PLNRT, AA
- Where
- 460 sites in United States, Canada and 2 more
- Volunteers
- 1,792 people
- Sponsor
- Radiation Therapy Oncology Group
Urinary Incontinence, Stress, Urinary Incontinence, Urge
Combined Treatment for Mixed Incontinence
The overarching goal of this randomized trial is to estimate the effect of combined midurethral sling (MUS) and peri-operative behavioral/pelvic floor therapy (BPTx) compared to MUS alone on successful treatment of MUI symptoms…
- Trial name
- ESTEEM (NCT01959347)
- Testing
- Miduretheral Sling, Miduretheral Sling with behavioral/pelvic floor therapy
- Where
- 10 sites in United States
- Volunteers
- 480 people
- Sponsor
- NICHD Pelvic Floor Disorders Network
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.