Clinical trials: Reconstructive Pelvic Surgery
Patient Satisfaction
Telehealth Postop Follow up RCT
A randomized controlled trial that will evaluate whether telephone two-week postoperative follow up visits are an acceptable and safe alternative to traditional face-to-face-clinic two-week postoperative visits.
- Trial name
- NCT03791697
- Testing
- Telehealth 2 week postoperative visit
- Where
- United States
- Volunteers
- 142 people, healthy volunteers welcome
- Sponsor
- Jackson, Elisha
Pelvic Organ Prolapse
The Follow-up of Mesh/Native Tissue Complications Study(Part II)
To study the incidence and distribution of complications after different pelvic reconstruction surgeries (mesh/native tissue) in multi-centers.
- Trial name
- NCT03617211
- Where
- 5 sites in China
- Volunteers
- 1,530 people
- Sponsor
- Peking Union Medical College Hospital
Vaginal Vault Prolapse, Post-Hysterectomy Vaginal Vault Prolapse
Intraperitoneal and Extraperitoneal Uterosacral Ligament Suspensions for Post-Hysterectomy Vaginal Vault Prolapse
Post-hysterectomy vaginal vault prolapse is a common pelvic floor disorder described as descent of the vaginal apex after hysterectomy.
- Conditions
- Vaginal Vault Prolapse, Post-Hysterectomy Vaginal Vault Prolapse, Prolapse, Vaginal
- Trial name
- NCT04172896
- Testing
- Intraperitoneal Uterosacral Ligament Suspension, Extraperitoneal Uterosacral Ligament Suspension
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- The Methodist Hospital Research Institute
Postoperative Urinary Retention
Self-discontinuation of a Transurethral Catheter
This study is to determine if self-discontinuation of transurethral foley catheters in patients diagnosed with postoperative urinary retention (POUR), which is defined as the continued need for catheterization, following…
- Trial name
- NCT02996968
- Testing
- Self-removal
- Where
- United States
- Volunteers
- 158 people
- Sponsor
- TriHealth Inc.
Pelvic Organ Prolapse (POP), Stress Urinary Incontinence (SUI)
Suzetrigine for Opioid-Sparing Postoperative Analgesia Following Transvaginal Pelvic Reconstructive Surgery
Suzetrigine is a selective NaV1.8 inhibitor that provides peripheral analgesia without opioid-related CNS effects. This single-center stepped-wedge randomized clinical trial evaluates whether a suzetrigine-based postoperative…
- Conditions
- Pelvic Organ Prolapse (POP), Stress Urinary Incontinence (SUI), Postoperative Pain
- Trial name
- NCT07600697
- Testing
- Suzetrigine, Opioid Analgesics (Tramadol or Oxycodone), Scheduled Acetaminophen and Ibuprofen
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- University of California, Los Angeles
Pelvic Floor
The Follow-up of Mesh/Native Tissue Complications Study(Part I)
This study aims to investigate the incidence and distribution of complications after different pelvic reconstruction surgeries using mesh/native tissue in multi-centers using the IUGA/ICS complication classification system(the…
- Trial name
- NCT03620565
- Where
- China
- Volunteers
- 13,120 people
- Sponsor
- Peking Union Medical College Hospital
Post Operative, Post Operative Analgesia
Postoperative Tizanidine Use in Pelvic Reconstructive Surgery: A Pilot Study
The goal of this clinical trial is to evaluate whether adding tizanidine to the standard postoperative pain regimen improves recovery after pelvic reconstructive surgery in adult women.
- Conditions
- Post Operative, Post Operative Analgesia, Urogynecologic Surgery
- Trial name
- TIPS (NCT07766837)
- Testing
- Tizanidine, Standard-of-Care Therapy
- Where
- United States
- Volunteers
- 186 people
- Sponsor
- Hartford Hospital
Post Operative Pain Control, Narcotic Use
Sprix for Postoperative Pain Control Following Gynecologic Surgery
The ongoing opioid epidemic has altered both how physicians prescribe narcotics and patients' perceptions of those prescriptions.
- Conditions
- Post Operative Pain Control, Narcotic Use, Pelvic Organ Prolapse, Urinary Incontinence , Stress
- Trial name
- NCT04444830
- Testing
- Sprix
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of Louisville
Estrogen, Menopause
Patient Adherence to Premarin Versus Vagifem Therapy After Female Pelvic Reconstructive Surgery
PURPOSE: To evaluate patient adherence to cream versus tablet based local estrogen therapy by randomizing treatment modalities to determine differences in adherence to either form.
- Conditions
- Estrogen, Menopause, Pelvic Floor Disorders, Surgery
- Trial name
- NCT02860897
- Testing
- Premarin, Vagifem
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- University Hospitals Cleveland Medical Center
Quality of Life, Pelvic Floor Distress and Impact Scores
Physical Therapy on Quality of Life and Function Following Vaginal Surgery Reconstructive Surgery
i) The primary objective of this study is to determine if physical therapy improves postoperative quality of life in participants following vaginal reconstructive surgery for pelvic organ prolapse and urinary incontinence.
- Conditions
- Quality of Life, Pelvic Floor Distress and Impact Scores, Sexual Function Scores
- Trial name
- PT and QOL (NCT01403701)
- Testing
- Physical therapy
- Where
- United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- TriHealth Inc.
Urinary Incontinence, Pelvic Organ Prolapse
Voiding Assessment Based on Minimum Spontaneous Void of 150 mL Compared to Retrograde Fill Method After Female Pelvic Floor Reconstructive Surgery
This study will compare voiding assessment based on a minimum spontaneous voided volume of 150 cc with the standard retrograde fill approach in women after pelvic floor procedures.
- Trial name
- NCT03539107
- Testing
- Retrograde bladder fill, spontaneous void
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Yale University
Pelvic Organ Prolapse
Dynamic Magnetic Resonance Imaging Before and After Vaginal Prolapse Repair
This study is to describe the impact of vaginal reconstruction, including an intraperitoneal vaginal vault suspension for pelvic organ prolapse (POP) on pelvic anatomy using dynamic magnetic resonance imaging (MRI) of the pelvis.
- Trial name
- NCT03315715
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- TriHealth Inc.
Pelvic Floor Disorders, Ureter; Kink
Ureteric Visualization: Vitamin B Vs 5% Dextrose in Water
Background: The risk of ureteric injury at the time of pelvic reconstructive surgery can be as high as 3% and the American College of Obstetricians and Gynecologists has stated that intraoperative cystoscopy should be done after…
- Trial name
- NCT03089671
- Testing
- Vitamin B (riboflavin, vitamin B2), 5% Dextrose in Water (D5W)
- Where
- 2 sites in Canada
- Volunteers
- 238 people
- Sponsor
- Mount Sinai Hospital, Canada
Sexual Function Disturbances, Pelvic Organ Prolapse
Postoperative Return to Sexual Activity
To determine if standardized counselling regarding first sexual encounter after pelvic reconstructive surgery for pelvic organ prolapse and / or urinary incontinence improves postoperative preparedness to return to sexual…
- Conditions
- Sexual Function Disturbances, Pelvic Organ Prolapse, Stress Urinary Incontinence, Surgery
- Trial name
- PoRS (NCT05342090)
- Testing
- Structured Counselling Tool
- Where
- Canada
- Volunteers
- 186 people
- Sponsor
- University of Calgary
Pelvic Organ Prolapse
Vaginal Orthosis Use After Vaginal Reconstructive Surgery
A novel vaginal orthosis, or splint, made of silicone will be used daily to help support the healing vaginal reconstruction during the post-operative phase from week 2 to week 12.
- Trial name
- NOVa (NCT05812859)
- Testing
- Vaginal Orthosis (COSM Medical)
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Catheter-Associated Urinary Tract Infection
Prevention of Catheter-Associated Urinary Tract Infection in Incontinence and Reconstructive Pelvic Surgery Patients
The study will assess the risk of catheter associated urinary tract infection in women undergoing incontinence or reconstructive pelvic surgery. Women will be given an antibiotic or placebo at the time of catheter removal.
- Trial name
- PRECAUTION (NCT01108757)
- Testing
- Bactrim
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- The Cleveland Clinic
Pelvic Organ Prolapse, PONV
Effects of Preoperative Dexamethasone Study on QOL After Vaginal Reconstructive Surgery for POP
The investigators hypothesize that preoperative administration of 8 mg IV dexamethasone will benefit patients' perceived quality of recovery after surgery.
- Trial name
- NCT02073734
- Testing
- Dexamethasone
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- TriHealth Inc.
Pelvic Organ Prolapse
Gabapentin Reduces Opioid Use Postoperatively ("GROUP Study")
Gabapentin is a medication used primarily to treat seizures and pain. Studies have shown that this medication can help reduce pain after surgery, including hysterectomy, where the uterus or "womb" is removed.
- Trial name
- GROUP (NCT02999724)
- Testing
- Gabapentin
- Where
- Canada
- Volunteers
- 44 people
- Sponsor
- Mount Sinai Hospital, Canada
Pelvic Organ Prolapse
Ischia Spinous Fascia Fixation Procedure Versus Modified Total Pelvic Floor Reconstructive Surgery for Pelvic Organ Prolapse Stage III
Pelvic organ prolapse is a common problem. The primary treatment is surgery. Ischia spinous fascia fixation procedure and modified total pelvic floor reconstructive surgery with mesh are both developed in China for vaginal apex…
- Trial name
- NCT01670682
- Testing
- ischia spinous fascia fixation, Modified Pelvic Floor Reconstruction Surgery with Mesh, polypropylene mesh(Gynemesh)
- Where
- 5 sites in China
- Volunteers
- 80 people
- Sponsor
- Peking Union Medical College Hospital
Pelvic Floor Prolapse, Surgery
The Effect of Preemptive Levator Ani Injections on Pain After Pelvic Reconstructive Surgery
Patients undergoing vaginal pelvic reconstructive surgery for pelvic organ prolapse (POP) under general anesthesia will be randomized to receive bilateral trans-vaginal pelvic floor muscle injections with bupivacaine or no…
- Conditions
- Pelvic Floor Prolapse, Surgery, Pain, Postoperative
- Trial name
- NCT04428320
- Testing
- Pelvic floor injection
- Where
- United States
- Volunteers
- 140 people
- Sponsor
- The Cooper Health System