Clinical trials: Reconstructive Pelvic Surgery
Urinary Retention Postoperative
Impact of Tamsulosin on Post-Operative Urinary Retention Following Pelvic Reconstructive Surgery
The objective of the study is to determine the effectiveness of postoperative Tamsulosin in reducing the duration of acute postoperative urinary retention (POUR) following pelvic reconstructive surgery through a double blind…
- Trial name
- NCT04597372
- Testing
- Tamsulosin
- Where
- United States
- Volunteers
- 154 people, healthy volunteers welcome
- Sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
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.
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
Reconstructive Surgery Using Pedicled Perforating or Free Perforating Flaps, Pelvic Eschar
Study and Modeling of Perforator Flap Vascularization
The aim of reconstructive surgery is to restore physical integrity altered by trauma, congenital malformations or cancerous pathologies.
- Conditions
- Reconstructive Surgery Using Pedicled Perforating or Free Perforating Flaps, Pelvic Eschar, Traumatic Pathology of the Lower and/or Upper Limb
- Trial name
- EMoVaLP (NCT07084740)
- Testing
- PeriCam and PeriFlux measurements
- Where
- France
- Volunteers
- 20 people
- Sponsor
- University Hospital, Montpellier
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 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
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
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
Pelvic Organ Prolapse, Surgery
Preoperative Levator Ani Muscle Injection and Pudendal Nerve Block for Pain Control After Vaginal Reconstructive Surgery
To test the hypothesis that preoperative injections along the levator ani muscles and pudendal nerve with bupivacaine and dexamethasone improve pain control after vaginal apical reconstructive surgery.
- Conditions
- Pelvic Organ Prolapse, Surgery, Postoperative Pain
- Trial name
- NCT03040011
- Testing
- Dexamethasone, Bupivacaine, Bilateral Pudendal Nerve Block
- Where
- United States
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- Lauren Giugale, MD
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
Postoperative Urinary Retention, Sacrospinous Vaginal Vault Suspension
Effect of Tizanidine on Postoperative Urinary Retention After Sacrospinous Suspension
Postoperative urinary retention has been defined as the inability to void despite having fluid in the bladder during the postoperative period.
- Conditions
- Postoperative Urinary Retention, Sacrospinous Vaginal Vault Suspension, Reconstructive Pelvic Surgery
- Trial name
- NCT06258785
- Testing
- Tizanidine
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Endeavor Health
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.
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.
Uterine Prolapse, Vault Prolapse
Laparoscopic Sacral Colpopexy Versus Modified Total Pelvic Floor Reconstructive Surgery for Apical Prolapse Stage III-IV
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. The primary treatment is surgery.
- Trial name
- NCT01762384
- Testing
- LSC, modified PFRS, "Gynemesh"
- Where
- 4 sites in China
- Volunteers
- 100 people
- Sponsor
- Peking Union Medical College Hospital
UTI
Silver-Coated vs Standard Catheter for UTI Prevention
Primary Aim: To determine whether silver-coated transurethral catheter decreases the incidence of culture-confirmed urinary tract infection for women with catheter-managed urinary retention after pelvic reconstructive surgery…
- Trial name
- NCT05408533
- Testing
- 2-Way Foley Urethral Urinary Catheter
- Where
- 2 sites in United States
- Volunteers
- 310 people
- Sponsor
- TriHealth Inc.
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
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
Pain, Postoperative, Pelvic Organ Prolapse
Ice T Postoperative Multimodal Pain Regimen in FPMRS Surgery
The purpose of this randomized controlled trial is to determine whether, "ICE-T," a novel multimodal postoperative pain regimen composed of around the clock ice packs, toradol, and tylenol, has improved pain control intake…
- Trial name
- ICET (NCT03052816)
- Testing
- Ice T, Motrin/Percocet/Dilaudid for breakthrough
- Where
- United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- University Hospitals Cleveland Medical Center
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
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