Clinical trials: Pelvic Prolapse
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
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
Pelvic Organ Prolapse
Permanent Versus Absorbable Colpopexy Trial
Primary Aim: The primary aim of this randomized controlled trial (RCT) is to compare vaginal mesh and suture exposure rates in women undergoing robotic total hysterectomy and sacrocolpopexy with a light-weight polypropylene mesh…
- Trial name
- PACT (NCT02277925)
- Testing
- Polytetrafluoroethylene, Polydioxanone
- Where
- 5 sites in United States
- Volunteers
- 204 people
- Sponsor
- University of North Carolina, Chapel Hill
Pelvic Organ Prolapse
Vaginally Assisted Laparoscopic Hysteropexy Versus Vaginal Hysterectomy
Utero-vaginal prolapse is a common, often disabling, condition experienced by women of varying ages. The traditional surgical treatment for utero-vaginal prolapse often includes vaginal hysterectomy and anterior or posterior…
- Trial name
- NCT03436147
- Testing
- POP-Q
- Where
- Turkey (Türkiye)
- Volunteers
- 49 people
- Sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
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.
Pelvic Organ Prolapse, Cystocele
A Randomized Controlled Trial of Permanent vs Absorbable Suture for Uterosacral Ligament Suspension
Uterosacral ligament suspension (USLS) is a commonly performed, vaginal surgery for the correction of female pelvic organ prolapse. The original description of this procedure included the use of permanent sutures.
- Conditions
- Pelvic Organ Prolapse, Cystocele, Uterine Prolapse
- Trial name
- NCT02888093
- Testing
- Absorbent suture (polydioxanone) and Permanent suture (Gore-Tex CV2)
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Joseph Kowalski
Pelvic Organ Prolapse
Smartmesh Technology in Pelvic Floor Repair Procedures
Pelvic organ prolapse repair involves conservative treatments and surgical treatments. Conservative treatments are for patients with moderate prolapse. Treatment of symptomatic prolapse remains essentially surgical.
- Trial name
- Restorelle (NCT03098641)
- Testing
- pelvic organ prolapse repair
- Where
- 16 sites in France
- Volunteers
- 272 people
- Sponsor
- Groupe Hospitalier de la Rochelle Ré Aunis
Constipation, Prolapse, Vaginal
Effect of Preoperative Fiber on Postoperative Bowel Function
Post-operative constipation is one of the most common complaints after pelvic organ prolapse surgery. Psyillum fiber is an FDA-approved, over the counter dietary supplement that is commonly used to treat constipation.
- Trial name
- NCT04882995
- Testing
- Psyillium fiber
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- University of Massachusetts, Worcester
Pelvic Organ Prolapse
Vaginal Estrogen and Pelvic Floor Physical Therapy in Women With Symptomatic Mild Prolapse
This is a randomized controlled trial in which women with symptomatic mild pelvic organ prolapse undergoing Pelvic Floor Physical Therapy (PFPT) receive vaginal estrogen versus placebo to see if a combined approach to treatment…
- Trial name
- NCT01648751
- Testing
- Vaginal estrogen
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Pamela Moalli
Pelvic Organ Prolapse
Axis™ Allograft Dermis for Female Pelvic Floor Repair: a Prospective Post Market Study
This study is a prospective, single arm, multi-center, post-market study to evaluate the efficacy of Axis™ Allograft Dermis used for anterior, posterior or combined (anterior and posterior) pelvic organ prolapse repair.
- Trial name
- NCT01541748
- Testing
- Axis
- Where
- 5 sites in United States
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Coloplast A/S
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, Urinary Incontinence,Stress
Minimally Invasive Burch Colposuspension to Reduce Occult Stress Incontinence
This study evaluates the addition of a laparoscopic Burch colposuspension procedure at the time of laparoscopic sacrocolpopexy to prevent stress urinary incontinence.
- Conditions
- Pelvic Organ Prolapse, Urinary Incontinence,Stress, Urinary Incontinence, Urge, Bowel Dysfunction
- Trial name
- MICRO (NCT03841513)
- Testing
- Laparoscopic Burch Colposuspension
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Northwestern University
Anterior Vaginal Wall Prolapse, Cystocele
Anterior Colporrhaphy Versus Cystocele Repair Using Polypropylene Mesh or Porcine Dermis
The purpose of this study is to evaluate the success rate of cystocele repair using polypropylene mesh or porcine dermis compared to that of anterior colporrhaphy in a prospective randomized fashion.
- Conditions
- Anterior Vaginal Wall Prolapse, Cystocele, Pelvic Organ Prolapse
- Trial name
- OARS (NCT01393171)
- Testing
- Polypropylene mesh (Polyform by Boston Scientific), Porcine Dermis (Pelvicol by CRBard), Anterior Colporrhaphy
- Where
- 2 sites in United States
- Volunteers
- 99 people, healthy volunteers welcome
- Sponsor
- Kaiser Permanente
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
Pelvic Organ Prolapse, Uterine Prolapse
Efficacy Study of Vaginal Mesh for Prolapse
The primary aim of this double-blind, randomized clinical trial (RCT) is to test the hypothesis that the addition of a standardized technique of interpositional synthetic polypropylene mesh placement improves the one-year outcome…
- Conditions
- Pelvic Organ Prolapse, Uterine Prolapse, Vaginal Prolapse, Cystocele
- Trial name
- VAMP (NCT00475540)
- Testing
- synthetic monofilament polypropylene mesh
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Medstar Health Research Institute
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, Urogenital Prolapse
Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen
This study randomizes postmenopausal women with symptomatic pelvic organ prolapse planning native tissue transvaginal surgical repair to 6-8 weeks of preoperative and 1-year continued postoperative vaginal estrogen cream compared…
- Conditions
- Pelvic Organ Prolapse, Urogenital Prolapse, Vaginal Vault Prolapse, Cystocele
- Trial name
- IMPROVE (NCT02431897)
- Testing
- Conjugated Estrogens Cream
- Where
- 3 sites in United States
- Volunteers
- 206 people
- Sponsor
- University of Texas Southwestern Medical Center
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
Vaginal Vault Prolapse, Pelvic Organ Prolapse
Prediction of Postsurgical Symptomatic Outcomes With Preoperative Pessary Use
This is a single center, prospective trial of pessary use prior to reconstructive pelvic floor surgery for pelvic organ prolapse.
- Conditions
- Vaginal Vault Prolapse, Pelvic Organ Prolapse, Uterine Prolapse, Pelvic Floor Prolapse
- Trial name
- NCT02680145
- Testing
- Preoperative Pessary Use
- Where
- United States
- Volunteers
- 58 people
- Sponsor
- Mayo Clinic
Pelvic Organ Prolapse
Intraperitoneal Bupivacaine for Pelvic Organ Prolapse
The purpose of this study is to evaluate the effects of 30 mL intraperitoneal Bupivacaine without epinephrine 0.25% on postoperative pain control in patients undergoing pelvic organ prolapse repair.
- Trial name
- NCT06120530
- Testing
- Bupivacaine, Saline
- Where
- United States
- Volunteers
- 91 people
- Sponsor
- Indiana University