Clinical trials: Pelvic Prolapse
Pelvic Organ Prolapse
Hysterectomy Versus Uterine Preservation for Pelvic Organ Prolapse Surgery
Pelvic organ prolapse (POP) is the descent of pelvic organs into the vagina resulting in bulge symptoms and occurs in approximately 50% of women. Almost 20% of women will elect surgical correction of this condition by age 85.
- Trial name
- HUPPS (NCT04890951)
- Testing
- Hysteropexy, Hysterectomy and vaginal vault suspension
- Where
- Canada
- Volunteers
- 321 people
- Sponsor
- University of Calgary
Stress Urinary Incontinence, Vaginal Prolapse
BELIEVE Trial: Bulking vErsus sLing for Treating Stress Urinary IncontinEnce at the Time of Vaginal prolapsE Repair (BELIEVE)
The goal of this clinical trial is to learn if retropubic midurethral sling (RP-MUS) or bulkamide injection (PAHG) at the time of pelvic organ prolapse repair is better from the patient's perspective.
- Trial name
- BELIEVE (NCT06754046)
- Testing
- RP-MUS, PAHG
- Where
- United States
- Volunteers
- 476 people
- Sponsor
- University Hospitals Cleveland Medical Center
Pelvic Organ Prolapse
Surgical Intervention With DermaPure vs Native Tissue in Pelvic Organ Prolapse
Comparing FDA-approved DermaPure with patient's own native tissue surgically for diagnosis of pelvic organ prolapse.
- Trial name
- NCT03939715
- Testing
- DermaPure®, native tissue
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Colorado Pelvic Floor Consultants
Pelvic Organ Prolapse, Urinary Incontinence
Validation of a French Version of the PISQ-R
The main objective of this study is to perform the linguistic validation of the french version of the PISQ-R questionnaire in a population of sexually active (or not) patients who have undergone surgery (or not) for stress…
- Conditions
- Pelvic Organ Prolapse, Urinary Incontinence, Fecal Incontinence
- Trial name
- NCT01548976
- Where
- France
- Volunteers
- 25 people
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
Pelvic Floor Dysfunction
Efficacy of Biofeedback in Women With Pelvic Floor Dysfunction
Recent studies have found that pelvic floor muscle training can relieve pelvic organ prolapse related symptoms. However, the rate of cure or improvement of symptoms with exercise prescription, different compliance of the…
- Trial name
- NCT04036578
- Testing
- A 12-week PFMT bio-assisted surface electromyographic program
- Volunteers
- 83 people
- Sponsor
- Far Eastern Memorial Hospital
Pelvic Organ Prolapse
Flat Polypropylene Mesh in the Treatment of Uterine and Recurrent or Advanced Pelvic Organ Prolapse
This study is being done to evaluate the safety and feasibility of using flat polypropylene Restorelle® mesh, an ultra-lightweight mesh, for transvaginal use in surgically correcting certain specific cases of pelvic organ…
- Trial name
- NCT06225375
- Testing
- Restorelle® Flat Mesh
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Michigan Institution of Women's Health PC
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
Nonabsorbable Versus Absorbable Sutures for Anterior Colporrhaphy
The objective of this is to compare surgical outcomes of anterior colporrhaphy using nonabsorbable sutures with anterior colporrhaphy using absorbable sutures.
- Trial name
- NCT03736811
- Testing
- Polyglactin 910 or polydioxanone, Polyester or polypropylene
- Where
- South Korea
- Volunteers
- 196 people
- Sponsor
- Seoul National University Hospital
Pelvic Organ Prolapse
Comparison of Sacrospinous Ligament Fixation and Uterosacral Ligament Suspension for Apical Prolapse Surgery: A Randomized Clinical Trial
the main aim of this study is to study the anatomical and functional outcomes of two vaginal apical fixation procedures; sacrospinous ligament fixation and uterosacral ligament suspension, for pelvic organ prolapse surgery.
- Trial name
- NCT05668130
- Testing
- Sacrospinous ligament fixation, Uterosacral Ligament Suspension
- Volunteers
- 194 people
- Sponsor
- B.P. Koirala Institute of Health Sciences
Pelvic Organ Prolapse, Prolapse
POMEGRANATE Trial: Comparing Reia Pessary Versus Standard of Care Pessary for Pelvic Organ Prolapse Treatment
This multi-centered, randomized controlled trial will evaluate the safety and efficacy of home use of the novel Reia System (RS), which includes the Reia pessary and applicator, compared to standard pessary care (Gellhorn or ring…
- Trial name
- POMEGRANATE (NCT06634459)
- Testing
- Reia System, Standard of Care Pessary
- Where
- 9 sites in United States
- Volunteers
- 218 people
- Sponsor
- Medstar Health Research Institute
Cystocele
Transobturator Approach for Paravaginal Repair
A new technique for Applying sutures to the white line in paravaginal repair.
- Trial name
- NCT02735772
- Testing
- transobturator approach for paravaginal repair
- Where
- Egypt
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Ain Shams Maternity Hospital
Pelvic Organ Prolapse
Native Tissue Repair With Surgical Pelvic Organ Pessary - an RCT
This is an RCT looking at the primary outcome of composite success following anterior repair with native tissue at 6, 12, 24 months in two arms.
- Trial name
- NTRSPOP (NCT02808377)
- Testing
- Surgical Pelvic Organ Pessary
- Where
- United Kingdom
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Cambridge University Hospitals NHS Foundation Trust
Vaginal Prolapse
Anterior Vaginal Wall Reconstruction
The purpose of this study is to assess the effectiveness of the polypropylene tape in preventing cystocele recurrence when placed underneath the bladder base as a concomitant measure to the anterior colporrhaphy procedure.
- Trial name
- NCT00571350
- Testing
- tvt-o operation, tvt o operation
- Where
- Greece
- Volunteers
- 50 people
- Sponsor
- Hippocration General Hospital
Pelvic Organ Prolapse, de Novo Stress Urinary Incontinence
CREDE Study: Intraoperative Crede Manoeuver Compared to Preoperative Prolapse Reduction Stress Test to Predict Postoperative de Novo Stress Urinary Incontinence (PONSUI) at the Time of Pelvic Organ Prolapse (POP) Surgery
The CREDE pilot randomized study will compare the intraoperative Crede manoeuver (M1) to preoperative prolapse (POP) reduction cough stress test (M2) for the prediction and prevention of PONSUI.
- Conditions
- Pelvic Organ Prolapse, de Novo Stress Urinary Incontinence, Stress Urinary Incontinence
- Trial name
- NCT04087642
- Testing
- Intraoperative Crede manoeuver, Preoperative prolapse reduction cough stress test
- Where
- 2 sites in Canada
- Volunteers
- 25 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Uterus Prolapse
Laparoscopic Supracervical Hysterectomy and Sacropexy Versus Hysteropexy Study
The purpose of this study is to compare the operative, anatomic functional outcome as well as the subjective outcome of laparoscopic supracervical hysterectomy and sacropexy compared to laparoscopic hysteropexy (conserving the…
- Trial name
- HysPex (NCT02345954)
- Testing
- Laparoscopic Supracervical Hysterectomy and Sacropexy, Laparoscopic Hysteropexy
- Where
- Switzerland
- Volunteers
- 100 people
- Sponsor
- Kantonsspital Aarau
Pelvic Organ Prolapse
Three-dimensional Ultrasound Assessment in Cases of Prolapse Surgeries
The levator ani muscle seems to play a key role in pelvic floor dysfunction. This muscle has two major components, the pubovisceral (including the pubococcygeus and puborectalis muscles) and the iliococcygeal muscles.Major…
- Trial name
- NCT03857724
- Testing
- prolapse surgery
- Where
- Egypt
- Volunteers
- 1 people
- Sponsor
- Assiut 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
Prolapse Genital, Prolapse Uterovaginal
Posterior Mesh Fixation at the Levator Ani Level in Apical Pelvic Organ Prolapse
This is a prospective, randomized, multicenter, non-inferiority trial including women with stage II-IV apical pelvic organ prolapse (POP), classified according to the POP-Q system.
- Conditions
- Prolapse Genital, Prolapse Uterovaginal, Prolapse; Female
- Trial name
- FIMEA (NCT07194343)
- Testing
- Laparoscopic colposacropexy with levator ani muscle mesh fixation, Simplified modification of laparoscopic colposacropexy
- Where
- 6 sites in Spain
- Volunteers
- 190 people
- Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Post-Operative Pain, Pelvic Organ Prolapse
Post-Operative Pain Control Using Direct Continuous Bupivacaine Infusion After Pelvic Organ Prolapse Repair
This prospective randomized controlled study will determine the efficacy of continuous local anesthesia at decreasing pain scores compared to patient controlled analgesia for pelvic organ prolapse procedures including posterior…
- Trial name
- NCT00695240
- Testing
- Continuous bupivacaine analgesia infusion (ON-Q PainBuster Post-Op Pain Relief System)
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- St. Luke's Hospital, Kansas City, Missouri
Pelvic Organ Prolapse, Urinary Incontinence,Stress
Timing of Repeat Voiding Trials After Outpatient Pelvic Floor Surgery
This study is a randomized controlled trial designed to assess the rate of failure of voiding trials in the early and late post-operative period within patients who underwent outpatient pelvic floor surgery that failed initial…
- Conditions
- Pelvic Organ Prolapse, Urinary Incontinence,Stress, Surgery
- Trial name
- NCT03048682
- Testing
- Foley catheter - Early Voiding Trial, Foley catheter - Late Voiding Trial
- Where
- 2 sites in United States
- Volunteers
- 64 people
- Sponsor
- The Cleveland Clinic