Uterine Prolapse Clinical Trial
This research protocol is a randomized controlled trial. It is being done to compare and
find out the relative differences between the materials, (Pelivisoft) "natural organic mesh"
to poly propylene mesh (Pelvitex) "manmade mesh" after a surgery known as sacral colpopexy.
This surgery involves supporting the prolapsed vaginal wall with a piece of material (known
as a graft) attached to a ligament along your backbone (or sacrum). These materials are both
FDA approved and widely used. The following objectives: anatomic outcomes, graft-related
complications between the two materials, changes in pelvic organ prolapse-related quality of
life, subjective changes in sexual function,changes in bowel function and the prolapse
related pain present after sacral colpopexy will be evaluated.
The study visits are all under standard of care. Study questionnaires are unique to the
study and will be completed at the enrollment in hospital, 2, 6,12 weeks, 6 months and one
year visits The questionnaires are related to bowel function, bladder function, prolapse and
sexual activity.
Permission will be requested to contact the patient again 5 years after surgery. Contact in
the future will in no way obligate the patient to participate.
There may or may not be direct medical benefits to the participant. Decreased risk of
erosion may be a possible benefit if placed in the organic "natural" arm of the study. The
information learned from this study may benefit other patients in the future
n/a
Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00158626 -
Does Doing Pelvic Floor Exercise Ease Symptoms for Women Living With Prolapse?
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04009694 -
Does a High BMI Affect Supervised Pelvic Floor Muscle Training for Improving Symptoms in Women With Various Stages of Pelvic Organ Prolapse?
|
N/A | |
| Recruiting |
NCT03095716 -
Laparoscopic Surgery in Elderly Patients
|
N/A | |
| Completed |
NCT02888093 -
A Randomized Controlled Trial of Permanent vs Absorbable Suture for Uterosacral Ligament Suspension
|
N/A | |
| Recruiting |
NCT04209036 -
Can 3D Laparoscopy Improve Surgical Performances in Surgeons in Training?
|
||
| Active, not recruiting |
NCT01097200 -
Sacrocolpopexy Versus Vaginal Mesh Procedure for Pelvic Prolapse
|
N/A | |
| Recruiting |
NCT00162604 -
Prophylactic Antibiotic Treatment During Vaginal Repair
|
N/A | |
| Recruiting |
NCT02547155 -
Does Spinal Anesthesia for Prolapse Surgery With Lead to Urinary Retention?
|
N/A | |
| Recruiting |
NCT01396109 -
GYNECARE PROSIMA* Procedure Versus Modified Total Pelvic Floor Reconstructive Surgery for Uterine Prolapse Stage III
|
N/A | |
| Not yet recruiting |
NCT03056586 -
The Effect of Pessary Post Vaginal Prolapse Repair, for One Month, to Reduce the Recurrence Rate of Prolapse
|
N/A | |
| Recruiting |
NCT06024109 -
Performance of SYMMCORA® vs. V-Loc® Suture Material in Patients Undergoing Laparoscopic Total Hysterectomy
|
||
| Completed |
NCT02680145 -
Prediction of Postsurgical Symptomatic Outcomes With Preoperative Pessary Use
|
N/A | |
| Completed |
NCT00557882 -
Efficacy Study of Vaginal Mesh for Anterior Prolapse
|
Phase 4 | |
| Recruiting |
NCT05586984 -
Transvaginal Sacrospinous Hysteropexy Versus Laparoscopic Uterine Lateral Suspension
|
||
| Recruiting |
NCT02935803 -
A Study on the Anti-incontinent Effectiveness of the mTVM Method in POPQ Stage II-III Patients
|
N/A | |
| Completed |
NCT01628432 -
Effect of Salpingectomy During Conservative Hysterectomy
|
N/A | |
| Recruiting |
NCT04637022 -
4K Versus 3D Laparoscopic Colporraphy by Surgeons in Training: a Prospective Randomized Trial
|
||
| Terminated |
NCT01594372 -
Comparison of Laparoscopic to Vaginal Surgical Repair for Uterine Prolapse
|
N/A | |
| Active, not recruiting |
NCT02231099 -
Effectiveness Prolift+M Versus Conventional Vaginal Prolapse Surgery
|
N/A | |
| Completed |
NCT00475540 -
Efficacy Study of Vaginal Mesh for Prolapse
|
N/A |