Ignite Creation Date:
2024-05-06 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06225375
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-25
First Post:
2021-08-05
Brief Title:
Flat Polypropylene Mesh in the Treatment of Uterine and Recurrent or Advanced Pelvic Organ Prolapse
Sponsor:
Michigan Institution of Womens Health PC
Organization:
Michigan Institution of Womens Health PC
Study Overview
Official Title:
Prospective Analysis of Flat Polypropylene Mesh in the Treatment of Uterine by Uterine-sparing Hysteropexy and Recurrent or Advanced Pelvic Organ Prolapse a Safety and Feasibility Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 prolapse such as recurrent previous failed native tissue repair large stage III or IV pelvic organ prolapse and those with symptomatic uterine prolapse desiring uterine-sparing surgery called hysteropexy
Detailed Description:
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 prolapse such as recurrent previous failed native tissue repair large stage III or IV pelvic organ prolapse and those with symptomatic uterine prolapse desiring uterine-sparing surgery called hysteropexySubjects shall undergo transvaginal mesh surgery per the surgeons specifications The surgical procedure may include either a posterior Restorelle or an anterior Restorelle or a combined anterior and posterior Restorelle based upon the findings of the prolapse
Briefly a sheet of Restorelle Flat Mesh-XL shall be cut to the dimensions of the former Restorelle Direct Fix Anterior and Posterior Mesh The posterior Restorelle procedure involves a posterior vaginal incision with dissection into the pararectal spaces with attachment of the mesh arms to the sacrospinous ligaments bilaterally A StatTack Medtronic Dublin Ireland device may be used to affix the mesh to the sacrospinous ligament The apical portions of the mesh will then be attached to the cervix with at least two 2-0 Prolene sutures
The anterior Restorelle procedure will be performed through an anterior vaginal incision with dissection into the paravaginal spaces with attachment of the arms to the obturator internus or the proximal arms to the sacrospinous ligaments bilaterally If the patient has occult stress urinary incontinence on preoperative urodynamic testing a midurethral sling will be placed Cystourethroscopy will be systematically performed on all subjects undergoing an anterior repair or a sling procedure A vaginal oval pessary device may be placed at the end of surgery and this will stay in for the next few weeks as a vaginal support mold while healing occurs Surgical details such as operative time estimated blood loss and complications will be documented accordingly Adverse events both immediate and delayed will be classified according to severityseriousness using Clavien-Dindo classification for reporting complications The timing resolution and relatedness of these adverse events to the procedure shall be documented as well
A clinical examination including vaginal wall retraction will be performed along with a POPQ exam and validated questionnaires at 6 months 12 months 24 months and 36 months from the index surgery Subjects will also complete a PGI-I assessment which asks Compared to how you were doing before your recent pelvic floor surgery would you say that now you are with answers being much better a little better about the same a little worse or much worse Subjects will also complete a survey with questions rating satisfactionregret with making the decision to proceed with treatment Additionally a pelvic ultrasound to assess the Restorelle mesh will be performed at these visits Subjects will also be seen at 1 week 1 month 3 months and 18 months after surgery and an examination and ultrasound will be performed at these visits but no study questionnaires will be requested At each follow-up visit the subject shall be questioned about de novo pelvic pain dyspareunia de novo urinary incontinence recurrent urinary tract infections repeat operations or treatments or other adverse events A vaginal examination shall be completed to determine any mesh exposures with location mesh erosions infection atypical vaginal discharge tenderness retraction or shortening of the vaginal walls vaginal scarring fistula formation de novo vaginal bleeding or granulomas or hematomas A bladder scan shall assess for voiding function and a dipstick urinalysis shall be obtained to determine the presence of cystitis Based upon subjects symptoms and results on dipstick urinalysis urine may also be sent for microscopic urinalysis and culture with sensitivities and antibiotics may be given
All CRFs will be kept confidential and maintained by the research coordinator in a locked cabinet The participants will keep the research team aware of any changes in medical history and if any adverse effects are detected Data collected onto a Microsoft Excel spreadsheet Patient reported measures will be collected on paper forms and data entered into the spreadsheet Analysis will be conducted after the study has been completed
Briefly a sheet of Restorelle Flat Mesh-XL shall be cut to the dimensions of the former Restorelle Direct Fix Anterior and Posterior Mesh The posterior Restorelle procedure involves a posterior vaginal incision with dissection into the pararectal spaces with attachment of the mesh arms to the sacrospinous ligaments bilaterally A StatTack Medtronic Dublin Ireland device may be used to affix the mesh to the sacrospinous ligament The apical portions of the mesh will then be attached to the cervix with at least two 2-0 Prolene sutures
The anterior Restorelle procedure will be performed through an anterior vaginal incision with dissection into the paravaginal spaces with attachment of the arms to the obturator internus or the proximal arms to the sacrospinous ligaments bilaterally If the patient has occult stress urinary incontinence on preoperative urodynamic testing a midurethral sling will be placed Cystourethroscopy will be systematically performed on all subjects undergoing an anterior repair or a sling procedure A vaginal oval pessary device may be placed at the end of surgery and this will stay in for the next few weeks as a vaginal support mold while healing occurs Surgical details such as operative time estimated blood loss and complications will be documented accordingly Adverse events both immediate and delayed will be classified according to severityseriousness using Clavien-Dindo classification for reporting complications The timing resolution and relatedness of these adverse events to the procedure shall be documented as well
A clinical examination including vaginal wall retraction will be performed along with a POPQ exam and validated questionnaires at 6 months 12 months 24 months and 36 months from the index surgery Subjects will also complete a PGI-I assessment which asks Compared to how you were doing before your recent pelvic floor surgery would you say that now you are with answers being much better a little better about the same a little worse or much worse Subjects will also complete a survey with questions rating satisfactionregret with making the decision to proceed with treatment Additionally a pelvic ultrasound to assess the Restorelle mesh will be performed at these visits Subjects will also be seen at 1 week 1 month 3 months and 18 months after surgery and an examination and ultrasound will be performed at these visits but no study questionnaires will be requested At each follow-up visit the subject shall be questioned about de novo pelvic pain dyspareunia de novo urinary incontinence recurrent urinary tract infections repeat operations or treatments or other adverse events A vaginal examination shall be completed to determine any mesh exposures with location mesh erosions infection atypical vaginal discharge tenderness retraction or shortening of the vaginal walls vaginal scarring fistula formation de novo vaginal bleeding or granulomas or hematomas A bladder scan shall assess for voiding function and a dipstick urinalysis shall be obtained to determine the presence of cystitis Based upon subjects symptoms and results on dipstick urinalysis urine may also be sent for microscopic urinalysis and culture with sensitivities and antibiotics may be given
All CRFs will be kept confidential and maintained by the research coordinator in a locked cabinet The participants will keep the research team aware of any changes in medical history and if any adverse effects are detected Data collected onto a Microsoft Excel spreadsheet Patient reported measures will be collected on paper forms and data entered into the spreadsheet Analysis will be conducted after the study has been completed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None