Ignite Creation Date:
2024-05-06 @ 7:24 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06000215
Status:
COMPLETED
Last Update Posted:
2023-08-22
First Post:
2023-02-16
Brief Title:
Credibility of Ultrasound Detection of Female Genital Prolapse Mesh
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
Official Title:
Credibility of Ultrasound Detection of Female Genital Prolapse Mesh
Status:
COMPLETED
Status Verified Date:
2023-08
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:
KIDS
Brief Summary:
The aim of the study is to investigate the credibility of ultrasound in detection of synthetic polypropylene vaginal implants In detail the study investigates if the ultrasound examiner experience and the standard method of examination may affect the detection of synthetic polypropylene vaginal implants by ultrasound
The primary hypothesis is if 90 of prolapse mesh could be detected by the ultrasound examiners who are blinded to the previous prolapse surgery the ultrasound is credible for prolapse mesh detection
The secondary hypothesis is if the ultrasound detection is not significantly different between the ultrasound examiners the method of ultrasound examination is mandatory to acheive credible ultrasound detection of the prolapse mesh
The primary hypothesis is if 90 of prolapse mesh could be detected by the ultrasound examiners who are blinded to the previous prolapse surgery the ultrasound is credible for prolapse mesh detection
The secondary hypothesis is if the ultrasound detection is not significantly different between the ultrasound examiners the method of ultrasound examination is mandatory to acheive credible ultrasound detection of the prolapse mesh
Detailed Description:
Pelvic organ prolapse POP is a common condition in post-delivery and post-reproductive aged women 1 The lifetime risk of undergoing a single operation for prolapse or incontinence by age 80 is 11 2 POP is mainly classified into three compartments anterior middle apical or posterior 1 Apical defects include descensus uteri or vaginal vault prolapse after previous hysterectomy Traditional Surgical repairs of POP using native connective tissues are commonly used but the risk for POP recurrence is high if apical prolapse is present ca 60 1 Thus the development of different mesh types using different approaches to support the vaginal apex uterus or vaginal top is highly growing Surgery may be done by transvaginal mesh TVM or robotic-assisted sacroclpopexy 3 Increasing evidence show effectivity of both methods and improved HR-QoL after surgery 4 5 6 7 8 9 However PFD including urinary incontinence urinary bladder emptying disorders and prolapse recurrence may be postoperative conditions 1 2
Growing needs worldwide is to improve diagnostic methods such as ultrasonography US This may improve the clinical knowledge to be further used for management of pelvic floor disorders PFD US is a cheap and safe method as compared to magnetic resonance MR or computed tomography CT 10 Thus if using US to provide clinical examination instead of MR and CT the health care cost may be reduced Indeed US can provide imaging in some cross sections giving same imaging results of MR 10
Some studies have been investigating the use of endo-vaginal trans-perinealintroital and trans-labial US techniques in detection of implants with more focus on TVT-surgery Tension-free vaginal tape for urinary incontinence UI and to some extent detection of prolapse mesh 11 However sensitivity of depiction has been reported to 92 at rest and 72 on physical examination when using endovaginal US examination 11 Also the depiction is dependent on the US expertise since no standardization has been achieved Furthermore the presence of scar tissues following previous POP or UI surgery in the pelvic floor region has been described as an interrupting factor for prediction 10
Thus development of a standardized US prediction of implants in order to elucidate anatomical and functional information in the pelvic floor when POP mesh is implanted may be useful in management of PFD It is to investigate the sensitivity and reproducibility of this US model of examination
The purpose of the present study is to investigate the credibility of the US detection of prolapse mesh implants when a standardized method of US examination is performed
Methodology of the present study Perinealintroital and vaginal ultrasound examination is done using a standard protocol by two different US examiners of four groups of patients previously received prolapse surgery Each examiner is to be entered from the pre-examination room do all requested examinations in one time and leave from the examination room to be followed by the next examiner without meeting each other Thus the ultrasound examiners are to be blinded to each other and to the previous prolapse surgery A controller is appointed to introduce each examiner from the pre-examination room record the time of each examination and collect the results of examinations The statistician is also to be blinded to the group of examination
References
1 Barber MD Maher C Apical prolapse Int Urogynecol J 2013 24111815-33
2 Olsen AL Smith VJ Bergstrom JO Colling JC Clark AL Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence Obstet Gynecol 1997 Apr894501-6
3 Maher C Feiner B Baessler K Schmid C Surgical management of pelvic organ prolapse in women Cochrane Database Syst Rev 2013 Apr 304CD004014
4 Oliver JL Kim JH Robotic Sacrocolpopexy-Is It the Treatment of Choice for Advanced Apical Pelvic Organ Prolapse Curr Urol Rep 2017 Sep18966-74
5 Rahkola-Soisalo P Mikkola TS Altman D Falconer C for Nordic TVM Group Pelvic Organ Prolapse Repair Using the Uphold Vaginal Support System 5-Year Follow-up Female Pelvic Med Reconstr Surg 2017 Dec 11 Fortcoming 2018
6 Gutman RE Rardin CR Sokol ER Matthews C Park AJ Iglesia CB st al Vaginal and laparoscopic mesh hysteropexy for uterovaginal prolapse a parallel cohort study Am J Obstet Gynecol 2017 Jan216138e1-38e11
7 Lua LL Vicente ED Pathak P Lybbert D Dandolu V Comparative analysis of overall cost and rate of healthcare utilization among apical prolapse procedures Int Urogynecol J 2017 Oct28101481-8
8 Rahkola-Soisalo P Altman D Falconer C Morcos E Rudnicki M Mikkola TS Quality of life after Uphold Vaginal Support System surgery for apical pelvic organ prolapse-A prospective multicenter study Eur J Obstet Gynecol Reprod Biol 2017 Jan20886-90 doi 101016jejogrb201611011 Epub 2016 Nov 14
9 Altman D Geale K Falconer C Morcos E A generic health-related quality of life instrument for assessing pelvic organ prolapse surgery correlation with condition-specific outcome measures Int Urogynecol J 2018 Mar 6 doi 101007s00192-018-3587-5
10 Khatri G Carmel ME Bailey AA Foreman MR Brewington CC Zimmern PE Pedrosa I Postoperative Imaging after Surgical Repair for Pelvic Floor Dysfunction Radiographics 2016 Jul-Aug3641233-56
11 Manonai J Rostaminia G Denson L Shobeiri SA Clinical and ultrasonographic study of patients presenting with transvaginal mesh complications Neurourol Urodyn 2016 Mar353407-11 doi 101002nau22725 Epub 2015 Jan 25
Growing needs worldwide is to improve diagnostic methods such as ultrasonography US This may improve the clinical knowledge to be further used for management of pelvic floor disorders PFD US is a cheap and safe method as compared to magnetic resonance MR or computed tomography CT 10 Thus if using US to provide clinical examination instead of MR and CT the health care cost may be reduced Indeed US can provide imaging in some cross sections giving same imaging results of MR 10
Some studies have been investigating the use of endo-vaginal trans-perinealintroital and trans-labial US techniques in detection of implants with more focus on TVT-surgery Tension-free vaginal tape for urinary incontinence UI and to some extent detection of prolapse mesh 11 However sensitivity of depiction has been reported to 92 at rest and 72 on physical examination when using endovaginal US examination 11 Also the depiction is dependent on the US expertise since no standardization has been achieved Furthermore the presence of scar tissues following previous POP or UI surgery in the pelvic floor region has been described as an interrupting factor for prediction 10
Thus development of a standardized US prediction of implants in order to elucidate anatomical and functional information in the pelvic floor when POP mesh is implanted may be useful in management of PFD It is to investigate the sensitivity and reproducibility of this US model of examination
The purpose of the present study is to investigate the credibility of the US detection of prolapse mesh implants when a standardized method of US examination is performed
Methodology of the present study Perinealintroital and vaginal ultrasound examination is done using a standard protocol by two different US examiners of four groups of patients previously received prolapse surgery Each examiner is to be entered from the pre-examination room do all requested examinations in one time and leave from the examination room to be followed by the next examiner without meeting each other Thus the ultrasound examiners are to be blinded to each other and to the previous prolapse surgery A controller is appointed to introduce each examiner from the pre-examination room record the time of each examination and collect the results of examinations The statistician is also to be blinded to the group of examination
References
1 Barber MD Maher C Apical prolapse Int Urogynecol J 2013 24111815-33
2 Olsen AL Smith VJ Bergstrom JO Colling JC Clark AL Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence Obstet Gynecol 1997 Apr894501-6
3 Maher C Feiner B Baessler K Schmid C Surgical management of pelvic organ prolapse in women Cochrane Database Syst Rev 2013 Apr 304CD004014
4 Oliver JL Kim JH Robotic Sacrocolpopexy-Is It the Treatment of Choice for Advanced Apical Pelvic Organ Prolapse Curr Urol Rep 2017 Sep18966-74
5 Rahkola-Soisalo P Mikkola TS Altman D Falconer C for Nordic TVM Group Pelvic Organ Prolapse Repair Using the Uphold Vaginal Support System 5-Year Follow-up Female Pelvic Med Reconstr Surg 2017 Dec 11 Fortcoming 2018
6 Gutman RE Rardin CR Sokol ER Matthews C Park AJ Iglesia CB st al Vaginal and laparoscopic mesh hysteropexy for uterovaginal prolapse a parallel cohort study Am J Obstet Gynecol 2017 Jan216138e1-38e11
7 Lua LL Vicente ED Pathak P Lybbert D Dandolu V Comparative analysis of overall cost and rate of healthcare utilization among apical prolapse procedures Int Urogynecol J 2017 Oct28101481-8
8 Rahkola-Soisalo P Altman D Falconer C Morcos E Rudnicki M Mikkola TS Quality of life after Uphold Vaginal Support System surgery for apical pelvic organ prolapse-A prospective multicenter study Eur J Obstet Gynecol Reprod Biol 2017 Jan20886-90 doi 101016jejogrb201611011 Epub 2016 Nov 14
9 Altman D Geale K Falconer C Morcos E A generic health-related quality of life instrument for assessing pelvic organ prolapse surgery correlation with condition-specific outcome measures Int Urogynecol J 2018 Mar 6 doi 101007s00192-018-3587-5
10 Khatri G Carmel ME Bailey AA Foreman MR Brewington CC Zimmern PE Pedrosa I Postoperative Imaging after Surgical Repair for Pelvic Floor Dysfunction Radiographics 2016 Jul-Aug3641233-56
11 Manonai J Rostaminia G Denson L Shobeiri SA Clinical and ultrasonographic study of patients presenting with transvaginal mesh complications Neurourol Urodyn 2016 Mar353407-11 doi 101002nau22725 Epub 2015 Jan 25
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?:
True
Is an FDA AA801 Violation?:
None