Ignite Creation Date:
2024-05-06 @ 6:15 PM
Last Modification Date:
2024-10-26 @ 2:44 PM
Study NCT ID:
NCT05602246
Status:
RECRUITING
Last Update Posted:
2023-02-14
First Post:
2022-10-23
Brief Title:
Study Comparing Transobturator Cystocele vs Anterior Vaginal RepairS
Sponsor:
Charles University Czech Republic
Organization:
Charles University Czech Republic
Study Overview
Official Title:
Study Comparing Transobturator Cystocele vs Anterior Vaginal RepairS
Status:
RECRUITING
Status Verified Date:
2023-02
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:
STARS
Brief Summary:
Surgical correction of the prolapse in the anterior compartment remains one of the major challenges in urogynecology Paravaginal defect in level II of vaginal fixation results in the majority of cystoceles Clinically these defects are often combined andor may be bilateral Hence careful assessment and individualized planning of the surgical procedure is essential to optimize cystocele repair outcome Several surgical techniques and approaches have been used for cystocele repair After the ban on transvaginal meshes the interest in native tissue repair has risen Paravaginal defect repair is an effective surgery for paravaginal defect reconstruction There is a current trend to utilize transvaginal surgery instead of more invasive transabdominal surgery A novel method of transvaginal paravaginal defect repair - TOCR transobturator cystocele repair was suggested The principle objective of the present trial is to compare its efficacy and safety to preexisting method of native tissue cystocele repair
Detailed Description:
Pelvic organ prolapse POP has a negative impact on the quality of life of affected women and anterior compartment defects remain the most challenging to repair It was reported that a women has almost a 1 in 5 risk of needing any kind of POP surgery in her lifetime with anterior wall repair accounting for 406 of all of these Depending on the structures affected cystocele can be secondary to defects at A Level I vaginal support provided by the uterosacral and cardinal ligaments or B Level II vaginal support mainly provided by the pubocervical fascia Level II defects can be midline or lateral paravaginal depending on whether the fascia is weak at the midline or detached from its lateral attachment to the arcus tendineus fasciae pelvis ATFP Clinically these defects are often combined andor may be bilateral Hence careful assessment and individualized planning of the surgical procedure is essential to optimize cystocele repair outcome
Several surgical techniques and approaches have been used for cystocele repair These involve native tissue and the use of mesh implanted transvaginally and or transabdominallyThe mainstay for the vaginal repair of a level I defects is to anchor the uterine cervix or vaginal vault to the sacrospinous or the anterior longitudinal ligaments However proper restoration of a level II defect is more complex Although a classical anterior colporrhaphy might be suitable to correct an isolated midline weakness in the endopelvic fascia it is suboptimal on its own for the repair an associated lateral defect which is a common association Indeed De Lancey reported that paravaginal defects PVDs were diagnosed in 89 of women undergoing surgery for cystocele and stress urinary incontinence
Although a variety of techniques for paravaginal defect repair PVDR have been suggested several of these are now not feasible in many countries following the FDAs ban on transvaginal mesh manufacture sale and distribution Therefore currently there are attempts to utilize minimally invasive approaches and modern devices in PVDR native tissue repair Applying this principle eg Capio Suture Capturing Device Boston Scientific has been proposed to re-attach the vagina to the ATFP using two to four non-absorbable sutures However based on anatomical observation the ATFP is thin its superior part and thicker inferiorly This is an issue that might affect the reliability of identifying and ensuring a secure anchorage to the ATFP when solely using a transvaginal route Recently a novel Technique of PVDR called transobturator cystocele repair has been published However as the technique was described recently no follow-up data have been reported to support its practice
The aim of this randomized controlled trial RCT is to compare the novel TOCR and standard anterior colporrhaphy AR regarding their safety efficacy and quality-of-life improvement in a one-year follow-up
Several surgical techniques and approaches have been used for cystocele repair These involve native tissue and the use of mesh implanted transvaginally and or transabdominallyThe mainstay for the vaginal repair of a level I defects is to anchor the uterine cervix or vaginal vault to the sacrospinous or the anterior longitudinal ligaments However proper restoration of a level II defect is more complex Although a classical anterior colporrhaphy might be suitable to correct an isolated midline weakness in the endopelvic fascia it is suboptimal on its own for the repair an associated lateral defect which is a common association Indeed De Lancey reported that paravaginal defects PVDs were diagnosed in 89 of women undergoing surgery for cystocele and stress urinary incontinence
Although a variety of techniques for paravaginal defect repair PVDR have been suggested several of these are now not feasible in many countries following the FDAs ban on transvaginal mesh manufacture sale and distribution Therefore currently there are attempts to utilize minimally invasive approaches and modern devices in PVDR native tissue repair Applying this principle eg Capio Suture Capturing Device Boston Scientific has been proposed to re-attach the vagina to the ATFP using two to four non-absorbable sutures However based on anatomical observation the ATFP is thin its superior part and thicker inferiorly This is an issue that might affect the reliability of identifying and ensuring a secure anchorage to the ATFP when solely using a transvaginal route Recently a novel Technique of PVDR called transobturator cystocele repair has been published However as the technique was described recently no follow-up data have been reported to support its practice
The aim of this randomized controlled trial RCT is to compare the novel TOCR and standard anterior colporrhaphy AR regarding their safety efficacy and quality-of-life improvement in a one-year follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None