Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06334848
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-28
First Post:
2024-03-12
Brief Title:
Efficacy of Mini Sling Versus Transobturator Tape in Surgical Management of Women With Stress Urinary Incontinence
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
Efficacy of Mini Sling Versus Transobturator Tape in Surgical Management of Women With Stress Urinary Incontinence
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
To compare the efficacy of mini sling against Transobturator tape for surgical management of women with stress urinary incontinence
Detailed Description:
Urinary incontinence is defined as involuntary loss of urine and is divided into subtypes according to symptoms These subtypes include SUI in which urine loss occurs during exertion physical exercise coughing or sneezing urgency urinary incontinence UUI in which urine loss is associated with urinary urgency and mixed urinary incontinence MUI which is characterized by the association of stress loss with urgency
There are non-surgical treatments eg lifestyle modifications pharmacotherapy physiotherapy and vaginal pessary and surgical treatments
As regards sling use it was found that mid urethral slings techniques achieved high cure rates in women with SUI and have become the mainstay for surgical treatment of SUI in women over the last 2 decades
One of the modalities of such procedures is the transobturator mid urethral tape TOT It was introduced to minimize the complications of the previous retropubic tapes which include injury to the bladder major vessels and bowel
In an effort to maintain efficacy while eliminating some of the side effects a new generation of tapes has been developed called single incision tapes or mini-slings They are designed to be shorter in length than standard mid-urethral slings and do not penetrate the tissues as deeply as standard slings
There are non-surgical treatments eg lifestyle modifications pharmacotherapy physiotherapy and vaginal pessary and surgical treatments
As regards sling use it was found that mid urethral slings techniques achieved high cure rates in women with SUI and have become the mainstay for surgical treatment of SUI in women over the last 2 decades
One of the modalities of such procedures is the transobturator mid urethral tape TOT It was introduced to minimize the complications of the previous retropubic tapes which include injury to the bladder major vessels and bowel
In an effort to maintain efficacy while eliminating some of the side effects a new generation of tapes has been developed called single incision tapes or mini-slings They are designed to be shorter in length than standard mid-urethral slings and do not penetrate the tissues as deeply as standard slings
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