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Based on previous studies the single incision minisling is an easy less invasive procedure with fewer complications and cure rate similar to conventional midurethral slings in the treatment of female stress urinary incontinence. The aim of this study is to test the hypothesis that the single incision mini-sling placed in the "U" position is not inferior to TVT in this patient population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| minisling | Experimental | patients in this arm will undergo single incision minisling |
|
| tension free vaginal tape | Sham Comparator | patients in this arm will undergo tension free vaginal tape |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| single incision minisling | Procedure | midline incision of the vagina at midurethral level dissection of the vagina from perivesical fascia insertion of the tape (polypropylene macropore mesh tape) in the retropubic direction with its end grasped with an artery forceps till level of perineal membrane closure of the vagina 2 sham incisions if the skin only will be made at suprapubic to maintain blindness posterior colpoperneorraphy will be carried out if needed |
| Measure | Description | Time Frame |
|---|---|---|
| objective cure rate of urinary incontinence at 12 months after surgery | Objective cure is indicated by a negative stress test and the absence of any additional surgical or nonsurgical treatment for stress urinary incontinence | 12 months |
| subjective cure rate of urinary incontinence at 12 months after surgery | subjective cure is indicated by an Incontinence Severity Index score of 0 and the absence of any additional surgical or nonsurgical treatment for stress urinary incontinence | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with short- term complications | short-term complications (less than 6 weeks): post-operative pain, urinary retention, denovo urgency and wound sepsis | 12 months |
| Number of participants with long-term complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ahmed reda, M.Sc | Ain Shams University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University, Maternity Hospital | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37888839 | Derived | Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD008709. doi: 10.1002/14651858.CD008709.pub4. |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D053825 | Suburethral Slings |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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|
| tension free vaginal tape | Procedure | midline incision of the vagina at midurethral level dissection of the vagina from perivesical fascia insertion of the tape (polypropylene macropore mesh tape) with the applicators in the retropubic direction and 2 skin incision will be made supra pubic through which the applicators will be passed and removed and the tape will be cut at level just below the skin closure of the vagina posterior colpoperneorraphy will be carried out if needed |
|
|
long-term complications: erosion, dyspareunia and recurrence
| 12 months |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |