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this study used to compare efficacy between platelet rich plasma periurethral injection versus mid urethral sling ( trans obturator tape ) in treatment of stress urinary incontinence
stress urinary incontinence classified in urodynamic study according to Valsalva leak point pressure to intrinsic sphincteric muscle weakness best treated by PRP periurethral injection and VLPP is less than or equal 60cmH2O and MUCP less than 20cmH2O(21 ) patients enrolled in this group , while hypermobile urethra identified by VLPP is high more than 90cmh2O best treated by trans obturator tape(21) patients recruited in this group , mode of preparation of PRP is by withdrawing 15 ml blood and placed in falcon tube with ACD ( acid citrate dextrose) added centrifuged first at 800 RPM and then the supernatant removed and re-centrifuged again at 3500 RPM and then injected periurethral by 5cc syringe with 30G needle after applying 2% lidocaine ,patient assessed at one and three month objectively by cough stress test and subjectively by ICIQ questionnaire and presence of any adverse effect
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients complaining of stress urinary incontinence based on urodynamic study | Experimental | GROUP 1: 21 patients allocated who have SUI ISD will receive PRP GROUP 2: 21 patient who have hypermobile urethra will receive TOT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet Rich Plasma | Procedure | GROUP 1 : 21patient will have platelet rich plasma injected periurethral in intrinsic muscle weakness in stress urinary incontinence |
|
| Measure | Description | Time Frame |
|---|---|---|
| objective assessment of SUI through cough stress test | after one and three months |
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Inclusion Criteria:
Exclusion Criteria:
because it depend on female genitourinary system urethral anatomy
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| nahla fathy khatab, master of science | Contact | 01030241711 | nahlafathy1995@gmail.com | |
| mahmoud mohamed Ghaleb, Doctor of medicine | Contact | 02 01007212975 |
| Name | Affiliation | Role |
|---|---|---|
| mohamed Abdelhamid nasr El Din, Doctor of medicine | urogynecology unit ainshams university | Study Director |
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in informed consent all participants information will be only known by the research and investigator committee and their personal information will be kept with confidentiality
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 19, 2025 | Apr 11, 2026 |
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randomized controlled clinical trial
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| Mid urethral sling ( trans obturator tape) | Procedure | GROUP 2 : (21) patient having SUI due to hypermobile urethra will have TOT |
|
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 19, 2025 | Apr 11, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| 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 |
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| ID | Term |
|---|---|
| D053825 | Suburethral Slings |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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