A Phase 2/3 interventional study of TVT-O in Stress Urinary Incontinence and Postmenopausal Disorder, sponsored by Kasr El Aini Hospital. Completed at 1 site in Egypt. Open to female participants aged 49 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-10-25.
Sponsored by Kasr El Aini Hospital · Phase 2/3, Interventional, and Treatment
To compare the subjective and objective outcomes of TVT-O procedure alone versus the same procedure followed by the use of premarin vaginal cream for 3 months in postmenopausal female with genuine stress incontinence.
a randomized controlled trial comparing the effect of using local estrogen cream after tot in postmenopausal female
-menopause patients included in group A should have: no history of breast cancer, ovarian cancer or uterine cancer No history of blood clots or thromboembolism No history of heart disease or stroke No history liver disease. Endometrial thickness less than 5mm Have a normal mammogram
Exclusion Criteria:
post menopausal female with genuine stress incontinence treated by TVT-O and local estrogen cream for 3 months after surgery
Procedure: TVT-O
post menopausal female with genuine stress incontinence treated by TVT-O only
Procedure: TVT-O
transobturator tape has been applied to all the patients in the study,and local estrogen vaginal cream is only applied to patients in group A
Also known as: local vaginal estrogen cream
outcome of the surgery
clinical and urodynamic test improvment of the stress incontinence
Time frame: immediately after surgery
outcome of the surgery
clinical and urodynamic test improvment of the stress incontinence
Time frame: 3 months after surgery
nocturia ,
symptom and sign from the patients
Time frame: immediatly after surgery
frequency,
symptom and sign from the patients
Time frame: immediatly after surgery
denovo urgency
symptom and sign from the patients
Time frame: immediatly after surgery
denovo urgency
symptom and sign from the patients
Time frame: 3 months after surgery
nocturia
symptom and sign from the patients
Time frame: 3 months after surgery
frequency
symptom and sign from the patients
Time frame: 3 months after surgery
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Kasr El Aini Hospital