An interventional study of Laparoscopic Burch colposuspension and Mid-urethral slings (TVT and TOT) in Treatment of Female Stress Urinary Incontinence, sponsored by Assiut University. Status unknown. Open to female participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-28.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
To compare the laparoscopic Burch colposuspension with the midurethral slings (TVT, TOT) for treatment of female stress urinary incontinence as regard efficacy and safety.
Stress urinary incontinence (SUI) is defined by the International Continence Society (ICS) as an involuntary loss of urine on physical exertion, sneezing, or coughing (1). It occurs primarily in multiparous women (2).
The prevalence of UI among Egyptian women is high (55%). Aging, low educational level, menopause, higher parity (>3), vaginal delivery, and previous multiple abortions (>3) are significant risk factors for UI(3) Mid-urethral slings (TVT and TOT) are now the recognized worldwide standard of care for the surgical treatment of stress urinary incontinence(4) (5) Mid-Urethral Slings have a very high satisfaction rate (85-90 %) (4) (6), with durability of satisfaction recently demonstrated out to 5-years (79-85 %) as well as a modest 5-year treatment success (43-51 %) (4, 7) Burch colposuspension is a well-accepted technique for surgical management of stress urinary incontinence (SUI), especially when it is associated with urethral hypermobility. it first description in 1961 (8) (9) Originally performed as an open surgical procedure and then Over time, Burch colposuspension has been adapted for laparoscopy, it was long considered as the "gold standard" for the treatment of SUI before emergent of midurethral slings (9) The cure rates for laparoscopic colposuspention is as high as 68.9% to 88.0% whereas recurrence rates remain low, however, it has been reported that the cure rate of retropubic suspension techniques in general decreases steadily from 90% at 1 year to about70% by 10 years postoperatively. After a decline, it seems to reach a plateau at 65-70% at a 20 year follow-up (9) After the Food and Drug Administration (FDA) issued a warning about the use of transvaginal meshes for pelvic organ prolapse (POP) in 2011, there has been much debate about the use of mesh in the MUS continence procedures. Concern is increasing that the use of transvaginal mesh devices to treat SUI and POP have exposed women to avoidable harms following complications such as infection, tissue extrusion, mesh exposure ,mesh shrinkage, and side effects such as severe pain, sexual dysfunction, and repeat surgical interventions (5).
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's planned enrollment of 40 is below the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.
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Exclusion Criteria:
Procedure: Laparoscopic Burch colposuspension and Mid-urethral slings (TVT and TOT)
Procedure: Laparoscopic Burch colposuspension and Mid-urethral slings (TVT and TOT)
Laparoscopic Burch colposuspension and Mid-urethral slings (TVT and TOT)
● the result of cough stress test. The outcome will be binary: either negative test meaning no leakage at all or positive meaning there is any sort of leakage on stress. The secondary outcome measures will be the scores
● Accordingly. the patients will be classified into three groups: 1. Cured: patients who have negative cough stress test and the patient scores 0 on UDI-6. 2. Improved: patients who have more than 50% improvement in symptoms as determined by UDI-6. 3. Failed treatment: patients who have less than 50% improvement in symptoms.
Time frame: 1 year
No study locations are listed for this record.
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Assiut University