Pelvic Organ Prolapse
Conditions
Keywords
Preventive, tvt-o, stress incontinence
Brief summary
Urinary stress incontinence is defined as leakage of urine during stress. Urinary stress incontinence is a health problem with social, economic and psychological consequences. The appearance of Urinary stress incontinence post vaginal wall prolapse repair is a known phenomena. Part of the cases relate to pre-surgical occult Urinary stress incontinence which has been asymptomatic, and part of the cases relate to de-novo urinary stress incontinence post surgery. Latest studies have demonstrated 11-22% rate of post surgical urinary stress incontinence. The aim of this study is to examine the efficacy of transobturator tension free vaginal tape (TVT-O) among women who intend to undergo vaginal wall repair by a vaginal approach.
Detailed description
Urinary stress incontinence is defined as leakage of urine during stress (cough, lough, sneezing, coitus, heavy lifting, physical activity). Urinary stress incontinence is a health problem with social, economic and psychological consequences. The appearance of Urinary stress incontinence post vaginal wall prolapse repair is a known phenomena. Part of the cases relate to pre-surgical occult Urinary stress incontinence which has been asymptomatic, and part of the cases relate to de-novo urinary stress incontinence post surgery. Latest studies have demonstrated 11-22% rate of post surgical urinary stress incontinence. The CARE study has examined the efficacy of preventive BURCH RETROPUBIC URETHROPEXY among women who underwent abdominal sacrocolpopexy. According to this study, the BURCH procedure reduced the rate of post surgery urinary stress incontinence. The authors recommend to offer those women the preventive surgery. Those results cannot be relied on when considering vaginal wall repair by the vaginal approach. The aim of this study is to examine the efficacy of transobturator tension free vaginal tape (TVT-O) among women who intend to undergo vaginal wall repair by a vaginal approach.
Interventions
PROCEDUREPreventive transobturator tension free vaginal tape
during the vaginal wall repair surgery, a TVT-O procedure will be done
Sponsors
HaEmek Medical Center, Israel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* women with vaginal wall prolapse grade 2 and more * no contraindication to vaginal wall repair or tvt-o * No stress incontinence
Exclusion criteria
* urinary tract malformations * past urinary stress incontinence surgical procedure * UDI - question 17 or 18 - positive answer * Occult urinary stress incontinence
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stress incontinence | One year post operation | The women will be classified as continent or not continent according to: * the Pelvic Floor Distress Inventory * stress test * need to other treatment for stress incontinence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical complications | one year | Surgical complication |
| post surgery urgency or urge incontinence | one year | urgency or urge incontinence |
Countries
Israel
Outcome results
None listed