Pelvic Organ Prolapse Clinical Trial
— PTOSOfficial title:
Improved Reconstruction Pelvic Surgery With and Without Tension-free Vaginal Tape-obturator in Women With Occult Stress Urinary Incontinence(PTOS): a Randomized Controlled Trial
Verified date | July 2014 |
Source | Peking Union Medical College Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Ministry of Health |
Study type | Interventional |
1. To evaluate whether a standardized tension-free vaginal tape-obturator(TVT-O)
procedure, when added to a planned improved reconstruction pelvic surgery, improves the
rate of urinary stress continence in subjects with occult stress incontinence.
2. Observe the immediate and short-term complications, overall urinary tract function, and
other aspects of pelvic health between subjects with and without a TVT-O procedure.
Status | Enrolling by invitation |
Enrollment | 196 |
Est. completion date | January 2017 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 55 Years and older |
Eligibility |
Inclusion Criteria: - In the absence of medical contraindications for improved pelvic floor reconstruction surgery and the TVT-O surgery - Bulge of paries anterior vaginas stage III-IV - Uterine prolapse stage II-II - Without symptoms of stress urinary incontinence - Screening tests of occult stress urinary incontinence(OSUI) should be positive - =55 years old. Exclusion Criteria: - Pregnancy - Illegible to follow up after surgery - Previous surgery for stress urinary incontinence - Unfinished data collection before surgery |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Obstetrics and Gynecology Department, Peking Union Medical College Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College Hospital |
China,
Brubaker L, Cundiff GW, Fine P, Nygaard I, Richter HE, Visco AG, Zyczynski H, Brown MB, Weber AM; Pelvic Floor Disorders Network. Abdominal sacrocolpopexy with Burch colposuspension to reduce urinary stress incontinence. N Engl J Med. 2006 Apr 13;354(15):1557-66. — View Citation
Schierlitz L, Dwyer PL, Rosamilia A, De Souza A, Murray C, Thomas E, Hiscock R, Achtari C. Pelvic organ prolapse surgery with and without tension-free vaginal tape in women with occult or asymptomatic urodynamic stress incontinence: a randomised controlled trial. Int Urogynecol J. 2014 Jan;25(1):33-40. doi: 10.1007/s00192-013-2150-7. Epub 2013 Jun 28. — View Citation
Wei JT, Nygaard I, Richter HE, Nager CW, Barber MD, Kenton K, Amundsen CL, Schaffer J, Meikle SF, Spino C; Pelvic Floor Disorders Network. A midurethral sling to reduce incontinence after vaginal prolapse repair. N Engl J Med. 2012 Jun 21;366(25):2358-67. doi: 10.1056/NEJMoa1111967. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Stress incontinence | Urine loss from physical activity such as coughing, sneezing or laughing. | 3 months to 2 years post-operation | Yes |
Secondary | Immediate and short-term complications | Immediate and short-term complications such as hemorrhage, bladder perforation and infection. | Intraoperative and 2 years post-opeartion | Yes |
Secondary | Overall urinary tract function | Overall urinary tract function: two validated questionnaires, standardized POP-Q measurements, urodynamic testing with prolapse reduction and 1 hour pad test. | 3 months, 12 months and 2 years post-operation | Yes |
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