PTOS: Outcomes of Pelvic Surgery With and Without Anti-incontinence Procedure in Occult Stress Urinary Incontinence Patients
Study Details
Study Description
Brief Summary
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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.
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The primary aim of this randomized study is evaluate whether a standardized TVT-O procedure, when added to a planned improved reconstruction pelvic surgery for the treatment of pelvic organ prolapse, improves the rate of urinary stress continence in subjects with occult stress incontinence. Secondary aims include comparison of immediate and short-term complications, overall urinary tract function, and other aspects of pelvic health between subjects with and without a TVT-O procedure. The value of preoperative urodynamic testing with prolapse reduction and 1 hour pad test will also be compared between subjects with and without a concomitant TVT-O procedure.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: No TVT-O Improved reconstruction pelvic surgery |
Procedure: Improved reconstruction pelvic surgery
Repair of severe pelvic organ prolapse with mesh.
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| Experimental: Combined surgery group Improved reconstruction pelvic surgery TVT-O procedure |
Procedure: TVT-O
Artificial mesh belt is placed in the middle urethra to provide support to remain no leak
Procedure: Improved reconstruction pelvic surgery
Repair of severe pelvic organ prolapse with mesh.
|
Outcome Measures
Primary Outcome Measures
- Stress incontinence [3 months to 2 years post-operation]
Urine loss from physical activity such as coughing, sneezing or laughing.
Secondary Outcome Measures
- Immediate and short-term complications [Intraoperative and 2 years post-opeartion]
Immediate and short-term complications such as hemorrhage, bladder perforation and infection.
- Overall urinary tract function [3 months, 12 months and 2 years post-operation]
Overall urinary tract function: two validated questionnaires, standardized POP-Q measurements, urodynamic testing with prolapse reduction and 1 hour pad test.
Eligibility Criteria
Criteria
Inclusion Criteria:
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In the absence of medical contraindications for improved pelvic floor reconstruction surgery and the TVT-O surgery
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Bulge of paries anterior vaginas stage III-IV
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Uterine prolapse stage II-II
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Without symptoms of stress urinary incontinence
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Screening tests of occult stress urinary incontinence(OSUI) should be positive
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≥55 years old.
Exclusion Criteria:
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Pregnancy
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Illegible to follow up after surgery
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Previous surgery for stress urinary incontinence
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Unfinished data collection before surgery
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Obstetrics and Gynecology Department, Peking Union Medical College Hospital | Beijing | Beijing | China | 100730 |
Sponsors and Collaborators
- Peking Union Medical College Hospital
Investigators
- Study Director: Lan Zhu, MD, Peking Union Medical College Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- 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. Erratum in: N Engl J Med. 2016 Jun 9;374(23):2297-8.
- 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.
- 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.
- PTOS-2014