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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT02193607
Other study ID # PTOS-2014
Secondary ID
Status Enrolling by invitation
Phase N/A
First received June 19, 2014
Last updated July 15, 2014
Start date January 2014
Est. completion date January 2017

Study information

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

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Intervention

Procedure:
TVT-O
Artificial mesh belt is placed in the middle urethra to provide support to remain no leak
Improved reconstruction pelvic surgery
Repair of severe pelvic organ prolapse with mesh.

Locations

Country Name City State
China Obstetrics and Gynecology Department, Peking Union Medical College Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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

Outcome

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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