Clinical trial NCT02193607: Outcomes of Pelvic Surgery With and Without Anti-incontinence Procedure in Occult Stress Urinary Incontinence Patients
Official 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Organ Prolapse
Stress Urinary Incontinence
Other Specified Urinary Incontinence
Keywords: Occult stress incontinence
Pelvic Organ Prolapse
Surgical Intervention
TVT-O(Tension-free vaginal tape-obturator)
Improved Reconstructive Pelvic Surgery
Combined Surgery
Two-step Approach
Prophylactic Incontinence Procedure
Randomized Controlled Trial
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2014-07-17
Enrollment: 196
Sex: FEMALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Stress incontinence
timeFrame: 3 months to 2 years post-operation
Secondary outcomes:
measure: Immediate and short-term complications
timeFrame: Intraoperative and 2 years post-opeartion
measure: Overall urinary tract function
timeFrame: 3 months, 12 months and 2 years post-operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Obstetrics and Gynecology Department, Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lan Zhu, MD
role: STUDY_DIRECTOR
References:
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.
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.
citation: 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. doi: 10.1056/NEJMoa054208.