Outcomes of Pelvic Surgery With and Without Anti-incontinence Procedure in Occult Stress Urinary Incontinence Patients

Pelvic Organ Prolapse Clinical Trial

— PTOS  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02193607
• Other study ID #: PTOS-2014
• 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

Related Conditions & MeSH terms

• Other Specified Urinary Incontinence
• Pelvic Organ Prolapse
• Prolapse
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress
• Urinary Incontinence, Urge

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