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

Improved Reconstruction Pelvic Surgery With and Without Tension-free Vaginal Tape-obturator in Women With Occult Stress Urinary Incontinence(PTOS): a Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Pelvic Organ Prolapse; Stress Urinary Incontinence; Other Specified Urinary Incontinence
• Intervention / Treatment: Procedure: Improved reconstruction pelvic surgery; Procedure: TVT-O

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 Type: Interventional
• Enrollment (Anticipated): 196
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Obstetrics and Gynecology Department, Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.
Experimental: Combined surgery group; Improved reconstruction pelvic surgery TVT-O procedure	Procedure: Improved reconstruction pelvic surgery; Repair of severe pelvic organ prolapse with mesh.; Procedure: TVT-O; Artificial mesh belt is placed in the middle urethra to provide support to remain no leak

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stress incontinence	Urine loss from physical activity such as coughing, sneezing or laughing.	3 months to 2 years post-operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immediate and short-term complications	Immediate and short-term complications such as hemorrhage, bladder perforation and infection.	Intraoperative and 2 years post-opeartion
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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Study Director: Lan Zhu, MD, Peking Union Medical College Hospital

Publications and helpful links

General 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. doi: 10.1056/NEJMoa054208. Erratum In: N Engl J Med. 2016 Jun 9;374(23):2297-8.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): January 1, 2016
• Study Completion (Anticipated): January 1, 2017

Study Registration Dates

• First Submitted: June 19, 2014
• First Submitted That Met QC Criteria: July 15, 2014
• First Posted (Estimate): July 17, 2014

Study Record Updates

• Last Update Posted (Estimate): July 17, 2014
• Last Update Submitted That Met QC Criteria: July 15, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Pelvic Organ Prolapse; Surgical Intervention; Occult stress incontinence; TVT-O(Tension-free vaginal tape-obturator); Improved Reconstructive Pelvic Surgery; Combined Surgery; Two-step Approach; Prophylactic Incontinence Procedure
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Pathological Conditions, Anatomical; Elimination Disorders; Urinary Incontinence; Prolapse; Pelvic Organ Prolapse; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: PTOS-2014