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

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
TVT-O
Improved reconstruction pelvic surgery
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring 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

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Obstetrics and Gynecology Department, Peking Union Medical College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

No TVT-O

Combined surgery group

Arm Description

Improved reconstruction pelvic surgery

Improved reconstruction pelvic surgery TVT-O procedure

Outcomes

Primary Outcome Measures

Stress incontinence
Urine loss from physical activity such as coughing, sneezing or laughing.

Secondary Outcome Measures

Immediate and short-term complications
Immediate and short-term complications such as hemorrhage, bladder perforation and infection.
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.

Full Information

First Posted
June 19, 2014
Last Updated
July 15, 2014
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02193607
Brief Title
Outcomes of Pelvic Surgery With and Without Anti-incontinence Procedure in Occult Stress Urinary Incontinence Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
January 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
196 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No TVT-O
Arm Type
Active Comparator
Arm Description
Improved reconstruction pelvic surgery
Arm Title
Combined surgery group
Arm Type
Experimental
Arm Description
Improved reconstruction pelvic surgery TVT-O procedure
Intervention Type
Procedure
Intervention Name(s)
TVT-O
Intervention Description
Artificial mesh belt is placed in the middle urethra to provide support to remain no leak
Intervention Type
Procedure
Intervention Name(s)
Improved reconstruction pelvic surgery
Intervention Description
Repair of severe pelvic organ prolapse with mesh.
Primary Outcome Measure Information:
Title
Stress incontinence
Description
Urine loss from physical activity such as coughing, sneezing or laughing.
Time Frame
3 months to 2 years post-operation
Secondary Outcome Measure Information:
Title
Immediate and short-term complications
Description
Immediate and short-term complications such as hemorrhage, bladder perforation and infection.
Time Frame
Intraoperative and 2 years post-opeartion
Title
Overall urinary tract function
Description
Overall urinary tract function: two validated questionnaires, standardized POP-Q measurements, urodynamic testing with prolapse reduction and 1 hour pad test.
Time Frame
3 months, 12 months and 2 years post-operation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lan Zhu, MD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Obstetrics and Gynecology Department, Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
22716974
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.
Results Reference
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PubMed Identifier
23812579
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.
Results Reference
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PubMed Identifier
16611949
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. Erratum In: N Engl J Med. 2016 Jun 9;374(23):2297-8.
Results Reference
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Outcomes of Pelvic Surgery With and Without Anti-incontinence Procedure in Occult Stress Urinary Incontinence Patients

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