NCT02193607

Brief Summary

  1. 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
196

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2014

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 17, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

July 17, 2014

Status Verified

July 1, 2014

Enrollment Period

2 years

First QC Date

June 19, 2014

Last Update Submit

July 15, 2014

Conditions

Pelvic Organ ProlapseStress Urinary IncontinenceOther Specified Urinary Incontinence

Keywords

Occult stress incontinencePelvic Organ ProlapseSurgical InterventionTVT-O(Tension-free vaginal tape-obturator)Improved Reconstructive Pelvic SurgeryCombined SurgeryTwo-step ApproachProphylactic Incontinence ProcedureRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • Stress incontinence

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

    3 months to 2 years post-operation

Secondary Outcomes (2)

  • Immediate and short-term complications

    Intraoperative and 2 years post-opeartion

  • Overall urinary tract function

    3 months, 12 months and 2 years post-operation

Study Arms (2)

No TVT-O

ACTIVE COMPARATOR

Improved reconstruction pelvic surgery

Procedure: Improved reconstruction pelvic surgery

Combined surgery group

EXPERIMENTAL

Improved reconstruction pelvic surgery TVT-O procedure

Procedure: TVT-OProcedure: Improved reconstruction pelvic surgery

Interventions

TVT-OPROCEDURE

Artificial mesh belt is placed in the middle urethra to provide support to remain no leak

Combined surgery group
Improved reconstruction pelvic surgeryPROCEDURE

Repair of severe pelvic organ prolapse with mesh.

Combined surgery groupNo TVT-O

Eligibility Criteria

Age55 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnancy
  • Illegible to follow up after surgery
  • Previous surgery for stress urinary incontinence
  • Unfinished data collection before surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Obstetrics and Gynecology Department, Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (3)

  • 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.

    PMID: 22716974BACKGROUND

  • 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.

    PMID: 23812579BACKGROUND

  • 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.

    PMID: 16611949BACKGROUND

MeSH Terms

Conditions

Pelvic Organ ProlapseUrinary Incontinence, Stress

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsUrinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and Symptoms

Study Officials

  • Lan Zhu, MD

    Peking Union Medical College Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2014

First Posted

July 17, 2014

Study Start

January 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2017

Last Updated

July 17, 2014

Record last verified: 2014-07

Locations

CN(1)