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OpenTrials
Completed

NCT Number: NCT02178735

Clinical Outcomes and Urodynamic Effects After Vaginal Tailored Mesh Surgery for Pelvic Organ Prolapse

To evaluate the clinical outcome and urodynamic effect of two novel vaginal tailored mesh surgeries.

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Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

20 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Department of Obstetrics & Gynecology, National Taiwan University Hospital

Taipei, 100, Taiwan

About this study

We will review the medical records (including medical data, urodynamic data, pad weight data, etc) of women who underwent either anterior or posterior novel vaginal tailored mesh surgeries at National Taiwan University Hospital between November 2011 and November 2013.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All women with pelvic organ prolapse who underwent either anterior or/and posterior vaginal tailored mesh surgeries in National Taiwan University Hospital between November 2011 and November 2013

Exclusion criteria

nil

Treatment and study plan

Anterior vaginal tailored mesh surgery

Procedure

Anterior vaginal tailored mesh surgery for repair of cystocele with or without stress urinary incontinence

Posterior vaginal tailored mesh surgery

Procedure

Posterior vaginal tailored mesh surgery for repair of enterocele, rectocele, vaginal vault prolapse or uterine prolapse

Primary outcomes

  1. Recurrence of pelvic organ prolapse

    Time frame: 1 year

    Recurrence rate of cystocele, rectocele, uterine prolapse, or vaginal vault prolapse within 1 year after surgery

Secondary outcomes

  1. The change of pad weight

    Time frame: 3 months

    The change of pad weight between baseline and 3 months after surgery for pelvic organ prolapse

  2. The change of maximum urethral closure pressure

    Time frame: 3 months

    The difference of maximum urethral closure pressure between baseline and 3 months after surgery

  3. Vaginal mesh erosion

    Time frame: 1 year

    Vaginal mesh erosion rate within 1 year after surgery

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 1, 2014
Registry last updated
Jan 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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