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Mechanism of Incontinence Before and After Genital Prolapse Surgery

NCT02050568 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2015-03-18

No results posted yet for this study

Summary

Since year 2003, Glostrup/Herlev Hospital has devised a novel technique, urethral pressure reflectometry (UPR), for measurements of pressure and cross-sectional area in the female urethra. UPR has been able to separate continent women from women with stress urinary incontinence (SUI, defined by involuntary leakage during increased abdominal pressure). The method stands alone in its field.

9.5 % of all women undergo genital prolapse surgery during their lives (genital prolapse is characterized by a portion of the vaginal canal protruding from the opening of the vagina). However, 10-30 % of these women develop SUI after surgery, while approximately 40 % with preoperative SUI actually experience an improvement in their condition. Efforts have been made to predict the likelihood of a patient having SUI after genital prolapse surgery; however the tests have shown disappointing positive and negative predictive values.

A mid-urethral sling is gold standard for treatment of SUI and to avoid SUI after genital prolapse surgery, some clinics choose to treat all their patients with a sling, simultaneously. However, not all patients with SUI require surgery and the sling is associated with some risks, such as bleeding and bladder injury. There is no international consensus on the use of mid-urethral slings in women undergoing genital prolapse surgery. Thus, there is great need for knowledge and know-how regarding the mechanism of continence in women with genital prolapse, before and after surgery.

The hypothesis is that UPR may be used to uncover the changes in the female urethra before and after genital prolapse surgery, revealing significant differences in the parameters in women who develop SUI after surgery. UPR may become an important tool in the preoperative assessment, helping clinicians give better information and guidance to their patients.

Conditions

  • Genital Prolapse

Sponsors & Collaborators

  • Herlev Hospital

    lead OTHER

Principal Investigators

  • Niels Klarskov, MD Lecturer · University of Copenhagen, Department of Gynaecology and Obstetrics, Herlev Hospital, Denmark

  • Yasmine SS Khayyami, MD · University of Copenhagen, Department of Gynaecology and Obstetrics, Herlev hospital, Denmark

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2015-09-30
Completion
2016-09-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02050568 on ClinicalTrials.gov