Mechanism of Incontinence Before and After Genital Prolapse Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02050568|
Recruitment Status : Unknown
Verified March 2015 by Yasmine Sahar Sandra Khayyami, Herlev Hospital.
Recruitment status was: Recruiting
First Posted : January 30, 2014
Last Update Posted : March 18, 2015
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.
|Condition or disease|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Measuring the Mechanism of Incontinence With Urethral Pressure Reflectometry, Before and After Genital Prolapse Surgery|
|Study Start Date :||October 2013|
|Estimated Primary Completion Date :||September 2015|
|Estimated Study Completion Date :||September 2016|
Anterior genital prolapse
Women with anterior genital prolapse ≥ grade 2, who are awaiting genital prolapse surgery.
Posterior genital prolapse
Women with posterior genital prolapse ≥ grade 2, who are awaiting genital prolapse surgery.
- Changes in UPR parameters before and after surgery. [ Time Frame: Before surgery and minimum 6 weeks postoperatively. ]The purpose is to see if and how the patients' parameters change after surgery.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02050568
|Contact: Niels Klarskov, MD Lecturer||0045 38 68 14 email@example.com|
|Contact: Yasmine SS Khayyami, MD||0045 26 96 72 firstname.lastname@example.org|
|Department of Gynaecology and Obstetrics, Herlev Hospital||Recruiting|
|Herlev, Denmark, 2730|
|Study Director:||Niels Klarskov, MD Lecturer||University of Copenhagen, Department of Gynaecology and Obstetrics, Herlev Hospital, Denmark|
|Principal Investigator:||Yasmine SS Khayyami, MD||University of Copenhagen, Department of Gynaecology and Obstetrics, Herlev hospital, Denmark|