Skip to main content
Clinical Trials/NCT02050568
NCT02050568UnknownNot Applicable

Measuring the Mechanism of Incontinence With Urethral Pressure Reflectometry, Before and After Genital Prolapse Surgery

Herlev Hospital1 site in 1 country60 target enrollmentStarted: October 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
60
Locations
1
Primary Endpoint
Changes in UPR parameters before and after surgery.

Study Overview

Brief 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.

Detailed Description

Aim of the project

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 has been validated and used in five DMSc and Ph.D. theses and stands alone in its field. (1-5)

A great percentage of women undergoing surgery for genital prolapse (characterized by a portion of the vaginal canal protruding from the opening of the vagina) develop SUI after surgery, researchers have yet to find the answer to why this occurs. Thus, there is a great need for knowledge regarding the mechanism of continence in women with genital prolapse.

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.

Background

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Women with anterior genital prolapse ≥ grade 2 (according to the pelvic-organ-prolapse quantification system (POP-Q) (19)), who are awaiting genital prolapse surgery
  • women with posterior genital prolapse ≥ grade 2 who are awaiting genital prolapse surgery,

Exclusion Criteria

  • Simultaneous prolapse ≥ grade 2 in the anterior or posterior part of the vagina
  • Former genital prolapse surgery
  • Former surgical removal of the uterus
  • Former surgical treatment of urinary incontinence
  • Neurological disorder
  • Bladder overactivity
  • Pregnancy
  • Women under the age of 18

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yasmine Sahar Sandra Khayyami

Medical Doctor, Ph.D. student

Herlev Hospital

Study Sites (1)

Loading locations...

Similar Trials