Mechanism of Incontinence Before and After Genital Prolapse Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Herlev Hospital
Sponsor:
Information provided by (Responsible Party):
Yasmine Sahar Sandra Khayyami, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT02050568
First received: January 29, 2014
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

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
Genital Prolapse

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Measuring the Mechanism of Incontinence With Urethral Pressure Reflectometry, Before and After Genital Prolapse Surgery

Resource links provided by NLM:


Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • Changes in UPR parameters before and after surgery. [ Time Frame: Before surgery and minimum 6 weeks postoperatively. ] [ Designated as safety issue: No ]
    The purpose is to see if and how the patients' parameters change after surgery.


Estimated Enrollment: 60
Study Start Date: October 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The suitable women are invited to volunteer at the outpatient clinic, at the Department of Gynaecology, at Herlev hospital.

Criteria

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

or

- 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02050568

Contacts
Contact: Niels Klarskov, MD Lecturer 0045 38 68 14 06 niels.klarskov@regionh.dk
Contact: Yasmine SS Khayyami, MD 0045 26 96 72 26 yasmine.khayyami@regionh.dk

Locations
Denmark
Department of Gynaecology and Obstetrics, Herlev Hospital Recruiting
Herlev, Denmark, 2730
Sponsors and Collaborators
Herlev Hospital
Investigators
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
  More Information

Publications:

Responsible Party: Yasmine Sahar Sandra Khayyami, Medical Doctor, Ph.D. student, Herlev Hospital
ClinicalTrials.gov Identifier: NCT02050568     History of Changes
Other Study ID Numbers: H-4-2013-069
Study First Received: January 29, 2014
Last Updated: January 31, 2014
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Herlev Hospital:
Genital prolapse
Genital prolapse surgery
Stress urinary incontinence
Reflectometry

Additional relevant MeSH terms:
Prolapse
Genital Diseases, Female
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 11, 2014