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Urethral Length Measurement in Women Undergoing Suburethral Sling Operative Procedure

This study is currently recruiting participants.
Verified February 2013 by Cantonal Hospital, Frauenfeld
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Volker Viereck, Cantonal Hospital, Frauenfeld
ClinicalTrials.gov Identifier:
NCT01660438
First received: August 6, 2012
Last updated: February 15, 2013
Last verified: February 2013
History of Changes
  Purpose

This is a prospective, non-randomized, observational, multicenter study in which urethral length is measured in women with surgically-correctable stress urinary incontinence who undergo a suburethral sling operative procedure.


Condition
Stress Urinary Incontinence

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Non-randomized, Observational Study of the Surgical Management of Suburethral Slings in Women With Stress Urinary Incontinence

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cantonal Hospital, Frauenfeld:

Primary Outcome Measures:
  • Cure rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Patients are classified as 'cured' if the postoperative cough test is negative, the 1-hour pad test is negative (less than 2 g) and the degree of subjective suffering improves to over 90% (VAS score of 0 or 1). All other patients are classified as therapeutic 'failures', even though they may experience marked improvement in one of the parameters compared with their preoperative status.


Secondary Outcome Measures:
  • Pelvic floor sonography [ Time Frame: Pre-operation, day 1 and 3 months ] [ Designated as safety issue: No ]
  • Residual urine [ Time Frame: Pre-operation, day 1 and 3 months ] [ Designated as safety issue: No ]
  • Pad test [ Time Frame: Pre-operation and 3 months ] [ Designated as safety issue: No ]
  • Urethral length measurement [ Time Frame: Intra-operation ] [ Designated as safety issue: No ]
    Urethral length will be measured using scaled catheters.


Estimated Enrollment: 400
Study Start Date: August 2010
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Stress urinary incontinence
Stress urinary incontinence

Detailed Description:

This is a prospective, non-randomized, observational, multicenter study in which urethral length is measured in women with surgically-correctable stress urinary incontinence who undergo a suburethral sling operative procedure. Data will be collected from preoperative urogynecological testing and medical histories. The urethral length will be measured intraoperatively using scaled catheters. Outcome data, including the development of postoperative complications, will be collected at several time intervals.

  Eligibility

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

Women who have surgically-correctable stress urinary incontinence and undergo a suburethral sling operative procedure.

Criteria

Inclusion Criteria:

  1. Patient has objective, demonstrable signs of stress urinary incontinence (SUI), including patients with intrinsic sphincter deficiency (ISD). Objective testing includes: standing stress test, urodynamics evaluation or pad test.
  2. Patient is age 18 or older.
  3. Patient agrees to participate in the study, including completion of all study-related procedures and evaluations, and documents this agreement by signing the IRB/EC-approved informed consent form.
  4. Patient is able to fill in all questionnaires (based on judgment of investigator)

Exclusion Criteria:

  1. Patient has an associated or suspected neurological disease.
  2. Patient has an active lesion or present injury to perineum or urethra.
  3. Patient has a urethral obstruction.
  4. Patient has significant pelvic organ prolapse (Grade III/IV) requiring surgical treatment.
  5. Patient has current urinary tract infection.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01660438

Contacts
Contact: Volker Viereck, Prof. Dr. ++41 52 723 70 50 volker.viereck@stgag.ch
Contact: Oliver Rautenberg, Dr. med. ++41 52 723 77 45 oliver.rautenberg@stgag.ch

Locations
Germany
Department of Gynecology and Obstetrics, Lutheran Hospital Hagen-Haspe Recruiting
Hagen, Germany
Contact: Jacek Kociszewski, Dr. med.         kociszewski@evk-haspe.de    
Principal Investigator: Jacek Kociszewski, Dr. med.            
Poland
Szpital im M. Madurowicza Recruiting
Lodz, Poland
Contact: Grzegorz Surkont, dr n. med.         surkontg@gmail.com    
Principal Investigator: Grzegorz Surkont, dr n. med.            
Switzerland
Blasenzentrum, Cantonal Hospital Recruiting
Frauenfeld, Thurgau, Switzerland
Contact: Volker Viereck, Prof. Dr.     ++41 52 723 70 50     volker.viereck@stgag.ch    
Contact: Oliver Rautenberg, Dr. med.     ++41 52 723 75 45     oliver.rautenberg@stgag.ch    
Principal Investigator: Volker Viereck, Prof. Dr.            
Sub-Investigator: Oliver Rautenberg, Dr. med.            
Sponsors and Collaborators
Cantonal Hospital, Frauenfeld
Investigators
Principal Investigator: Volker Viereck, Prof. Dr. Cantonal Hospital, Frauenfeld
  More Information

No publications provided

Responsible Party: Prof. Dr. Volker Viereck, Cantonal Hospital, Frauenfeld
ClinicalTrials.gov Identifier: NCT01660438     History of Changes
Other Study ID Numbers: TVT 112010
Study First Received: August 6, 2012
Last Updated: February 15, 2013
Health Authority: Switzerland: Swissmedic

Keywords provided by Cantonal Hospital, Frauenfeld:
Stress urinary incontinence
Suburethral sling

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
 Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013