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Completed

NCT Number: NCT01660438

Urethral Length Measurement in Women Undergoing Suburethral Sling Operative Procedure

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Department of Gynecology and Obstetrics, Lutheran Hospital Hagen-Haspe, Hagen, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Patient is age 18 or older.
  • Patient agrees to participate in the study, including completion of all study-related procedures and evaluations, and documents this agreement by signing the Institutional Review Board/Ethics Committee-approved informed consent form.
  • Patient is able to fill in all questionnaires (based on judgment of investigator)

Exclusion criteria

  • Patient has an associated or suspected neurological disease.
  • Patient has an active lesion or present injury to perineum or urethra.
  • Patient has a urethral obstruction.
  • Patient has significant pelvic organ prolapse (Grade III/IV) requiring surgical treatment.
  • Patient has current urinary tract infection.

Treatment and study plan

Primary outcomes

  1. Cure rate

    Time frame: 3 months

    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 outcomes

  1. Pelvic floor sonography

    Time frame: Pre-operation, day 1 and 3 months

  2. Residual urine

    Time frame: Pre-operation, day 1 and 3 months

  3. Pad test

    Time frame: Pre-operation and 3 months

  4. Urethral length measurement

    Time frame: Intra-operation

    Urethral length will be measured using scaled catheters.

Sponsors and collaborators

Lead sponsor

Cantonal Hospital, Frauenfeld

Other

Registry information

Official study title

Prospective, Non-randomized, Observational Study of the Surgical Management of Suburethral Slings in Women With Stress Urinary Incontinence

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Aug 8, 2012
Registry last updated
May 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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