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NCT Number: NCT01753011

Urethral Length and TOT (Transobturator Tape) Positioning

This is a prospective, observational, multicenter study of women with surgically-correctable stress urinary incontinence who undergo a TOT-sling operative procedure.

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Key information

Conditions

Stress Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–99 year

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, observational, multicenter study of women with surgically-correctable stress urinary incontinence who undergo a TOT-sling operative procedure. Data will be collected from preoperative urogynecological testing and medical histories. Outcome data will be collected 1-3 days and 6 months after procedure.

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 (IRB)/Ethic commission (EC)-approved informed consent.
  • Patient is able to fill in all questionnaires (on judgement 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 currently has an urinary tract infection.

Treatment and study plan

Primary outcomes

  1. Cure rate

    Time frame: 6 months postoperative

    The primary outcome of the TOT procedure will be assessed using a combination of objective and subjective criteria. Patients with a negative stress test, a negative 1-h pad test (less than 2 g) and the degree of subjective suffering improving to over 90% (VAS score of 0-1) at 6 months follow-up evaluation are classified as cured. All other patients are classified as treatment failure even if one aspect shows marked improvement from the preoperative condition.

Secondary outcomes

  1. Urethral length

    Time frame: Preoperative

    Urethral length will be measured by pelvic floor sonography.

  2. Linear urethral dorsocaudal movement (LUDM)

    Time frame: Preoperative

    Linear urethral dorsocaudal movement (LUDM) will be assessed by pelvic floor sonography.

  3. Urethral tape position

    Time frame: 1-3 days and 6 months postoperative

    The position of the TOT along the urethra will be determined by pelvic floor sonography and expressed as percentage of urethral length.

  4. Distance between tape and longitudinal smooth muscle (LSM) complex

    Time frame: 1-3 days and 6 months postoperative

    To characterize the location of the TOT, the shortest distance between the tape and the longitudinal smooth muscle (LSM) complex of the urethra will be measured by pelvic floor sonography.

  5. Urodynamic testing

    Time frame: Preoperative

    Urodynamic testing will be performed only for patients undergoing recurrent incontinence surgery.

Sponsors and collaborators

Lead sponsor

Cantonal Hospital, Frauenfeld

Other

Registry information

Official study title

Prospective, Observational Study: Can Pelvic Floor Ultrasound Help to Optimize TOT (Transobturator Tape) Positioning?

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Dec 19, 2012
Registry last updated
Mar 7, 2024

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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