Urethral Length and TOT (Transobturator Tape) Positioning

NCT01753011 | Completed DMC

• 1 other identifier: TOT 1/2-Rule
• Study Type: observational
• Target: 123
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Stress Urinary Incontinence

Keywords

Stress urinary Incontinence; Transobturator sling; TOT

Outcome Measures

Primary Outcomes (1)

• Cure rate

  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.

  6 months postoperative

Secondary Outcomes (5)

• Urethral length

  Preoperative

• Linear urethral dorsocaudal movement (LUDM)

  Preoperative

• Urethral tape position

  1-3 days and 6 months postoperative

• Distance between tape and longitudinal smooth muscle (LSM) complex

  1-3 days and 6 months postoperative

• Urodynamic testing

  Preoperative

Study Arms (1)

Stress Urinary Incontinence

Stress Urinary Incontinence

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population includes women with surgically-corrected stress urinary incontinence who undergo a TOT operative procedure.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cantonal Hospital, Frauenfeld: lead

Study Sites (2)

Department of Gynecology and Obstetrics, Lutheran Hospital Hagen-Haspe

Hagen, Germany

Location

Blasenzentrum, Cantonal Hospital

Frauenfeld, Thurgau, Switzerland

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

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

Study Officials

• Volker Viereck, Prof. Dr.

  Cantonal Hospital, Frauenfeld

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Volker Viereck

Study Record Dates

• First Submitted: December 17, 2012
• First Posted: December 19, 2012
• Study Start: May 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: March 7, 2024

Record last verified: 2024-03

Locations

DE (1); CH (1)