Urethral Length Measurement in Women Undergoing Suburethral Sling Operative Procedure

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01660438

Enrollment

188

Registered

2012-08-08

Start date

2010-08-31

Completion date

2013-02-28

Last updated

2016-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Urinary Incontinence

Keywords

Stress urinary incontinence, Suburethral sling

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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 Institutional Review Board/Ethics Committee-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.

Design outcomes

Primary

Measure	Time frame	Description
Cure rate	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

Measure	Time frame	Description
Pelvic floor sonography	Pre-operation, day 1 and 3 months	—
Residual urine	Pre-operation, day 1 and 3 months	—
Pad test	Pre-operation and 3 months	—
Urethral length measurement	Intra-operation	Urethral length will be measured using scaled catheters.

Countries

Germany, Poland, Switzerland

Outcome results