Surgical Management for Suburethral Slings

Prospective, Non-Randomized, Observational Trial of the Surgical Management for Suburethral Slings in Women With Stress Urinary Incontinence

This is a prospective, non-randomized, observational, single center study in which subjects that have surgically-correctable Stress Urinary Incontinence undergo a suburethral sling operative procedure.

Study Overview

• Status: Recruiting
• Conditions: Stress Urinary Incontinence

Detailed Description

The study will collect preoperative urologic testing, medical history, and subject quality of life patient questionnaires. Intraoperative procedural data will be collected.

Postoperative complications, urologic, testing, and subject questionnaires will be collected at intervals. The anatomic position of the device will be characterize by introital ultrasound testing.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Volker Viereck, Physican; Phone Number: ++41 52 723 70 50; Email: volker.viereck@stgag.ch
• Study Contact Backup: Name: Oliver Rautenberg, Physican; Phone Number: ++41 52 723 77 45; Email: oliver.rautenberg@stgag.ch

Study Locations

• Switzerland
  • Thurgau
    • Frauenfeld, Thurgau, Switzerland, 8501
      • Recruiting
      • Blasenzentrum, Cantonal Hospital
      • Contact: Volker VV Viereck, Physican; Phone Number: ++41 52 723 70 50; Email: volker.viereck@stgag.ch
      • Contact: Oliver OR Rautenberg, Physican; Phone Number: ++41 52 723 75 45; Email: oliver.rautenberg@stgag.ch
      • Principal Investigator: Volker VV Viereck, Physican
      • Sub-Investigator: Oliver OR Rautenberg, Physican

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Subjects that have surgically-correctable Stress Urinary Incontinence and undergo a suburethral sling operative procedure.

Description

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.
4. Patient is able to fill in all questionnaires (on judgement 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. The subject has current urinary tract infection.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Stress Urinary Incontinence; Females with stress urinary incontinence, who undergo a tension free surgical sling procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cure/improvement rate	Patients are classified as cured if the postoperative cough test (see Outcome 4 below) is negative and the degree of subjective suffering (see Outcome 2 below) improves to over 90% (VAS score of 0 or 1). Criteria for improvement are involuntary loss of only a few drops of urine during straining and an improvement of the degree of suffering to over 75% (VAS score of 2 or 3). All other patients are classified as therapeutic failures (even if they show marked improvement of one of the parameters compared with their preoperative status).	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective symptom assessment by visual analogue scale	Scale: 0-10 (0-no suffering, 10-severe suffering)	3 and 6 months
Post-Operative Pain Assessment	Scale: 0-10 (0-no pain, 10-severe pain)	1 day
Standing Cough Stress Test	3 categories: negative/severe, if flow of urine is observed. negative/mild, if the loss of only a few drops is observed. positive, if no urine loss occurs.	baseline, 3 and 6 months
King Health Questionnaire		pre-operation, 3 and 6 months
International Consultation on Incontinence Questionnaire		pre-operation, 3 and 6 months

Collaborators and Investigators

• Sponsor: Cantonal Hospital, Frauenfeld
• Investigators: Principal Investigator: Volker Viereck, Physican, Cantonal Hospital, Frauenfeld

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: May 19, 2016
• First Submitted That Met QC Criteria: May 26, 2016
• First Posted (Estimated): May 27, 2016

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Stress Urinary Incontinence; Suburethral Sling
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: TVT 3D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED