To Evaluate the Use of Bioresorbable Tephaflex™ Sling for Stress Urinary Incontinence

NCT03673488 | Unknown DMC

• 1 other identifier: URO001
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Urinary incontinence (UI) is a major public health issue affecting up to 25-50% of all women and has a detrimental impact on patient quality of life. Stress urinary incontinence (SUI) is the most common form of urinary incontinence and is defined as the leakage of urine, which occurs during physical activity of exertion or on sneezing or coughing. It has been reported that the prevalence of SUI is 25 to 45% of the female population. If pelvic floor exercises are not effective, mid-urethral slings (MUS) are widely used as a first-line surgical treatment. Subjective and objective cure rates of 91% and 85% respectively have been reported for retropubic midurethral slings. Midurethral slings are commonly made of polypropylene (PP). Although the polypropylene products are effective and have relatively low rates of adverse events, the adverse events that do occur, like exposure and pain, have been related to the fact that a permanent synthetic mesh is implanted. Mesh-related complications are difficult to manage and may even involve partial or complete removal of the implant. Clinically, there is a need to investigate whether mid-urethral sling surgery can be performed with a non-permanent mesh made from a resorbable biomaterial, as an alternative for PP. Non-permanent meshes may be associated with fewer complications and better quality of life. However, before non-permanent and permanent mesh procedures can be compared, there is a need to first establish the feasibility of using a mesh in a mid-urethral sling procedure. The investigators hypothesize that a retropubic mid-urethral sling procedure to treat stress urinary incontinence, can be successfully performed using an implant made of poly-4-hydroxybutyrate (P4HB).

Conditions

Stress Urinary Incontinence

Keywords

Incontinence

Outcome Measures

Primary Outcomes (1)

• Device safety will be established by measuring the incidence of treatment-emergent adverse events.

  The retropubic mid-urethral sling procedure using UroFLEX sling is considered to be safe at 6 months after implantation if the number of serious adverse events comply with safety standards as defined by the safety criteria outlined below and analyzed using sequential analysis. The device will be considered safe at A) a maximum of 3 of the first 5 patients experience a device or procedure-related SAE (60%); B) a maximum of 5 of the first 10 patients experience a device or procedure-related SAE (50%); C) a maximum of 7 of the first 20 patients experience a device or procedure-related SAE (35%); D) a maximum of 8 of the first 25 patients experience a device or procedure-related SAE (32%).

  2 years

Secondary Outcomes (5)

• Objective cure measurement using Cough Stress Test

  Measured at enrolment, 4-6 weeks, 3, 6, 12 and 24 months post procedure (2 years total)

• Subjective cure with PGI-I questionnaire Patient Global Impression of Improvement

  Administered at 4-6 weeks, 3, 6, 12 and 24 months post procedure (2 years total)

• Subjective cure with Sandvik scores (Incontinence severity index)

  Administered at 4-6 weeks, 3, 6, 12 and 24 months post procedure (2 years in total)

• Subjective cure with PISQ-IR- Sexual Function for Women with Pelvic Organ Prolapse, Urinary Incontinence and / or Fecal Incontinence questionnaire

  Administered at 4-6 weeks, 3, 6,12,24 months post procedure (2 years in total)

• Subjective cure with Urogenital Distress Inventory (UDI-6)

  Administered at 4-6 weeks, 3,6,12 and 24 months post procedure ( 2 years in total)

Study Arms (1)

TephaFlex™ mid-urethral sling for SUI

P4HB material ( TephaFlex ™) will be implanted in 25 women with confirmed Stress Urinary Incontinence (SUI).

Device: TephaFlex™ mid-urethral sling

Interventions

TephaFlex™ mid-urethral sling DEVICE

The sling is made from P4HB material. It is placed in a similar technique to standard retropubic sling procedures, but will resorb over 18-24 months post surgery.

Also known as: P4HB mid-urethral bioresorbable sling

TephaFlex™ mid-urethral sling for SUI

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population are eligible women, older than 18 years of age, with demonstrable stress urinary incontinence who present to the Out-Patient Department for Urogynaecology at Groote Schuur Hospital in Cape Town South Africa. Groote Schuur Hospital is a tertiary academic hospital and serves the city of Cape Town and surrounds.

You may qualify if:

• Be female, = 18 years of age
• Female symptomatic (moderate or severe) SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).
• Patients who have planned to undergo surgical correction of symptomatic SUI after consultation with their physician about the risks and benefits of such a procedure, and a determination by the physician that surgical treatment is the most appropriate treatment option for the patient.
• Understand and be willing to follow all aspects of the study protocol and have signed and dated the EC-approved Informed Consent prior to any study-related procedures being performed

You may not qualify if:

• Subjects who have mixed or urge incontinence
• Subjects who have stage 2 or more genital prolapse, according to the ICS classification
• Subjects with previous surgery for SUI
• Subjects who undergo concomitant surgical procedures
• Subjects who are pregnant or want to become pregnant in the next 24 months
• Subjects who are not capable of giving informed consent
• Subjects with a BMI = 35 kg/m2
• Subjects diagnosed with a current urinary tract infection or chronic urinary tract infections (defined as 4 or more UTI in the last year)
• Subjects with known sensitivity to tetracycline or kanamycin

Sponsors & Collaborators

• Pelvic Floor Research Foundation of South Africa: lead
• University of Cape Town: collaborator

Study Sites (1)

Groote Schuur Academic Hospital

Cape Town, Western Cape, South Africa

RECRUITING

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

• Jan-Paul Roovers, MD

  Pelvic Floor Research Foundation of South Africa

  STUDY CHAIR

Central Study Contacts

Erika M Drewes, MbChB

CONTACT

+27825518440; erika.drewes@uct.ac.za

Stephen T Jeffery, MbChB

CONTACT

stephen.jeffery@ac.za

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2018
• First Posted: September 17, 2018
• Study Start: June 22, 2018
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: September 17, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)