Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201808641266843 Date of Approval: 28/08/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Prospective study to evaluate use of TephaFLEX sling implanted via a retropubic mid-urethral sling procedure for treatment of women with stress urinary incontinence
Official scientific title Prospective study to evaluate use of TephaFLEX sling implanted via a retropubic mid-urethral sling procedure for treatment of women with stress urinary incontinence
Brief summary describing the background and objectives of the trial 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-premanent meshes may be associated with fewer complications and better quality of life. However, before non-premanent and permanent mesh procedures can be compared, there is a need to first establish the feasibility of using a resobable mesh in a mid-urethral sling procedure. We 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). The overall objective of this study is to determine the preliminary safety and efficacy of resorbable TephaFLEX sling implanted via a retropubic procedure to treat SUI.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Stress Urinary Incontinence
Purpose of the trial Treatment: Devices
Anticipated trial start date 21/06/2018
Actual trial start date 21/06/2018
Anticipated date of last follow up 20/06/2019
Actual Last follow-up date 20/06/2018
Anticipated target sample size (number of participants) 25
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group TephaFlex resorbable sling not applicable not applicable TephaFLEX sling, manufactured by Tepha, Inc., will be implanted via a retropubic mid-urethral sling procedure for treatment of women with stress urinary incontinence. The product is supplied as a sterile, single -use device. One device will be utilized per patient. TephaFLEX sling, developed specifically for treatment of stress urinary incontinence, is a single layer, bioresorbable, mesh made from poly-4-hydroxybutyrate (P4HB) monofilament fiber. The mesh is constructed as a 11mm x 60cm tape with an open pore structure (see image below), and is enclosed in a polyethylene sleeve to ease insertion. The mesh was designed specifically to provide strength over the three-month critical wound healing period in soft tissue repair and reinforcement, and to encourage the proliferation of healthy tissue at the repair site. The product undergoes a gradual loss of strength after implantation and is essentially resorbed by 18 – 24 months. 0 Uncontrolled
Experimental Group TephaFlex resorbable sling Not applicable Not Applicable Patients with SUI will be operated withe Tephaflex resorbable sling. 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
To be eligible for enrollment, the subject must: 1. Be female, = 18 years of age 2. Female symptomatic (moderate or severe) SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). 3. 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. 4. 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 1. Subjects who have mixed or urge incontinence 2. Subjects who have stage 2 or more genital prolapse, according to the ICS classification 3. Subjects with previous surgery for SUI 4. Subjects who undergo concomitant surgical procedures 5. Subjects who are pregnant or want to become pregnant in the next 24 months 6. Subjects who are not capable of giving informed consent 7. Subjects with a BMI = 35 kg/m2 8. Subjects diagnosed with a current urinary tract infection or chronic urinary tract infections (defined as 4 or more UTI in the last year) 9. Subjects with known sensitivity to tetracycline or kanamycin Adult: 19 Year-44 Year 18 Year(s) 80 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/06/2018 Human Research Ethics Committee UCT
Ethics Committee Address
Street address City Postal code Country
Floor E53, Room 46 Old Main Building Groote Schuur Hospital Observatory, 7925 Cape Town 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Preliminary effectiveness will be assessed by examining: • # of patients that exhibit subjective cure based on PGI-I questionnaire at 4-6 weeks, 3, 6, 12 and 24 months; • # of patients that exhibit objective cure based on Cough Stress Test at 4-6 weeks, 3, 6, 12 and 24 months; • Sandvik scores at 4-6 weeks, 3, 6, 12 and 24 months • Collecting quality of life scores using IIQ-7 and UDI-6 questionnaires at 4-6 weeks, 3, 6, 12 and 24 months • Collecting quality of life scores using PISQ-IR questionnaire at 3, 6, 12 and 24 months Safety assessments will include: • Number of device- or procedure-related adverse events will be collected on a continual basis and summarized at each of the following timepoints: 4-6 weeks, 3, 6, 12, and 24 months after the procedure. Additional measures: • Collection of operation characteristics (i.e. duration, anesthesia); • Collection of rate and time of duration of catheter use after the operation 4-6 weeks, 3 months, 6 months, 12 months, and 24 months.
Primary Outcome 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. All pelvic floor related adverse events will be collected and assessed for seriousness, severity, and relationship to device/procedure. Events will be classified as adverse events, serious adverse events, and major and minor complications. Major complications are classified as device and/or procedure related adverse events, and must be Dindo Grade III or higher. The use of UroFLEX sling implanted via a retropubic mid-urethral sling procedure is considered to be safe when in the first six months following implantation: 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%). The type and nature of the SAE(s) will be examined by a Data Monitoring Committee prior to the determination of safety of the device 4-6 weeks, 3months, 6 months, 12 months, 18 months , 24 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Groote Schuur Hospital Gynaecology Out Patient Department Main Road, Observatory Cape Town 8000 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Pelvic Floor Foundation of South Africa NPC suite 1203, Netcare Chris Barnard Memorial Hospital, Foreshore Cape Town 8001 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Pelvic Floor Foundation of South Africa Suite 1203, Netcare Chris Barnard Memorial Hospital, Foreshore, Cape Town 8001 South Africa Charities/Societies/Foundation
Secondary Sponsor University of Cape Town Department of Obstetrics and Gynaecology, Old Main Building, Groote Schuur Hospital, Observatory Cape Town 8001 South Africa University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Stephen Jeffery Stephen.jeffery@uct.ac.za +27731109749 Suite 1203, Netcare Chris Barnard Hospital, Foreshore
City Postal code Country Position/Affiliation
Cape Town 8001 South Africa HOD Urogynaecology Department of Obstetrics and Gynaecology
Role Name Email Phone Street address
Scientific Enquiries Erika Drewes erika.drewes@uct.ac.za +27825518440 Suite 1201, Netcare Chris Barnard Memorial Hospital, Foreshore
City Postal code Country Position/Affiliation
Cape Town 8001 South Africa Coordinator
Role Name Email Phone Street address
Public Enquiries Leigh Anne Davids leigh-anne@pffsa.org 0744358753 Suite 1203, Netcare Chris Barnard Hospital, Foreshore
City Postal code Country Position/Affiliation
Cape Town 8001 South Africa Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information