Stress Urinary IncontinenceTephaflexNCT03673488
To Evaluate the Use of Bioresorbable Tephaflex™ Sling for Stress Urinary Incontinence
An observational study of Stress Urinary Incontinence, run by Pelvic Floor Research Foundation of South Africa at 1 site in South Africa.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- TephaFlex™ mid-urethral sling
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteSouth Africa
- Study dates
- 22 Jun 2018to Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Stephen T Jeffery, MbChB contact
South Africa1 site, 1 recruiting
- Recruiting
Groote Schuur Academic Hospital
Cape Town, Western Cape
Erika Drewes, MbCHB, +275518440, erika.drewes@uct.ac.za
Stephen Jeffery, MbChB, stephen.jeffery@uct.ac.za
About this study
Official 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
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.
Read more
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).
Read the detailed description
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.
Prospective, observational single-center study with a follow-up of 24 months post-surgery. Up to 25 patients will be recruited at Groote Schuur Hospital Urogynecology Out-Patient Department. Eligible patients will receive a retropubic surgical producedure where a TephaFLEX sling, composed of the resorbable material P4HB, is placed. After the surgical procedure, follow-up visits are scheduled at 4-6 weeks, 3 months (+/- 2 weeks), 6 months (+/- 2 weeks), 12 months (+/- 1 month), and 24 months (+/- 1 month) post-procedure. 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, 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.
- Conditions
- Stress Urinary Incontinence
- Being tested
- TephaFlex™ mid-urethral sling
- Keywords
- Incontinence
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TephaFlex™ mid-urethral slingDevice
Also called P4HB mid-urethral bioresorbable sling
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.
| Study group | Role | What they receive |
|---|---|---|
| TephaFlex™ mid-urethral sling for SUI | P4HB material ( TephaFlex ™) will be implanted in 25 women with confirmed Stress Urinary Incontinence (SUI). Receives: Device: TephaFlex™ mid-urethral sling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%).
Measured: 2 years
Secondary outcomes (5)
Objective cure measurement using Cough Stress Test
Preliminary effectiveness will be assessed by measuring the number of patients that exhibit objective cure based on Cough Stress Test
Measured: 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
Number of patients that exhibit subjective cure based on PGI-I questionnaire.
Measured: Administered at 4-6 weeks, 3, 6, 12 and 24 months post procedure (2 years total)
Subjective cure with Sandvik scores (Incontinence severity index)
Number of patients showing subjective cure on Sandvik scores questionnaire
Measured: 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
Number of patients showing subjective cure using the PISQ-IR questionairre as measurement
Measured: Administered at 4-6 weeks, 3, 6,12,24 months post procedure (2 years in total)
Subjective cure with Urogenital Distress Inventory (UDI-6)
Number of patients showing subjective cure using the UDI-6
Measured: Administered at 4-6 weeks, 3,6,12 and 24 months post procedure ( 2 years in total)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start22 Jun 2018
- Primary completionAug 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pelvic Floor Research Foundation of South Africa
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cape Town
- Responsible party
- Sponsor
- Investigators
- Jan-Paul Roovers, MD, Study chair, Pelvic Floor Research Foundation of South Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03673488
- Sponsor's protocol ID
- URO001
- Acronym
- Tephaflex
- Status last verified
- Sep 2018
- First submitted
- 3 Sep 2018
- Last updated
- 17 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03673488
- Acronym / sponsor ID
- Tephaflex / URO001
- Conditions
- Stress Urinary Incontinence
- Keywords
- Incontinence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Pelvic Floor Research Foundation of South AfricaUniversity, hospital or other
- Collaborators
- University of Cape Town
- Study start
- 22 Jun 2018 (actual)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 17 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Prospective, observational single-center study with a follow-up of 24 months post-surgery. Up to 25 patients will be recruited at Groote Schuur Hospital Urogynecology Out-Patient Department. Eligible patients will receive a retropubic surgical producedure where a TephaFLEX sling, composed of the resorbable material P4HB, is placed. After the surgical procedure, follow-up visits are scheduled at 4-6 weeks, 3 months (+/- 2 weeks), 6 months (+/- 2 weeks), 12 months (+/- 1 month), and 24 months (+/- 1 month) post-procedure. 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, 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TephaFlex™ mid-urethral sling for SUI | – | Device: TephaFlex™ mid-urethral slingP4HB material ( TephaFlex ™) will be implanted in 25 women with confirmed Stress Urinary Incontinence (SUI). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TephaFlex™ mid-urethral slingAlso: P4HB mid-urethral bioresorbable slingThe 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. | Device | TephaFlex™ mid-urethral sling for SUI |
Primary outcome
Device safety will be established by measuring the incidence of treatment-emergent adverse events.
Time frame: 2 years
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%).
5 secondary outcomes
Objective cure measurement using Cough Stress Test
Time frame: 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
Time frame: Administered at 4-6 weeks, 3, 6, 12 and 24 months post procedure (2 years total)
Subjective cure with Sandvik scores (Incontinence severity index)
Time frame: 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
Time frame: Administered at 4-6 weeks, 3, 6,12,24 months post procedure (2 years in total)
Subjective cure with Urogenital Distress Inventory (UDI-6)
Time frame: Administered at 4-6 weeks, 3,6,12 and 24 months post procedure ( 2 years in total)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen T Jeffery, MbChB contact
Jan-Paul Roovers, MD study chair
Pelvic Floor Research Foundation of South Africa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Urinary Incontinence, run by Pelvic Floor Research Foundation of South Africa at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erika M Drewes, MbChB (+27825518440, erika.drewes@uct.ac.za), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device safety will be established by measuring the incidence of treatment-emergent adverse events. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2018.