Urodynamic Stress IncontinenceNCT00843908
Tension Free Vaginal Tape (TVT) Versus the Miniarc Sling
A study testing Tension Free Vaginal Tape and Miniarc in people with Urodynamic Stress Incontinence, run by Medway NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The aim of this study is to assess whether the Miniarc suburethral sling is equivalent to the TVT in the treatment of women with urodynamic stress incontinence (USI). If equivalence is proven, the advantages to women with USI will be potentially significant since the Miniarc may be carried out as an office based… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Urodynamic Stress Incontinence
- What is being tested?
- Tension Free Vaginal Tape and Miniarc
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2008to Aug 2009
- Phase
- Interventional
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must be female
- Subjective evidence of stress predominant symptoms on symptom specific questionnaire
- Stress incontinence on urodynamics
- Patients who are capable of understanding and signing the written consent form for participation in the study
- Patients must have completed their family
- Patients must be capable of filling in the symptom diary and micturition diary
Who cannot join
- Patients who are medically unfit to undergo surgical intervention.
- Patients who have undergone previous continence surgery
- Prolapse beyond the introitus
- Patients with voiding dysfunction
- Patients with recurrent urinary tract infections
- Patients with haematuria of unknown origin or known bladder pathology
- Patients who are not sure that their family is complete
- Patients unwilling to use a safe method of contraception following the procedure
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Medway Maritime Hospital
Gillingham, Kent, ME7 5NY
About this study
Official title: A Randomized Study of the Treatment of Urodynamic Stress Incontinence: the Tension Free Vaginal Tape (TVT) Versus the Miniarc Sling.
The aim of this study is to assess whether the Miniarc suburethral sling is equivalent to the TVT in the treatment of women with urodynamic stress incontinence (USI). If equivalence is proven, the advantages to women with USI will be potentially significant since the Miniarc may be carried out as an office based procedure, negating the need for an anaesthetic and hospital admission. The investigators null hypothesis is that there is no difference in subjective or objective outcome between the TVT and the Miniarc in the treatment of USI.
Eligible women will be initially assessed with a full history and examination, King's Health Questionnaire and twin channel subtraction cystometry. They will be randomised (using a series of numbered opaque envelopes) to undergo either the TVT or Miniarc. Follow up will be at 6 weeks, with a subjective outcome measure and at 6 months with a repeat subjective assessment and repeat twin channel cystometry.
Read the detailed description
Description Randomised, prospective study. Objective and subjective outcomes to be evaluated 6 weeks an d6 months post-operatively.
Study population The number of patients enrolled in the study will be decided after consultation with a statistician.
All patients will be recruited from urogynaecology clinics at Medway Maritime Hospital. They will be female and have a urodynamic diagnosis of stress incontinence, having failed conservative management. Those deemed suitable for the TVT operation will be offered entry to the study.
Randomisation and blinding
Patients who have consented to take part in the study will be randomised to have either a conventional TVT (Group A) or a MiniArc (Group B). Each group will be run in parallel. Method of randomisation - consecutively numbered opaque envelopes detailing type of operation.
Patients will be blinded as to the type of tape used. Due to the obvious differences between the devices, it will not be possible to blind researchers to the type of tape.
Each patient will undergo a pre-operative assessment (which may be incorporated into the initial clinic visit), be admitted as an in-patient for the TVT/Mini-arc procedure, and attend a post-operative assessment visit. This last visit will be the exit point from the study. These are detailed below
Pre-operative Assessment
- Detailed symptom history and examination
- 3 day urinary diary
- King's Quality of Life questionnaire
- Dual channel normal saline subtracted cystometry at a filling rate of 50-100ml/min whilst supine and standing. 7F double lumen catheter used for all measurements
Surgical Technique
Group A will have the TVT inserted under spinal anaesthesia as described by Ulmsten12. Group B will have the MiniArc tape inserted under spinal anaesthesia. All procedures will be undertaken in an operating theatre environment, and carried out by Mr Duckett or a member of his team who has undergone appropriate training. Patients will be catheterised until 6 hours post-operatively. Those who void with a residual of less than 100mls will be discharged the day after the procedure.
Post-operative assessment
- Carried out at 6 weeks' post-operatively
- Symptoms assessed using 3 day urinary diary and Patient Global Impression of Improvement (PGI-I)
- King's quality of life questionnaire
- Repeat urodynamic studies as described previously, including voiding cystometry (6 months only)
- Any complications noted, e.g. readmission to hospital, UTI, voiding difficulties
- Patient satisfaction will be assessed using a 5 point scale at the follow up visit
- Conditions
- Urodynamic Stress Incontinence
- Being tested
- Tension Free Vaginal Tape, Miniarc
- Keywords
- Stress incontinence, Surgical Treatments, Minislings
- 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.
Tension Free Vaginal TapeDevice
Also called Advantage TVT, Boston Scientific
Tension Free Vaginal Tape inserted in the conventional manner in a theatre environment
MiniarcDevice
Also called Miniarc, American Medical Systems
The Miniarc suburethral sling will be inserted in the conventional manner in a theatre environment under general anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| TVT | Active comparator | Women in this arm will undergo the Tension Free Vaginal Tape procedure Receives: Device: Tension Free Vaginal Tape |
| Miniarc | Experimental | Women in this group will undergo the Miniarc suburethral sling procedure Receives: Device: Miniarc |
What is being measured
The primary outcome is the main question the study is designed to answer.
The absence of stress incontinence at 6 weeks ascertained by direct questioning and from the Kings Quality of life questionnaire and the absence at 6 months by the same criteria and by urodynamics.
Measured: 6 weeks and 6 months
Secondary outcomes (3)
Quality of life (as measured using the King's Health Questionnaire)
Measured: 6 weeks and 6 months
Intra-operative complications, e.g. bladder injury
Measured: Time of surgery
Post-operative voiding dysfunction
Measured: 0-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2009 (estimated)
- Study startFeb 2008
- Primary completionMar 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urodynamic Stress 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medway NHS Foundation Trust
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00843908
- Sponsor's protocol ID
- 07/H1101/112
- Status last verified
- Aug 2009
- First submitted
- 12 Feb 2009
- Last updated
- 27 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD008709. doi: 10.1002/14651858.CD008709.pub4.
PubMed 37888839
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of the Treatment of Urodynamic Stress Incontinence: the Tension Free Vaginal Tape (TVT) Versus the Miniarc Sling.
- ClinicalTrials.gov ID
- NCT00843908
- Acronym / sponsor ID
- 07/H1101/112
- Conditions
- Urodynamic Stress Incontinence
- Keywords
- Stress incontinence, Surgical Treatments, Minislings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Medway NHS Foundation TrustUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 13 Feb 2009 (estimated)
- 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.
The aim of this study is to assess whether the Miniarc suburethral sling is equivalent to the TVT in the treatment of women with urodynamic stress incontinence (USI). If equivalence is proven, the advantages to women with USI will be potentially significant since the Miniarc may be carried out as an office based procedure, negating the need for an anaesthetic and hospital admission. The investigators null hypothesis is that there is no difference in subjective or objective outcome between the TVT and the Miniarc in the treatment of USI.
Eligible women will be initially assessed with a full history and examination, King's Health Questionnaire and twin channel subtraction cystometry. They will be randomised (using a series of numbered opaque envelopes) to undergo either the TVT or Miniarc. Follow up will be at 6 weeks, with a subjective outcome measure and at 6 months with a repeat subjective assessment and repeat twin channel cystometry.
Detailed description
Description Randomised, prospective study. Objective and subjective outcomes to be evaluated 6 weeks an d6 months post-operatively.
Study population The number of patients enrolled in the study will be decided after consultation with a statistician.
All patients will be recruited from urogynaecology clinics at Medway Maritime Hospital. They will be female and have a urodynamic diagnosis of stress incontinence, having failed conservative management. Those deemed suitable for the TVT operation will be offered entry to the study.
Randomisation and blinding
Patients who have consented to take part in the study will be randomised to have either a conventional TVT (Group A) or a MiniArc (Group B). Each group will be run in parallel. Method of randomisation - consecutively numbered opaque envelopes detailing type of operation.
Patients will be blinded as to the type of tape used. Due to the obvious differences between the devices, it will not be possible to blind researchers to the type of tape.
Each patient will undergo a pre-operative assessment (which may be incorporated into the initial clinic visit), be admitted as an in-patient for the TVT/Mini-arc procedure, and attend a post-operative assessment visit. This last visit will be the exit point from the study. These are detailed below
Pre-operative Assessment
- Detailed symptom history and examination
- 3 day urinary diary
- King's Quality of Life questionnaire
- Dual channel normal saline subtracted cystometry at a filling rate of 50-100ml/min whilst supine and standing. 7F double lumen catheter used for all measurements
Surgical Technique
Group A will have the TVT inserted under spinal anaesthesia as described by Ulmsten12. Group B will have the MiniArc tape inserted under spinal anaesthesia. All procedures will be undertaken in an operating theatre environment, and carried out by Mr Duckett or a member of his team who has undergone appropriate training. Patients will be catheterised until 6 hours post-operatively. Those who void with a residual of less than 100mls will be discharged the day after the procedure.
Post-operative assessment
- Carried out at 6 weeks' post-operatively
- Symptoms assessed using 3 day urinary diary and Patient Global Impression of Improvement (PGI-I)
- King's quality of life questionnaire
- Repeat urodynamic studies as described previously, including voiding cystometry (6 months only)
- Any complications noted, e.g. readmission to hospital, UTI, voiding difficulties
- Patient satisfaction will be assessed using a 5 point scale at the follow up visit
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TVT | Active comparator | Device: Tension Free Vaginal TapeWomen in this arm will undergo the Tension Free Vaginal Tape procedure |
| Miniarc | Experimental | Device: MiniarcWomen in this group will undergo the Miniarc suburethral sling procedure |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must be female
- Subjective evidence of stress predominant symptoms on symptom specific questionnaire
- Stress incontinence on urodynamics
- Patients who are capable of understanding and signing the written consent form for participation in the study
- Patients must have completed their family
Key exclusion criteria (8 listed)
- Patients who are medically unfit to undergo surgical intervention.
- Patients who have undergone previous continence surgery
- Prolapse beyond the introitus
- Patients with voiding dysfunction
- Patients with recurrent urinary tract infections
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 |
|---|---|---|
| Tension Free Vaginal TapeAlso: Advantage TVT, Boston ScientificTension Free Vaginal Tape inserted in the conventional manner in a theatre environment | Device | TVT |
| MiniarcAlso: Miniarc, American Medical SystemsThe Miniarc suburethral sling will be inserted in the conventional manner in a theatre environment under general anaesthesia | Device | Miniarc |
Primary outcome
The absence of stress incontinence at 6 weeks ascertained by direct questioning and from the Kings Quality of life questionnaire and the absence at 6 months by the same criteria and by urodynamics.
Time frame: 6 weeks and 6 months
3 secondary outcomes
Quality of life (as measured using the King's Health Questionnaire)
Time frame: 6 weeks and 6 months
Intra-operative complications, e.g. bladder injury
Time frame: Time of surgery
Post-operative voiding dysfunction
Time frame: 0-6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2009.
- Derived from this study: PubMed 37888839Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD008709. doi: 10.1002/14651858.CD008709.pub4.
Related trials for Urodynamic Stress Incontinence
Not yet recruiting
Peri-Urethral Platelet-Rich Plasma Injections for Postmenopausal Female Stress Urinary Incontinence
Stress Urinary Incontinence
Recruiting
Does Use of a Pre-Procedure Educational Video for Urodynamic Testing Reduces Anxiety?
Urinary Incontinence, Urinary Bladder Overactive
Enrolling by invitation
Urethral Vascularization and Urodynamics
Stress Urinary Incontinence, Ultrasound
Recruiting
Impact of CMG vs VCMG in Recurrent Stress Incontinence- A Pilot Study
Stress Incontinence Female, Urodynamic Exam
Not yet recruitingObservational study
PFU vs. UDS in SUI
Stress Urinary Incontinence (SUI)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tension Free Vaginal Tape and Miniarc in people with Urodynamic Stress Incontinence, run by Medway NHS Foundation Trust at 1 site in United Kingdom.
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 27 Aug 2009. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The absence of stress incontinence at 6 weeks ascertained by direct questioning and from the Kings Quality of life questionnaire and the absence at 6 months by the same criteria and by urodynamics. (time frame: 6 weeks and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00843908, which also lists 1 linked publication.
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 27 Aug 2009.