Female Stress IncontinencePhase 1SITOTNCT01230450
Feasibility of Comparing Two Surgical Treatment of Female Urodynamic Stress
A Phase 1 study testing sub-urethral tape (TVT-O) and stand standard mid-urethral sling (TVT-O) in people with Female Stress Incontinence, run by University of Aberdeen at 1 site in United Kingdom.
Trial summary
Aim: The study aim to assess the feasibly a large prospective multi-centre randomised study for comparing the relatively new "Single incision sub-urethral tapes" with the standard surgical treatment of female urodynamic stress incontinence (USI). Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Female Stress Incontinence
- What is being tested?
- sub-urethral tape (TVT-O) and stand standard mid-urethral sling (TVT-O)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2009to Oct 2011
- Phase
- Phase 1
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- USI
- Mixed incontinence symptoms with predominantly bothering stress component (No DO on UDS).
- Primary Incontinence Surgery.
- BMI < 35
- Ability to understand the information leaflet and sign an informed consent form in English.
- All would have had failed or declined PFMT.
Who cannot join
- Mixed incontinence with pre-dominant OAB and/or Neurological conditions e.g. MS.
- Detrusor Overactivity on Urodynamics.
- Inability to understand English.
- Un-willing for randomisation.
- Concomitant surgery.
- Patient requiring postoperative hospital-stay for medical or social reasons
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
(Grampian) Aberdeen Royal Infermary
Aberdeen, Aberdeenshire, AB25 2ZD
About this study
Official title: Feasibility of Comparing Two Surgical Treatment of Female Urodynamic Stress Incontinence (SITOT)
Aim: The study aim to assess the feasibly a large prospective multi-centre randomised study for comparing the relatively new "Single incision sub-urethral tapes" with the standard surgical treatment of female urodynamic stress incontinence (USI).
Read the detailed description
Single incision tension-free sub-urethral vaginal tapes procedures8 have been recently described in an attempt to avoid the blind passage of the trochars through the groin \& the adductor muscles and consequently reducing the incidence \& severity of postoperative leg pain. The obvious advantages would be shorter hospital stay, early recovery, early resumption of day to day activities \& earlier return to work. A number of small prospective audits and case-series have been presented in international conferences reporting on the safety \& outcomes for these procedures. However all these studies were for preliminary reports for proof of concept and therefore the studies populations were 15-70 women with short term follow-up of 2-3 month9-11.These studies have shown low perioperative complication rates: bladder injury 0-1%, vaginal erosion 1-3% \& one study showing 1.3% pain at 6 weeks follow-up. The patient reported success rates were 77-93% at 2-3 month follow-up9-12.
Objectives:
- Establish the feasibility of the "Single incision sub-urethral tapes" to be done under local anaesthesia.
- The feasibility of randomisation to the standard surgical treatment TVT-O / TVT.
- To compare the surgical approach in this relatively new procedure against the standard procedures as regard: Peri-operative complication rates, Postoperative pain, Time to discharge from the hospital,
- To compare the outcomes as regard: Patient-reported cure rates, Patient satisfaction, Impact on Quality of life (QoL) and sexual function at 3 month \& 1 -year follow-up. The objective cure rates will be assessed at 3 month follow-up.
Design:
A pilot prospective randomised study within participating urogynaecology units of the "Scottish Pelvic Floor Network".
- Conditions
- Female Stress Incontinence
- Being tested
- sub-urethral tape (TVT-O), stand standard mid-urethral sling (TVT-O)
- Keywords
- urodynamic urinary incontinence, sub-urethral tape
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sub-urethral tape (TVT-O)Procedure or surgery
Tension free vaginal tape vs. single incision sub-urethral tension free vaginal tape
stand standard mid-urethral sling (TVT-O)Other
| Study group | Role | What they receive |
|---|---|---|
| Single-incision Mini-slings (SIMS- Ajust) | Experimental | AjustTM has polypropylene fixing anchors (one is fixed and the other adjustable) which are anchored onto the obturator membrane. The pulley like system enables adjustment of the tension once the arms have been anchored. Once in place, the anchors rest at right angles to insertion which is claimed to reduce the chances of anchor dislodgment Receives: Procedure: sub-urethral tape (TVT-O) |
| standared med urethral sling (SMUS) | Other | standard med urethral sling (SMUS)TVT-O, was done as originally described by Deleval et al. Receives: Other: stand standard mid-urethral sling (TVT-O) |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Feasibility of the single incision sub-urethral tape to be done under local anaesthesia
- Feasibility of the single incision sub-urethral tape to be done under local anaesthesia?
- Number of women approached and declining LA o Number of women in LA group converted to GA
Measured: 1 year
Secondary outcomes (1)
• Patient-reported Success rates
Patient-reported Success rates
- Assessed by PGI-I "Very Much Improved/ Much Improved."
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2010 (estimated)
- Study startNov 2009
- Primary completionOct 2010
- Study completionOct 2011
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 Female 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Collaborators
- Aberdeen Royal Infirmary
- Responsible party
- Sponsor
- Investigators
- Mohamed Abdel-Fattah, MRCOG, Principal investigator, University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01230450
- Sponsor's protocol ID
- SI-TOT
- Acronym
- SITOT
- Status last verified
- Jan 2013
- First submitted
- 27 Oct 2010
- Last updated
- 24 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
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 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Comparing Two Surgical Treatment of Female Urodynamic Stress Incontinence (SITOT)
- ClinicalTrials.gov ID
- NCT01230450
- Acronym / sponsor ID
- SITOT / SI-TOT
- Conditions
- Female Stress Incontinence
- Keywords
- urodynamic urinary incontinence, sub-urethral tape
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Collaborators
- Aberdeen Royal Infirmary
- Study start
- Nov 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 29 Oct 2010 (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.
Aim: The study aim to assess the feasibly a large prospective multi-centre randomised study for comparing the relatively new "Single incision sub-urethral tapes" with the standard surgical treatment of female urodynamic stress incontinence (USI).
Detailed description
Single incision tension-free sub-urethral vaginal tapes procedures8 have been recently described in an attempt to avoid the blind passage of the trochars through the groin \& the adductor muscles and consequently reducing the incidence \& severity of postoperative leg pain. The obvious advantages would be shorter hospital stay, early recovery, early resumption of day to day activities \& earlier return to work. A number of small prospective audits and case-series have been presented in international conferences reporting on the safety \& outcomes for these procedures. However all these studies were for preliminary reports for proof of concept and therefore the studies populations were 15-70 women with short term follow-up of 2-3 month9-11.These studies have shown low perioperative complication rates: bladder injury 0-1%, vaginal erosion 1-3% \& one study showing 1.3% pain at 6 weeks follow-up. The patient reported success rates were 77-93% at 2-3 month follow-up9-12.
Objectives:
- Establish the feasibility of the "Single incision sub-urethral tapes" to be done under local anaesthesia.
- The feasibility of randomisation to the standard surgical treatment TVT-O / TVT.
- To compare the surgical approach in this relatively new procedure against the standard procedures as regard: Peri-operative complication rates, Postoperative pain, Time to discharge from the hospital,
- To compare the outcomes as regard: Patient-reported cure rates, Patient satisfaction, Impact on Quality of life (QoL) and sexual function at 3 month \& 1 -year follow-up. The objective cure rates will be assessed at 3 month follow-up.
Design:
A pilot prospective randomised study within participating urogynaecology units of the "Scottish Pelvic Floor Network".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-incision Mini-slings (SIMS- Ajust) | Experimental | Procedure: sub-urethral tape (TVT-O)AjustTM has polypropylene fixing anchors (one is fixed and the other adjustable) which are anchored onto the obturator membrane. The pulley like system enables adjustment of the tension once the arms have been anchored. Once in place, the anchors rest at right angles to insertion which is claimed to reduce the chances of anchor dislodgment |
| standared med urethral sling (SMUS) | Other | Other: stand standard mid-urethral sling (TVT-O)standard med urethral sling (SMUS)TVT-O, was done as originally described by Deleval et al. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- USI
- Mixed incontinence symptoms with predominantly bothering stress component (No DO on UDS).
- Primary Incontinence Surgery.
- BMI < 35
- Ability to understand the information leaflet and sign an informed consent form in English.
Key exclusion criteria (6 listed)
- Mixed incontinence with pre-dominant OAB and/or Neurological conditions e.g. MS.
- Detrusor Overactivity on Urodynamics.
- Inability to understand English.
- Un-willing for randomisation.
- Concomitant surgery.
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 |
|---|---|---|
| sub-urethral tape (TVT-O)Tension free vaginal tape vs. single incision sub-urethral tension free vaginal tape | Procedure or surgery | Single-incision Mini-slings (SIMS- Ajust) |
| stand standard mid-urethral sling (TVT-O) | Other | standared med urethral sling (SMUS) |
Primary outcome
• Feasibility of the single incision sub-urethral tape to be done under local anaesthesia
Time frame: 1 year
* Feasibility of the single incision sub-urethral tape to be done under local anaesthesia? * Number of women approached and declining LA o Number of women in LA group converted to GA
1 secondary outcome
• Patient-reported Success rates
Time frame: 1 year
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 24 Jan 2013.
- 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.
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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.
Mohamed Abdel-Fattah, MRCOG principal investigator
University of Aberdeen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing sub-urethral tape (TVT-O) and stand standard mid-urethral sling (TVT-O) in people with Female Stress Incontinence, run by University of Aberdeen 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 6 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 24 Jan 2013. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
• Feasibility of the single incision sub-urethral tape to be done under local anaesthesia (time frame: 1 year). 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 NCT01230450, 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 24 Jan 2013.