Clinical Trial: TVT-O Vs TOT in Management of Urodynamic Stress Urinary Incontinence

This study is currently recruiting patients.
Verified by South Glasgow University Hospital May 2005

Sponsors and Collaborators: South Glasgow University Hospital
Henry Smith Grant
Information provided by: South Glasgow University Hospital
ClinicalTrials.gov Identifier: NCT00136071

Purpose

Urinary incontinence (involuntary leakage of urine) is an extremely common, distressing and socially disabling condition. It is known to affect up to 14 % of the adult female population in the United Kingdom. Sufferers tend to become social recluses, not wanting to socialise for fear of embarrassment and ridicule. It typically takes up to 5 years from the onset of symptoms for a patient to admit their problem, seek help and reach a specialist. Unfortunately it is commonest in the elderly when the incidence is as high as 50% in some studies. Furthermore this group of patients are the least likely to seek help, the least likely to receive help and up until recently the least likely to be cured of their problems.

Things are improving however, as everyone is more prepared to talk about this awful condition rather than accept it as a part of growing old. Furthermore better treatments are becoming available which can help the old as well as the young.

Two years ago a new operation for urinary leakage was launched in the UK. This is a smaller operation than those previously available and more suitable for the frail and elderly. We have been using this operation for 18 months with good success. Several versions however are now on the market, some much more expensive than the original, and perhaps not as good. We need to know which one is best and hence we intent to do a study to find out.

We aim to select patients with leakage to have one or other operation and to follow the patients over several years to find out which operation is best, safest, lasts longest and is most acceptable to patients. Only then will we know which of the versions of this procedure we should be offering our patients.

Condition Intervention
Urinary Stress Incontinence
 Device: Transobturator tape- ARIS
 Device: TVT-O

MedlinePlus related topics:  Pelvic Support Problems

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Official Title: Randomised Prospective Blinded Trial Comparing Transvaginal Tension Free Vaginal Tape- Obturator 9outside-in) with Transobturator Tape- Mentor (Inside -Out)in Surgical Management Od Urodynamic Stress Urinary Incontinence

Further Study Details: 
Primary Outcomes: the Objective cure rates of STRESS INCONTINENCEaccording to URODYNAMICS
Secondary Outcomes: • Improvement in Total KHQ scores { > or = 10%}; • Complication rates; • Patient satisfaction rates
Expected Total Enrollment:  230

Study start: May 2005;  Expected completion: October 2010
Last follow-up: May 2010;  Data entry closure: August 2010

Randomised trial comparing TVT-O & TOT in surgical management of USI (Urodynamic Stress Incontinence):

Aim: To compare two transobturator tension free vaginal tape procedures; TVT-O Gynecare vs. TOT mentor for management of USI. This study will compare the surgical approach & tape material in both procedures [In-Out (TVT-O) Vs. the Out-In (TOT)] as regard; Complication rates, Objective & subjective cure rates, Patient satisfaction & quality of life (QoL) changes.

Design: Randomised trial in a regional referral centre, approved by ethical committee.

Background: Transobturator tension free vaginal tape is currently the first choice mid-urethral tape procedure for surgical treatment of USI in our unit. The choice of the surgical approach and tape material; In-Out (TVT-O) vs. the Out-In (TOT) is currently taken predominately according to the surgeon preference without any solid clinical evidence to support that one approach or one tape is superior to the other.

Methods: All women undergoing Transobturator tension free vaginal tape procedure in our department for Pure USI, done as a primary anti-incontinence procedure and as the sole procedure at time of surgery, will be invited to participate in the study and will receive information leaflet and will sign consent form. All would have had failed or declined physiotherapy treatment. Procedures mainly take place in the day surgery unit under general anaesthesia; those who are done in the main surgical list are due to associated medical conditions or needing spinal anaesthesia or living in remote areas. Randomisation will be performed using sealed opaque envelopes. TVT-O & TOT will be done as originally described (1, 2), we do not perform cough stress test routinely. All patients will receive intra-operative; prophylactic antibiotics & anti- inflammatory if not contraindicated. Lidocaine 1% will be infiltrated into the needle pathway at the end of the procedure; 10mls. on each side. Satisfactory postoperative voiding - for the purpose of this study - is defined as passing at least 200mls with post-voiding residual urinary volume <100mls assessed at least twice.

Preoperative assessment would include;

  • Detailed history & pelvic examination.
  • Urodynamic assessment.
  • Preoperative quality of life assessment will include:
  • Completion of the King’s Health Questionnaire- version 7 (KHQ).
  • Incontinence Bothersome Scale.
  • Bristol Lower Urinary Tract Symptoms Questionnaire (BULTS).
  • Pelvic Organ Prolapse/ Urinary Incontinence Sexual Function Questionnaire (PISQ-12).

Operative assessment would include;

  • Operative time
  • Blood loss.
  • Surgeon assessment of procedure difficulty using Visual analogue score (VAS)
  • Intra-operative complications:
  • Bladder / Urethral injury.
  • Haemorrhage (>200 mls.).
  • Further procedures needed.
  • Immediate postoperative assessment:
  • Postoperative pain assessment will include

    • Patient self assessment using Visual analogue score (VAS) (Figure3).
    • Unscheduled ward admission for postoperative pain.
  • Postoperative Voiding dysfunction will be defined as any deviation from satisfactory postoperative voiding described above. This will include assessment of;

    • Days of catheterization.
    • Intermittent self catheterization or Permanent supra-pubic catheter.
    • Urethral dilatation.
    • Surgical release/ excision of the tape.
    • Postoperative Pyrexia,
    • UTI.
    • Hospital Stay (for medical reasons).

Outpatient Postoperative assessment:

Patients will be reviewed at three month for:

  • Urodynamic assessment.
  • Completion of the King’s Health Questionnaire- version 7 (KHQ).
  • Completion of the Incontinence Bothersome Scale.
  • Completion of the Patient Satisfaction questionnaire.
  • Bristol Lower Urinary Tract Symptoms Questionnaire (BULTS).
  • Complications: Tape erosions, De-novo Urgency, Worsening of pre-existing urgency, long-term Voiding dysfunction.

Patients will be reviewed at Six month, 12 month, 3 years & 5 years for:

  • 24 hour Pad test.
  • Completion of the King’s Health Questionnaire- version 7 (KHQ).
  • Completion of the Incontinence Bothersome Scale.
  • Bristol Lower Urinary Tract Symptoms Questionnaire (BULTS).
  • Pelvic Organ Prolapse/ Urinary Incontinence Sexual Function Questionnaire (PISQ-12).
  • Completion of the Patient Satisfaction questionnaire.
  • Complications: Tape erosions, De-novo Urgency, Worsening of pre-existing urgency, long-term Voiding dysfunction.
  • Further treatment needed.

Eligibility

Genders Eligible for Study:  Female
Criteria

Inclusion Criteria:

  • All women undergoing Transobturator tension free vaginal tape procedure in our department for USI, whether a primary or secondary anti-incontinence procedure and as the sole procedure at time of surgery, will be invited to participate in the study and will receive information leaflet and will sign consent form.

Exclusion Criteria:

  • Concomitant surgical procedure
  • Non-english speakers
  • Lack of consent

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00136071

Mohamed Abdel-fattah, MRCOG      01412012818    msakr99@aol.com
Ian Ramsay, MRCOG      01412012237    IRamsay@sgh.scot.nhs.uk

United Kingdom
      Southern General Hospital, Glasgow,  G51 4TF,  United Kingdom; Recruiting
Mohamed Abdel-fattah, MRCOG  01412012818    msakr99@aol.com 
Ian Ramsay, MRCOG  01412012237    IRamsay@sgh.scot.nhs.uk 

Study chairs or principal investigators

Ian Ramsay, MRCOG,  Study Chair,  SOUTHERN GENERAL HOSPITAL   
Mohamed Abdel-fattah, MRCOG,  Study Director,  SOUTHERN GENERAL HOSPITAL   

More Information

Study ID Numbers:  msakr99; Henry Smith Grant
Last Updated:  August 25, 2005
Record first received:  August 25, 2005
ClinicalTrials.gov Identifier:  NCT00136071
Health Authority: United Kingdom: National Health Service
ClinicalTrials.gov processed this record on 2005-08-30



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