Tension Free Vaginal Tape (TVT) Versus the Miniarc Sling

Urodynamic Stress Incontinence Clinical Trial

Official title:

A Randomized Study of the Treatment of Urodynamic Stress Incontinence: the Tension Free Vaginal Tape (TVT) Versus the Miniarc Sling.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00843908
• Other study ID #: 07/H1101/112
• Status: Completed
• Phase: N/A
• First received: February 12, 2009
• Last updated: August 26, 2009
• Start date: February 2008
• Est. completion date: August 2009

Study information

• Verified date: August 2009
• Source: Medway NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical 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 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.

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

1. Detailed symptom history and examination

2. 3 day urinary diary

3. King's Quality of Life questionnaire

4. 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

1. Carried out at 6 weeks' post-operatively

2. Symptoms assessed using 3 day urinary diary and Patient Global Impression of Improvement (PGI-I)

3. King's quality of life questionnaire

4. Repeat urodynamic studies as described previously, including voiding cystometry (6 months only)

5. Any complications noted, e.g. readmission to hospital, UTI, voiding difficulties

6. Patient satisfaction will be assessed using a 5 point scale at the follow up visit

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Patients must be female

2. Subjective evidence of stress predominant symptoms on symptom specific questionnaire

3. Stress incontinence on urodynamics

4. Patients who are capable of understanding and signing the written consent form for participation in the study

5. Patients must have completed their family

6. Patients must be capable of filling in the symptom diary and micturition diary

Exclusion Criteria:

1. Patients who are medically unfit to undergo surgical intervention.

2. Patients who have undergone previous continence surgery

3. Prolapse beyond the introitus

4. Patients with voiding dysfunction

5. Patients with recurrent urinary tract infections

6. Patients with haematuria of unknown origin or known bladder pathology

7. Patients who are not sure that their family is complete

8. Patients unwilling to use a safe method of contraception following the procedure

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Incontinence, Stress
• Urodynamic Stress Incontinence

Intervention

Device:
• Tension Free Vaginal Tape
Tension Free Vaginal Tape inserted in the conventional manner in a theatre environment
• Miniarc
The Miniarc suburethral sling will be inserted in the conventional manner in a theatre environment under general anaesthesia

Locations

Country	Name	City	State
United Kingdom	Medway Maritime Hospital	Gillingham	Kent

Sponsors (1)

Lead Sponsor	Collaborator
Medway NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		6 weeks and 6 months	No
Secondary	Quality of life (as measured using the King's Health Questionnaire)		6 weeks and 6 months	No
Secondary	Intra-operative complications, e.g. bladder injury		Time of surgery	Yes
Secondary	Post-operative voiding dysfunction		0-6 weeks	No