Tension Free Vaginal Tape (TVT) Versus the Miniarc Sling

NCT00843908 | Completed

• 1 other identifier: 07/H1101/112
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Urodynamic Stress Incontinence

Keywords

Stress incontinence; Surgical Treatments; Minislings

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Quality of life (as measured using the King's Health Questionnaire)

  6 weeks and 6 months

• Intra-operative complications, e.g. bladder injury

  Time of surgery

• Post-operative voiding dysfunction

  0-6 weeks

Study Arms (2)

TVT

ACTIVE COMPARATOR

Women in this arm will undergo the Tension Free Vaginal Tape procedure

Device: Tension Free Vaginal Tape

Miniarc

EXPERIMENTAL

Women in this group will undergo the Miniarc suburethral sling procedure

Device: Miniarc

Interventions

Tension Free Vaginal Tape DEVICE

Tension Free Vaginal Tape inserted in the conventional manner in a theatre environment

Also known as: Advantage TVT, Boston Scientific

TVT

Miniarc DEVICE

The Miniarc suburethral sling will be inserted in the conventional manner in a theatre environment under general anaesthesia

Also known as: Miniarc, American Medical Systems

Miniarc

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medway NHS Foundation Trust: lead

Study Sites (1)

Medway Maritime Hospital

Gillingham, Kent, ME7 5NY, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 37888839 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Suburethral Slings

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 12, 2009
• First Posted: February 13, 2009
• Study Start: February 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: August 1, 2009
• Last Updated: August 27, 2009

Record last verified: 2009-08

Locations

GB (1)