A Randomized Controlled Study Comparing Three Single-incision Devices for Female Urinary Stress Incontinence

February 26, 2013 updated by: University Magna Graecia

A Comparison Among Three Single-incision Devices for the Treatment of Female Urinary Genuine Stress Incontinence: a Randomized Controlled Study.

The prevalence of urinary stress incontinence in middle age women is rated at about 30%. To date, there is an increasing use in the clinical practice of new techniques for the treatment of this condition and several surgical devices, characterized by minimally invasive approach, are commercialized.

Recently, single-incision devices have been proposed. One of the most relevant potential advantages of these devices is the possibility of performing their positioning under local anesthesia, thus, in ambulatory regimen. The employment of these devices is particularly useful in two subgroups of patients with urinary incontinence, i.e. women with genuine stress incontinence not associated to pelvic organ prolapse (POP) and women whose stress incontinence raised after surgical correction of (severe) POP.

Poor data coming from randomized controlled trials (RCTs) are available regarding single-incision devices for the treatment of stress incontinence, and there are no conclusions in terms of their feasibility, efficacy and safety. Finally, to our knowledge no randomized controlled trial is actually available in literature comparing different single-incision devices.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Women with genuine urinary stress incontinence not associated with POP will be enrolled and randomized in three groups (arm 1, arm 2 and arm 3). All patients eligible will undergo baseline assessment consisting of anthropometric, clinical, hormonal, ultrasonographic and urodynamic evaluations. At time of surgery, all patients will be randomized in three surgical treatment groups (arm 1, 2 and 3). Patients of arm 1 will be treated with positioning of Ajust (Bard Urological Division, Covington, GA, USA), patients of group 2 will be treated with positioning of MiniArc (AMS, Minnetonka, MN, USA) and patients of arm 3 will be treated with positioning of TVT Secur System (Ethicon, Somerville, NJ, USA).

During the study, the clinical outcomes, and the adverse experience will be evaluated in each patient.

Data will be analyzed using the intention-to-treat principle and a P value of 0.05 or less will be considered significant.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Catanzaro, Italy, 88100
        • "Pugliese" Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • genuine stress incontinence

Exclusion Criteria:

  • pregnancy
  • <12 months postpartum
  • systemic disease and/or drugs known to affect bladder function
  • current chemotherapy or radiation therapy
  • urethral diverticulum
  • augmentation cytoplasty
  • artificial sphincter
  • genital prolapse equal to or more than second degree
  • history of severe abdominopelvic infections
  • detrusor instability and/or intrinsic sphincter dysfunction
  • other gynecologic pathologies
  • BMI >30

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Patients treated with Ajust positioning
Procedure: Ajust positioning
Patient placed in lithotomic position. 1.5 cm incision made, starting 1 cm down to the urethral meatus. Tunneling wide to 12-15 mm up to the bonny edge horizontally to the inferior pubic arm by spreading the scissors blades while withdrawing it, at a plane parallel to the vaginal wall. Mucosal undermining performed at the level of the upper and lower "frenulum" attaching the sub-urethral tissue to the vaginal wall. Insertion of the device to the bonny edge, horizontaly to the inferior pubic arm, and behind the bone edge to the internal obturator muscle. Ajust will be placed by means of a safe hook geometry introducer. Incision closure.
Active Comparator: 2
Patients treated with MiniArc positioning
Procedure: MiniArc positioning
Patient placed in lithotomic position. 1.5 cm incision made, starting 1 cm down to the urethral meatus. Tunneling wide to 12-15 mm up to the bonny edge horizontally to the inferior pubic arm by spreading the scissors blades while withdrawing it, at a plane parallel to the vaginal wall. Mucosal undermining performed at the level of the upper and lower "frenulum" attaching the sub-urethral tissue to the vaginal wall. Insertion of the device to the bonny edge, horizontaly to the inferior pubic arm, and behind the bone edge to the internal obturator muscle. MiniArc will be placed by means of curved single use needle. Incision closure.
Active Comparator: 3
Patients treated with TVT secur system
Procedure: TVT secur system positioning
Patient placed in lithotomic position. 1.5 cm incision made, starting 1 cm down to the urethral meatus. Tunneling wide to 12-15 mm up to the bonny edge horizontally to the inferior pubic arm by spreading the scissors blades while withdrawing it, at a plane parallel to the vaginal wall. Mucosal undermining performed at the level of the upper and lower "frenulum" attaching the sub-urethral tissue to the vaginal wall. Insertion of the device to the bonny edge, horizontaly to the inferior pubic arm, and behind the bone edge to the internal obturator muscle. TVT Secur System will be placed by means of two curved, stainless steel, single use introducers. Incision closure.
Active Comparator: 4
Patients treated with tension free vaginal tape
Procedure: Tension free vaginal ttape
Patient placed in lithotomic position. 15 mm vaginal incision below urethral meatus. Dissection of the paraurethral space on each side of the incision and of the bladder from the inferior edge of the pubis. Transversal 10 mm skin incisions at level of superior pubic margin. Top-down or bottom-up approach passage of the needles and sling. Adjustment of sling tension. Closure of vaginal and skin incisions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Subjective cure rate (compared to results of TVT)

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life
Recurrence rate
Blood loss
Postoperative pain
Objective cure rate
Intraoperative complication rate
Time Frame: one day
one day
Postoperative complication rate
Time Frame: thirty days
thirty days
Long-term complication rate
Time Frame: twelve months
twelve months
Patients' satisfaction
Sexual function
Feasibility (degree of surgical difficulty in non-trained surgeons)
Learning curve (change in operative time, intra- and post-operative complications over the time

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Magna Graecia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Study Registration Dates

First Submitted

September 10, 2008

First Submitted That Met QC Criteria

September 10, 2008

First Posted (Estimate)

September 11, 2008

Study Record Updates

Last Update Posted (Estimate)

February 27, 2013

Last Update Submitted That Met QC Criteria

February 26, 2013

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04/2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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