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

This study has been completed.
Sponsor:
Information provided by:
University Magna Graecia
ClinicalTrials.gov Identifier:
NCT00751088
First received: September 10, 2008
Last updated: February 26, 2013
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Urinary Incontinence
Procedure: MiniArc positioning
Procedure: TVT secur system positioning
Procedure: Ajust positioning
Procedure: Tension free vaginal ttape
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparison Among Three Single-incision Devices for the Treatment of Female Urinary Genuine Stress Incontinence: a Randomized Controlled Study.

Resource links provided by NLM:


Further study details as provided by University Magna Graecia:

Primary Outcome Measures:
  • Subjective cure rate (compared to results of TVT) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective cure rate [ Designated as safety issue: No ]
  • Intraoperative complication rate [ Time Frame: one day ] [ Designated as safety issue: Yes ]
  • Blood loss [ Designated as safety issue: Yes ]
  • Postoperative complication rate [ Time Frame: thirty days ] [ Designated as safety issue: Yes ]
  • Long-term complication rate [ Time Frame: twelve months ] [ Designated as safety issue: Yes ]
  • Postoperative pain [ Designated as safety issue: Yes ]
  • Patients' satisfaction [ Designated as safety issue: No ]
  • Sexual function [ Designated as safety issue: No ]
  • Quality of life [ Designated as safety issue: No ]
  • Recurrence rate [ Designated as safety issue: No ]
  • Feasibility (degree of surgical difficulty in non-trained surgeons) [ Designated as safety issue: No ]
  • Learning curve (change in operative time, intra- and post-operative complications over the time [ Designated as safety issue: Yes ]

Study Start Date: September 2008
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00751088

Locations
Italy
"Pugliese" Hospital
Catanzaro, Italy, 88100
Sponsors and Collaborators
University Magna Graecia
Investigators
Principal Investigator: Stefano Palomba, MD Chair of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
Study Chair: Fulvio Zullo, MD Chair of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
  More Information

No publications provided by University Magna Graecia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stefano Palomba, University "Magna Graecia" of Catanzaro
ClinicalTrials.gov Identifier: NCT00751088     History of Changes
Other Study ID Numbers: 04/2008
Study First Received: September 10, 2008
Last Updated: February 26, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by University Magna Graecia:
single-incision
sling
stress incontinence
surgery
treatment
Female urinary stress incontinence

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Lower Urinary Tract Symptoms
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on October 23, 2014