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Completed

NCT Number: NCT02599051

Transobturator Verus Single Incision Slings

A randomized control trial to compare the efficacy of the single incision mini-sling to the transobturator sling

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

Transobturator slings are one type of sling that has become standard treatment for stress urinary incontinence. However, this procedure involves a total of 3 incisions to perform.

In contrast, single incision slings have been developed to treat stress urinary incontinence by using only one incision.

However, to date the success and complications of these two procedures have not been compared or studied.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with urodynamically proven stress urinary incontinence who were planning on undergoing surgery for treatment.

Exclusion criteria

  • Patients with prior incontinence surgery, a urodynamic diagnosis of intrinsic sphincter deficiency and mixed incontinence with a predominance of detrusor overactivity were excluded.

Treatment and study plan

Mini-arc

Device

We will place a single incision sling at the time of surgery for stress urinary incontinence

Other names: single incision sling

Monarc

Device

We will place a transobturator sling at the time of surgery for stress urinary incontinence

Other names: transobturator sling

Primary outcomes

  1. Objective Stress Urinary Incontinence

    Time frame: 1 year

    The primary outcome was presence of leakage during cough stress test(CST) on examination

Secondary outcomes

  1. Quality of Life Questionnaire UDI-6

    Time frame: 1 year

    Response to validated questionnaire: Urinary Distress Index(UDI-6) Measures symptoms on three subscales: 1. Irritative 2. Stress 3. Obstructive/Discomfort. The mean value of all questions answered is then multiplied by 25 for the actual score (range 0 to 100) Summary score - Add the scores from the 3 scales together to obtain the summary score (range 0 to 300) The higher the score the greater the perceived impact that pelvic floor dysfunction has on a patient's life.

  2. Subjective Patient Reported Recurrent or Persistent Stress Urinary Incontinence

    Time frame: 1 year

    Assess if the patient has any complaint of stress urinary incontinence after surgery in follow up visits. This will be history only, no examination.

  3. Number of Participants Who Completed Self- Assessment of Cure

    Time frame: 1 year

    Self-assessment of cure is based on 5 point scale, cured, greatly improved, somewhat improved, not improved, and worsened. This is calculated by the number of patients that were analyzed.

  4. Quality of Life Questionnaire IIQ-7

    Time frame: 1 year

    Response to validated questionnaire: Incontinence Impact Questionnaire(IIQ-7) The IIQ measures the impact of urinary incontinence on activities roles, and emotional states. A mean score is derived from each domain, then transferred to give weight to each subscale. Subscale scores range from 0-100. The total IIQ score is calculated by adding the four subscales score with a range of 0-400 possible. A score closer to 0 represents activities not affected at all versus closer to 400 represent activities that were greatly affected.

  5. Quality of Life Questionnaire ICIQ

    Time frame: 1 year

    Response to validated questionnaire: International Consultation on Incontinence Questionnaire(ICIQ). The ICIQ is a screening tool for incontinence. The scoring scale is 0-21, minimum 0, maximum 21. a higher score indicates greater impairment from incontinence.

Sponsors and collaborators

Lead sponsor

Cecilia Calvo

Other

Registry information

Official study title

Transobturator Versus Single Incision Slings: 1 Year Results of a Randomized Control Trial

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Nov 6, 2015
Registry last updated
Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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