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Completed

NCT Number: NCT00904969

A Pre-Market Study of the American Medical Systems (AMS) Transobturator Male Sling System for the Treatment of Male Stress Urinary Incontinence

The purpose of this study is to obtain surgical technique data for use in physician education and training and to collect early clinical outcomes data for future publication.

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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 Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

40 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

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About this study

A multi-center study conducted under a common implant and follow-up protocol. The study will collect pre-operative urologic testing, medical history and subject quality of life (Incontinence Quality of Life Questionnaire). Intra-operative procedural data will be collected.

Pad weight and incontinence severity rating (using the International Consultation on Incontinence Questionnaire (ICIQ)) will be used to characterize continence status.

Post-operative complications, urologic testing, and subject quality of life will be collected at six weeks and three, six, 12, and 24 months.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The subject has agreed to be implanted with the AMS Male Transobturator Sling System.
  • The subject is willing and able to give valid informed consent.
  • The subject is > 40 years of age.
  • The subject has confirmed stress urinary incontinence for at least 6 months and uses no more than 8 pads per day for incontinence management.
  • The subject has any of the following: an observable degree of incontinence during stress related activities, more than one pad is used in a 24 hour period, has more than two episodes of incontinence per day.
  • Internal sphincter contractility confirmed by endoscopic view.
  • The subject's primary etiology is TUR, TURP, radical prostatectomy, open prostatectomy, or suprapubic prostatectomy
  • Pre-existing urological conditions, other than incontinence have been treated and are under control.
  • The subject is willing and able to return for follow-up evaluations and questionnaire completion according to the study protocol.
  • The subject is a good surgical candidate.

Exclusion criteria

  • The subject has a neurogenic bladder condition that is not treatable or controllable by pharmacological or alternative methods.
  • The subject has an atonic bladder.
  • The subject has a post-void residual > 75 cc.
  • The subject has detrusor-external sphincter dyssynergia.
  • The subject has a urinary tract infection (UTI).
  • The subject was treated with pelvic radiation within the last 6 months.
  • The subject currently has an inflatable penile prosthesis.
  • The subject self-catheterizes.
  • The subject has symptomatic or unstable bladder neck stricture disease.
  • The subject has a history of urethral strictures that may require repetitive instrumentation.
  • The subject has previously had a urethral Sling System, an AMS Sphincter 800™, or any implanted device for the treatment of urinary incontinence (not including bulking agents).
  • The subject has a history of connective tissue or autoimmune conditions.
  • The subject has a compromised immune system.
  • The subject has renal insufficiency, and upper and/or lower urinary tract relative obstruction.
  • The subject's reading level is judged inadequate for reading and understanding the quality of life questionnaires and other study materials.

Treatment and study plan

The AMS Male Transobturator Sling System

Device

The AMS Male Transobturator Sling System was developed to treat urinary stress incontinence in men resulting from intrinsic sphincter deficiency (ISD) secondary to radical prostatectomy. The Male Transobturator Sling System procedure is minimally invasive and consists of using two single-use needle passers and passing them through two small incisions over the obturator foramen. The needles are pushed in an arc through the tissue and exited at a perineal incision. Once the passers are through the perineal incision, the Sling System mesh arms are attached to the needles which are then pulled back through the needle track to their points of origin over the obturator foramen. The Sling System is subsequently tensioned and all incisions are closed.

AdVance Male Sling

Device

A transobturator sling for the treatment of post-prostatectomy incontinence

Other names: Male TO, transobturator sling, suburethral sling, retrourethral sling

Primary outcomes

  1. Procedural Endpoint: Procedure Time From First Incision to Closing.

    Time frame: During Procedure, Approximately 60 Minutes

    Characterize procedure time from first incision to closing.

  2. Procedural Endpoint: Type of Anesthesia Used

    Time frame: During Procedure, Approximately 60 Minutes

    Describe the type of anesthesia used.

  3. Procedural Endpoint: Rate of Foley Catheter Use - Intraoperative

    Time frame: During Procedure, Approximately 60 Minutes

    Number of participants requiring the use of a foley catheter intra-operatively.

  4. Procedural Endpoint: Rate of Foley Catheter Use - Post-operative

    Time frame: post-operative to discharge

    Number of participants requiring the use of a foley catheter who were able to void prior to discharge.

  5. Procedural Endpoint: Rate of Foley Catheter Use - Post-discharge

    Time frame: post discharge

    Number of participants requiring the use of a foley catheter post-discharge following Bladder Management instructions.

  6. Procedural Endpoint: Descriptive Procedural Parameters - Use of Tack Sutures

    Time frame: During Procedure, Approximately 60 Minutes

    Characterize procedural parameters including the use of tack sutures.

  7. Procedural Endpoint: Descriptive Procedural Parameters - Muscle Dissection

    Time frame: During Procedure, Approximately 60 Minutes

    Characterize procedural parameters, including muscle dissection across all participants.

  8. Procedural Endpoint: Descriptive Procedural Parameters - Movement of Urethral Bulb While Tensioning

    Time frame: During Procedure, Approximately 60 Minutes

    Characterize procedural parameters, including the movement of urethral bulb while tensioning in all participants.

  9. Device Success as Defined as Successful Placement of the Device in Desired Position Peri-operatively

    Time frame: During Procedure, Approximately 60 Minutes

    Summarize device success as defined as a successful placement of the device in a desired position, peri-operatively, in participants.

Secondary outcomes

  1. Subject Satisfaction Endpoint: 1-Hour Pad Weight

    Time frame: Baseline to 24 month

    Summarize subject satisfaction of 1-hour pad weight for participants.

  2. Subject Satisfaction Endpoint: 24-Hour Pad Weight

    Time frame: Baseline to 24 month

    Summarize subject satisfaction with 24-hour pad weight across participants.

  3. Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (1 Hour Pad Weight Test)

    Time frame: Baseline to 24 month

    Summarize the percent of subjects that have a decrease of pad weight of 25%, 50%, or 75% at follow-up (1-hour pad weight test used).

  4. Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (24 Hour Pad Weight Test)

    Time frame: Baseline to 24 Month

    Summarize the percent of subjects that have a decrease of pad weight of 25%, 50%, or 75% at follow-up (24-hour pad weight test used).

  5. Subject Satisfaction Endpoint: Pads Per Day Use

    Time frame: Baseline to 24 Months

    Summarize the subject satisfaction using pads per day use collected in follow-up in participants.

  6. Subject Satisfaction Endpoint: Quality of Life I-QOL Scores

    Time frame: Baseline to 24 Months

    The Incontinence Quality of Life (I-QOL) questionnaire contains 22 items, each with a 5-point Likert-type response scale, evaluating a subject's quality of life with respect to his urinary problems or incontinence. A possible total score can be 0-100, with a higher score meaning less problems.

  7. Subject Satisfaction Endpoint: Quality of Life International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF) Scores

    Time frame: Baseline to 24 Months

    The ICIQ-SF questionnaire evaluates the impact of urinary incontinence on quality of life through four questions that evaluate the frequency, severity and impact of urinary incontinence. A set of eight self-diagnosis items related to the causes or situations of urinary incontinence experienced by the subject are also assessed. Scores may range from 0 to 21. Improvement in the subject's quality of life from baseline to follow-up is indicated by a decrease in the ICIQ-SF score.

  8. Subject Satisfaction Endpoint: Quality of Life UCLA (University of California Los Angeles) / RAND (RAND Corporation) Scores

    Time frame: Baseline to 24 Months

    Improvement in the subject's quality of life from baseline to follow-up is indicated by an increase in the UCLA/RAND urinary function score. Scores may range from 0 to 100.

  9. Subject Satisfaction Endpoint: Physician Evaluation of Subject's Incontinence Status

    Time frame: 6 Weeks post implant to 24 Months

    Physician evaluation of subject's incontinence status at 6 weeks and subsequent follow-up evaluations

  10. Procedural and Device Complication Rates

    Time frame: Procedure to 24 Months Post implant

    Percentage of participants with serious and non-serious adverse events.

Sponsors and collaborators

Lead sponsor

American Medical Systems

Industry

Registry information

Official study title

A Pre-Market Study of the AMS Transobturator Male Sling System for the Treatment of Male Stress Urinary Incontinence

Acronym: AMS051

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
May 20, 2009
Registry last updated
Jan 30, 2018

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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