Tower Urology Research Projects

Should you have interest in participating in either of the following studies, or if you have questions related to this research, please contact us at the Tower Urology Institute for Continence at our toll free number: 1-888-248-6937 or 310-854-9898

Collagen vs Urethrin Study

This research project involves the comparison of two agents used to inject the urethra and strengthen the valve muscle. These two agents are collagen and Urethrin ( a Teflon like material). The injection is performed in the office under local anesthesia and is usually a very simple procedure. Usually multiple injections are required. The exact criteria for entry/exclusion for this study follow.

Male and female patients will be enrolled in the study according to the following:

Inclusion Criteria:

1. Patient has urinary incontinence due to Intrinsic Sphincter Dysfunction (ISD) and has experienced incontinence for at least 12 months.
2. Patient is 50 years or older.
3. Patient has good bladder function.
4. Patient's incontinence has not shown any improvement for at least 12 months prior to treatment.
5. Patient has failed prior noninvasive treatment such as behavior modification and/or drug therapy.
6. Patient agrees to sign the Patient Informed Consent Document.
7. Patient agrees to be available for the follow-up evaluations as required by the protocol.

Exclusion Criteria:

1. Patient has vesicoureteral reflux, spastic bladder, detrusor instability, or high pressure instability.
2. Patient with indwelling catheters for an extended period of time.
3. Patient has current or acute conditions involving cystitis or urethritis.
4. Patient has any condition which could lead to significant postoperative complication, inncluding patients with current infection anywhere in the body, uncontrolled diabetes (glycosylated hemoglobin levels > 11.5%) or elevated residual urine from bladder outlet obstruction.
5. Patient has history of anaphylactic reactions.
6. Patient is morbidly obese (defined as 100 pounds over their ideal body weight according to Metropolitan Life Insurance Co. tables).
7. Patient has recieved pelvic radiotherapy.
8. Patient has incontinence of neurogenic etiology.
9. Patient is pregnant or lactating woman.
10. Patient is allergic to any bovine collagen products as shown in results of Contigen® skin test or is undergoing or intends to undergo desensitization injections to meat products.
11. Patient has any condition that would preclude treatment due to Contraindications and/or Warnings on either Urethrin(tm) or Contigen® labeling.

ProtoGen Sling Study:

This project is a new type of surgical procedure for certain women with stress incontinence called the Protogen Sling procedure. This is an operative procedure done in the hospital under anesthesia. The procedure involves placement of a synthetic graft material beneath the urethra to act as a "sling" and help the urethra close more effectively. This pilot study (performed at multiple centers throughout the country) will examine the results and complications associated with this procedure.

Entry / Exclusion Criteria for ProtoGen Sling Study:

Inclusion Criteria:

Patients must meet ALL of the inclusion criteria specified to be eligible for the study:

1. Female adults over the age of 18 years.
2. Documented diagnosis of urinary incontinence secondary to ISD, vesicourethral junction hypermobility or both.
3. Signed patient informed consent.
4. Willing to return for and complete all required follow-up evaluations.

Exclusion Criteria:

Patients should NOT be entered if any of the following are present:

1. Urodynamic evidence of detrusor instability in absence of abdominal straining.
2. Radiation changes and/or severe estrogen deficiency.
3. Treatment with corticosteroids or other immunosuppressive agents within the last 90 days.
4. Medications that effect the bladder neck (including but not limited to alpha-adrenergic blockers, anticholinergics and psychotropins).
5. Concurrent medical disorders such as: diabetes, bronchitis, asthma or coagulation defects.
6. Immune conditions (e.g., lupus, AIDS, HIV)
7. Active sexuality transmitted diseases (e.g., genital herpes).
8. Concurrent treatment with an investigational device or drug.
9. Participation in any investigational studies in the past 6 months.
10. Interstitial cystitis or other conditions that could confound the results of the study.
11. Known or suspected allergies to polyester.

Urethral Valve Project:

To evaluate the usefulness of a removable urethral valve to help empty the bladder in women who are on self-catheterization (i.e. - they do not empty their bladder with the use of a catheter (tube) inserted into the bladder).

Purpose of Study:

How the valve works:
The valve is contained in a small plastic tube that is inserted and remains in the urethra (the tube that carries the urine from the bladder to the outside). To empty the bladder, a battery operated magnet is placed near the device and turned on. This magnet opens the valve and with a small turbine like mechanism, actually empties the bladder. Biweekly, Triweekly, or monthly reinsertion schedules, will be followed for the duration of the 14 to 15 week treatment phase.

It is anticipated that approximately ten U.S. sites will participate in this study and that up to 150 patients will be enrolled, approximately 15 to 25 patients per site. If enrollment is below the anticipated level, however, one or two European sites (using the identical protocol) may participate in the clinical investigation. The duration of the investigation is anticipated to be one year.

Eligibility Criteria:

In order to be eligible for participation in the study, patients must meet all of the inclusion criteria enumerated below and must not have any of the enumerated exclusion criteria.

Inclusion Criteria:

1. Women 18 years of age or older.
2. Patient must be mentally coherent and either have sufficient manual dexterity to operate (and, if necessary remove) the device or be assisted by a caregiver.
3. Patients:
   (A) With atonic bladder, where atonic bladder may result from:
   

   * Intrinsic damage to the detrusor muscle due to trauma

   * Systemic Diseases including central nervous system disorders

   * Peripheral damage to the nervous system

   * latrogenic causes secondary to the use of anticholinergic drugs to treat hyperreflex bladder (such as in patients with multiple sclerosis)

   AND

   (B) Whose existing treatment consists of intermittent catheterization by self of by caregiver.
4. Voluntary consent (patient or legal guardian) to participate in the study, following a full explanation of the nature and purpose of the study, by signing the IRB-approved Informed Consent document at the eligibility assessment visit (Week 0).
5. Willingness to return for all required follow-up visits and to undergo all required study procedures.
6. Capable of determining when to void (either by urge to void or by adherence to timed voiding schedule), or has caregiver who will attend to bladder emptying at least four times daily.
7. Anatomic characteristics which are compatible with the device geometry (i.e. - catheter length and diameter).

Exclusion Criteria:

1. Diagnostic and/or treatment of a symptomatic urinary tract infection ("UTI") during the two weeks prior to the Week 0 visit, (Subjects may, however, be enrolled in the study two weeks after resolution of a UTI. Asymptomatic bacteriuria is common in patients undergoing intermittent catheterization and is not a cause for exclusion.)
2. Women who have uninhibited bladder contractions > 15 cm H20 that are not controlled with anticholinergic drugs (as documented by cystometrography).
3. Neoplastic or inflammatory processes involving the lower urinary tract, uterus, cervix, or vagina.
4. History of urolithiasis within the last year.
5. Concurrent use of external or internal medical devices with electronic or magnetic components, including pacemakers.
6. Patients undergoing radiation therapy during the study period.
7. Psychiatric or physical condition which would impede the ability of a patient to follow instructions for use of the external control unit or to remove the catheter if necessary. If a patient is unable to operate the control unit or to remove the catheter they may still be eligible to enroll in the study without contravening this exclusion criterion if they have a caregiver (trained in device removal) who will attend to bladder emptying for the patient at least four times daily.
8. Patients who have received any investigational drug or device within the last 30 days and/or patients who are currently participating in another clinical trial.
9. Any patient for whom the need for MRI is anticipated during the study period.
10. Urinary tract fistula.
11. Bladder diverticulum which cannot be emptied by routine catheterization.
12. Pregnancy at any time during the study period makes the patient ineligible to participate in the trial and requires discontinuation of treatment.
13. Patient with a contracted, low-volume bladder (< 200cc bladder capacity).
14. Known vesicoureteral reflux from history, impaired kidney function, recurrent pyelonephritis, or moderate to severe hydronephrosis.
15. Autonomic dysreflexia.
16. Patients with a compromised immune system.
17. Patients who are allergic to or who otherwise cannot take antibiotics.
18. Patients who are taking prophylactic antibiotics for their current management technique for atonic bladder or patients who require the use of prophylactic antibiotics for invasive procedures, e.g., due to mitral valve prolapse or the presence of prosthetic devices.