Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT00166361
• Collaborator: Pnn Medical A/S (Industry)
• Enrollment: 29
• Location: 1
• Arms: 2
• Duration (Months): 57
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of the Memokath 051 ureteral stent as a long-term temporary and minimally invasive means of providing ureteral drainage in the setting of malignant extrinsic ureteral obstruction secondary to inoperable abdominal or pelvic malignancies. Up to 15 adults who have extrinsic ureteral obstruction secondary to an inoperable abdominal or pelvic malignancy and need ureteral stent drainage will undergo outpatient placement of the ureteral stent. Ongoing monitoring will continue for as long as the stent is in place.

Condition or Disease	Intervention/Treatment	Phase
Ureteral Obstruction	Device: Memokath 051 Ureteral Stent; Device: JJ Stent	N/A

Detailed Description

The Memokath 051 ureteral stent is a device designed to provide long-term temporary ureteral drainage in the setting of extrinsic ureteral obstruction secondary to inoperable pelvic and abdominal malignancies or secondary to changes caused by surgery, chemotherapy, or radiation for pelvic and/or abdominal malignancies. The management of malignant extrinsic ureteral obstruction secondary to inoperable neoplastic disease of the abdomen or pelvis is a common urologic problem, and has important implications for a patient's quality as well as quantity of life, which has been estimated to generally range between 6.5 to 23 months in this population. Currently, extrinsic ureteral obstructions are usually managed with double-J ureteral stents, placed either cystoscopically, or antegrade via a percutaneous nephrostomy tube. Double-J stents are prone to encrustation and obstruction over time, necessitating stent exchange under general anesthesia every 3 to 4 months. These repeat surgical procedures under general anesthesia carry subsequent risks of infection, drug reactions, and iatrogenic injury, leading to degradation in the quality of life of these patients who often have a year or less to live. To circumvent these disadvantages, the nickel-titanium Memokath 051 ureteral stent was developed to provide a means of minimally invasive long-term temporary ureteral drainage.

This is a prospective non-randomized clinical study to evaluate the efficacy of the Memokath 051 ureteral stent in managing extrinsic malignant ureteral obstruction secondary to an inoperable abdominal or pelvic malignancy or secondary to changes caused by surgery, chemotherapy, or radiation for pelvic and/or abdominal malignancies. Enrollment of study subjects will take place over a period of two to three years for to a total of 15 patients.

A control group 10 patients with extrinsic ureteral obstruction secondary to an inoperable pelvic or abdominal malignancy or secondary to changes caused by surgery, chemotherapy, or radiation for pelvic and/or abdominal malignancies and treated by other urologic staff surgeons in a standard fashion with retrogradely placed double-J stents will also be followed every 3 to 4 months.

Study Design

• Study Type: Interventional
• Actual Enrollment: 29 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Long-Term Temporary Drainage of Malignant Extrinsic Ureteral Obstruction Secondary to Inoperable Pelvic or Abdominal Malignancies Using the Memokath 051 Ureteral Stent
• Study Start Date: Feb 1, 2004
• Actual Primary Completion Date: Nov 1, 2008
• Actual Study Completion Date: Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Memokath 051 Ureteral Stent Subjects assigned to this arm received a Memokath 051 Ureteral Stent.	Device: Memokath 051 Ureteral Stent; The Memokath 051 ureter stent is used for the treatment of malignant or benign ureteric strictures in both men and women. The stent design consists of a tightly-coiled nickel-titanium alloy, with a diameter of 10.5 French (Fr) and a fluted proximal diameter expanding to 22 Fr. The stent is manufactured in multiple lengths which are chosen to position the device across the narrowed area rather than crossing the ureteropelvic or ureterovesical junction. It has a thermal memory system for its predetermined shape; the stent softens at temperatures below 10 degrees Celsius but regains its shape when heated above 55 degrees Celsius.
Active Comparator: JJ Stent Subjects assigned to this arm received a JJ stent.	Device: JJ Stent; A JJ stent is a flexible plastic tube that drains urine from the kidney to the bladder and is supposed to stay in place temporarily. There is a coil on each end to keep the stent in place, preventing the stent from migrating down and out from the kidney or up from the bladder into the ureter. The stent can stay in place for few weeks to 3 months or more depending on the indication. If left for more than 6-9 months some stents may get encrusted leading to stone formation around the stent.; Other Names: Double J stent

Outcome Measures

Primary Outcome Measures

1. Mean Stent Dwell Time [baseline to 59 months after placement of stent]

   Stent dwell time is defined as the amount of time a stent can remain in the body after it placed, before it needs to be removed due to failure.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Presence of extrinsic ureteral obstruction

2. secondary to inoperable pelvic or abdominal malignancy or

3. secondary to changes caused by surgery, chemotherapy, or radiation for pelvic and/or abdominal malignancies who have had >2 standard double J stent exchanges with no prospect of being stent-free

4. Life expectancy greater than 4 months

5. Adult patient (18 years of age or older)

6. Preoperative medical examination clearing the patient for general anesthesia

7. No active urinary tract infection by urinalysis and urine culture.

Exclusion Criteria:

1. Ureteral obstruction of a benign or intrinsic etiology

2. Lower urinary tract abnormality precluding cystoscopic stent placement

3. Patients with a solitary kidney

4. Patients not willing or unable to receive their post-operative follow-up at the Mayo Clinic in Rochester, Minnesota

5. Pregnant female patient.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic
• Pnn Medical A/S

Investigators

• Principal Investigator: Lance A Mynderse, M.D., Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lance A. Mynderse, MD, Consultant in Urology (Surgical), Mayo Clinic
• ClinicalTrials.gov Identifier: NCT00166361
• Other Study ID Numbers: 255-03
• First Posted: Sep 14, 2005
• Last Update Posted: Jul 18, 2014
• Last Verified: Jun 1, 2014

• Keywords provided by Lance A. Mynderse, MD, Consultant in Urology (Surgical), Mayo Clinic: Extrinsic ureteral obstruction; Memokath 051 Ureteral Stent; JJ Stent; Stent
• Additional relevant MeSH terms: Ureteral Obstruction

Study Results

Participant Flow

Recruitment Details	Patients were recruited from Oncologic practice of the Mayo Clinic, Rochester, Minnesota from February 2004 to May 2011.
Pre-assignment Detail	29 subjects were enrolled, 4 subjects were screen failures, and were not treated, one subject was treated as a compassionate use patient with a smaller memokath stent.

Arm/Group Title	Memokath 051 Ureteral Stent	JJ Stent
Arm/Group Description	Subjects assigned to this arm received a Memokath 051 Ureteral Stent.	Subjects assigned to this arm received a JJ stent.
Period Title: Overall Study
STARTED	14	10
COMPLETED	14	10
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Memokath 051 Ureteral Stent	JJ Stent	Total
Arm/Group Description	Subjects assigned to this arm received a Memokath 051 Ureteral Stent.	Subjects assigned to this arm received a JJ stent.	Total of all reporting groups
Overall Participants	14	10	24
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	9 64.3%	0 0%	9 37.5%
>=65 years	5 35.7%	10 100%	15 62.5%
Sex: Female, Male (Count of Participants)
Female	11 78.6%	7 70%	18 75%
Male	3 21.4%	3 30%	6 25%
Region of Enrollment (participants) [Number]
United States	14 100%	10 100%	24 100%

Outcome Measures

1. Primary Outcome

Title	Mean Stent Dwell Time
Description	Stent dwell time is defined as the amount of time a stent can remain in the body after it placed, before it needs to be removed due to failure.
Time Frame	baseline to 59 months after placement of stent

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Memokath 051 Ureteral Stent	JJ Stent
Arm/Group Description	Subjects assigned to this arm received a Memokath 051 Ureteral Stent.	Subjects assigned to this arm received a JJ stent.
Measure Participants	14	10
Mean (Full Range) [months]	17	3.97

Adverse Events

Arm/Group Title	Memokath 051 Ureteral Stent		JJ Stent
Arm/Group Description	Subjects assigned to this arm received a Memokath 051 Ureteral Stent.		Subjects assigned to this arm received a JJ stent.
All Cause Mortality
	Memokath 051 Ureteral Stent		JJ Stent
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Memokath 051 Ureteral Stent		JJ Stent
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/14 (85.7%)		2/10 (20%)
Blood and lymphatic system disorders
Hypokalemia	1/14 (7.1%)	1	0/10 (0%)	0
Acute Chronic Anemia	1/14 (7.1%)	1	0/10 (0%)	0
Pulmonary embolism	1/14 (7.1%)	1	0/10 (0%)	0
Cardiac disorders
Carcinoid heart disease	1/14 (7.1%)	1	0/10 (0%)	0
Heart failure related to underlying disease	1/14 (7.1%)	1	0/10 (0%)	0
Gastrointestinal disorders
Surgery related to underlying disease	1/14 (7.1%)	1	0/10 (0%)	0
Bowel Obstruction	4/14 (28.6%)	4	0/10 (0%)	0
General disorders
Dehydration	1/14 (7.1%)	1	0/10 (0%)	0
Hospitalization for sepsis	0/14 (0%)	0	2/10 (20%)	2
Injury, poisoning and procedural complications
Stent encrustation/obstruction	4/14 (28.6%)	6	0/10 (0%)	0
Hospitalization for fractured ankle	1/14 (7.1%)	1	0/10 (0%)	0
Trouble with stent placement due to faulty guide wire	1/14 (7.1%)	1	0/10 (0%)	0
Renal and urinary disorders
Ureteral Obstruction	7/14 (50%)	7	0/10 (0%)	0
Hematuria	1/14 (7.1%)	2	0/10 (0%)	0
Hospitalization due to disease progression	3/14 (21.4%)	3	0/10 (0%)	0
Edema of ureter	2/14 (14.3%)	2	0/10 (0%)	0
Acute renal failure	1/14 (7.1%)	1	0/10 (0%)	0
Hydroureteronephrosis	3/14 (21.4%)	3	0/10 (0%)	0
Atropy of the kidney	1/14 (7.1%)	1	0/10 (0%)	0
Nephrectomy	0/14 (0%)	0	1/10 (10%)	1
Partial ureterectomy	0/14 (0%)	0	1/10 (10%)	1
Hospitalization for urinary tract infection (UTI)	0/14 (0%)	0	1/10 (10%)	1
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	1/14 (7.1%)	1	0/10 (0%)	0
Surgical and medical procedures
Stent migrated into bladder	1/14 (7.1%)	2	0/10 (0%)	0
Other (Not Including Serious) Adverse Events
	Memokath 051 Ureteral Stent		JJ Stent
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/14 (71.4%)		8/10 (80%)
Cardiac disorders
Essential hypertension	1/14 (7.1%)	1	0/10 (0%)	0
Gastrointestinal disorders
Abdominal pain	4/14 (28.6%)	4	1/10 (10%)	1
Iliac pain	0/14 (0%)	0	1/10 (10%)	1
Acid reflux	1/14 (7.1%)	1	0/10 (0%)	0
Ascites	1/14 (7.1%)	1	0/10 (0%)	0
Constipation	1/14 (7.1%)	1	0/10 (0%)	0
Diarrhea	2/14 (14.3%)	2	0/10 (0%)	0
Difficulty eating	1/14 (7.1%)	1	0/10 (0%)	0
Nausea	8/14 (57.1%)	10	0/10 (0%)	0
Vomiting	6/14 (42.9%)	7	0/10 (0%)	0
General disorders
Chest pain	1/14 (7.1%)	1	0/10 (0%)	0
Groin pain	3/14 (21.4%)	3	3/10 (30%)	5
Left lower quadrant pain	3/14 (21.4%)	4	0/10 (0%)	0
Right lower quadrant pain	0/14 (0%)	0	1/10 (10%)	3
Chills	1/14 (7.1%)	1	1/10 (10%)	1
Deydration	1/14 (7.1%)	1	0/10 (0%)	0
Flu like symptoms	3/14 (21.4%)	4	1/10 (10%)	1
Fever	3/14 (21.4%)	4	2/10 (20%)	2
Fragility	2/14 (14.3%)	2	0/10 (0%)	0
Headache	1/14 (7.1%)	5	0/10 (0%)	0
Insomnia	1/14 (7.1%)	1	0/10 (0%)	0
Knee weakness	1/14 (7.1%)	1	0/10 (0%)	0
Night Sweats	1/14 (7.1%)	1	0/10 (0%)	0
Weight Loss	1/14 (7.1%)	1	0/10 (0%)	0
Tiredness/fatigue	2/14 (14.3%)	3	0/10 (0%)	0
Weakness	2/14 (14.3%)	2	0/10 (0%)	0
Injury, poisoning and procedural complications
Fall resulting in fractured ribs	1/14 (7.1%)	1	0/10 (0%)	0
Musculoskeletal and connective tissue disorders
Back Pain	2/14 (14.3%)	2	1/10 (10%)	1
Hip pain	1/14 (7.1%)	1	0/10 (0%)	0
Leg pain	2/14 (14.3%)	2	0/10 (0%)	0
Thigh pain	1/14 (7.1%)	1	0/10 (0%)	0
Nervous system disorders
Migraine	1/14 (7.1%)	1	0/10 (0%)	0
Vasovagal episode	1/14 (7.1%)	1	0/10 (0%)	0
Renal and urinary disorders
Flank pain	6/14 (42.9%)	8	3/10 (30%)	4
Bladder spasms	0/14 (0%)	0	1/10 (10%)	2
Decreased renal function	1/14 (7.1%)	1	0/10 (0%)	0
Hematuria	1/14 (7.1%)	1	3/10 (30%)	3
Hydronephrosis	7/14 (50%)	8	0/10 (0%)	0
Renal colic	1/14 (7.1%)	1	0/10 (0%)	0
Ureterectasis	2/14 (14.3%)	2	0/10 (0%)	0
Urinary tract infections (UTI)	9/14 (64.3%)	19	4/10 (40%)	7
Urine leakage	0/14 (0%)	0	3/10 (30%)	6
Burning when urinating	0/14 (0%)	0	2/10 (20%)	2
Urinary urgency	0/14 (0%)	0	1/10 (10%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnea	1/14 (7.1%)	2	0/10 (0%)	0

Limitations/Caveats

Low number of subjects in each cohort.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.