NCT00270504

Brief Summary

The purpose of this study is to evaluate if the placement of a temporary urethral stent for up to 12 months, following dilation or internal urethrotomy (cutting open), results in a higher rate of urethral patency during the first year of follow-up when compared to the control group that does not receive a stent.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2002

Longer than P75 for phase_3

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

December 23, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 28, 2005

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

November 18, 2009

Status Verified

December 1, 2008

Enrollment Period

6.8 years

First QC Date

December 23, 2005

Last Update Submit

November 17, 2009

Conditions

Urethral Stricture

Keywords

MemokathUrethral strictureurethral stentBulbar urethral stricture

Outcome Measures

Primary Outcomes (1)

  • Stent/control effectiveness - urethral patency

    1 year

Secondary Outcomes (5)

  • Peak urinary flow rate

    Immediate

  • Re-intervention

    Short term

  • Standard survey instruments (QOL, IPSS etc.)

    15 mos

  • Stent placement success

    immediate

  • Stent removal success

    immediate

Interventions

Memokath stentingDEVICE

Urethral Stenting

Eligibility Criteria

Age21 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males \> 21 years of age
  • Recurrent stricture of the bulbar urethra:
  • \< 50 mm in length on urethrography; and which
  • has a segment unable to accommodate a 16Fr flexible cystoscope
  • Healthy tissue on both sides of stent
  • Urinary flow in the abnormal range of the Siroky nomogram.
  • Written informed consent obtained prior to participation in the study
  • Patients must be available for all follow-up visits.

You may not qualify if:

  • Strictures:
  • outside the bulbous urethra
  • associated with, or suspected to be, urethral carcinoma
  • secondary to pelvic distraction injuries
  • Inability to enlarge the bulbar urethral stricture to \> 26 Fr.
  • Presence of any other urologic implant
  • Presence of urethral diverticuli
  • History of hypospadias repair
  • Presence or prior history of balanitis xerotica obliterans.
  • Uncontrolled bleeding disorder
  • Active urinary tract infection
  • Any urological condition that would be likely to require additional urethral instrumentation during the period of the investigation, including, but not limited to, benign prostatic hypertrophy requiring treatment; use of alpha blockers; active prostate cancer; an unevaluated elevated prostate-specific antigen (PSA); bladder malignancy; or any recurrent urinary stone formation.
  • Serum creatinine \> 2.0 mg/dl or evidence of progressive renal disease
  • Concurrent participation in another clinical investigation
  • Current illness that might confound the results of this investigation
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Jack McAninch

San Francisco, California, 94110, United States

Location

Mississippi Urology

Jackson, Mississippi, 39202, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Bryn Mawr Urology

Bryn Mawr, Pennsylvania, 19010, United States

Location

University Urological Associates

Providence, Rhode Island, 02904, United States

Location

Devine-Tidewater Urology

Norfolk, Virginia, 23510, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Urethral Stricture

Condition Hierarchy (Ancestors)

Urethral ObstructionUrethral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Gerry Jordan, MD

    Sentara/Engineers and Doctors

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 23, 2005

First Posted

December 28, 2005

Study Start

December 1, 2002

Primary Completion

October 1, 2009

Study Completion

November 1, 2009

Last Updated

November 18, 2009

Record last verified: 2008-12

Locations

US(7)