The Spanner Prostatic Stent and Patient's Quality of Life

NCT01705444 | Completed DMC

• 1 other identifier: E-11-541
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

Acute urinary retention is considered one of the most common problems in the older age, especially those who have benign prostatic hyperplasia. Solving the problem of acute urinary retention using the Foley catheter still causes problems at the level of patient movement and the daily exercises. However, with the emergence of a new device, the spanner, investigators believe that many of the above mentioned problems can be resolved. This tool may provide more freedom for the patient.

Conditions

Prostatic Obstruction

Keywords

Urinary retention; Foley catheter; The Spanner; Quality of life

Outcome Measures

Primary Outcomes (1)

• Quality of life questionnaire after using the Foley catheter

  Using a validated Quality of life questionnaire designed for the study

  After five days

Secondary Outcomes (1)

• Quality of life questionnaire after using the spanner

  After five days

Other Outcomes (1)

• IPSS international prostate symptom score assessment

  After five days of using the Spanner

Study Arms (1)

Foley catheter and The Spanner Insertion

OTHER

Quality of life questionnaire after using the Foley catheter and the Spanner

Device: Foley Catheter and The Spanner Insertion

Interventions

Foley Catheter and The Spanner Insertion DEVICE

A Foley catheter will be inserted for 3-5 days, then a voiding trail will be attempted by the patient himself without the catheter. Then, the Spanner will be inserted into the same patient for another 3-5 days and an evacuation trail will be attempted also by the patient after removal of the Spanner. Treatment Satisfaction Questionnaire (TSQ) will be applied by the same person to the patient twice, once after removal of the Foley catheter and the second after removal of the Spanner.

Also known as: Foley Catheter, The Spanner

Foley catheter and The Spanner Insertion

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute Urinary retention due to Prostatic Obstruction

You may not qualify if:

• Subjects were excluded if they had prior surgery for prostate cancer, had any other urethral or bladder surgery, or if they were at high risk of developing bladder or kidney stones

Sponsors & Collaborators

• Princess Al-Johara Al-Ibrahim Cancer Research Center: lead

Study Sites (1)

Princess Al-Johara Cancer Research Center, Riyadh, Saudi Arabia

Riyadh, Riyadh Region, 11541, Saudi Arabia

Location

MeSH Terms

Conditions

Urinary Retention

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Danny M. Rabah, MD

  Princess Al-Johara Al-Ibrahim Cancer Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2012
• First Posted: October 12, 2012
• Study Start: March 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 31, 2016

Record last verified: 2012-10

Data Sharing

• IPD Sharing: Will share

Locations

SA (1)