NCT04363970

Brief Summary

Transurethral resection of prostate is the gold standard operation for bladder outflow obstruction due to benign prostatic enlargement. However, catheter removal day is variable. The objective of this study is to compare early and delayed catheter removal groups in terms of, urinary retention after catheter removal, length of hospital stay, weight of resected prostate, duration of resection, peri-operative blood transfusion, and postoperative complications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 27, 2020

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

August 20, 2021

Status Verified

August 1, 2021

Enrollment Period

10 months

First QC Date

April 16, 2020

Last Update Submit

August 18, 2021

Conditions

Keywords

Benign Prostate HyperplasiaUrinary retentionRe-catheterization

Outcome Measures

Primary Outcomes (1)

  • urinary retention

    inability to void

    after 3 months.

Secondary Outcomes (1)

  • Lower urinary tract symptoms

    after 3 months.

Study Arms (2)

group A- early catheter removal)

in group A, we will remove the catheter after 24 h.

Other: removal of the urinary catheter

Group B- delayed catheter removal

In group B, we will remove the catheter after 48 h.

Other: removal of the urinary catheter

Interventions

in group A, we will remove the catheter after 24 h. In group B, we will remove the catheter after 48 h.

Group B- delayed catheter removalgroup A- early catheter removal)

Eligibility Criteria

Age45 Years - 90 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

200 adult males from urology clinic atJordan university hospital, with benign prostate hyperplasia who undergo trans-urethral resection of the prostae will be included in this study,

You may qualify if:

  • \- All men with benign prostate hyperplasia who planned to undergo TURP will be included in this study.

You may not qualify if:

  • Large post void residual urine.
  • Simultaneous internal urethrotomy and TURP.
  • Uncontrolled Diabetes Mellitus (DM).
  • Cerebrovascular accident accident (CVA).
  • Spinal cord injury.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saddam Al Demour

Amman, 11942, Jordan

Location

Related Publications (1)

  • Demour SA, Al-Zubi MT, Ababneh M, Al-Rawashdah SF, Ahmad M. A randomized clinical trial: timing of indwelling urethral catheter removal following transurethral resection of prostate. Future Sci OA. 2024 May 20;10(1):FSO927. doi: 10.2144/fsoa-2023-0195. eCollection 2024.

MeSH Terms

Conditions

Urinary RetentionProstatic Hyperplasia

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesProstatic DiseasesGenital Diseases, MaleGenital Diseases

Study Officials

  • Saddam Al Demour, MD

    Jordan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 16, 2020

First Posted

April 27, 2020

Study Start

June 30, 2019

Primary Completion

April 30, 2020

Study Completion

April 30, 2021

Last Updated

August 20, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations