NCT03959917

Brief Summary

This study aims to investigate the impact of transurethral prostate resection in regard to complications. These are direct surgical complications, such as bleeding, infection and readmissions, as well as the long term complications as incontinence and impotence. Also, the study aims to investigate if selected cases of patients could be performed as outpatient surgery, thereby reducing cost.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
unknown

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

May 15, 2019

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 22, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

May 24, 2019

Status Verified

May 1, 2019

Enrollment Period

9 months

First QC Date

May 21, 2019

Last Update Submit

May 23, 2019

Conditions

Benign Prostatic Hyperplasia

Keywords

prostateresectionincontinenceerectile dysfunction

Outcome Measures

Primary Outcomes (2)

  • Proportion of patients able to be discharged the day of surgery

    One day

  • Proportion of patients readmitted to hospital the first day of surgery

    One day

Secondary Outcomes (5)

  • Change in IPSS score

    6 months

  • Number of patients with cancer in surgical specimen

    6 months

  • Readmission rates within 30 days of surgery

    30 days

  • Complications

    30 days

  • Proportion catheter free

    6 months

Interventions

transurethral resection of the prostatePROCEDURE

Surgical removal of benign prostatic tissue

Also known as: TUR P

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This is a feasibility cohort study. All patients planned for TUR P are eligible. Patients in the ambulatory group have prostate size less than 50 cc and ASA score less less than 4 and ser under 80 years of age. This is clinical routine at the study site.

You may qualify if:

  • Planned for transurethral resection of the prostate (TUR P)

You may not qualify if:

  • No consent to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Östersunds hospital

Östersund, Jämtland County, 83133, Sweden

RECRUITING

MeSH Terms

Conditions

Prostatic HyperplasiaErectile Dysfunction

Interventions

Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesSexual Dysfunction, PhysiologicalSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

ProstatectomyUrologic Surgical Procedures, MaleUrologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2019

First Posted

May 22, 2019

Study Start

May 15, 2019

Primary Completion

February 15, 2020

Study Completion

September 30, 2020

Last Updated

May 24, 2019

Record last verified: 2019-05

Locations

SE(1)