NCT05771168

Brief Summary

The purpose of this observational prospective study is to evaluate the success rate (cure plus improvement) of procedures for treatment of male stress urinary incontinence (artificial urinary sphincter or male slings) at 5 years of study follow-up and to determine other outcomes of surgical treatment for each of the devices and, to perform a prognostic factor analysis to identify clinical and surgical variables that correlate with (in)continence or revisions for each of the device subtypes. Cure is defined as urinary continence with no need for use of pads or the use of 1 light security pad; the improvement is defined as the reduction of≥ 50% of the number of pads with use of no more than two pads.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
138

participants targeted

Target at P50-P75 for all trials

Timeline
17mo left

Started Sep 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress72%
Sep 2022Sep 2027

Study Start

First participant enrolled

September 29, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 16, 2023

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2027

Last Updated

March 16, 2023

Status Verified

February 1, 2023

Enrollment Period

5 years

First QC Date

February 3, 2023

Last Update Submit

March 5, 2023

Conditions

Male Stress Urinary Incontinence

Keywords

Urinary incontinenceMale incontinencePost-prostatectomy incontinenceRadical prostatectomyMale slingArtificial urinary sphincter

Outcome Measures

Primary Outcomes (1)

  • Success rate (cure plus improvement)

    Will be obtained through patient 24-hour pad use. Cure rate is defined as urinary continence with no need for use of pads or the use of 1 light security pad.

    5-years after surgery

Secondary Outcomes (6)

  • Time being continent

    12-weeks, 12-months, 2-years, 3-years, 4-years, 5-years

  • Time being revision-free

    12-weeks, 12-months, 2-years, 3-years, 4-years, 5-years

  • Revision-free rate

    5-years after surgery

  • Patient-reported quality of life

    12-weeks, 12-months, 2-years, 3-years, 4-years, 5-years

  • Post-operative general adverse events

    12-weeks, 12-months, 2-years, 3-years, 4-years, 5-years

  • +1 more secondary outcomes

Study Arms (2)

AUS

Male patients undergoing surgery for stress urinary incontinence using artificial urinary sphincter (AUS)

Device: Artificial urinary sphincter

Sling

Male patients undergoing surgery for stress urinary incontinence using slings

Device: Male sling

Interventions

Artificial urinary sphincterDEVICE

Implantation of peri-urethral artificial urinary sphincter

AUS
Male slingDEVICE

Retrourethral implantation of male sling

Sling

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult male patients undergoing surgery for treatment of stress urinary incontinence (AUS or male sling)

You may qualify if:

  • Male patients undergoing surgery for stress incontinence using medical devices such as AUS or sling
  • Participant is willing and able to complete the questionnaires and give informed consent for participation in the study

You may not qualify if:

  • \- Participant unable to complete the questionnaires and declining informed consent for participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Università Cattolica del Sacro Cuore, Fondazione Policlinico Agostino Gemelli

Roma, Rome, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Urinary Sphincter, ArtificialSuburethral Slings

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and SuppliesArtificial OrgansSurgical Equipment

Central Study Contacts

Emilio Sacco, Professor

CONTACT

+390630155290emilio.sacco@policlinicogemelli.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 3, 2023

First Posted

March 16, 2023

Study Start

September 29, 2022

Primary Completion (Estimated)

September 29, 2027

Study Completion (Estimated)

September 29, 2027

Last Updated

March 16, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)