NCT06098963

Brief Summary

to report our patients' outcomes of SNM in tertiary health centres in Turkey

Trial Health

100
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

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

January 1, 2017

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 25, 2023

Completed
Last Updated

October 25, 2023

Status Verified

October 1, 2023

Enrollment Period

5 years

First QC Date

October 15, 2023

Last Update Submit

October 22, 2023

Conditions

Sacral Neuromodulation

Keywords

Sacral neuromodulationOveractive bladderUrinary incontinenceFecal incontinenceLower urinary tract dysfunction

Outcome Measures

Primary Outcomes (1)

  • Recovery of urinary or fecal incontinence

    Significant decrease in urinary or fecal incontinence episode

    1 year

Secondary Outcomes (1)

  • increase in the score of ICIQ-SF questionnaire

    1 year

Interventions

sacral neuromodulationDEVICE

sacra neuromodulator implantation outcomes

Eligibility Criteria

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

Patients with urinary or faecal incontinence and interstitial cystitis who are unresponsible for medical therapy between the age of 18-85.

You may qualify if:

  • Patients diagnosed with urinary incontinence
  • Patients diagnosed with faecal incontinence
  • Patients diagnosed with interstitial cystitis

You may not qualify if:

  • Presence of urinary infection
  • Presence of previous incontinence surgery
  • Presence of 2nd motor neurone disease
  • Inability of detrusor muscle contraction activity
  • Previous radical cystoprostatectomy history
  • Presence of bladder outlet obstruction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urinary Bladder, OveractiveUrinary IncontinenceFecal Incontinence

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrination DisordersRectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated professor

Study Record Dates

First Submitted

October 15, 2023

First Posted

October 25, 2023

Study Start

January 1, 2017

Primary Completion

January 1, 2022

Study Completion

January 1, 2023

Last Updated

October 25, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share