Preliminary Outcomes of Sacral Neuromodulation Applicatio... | NCT06098963

Studies
Preliminary Outcomes of Sacral Neuromodulation Applications; Tertiary-Center Experience in Turkey

NCT06098963

Sponsor

Cigli Regional Training Hospital

Status

Completed

Last Update Posted

Oct 25, 2023Actual

Enrollment

16Actual

Phase

Not provided

Conditions

Sacral Neuromodulation

Interventions

sacral neuromodulation

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2017Actual

Primary Completion Date

Jan 1, 2022Actual

Completion Date

Jan 1, 2023Actual

First Submitted Date

Oct 15, 2023

First Submission Date that Met QC Criteria

Oct 22, 2023

First Posted Date

Oct 25, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 22, 2023

Last Update Posted Date

Oct 25, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mustafa Ozan Horsanalı, Associated professor, Cigli Regional Training HospitalPrincipal Investigator

Lead Sponsor

Cigli Regional Training HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

We retrospectively analyzed 18 patients who underwent SNM for urinary or bowel dysfunction between 2017 and 2022 in our clinic. We excluded 2 patients due to non-effective responses after the test period. After local ethics committee approval was obtained from our institute (Number and date: 21-12.1T/14). Patient characteristics and demographic data including age, gender, indications to the SNM, age at diagnosis, and comorbidities were collected from our Hospital patients' record system. Urinary functions were evaluated by the ICIQ-SF questionnaire form. Patients' diagnosis, implantation duration, complications, and improvement of symptoms were recorded.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
sacral neuromodulation	Device	sacra neuromodulator implantation outcomes

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recovery of urinary or fecal incontinence	Significant decrease in urinary or fecal incontinence episode	1 year

Secondary Outcomes

Measure	Description	Time Frame
increase in the score of ICIQ-SF questionnaire	improvement of quality of life and increase in the score of ICIQ-SF questionnaire	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D053201	Urinary Bladder, Overactive
D014549	Urinary Incontinence
D005242	Fecal Incontinence

Ancestor Terms

ID	Term
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided