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

October 22, 2023 updated by: Mustafa Ozan Horsanalı, Cigli Regional Training Hospital
to report our patients' outcomes of SNM in tertiary health centres in Turkey

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

16

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cigli Regional Training Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

January 1, 2022

Study Completion (Actual)

January 1, 2023

Study Registration Dates

First Submitted

October 15, 2023

First Submitted That Met QC Criteria

October 22, 2023

First Posted (Actual)

October 25, 2023

Study Record Updates

Last Update Posted (Actual)

October 25, 2023

Last Update Submitted That Met QC Criteria

October 22, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CigliRTH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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