Sacral NeuromodulationNCT06098963
Preliminary Outcomes of Sacral Neuromodulation Applications; Tertiary-Center Experience in Turkey
An observational study of Sacral Neuromodulation, run by Cigli Regional Training Hospital.
Trial summary
to report our patients' outcomes of SNM in tertiary health centres in Turkey Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sacral Neuromodulation
- What is being tested?
- sacral neuromodulation
- Type of treatment
- Medical device
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 1 Jan 2023
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with urinary or faecal incontinence and interstitial cystitis who are unresponsible for medical therapy between the age of 18-85.
Who may be able to join
- Patients diagnosed with urinary incontinence
- Patients diagnosed with faecal incontinence
- Patients diagnosed with interstitial cystitis
Who cannot join
- 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
About this study
to report our patients' outcomes of SNM in tertiary health centres in Turkey
Read the 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.
- Conditions
- Sacral Neuromodulation
- Being tested
- sacral neuromodulation
- Keywords
- Sacral neuromodulation, Overactive bladder, Urinary incontinence, Fecal incontinence, Lower urinary tract dysfunction
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sacral neuromodulationDevice
sacra neuromodulator implantation outcomes
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of urinary or fecal incontinence
Significant decrease in urinary or fecal incontinence episode
Measured: 1 year
Secondary outcomes (1)
increase in the score of ICIQ-SF questionnaire
improvement of quality of life and increase in the score of ICIQ-SF questionnaire
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start1 Jan 2017
- Primary completion1 Jan 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacral NeuromodulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 16 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Cigli Regional Training Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Ozan Horsanalı, Cigli Regional Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098963
- Sponsor's protocol ID
- CigliRTH
- Status last verified
- Oct 2023
- First submitted
- 15 Oct 2023
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Outcomes of Sacral Neuromodulation Applications; Tertiary-Center Experience in Turkey
- ClinicalTrials.gov ID
- NCT06098963
- Acronym / sponsor ID
- CigliRTH
- Conditions
- Sacral Neuromodulation
- Keywords
- Sacral neuromodulation, Overactive bladder, Urinary incontinence, Fecal incontinence, Lower urinary tract dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Cigli Regional Training HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 25 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with urinary or faecal incontinence and interstitial cystitis who are unresponsible for medical therapy between the age of 18-85.
Key inclusion criteria (3 listed)
- Patients diagnosed with urinary incontinence
- Patients diagnosed with faecal incontinence
- Patients diagnosed with interstitial cystitis
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sacral neuromodulationsacra neuromodulator implantation outcomes | Device | – |
Primary outcome
Recovery of urinary or fecal incontinence
Time frame: 1 year
Significant decrease in urinary or fecal incontinence episode
1 secondary outcome
increase in the score of ICIQ-SF questionnaire
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Sacral Neuromodulation
Recruiting
Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction
Neurogenic Dysfunction of the Urinary Bladder, Multiple Sclerosis
RecruitingObservational study
Neuspera Revision Registry - Follow up Revision Experience and Evaluation of Device Outcomes Metrics
Urinary Urge Incontinence
Recruiting
Sacral Neuromodulation for Male Overactive Bladder (MOAB)
Overactive Bladder, Urinary Urgency Incontinence
RecruitingObservational study
Axonics R20 Post-Market Clinical Follow-up (PMCF) Study for the Indication of Fecal Incontinence
Fecal Incontinence
Not yet recruitingObservational study
Long-Term Effectiveness and Safety of Sacral Neuromodulation With InterStim for Lower Urinary Tract Dysfunction
Overactive Bladder (OAB), Urgency Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Sacral Neuromodulation, run by Cigli Regional Training Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery of urinary or fecal incontinence (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2023.