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

Sacral Neuromodulation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06098963
• Other study ID #: CigliRTH
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: January 1, 2023

Study information

• Verified date: October 2023
• Source: Cigli Regional Training Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Sacral Neuromodulation

Intervention

Device:
• sacral neuromodulation
sacra neuromodulator implantation outcomes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cigli Regional Training Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery of urinary or fecal incontinence	Significant decrease in urinary or fecal incontinence episode	1 year
Secondary	increase in the score of ICIQ-SF questionnaire	improvement of quality of life and increase in the score of ICIQ-SF questionnaire	1 year