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

• Sponsor: Cigli Regional Training Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT06098963
• Collaborator: (none)
• Enrollment: 16
• Actual Duration (Months): 72

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Sacral Neuromodulation	Device: sacral neuromodulation

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

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 16 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Preliminary Outcomes of Sacral Neuromodulation Applications; Tertiary-Center Experience in Turkey
• Actual Study Start Date: Jan 1, 2017
• Actual Primary Completion Date: Jan 1, 2022
• Actual Study Completion Date: Jan 1, 2023

Outcome Measures

Primary Outcome Measures

1. Recovery of urinary or fecal incontinence [1 year]

   Significant decrease in urinary or fecal incontinence episode

Secondary Outcome Measures

1. increase in the score of ICIQ-SF questionnaire [1 year]

   improvement of quality of life and increase in the score of ICIQ-SF questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Cigli Regional Training Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mustafa Ozan Horsanalı, Associated professor, Cigli Regional Training Hospital
• ClinicalTrials.gov Identifier: NCT06098963
• Other Study ID Numbers: CigliRTH
• First Posted: Oct 25, 2023
• Last Update Posted: Oct 25, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mustafa Ozan Horsanalı, Associated professor, Cigli Regional Training Hospital: Sacral neuromodulation; Overactive bladder; Urinary incontinence; Fecal incontinence; Lower urinary tract dysfunction

Study Results

No Results Posted as of Oct 25, 2023