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OpenTrials
Completed

NCT Number: NCT06098963

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

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

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Key information

Conditions

Sacral Neuromodulation Digestive System Diseases Fecal Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Intestinal Diseases Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Rectal Diseases Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sacral Neuromodulation

Device

sacra neuromodulator implantation outcomes

Primary outcomes

  1. Recovery of urinary or fecal incontinence

    Time frame: 1 year

    Significant decrease in urinary or fecal incontinence episode

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Cigli Regional Training Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2022
Study completion
2023
First posted
Oct 25, 2023
Registry last updated
Oct 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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