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Clinical Trials/NCT05127447
NCT05127447
Unknown
Not Applicable

Effects of External Electric Stimulating in Individuals With Urinary Incontinence After Prostatectomy

Ataturk Training and Research Hospital0 sites40 target enrollmentDecember 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Urinary Incontinence
Sponsor
Ataturk Training and Research Hospital
Enrollment
40
Primary Endpoint
UI symptoms
Last Updated
4 years ago

Overview

Brief Summary

The aim of this study is to investigate effects of external electric stimulating in individuals with urinary incontinence after prostatectomy.

Detailed Description

Urinary incontinence (UI) is common in men after prostotectomy, and patients' quality of life is adversely affected. In addition, electric stimulation (ES) can be played an important role in the management of UI . However, there are limitations in clearly demonstrating the effects of ES on men with UI after prostatectomy.

Registry
clinicaltrials.gov
Start Date
December 2021
End Date
December 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Ataturk Training and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Seyda TOPRAK CELENAY

associate professor

Ataturk Training and Research Hospital

Eligibility Criteria

Inclusion Criteria

  • Being a male individual with stress or stress-dominant mixed UI symptoms after undergoing prostatectomy surgery for prostate cancer in the urology clinic
  • Being over 40 years old
  • Being 24 and over with Mini Mental Test results in individuals over 65 years of age.
  • Not having residual cancerous tissue
  • Volunteering to participate in the study

Exclusion Criteria

  • Having serious cardiovascular disease (unstable angina and arrhythmia patients, heart failure patients, etc.)
  • Having sensory loss
  • Having an ongoing urinary infection
  • Having only urgency urinary incontinence
  • Using a pacemaker
  • Receiving active cancer treatment (radiotherapy, chemotherapy)
  • Lack of evaluation parameters
  • Not continuing the treatment regularly

Outcomes

Primary Outcomes

UI symptoms

Time Frame: change from baseline at 8 weeks

The ICIQ_SF is a UI questionnaire that evaluates symptom type and severity. It consists of 6 questions in total and the total score is 3., 4., 5. It is obtained by adding the scores they get from the questions

Pad Test

Time Frame: change from baseline at 8 weeks

A 1-hour pad test will be applied. Beginning with an empty bladder, a pre-weighed sanitary napkin will be inserted into the underwear. The patient will be asked to drink 500 ml of water within 15 minutes and then remain active for half an hour. Then, various activities will be made to the patient to provoke involuntary urine leakage with a full bladder. weight will be measured.

Secondary Outcomes

  • Life quality(change from baseline at 8 weeks)
  • Evaluation of Treatment Satisfaction(after treatment (8th week))
  • Evaluation of Subjective Improvement Perception(after treatment (8th week))
  • Sexual Function(change from baseline at 8 weeks)

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