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

NCT05127447 | Unknown

• 1 other identifier: 2021/11/17
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (2)

• Pad Test

  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.

  change from baseline at 8 weeks

• UI symptoms

  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

  change from baseline at 8 weeks

Secondary Outcomes (4)

• Life quality

  change from baseline at 8 weeks

• Sexual Function

  change from baseline at 8 weeks

• Evaluation of Subjective Improvement Perception

  after treatment (8th week)

• Evaluation of Treatment Satisfaction

  after treatment (8th week)

Study Arms (2)

ES group

EXPERIMENTAL

External neuromuscular electrical stimulation was applied to the patients in supine position. It was applied for 30 minutes 3 days a week for 8 weeks. This stimulation consists of a total of eight external electrodes, including 2 sheaths wrapped around the thigh area and 4 electrodes for each leg. Electrodes were placed on the anterior and posterior proximal thighs, buttocks, and outside of the hips. The treatment protocol was applied with symmetrical biphasic current at a frequency of 50 Hertz (Hz), with stimulation and rest periods of 5 seconds of contraction and 5 seconds of rest.

Device: ES application

Sham group

SHAM COMPARATOR

In the Sham group, for 45 minutes, 2 days a week, a vacuum electrode was connected from combined vacuum electrotherapy device over the pelvis and thigh, and only vacuum was applied while the patient was in the supine position, and no current was given from the applied device.

Other: Sham application

Interventions

ES application DEVICE

Electrical stimulation (ES) application will be given to the ES group

ES group

Sham application OTHER

Only vacuum was applied and no current was given from the applied device

Sham group

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: Participants with post-prostatectomy urinary incontinence
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ataturk Training and Research Hospital: lead

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Seyda Toprak Celenay

  Ankara Yildirim Beyazıt University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seyda Toprak Celenay

CONTACT

+90312 906 1000; sydtoprak@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Model Details: Participants will be randomly divided into two groups (such as ES and sham groups)

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: November 19, 2021
• Study Start: December 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: December 1, 2022
• Last Updated: November 19, 2021

Record last verified: 2021-11