Effects of External Electrical Stimulating Applied on the Thigh in Men With Urinary Incontinence After Prostatectomy

Sponsor
Ankara Yildirim Beyazıt University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05432869
Collaborator
(none)
40
2
5

Study Details

Study Description

Brief Summary

The aim of this study is to investigate the effects of external electrical stimulation applied on the thigh on urinary symptoms, quality of life, sexual function, perception of subjective improvement and satisfaction in men with urinary incontinence after prostatectomy

Condition or Disease Intervention/Treatment Phase
  • Other: ES and lifestyle advices
  • Other: Lifestyle advices
N/A

Detailed Description

The most common complication after prostatectomy surgeries is urinary incontinence. There are conservative and surgical treatment options in post-prostatectomy urinary incontinence. One of the conservative treatment options is electrical stimulation application.

Electrical stimulation with the intraanal probe in men is painful and uncomfortable.

And also there are few studies, demonstrating the effects of electrical stimulation on urinary incontinence after prostatectomy in the literature.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of External Electrical Stimulating Applied on the Thigh in Men With Urinary Incontinence After Prostatectomy
Anticipated Study Start Date :
Jul 15, 2022
Anticipated Primary Completion Date :
Oct 15, 2022
Anticipated Study Completion Date :
Dec 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Electrical stimulation (ES) group

ES group will be given additional external electrical stimulation to the lifestyle advices.

Other: ES and lifestyle advices
The lifestyle advices include fluid consumption, diet, weight control, constipation, smoking, etc. External electrical stimulation will be applied for 30 minutes 3 days a week during 4 weeks. Electrodes were placed on the thighs.

Experimental: Control group

Control group will be given only lifestyle advices .

Other: Lifestyle advices
The lifestyle advices include fluid consumption, diet, weight control, constipation, smoking, etc.

Outcome Measures

Primary Outcome Measures

  1. Urinary incontinence severity [change from baseline at 4 weeks]

    Urinary incontinence severity will be assessed with a 1-hour pad test. This amount; less than 2 grams is considered normal, 2-10 grams is mild, 10-50 grams is moderate, and over 50 grams is severe stress urinary incontinence.

Secondary Outcome Measures

  1. Presence of urinary incontinence symptoms [change from baseline at 4 weeks]

    Urinary incontinence symptoms will be assessed with International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF). 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. A low score in the scale indicates that urinary incontinence symptoms are less.

  2. Life quality [change from baseline at 4 weeks]

    Life quality will be assessed with King Health Questionnaire. The questionnaire, consisting of thirty-two items, consists of 2 parts. In the first part, there are 2 questions questioning the general health perception and incontinence effect, and 19 questions dividing the quality of life into 7 areas (role limitations, physical limitations, social limitations, personal relationships, emotional problems, sleep/energy disorders, symptom severity measurement). In the second part, there are 11-item complaint severity scales that evaluate the presence and severity of urinary symptoms. While the best score that can be obtained on the complaint severity scale is "0", the worst score is "30", the best score that can be obtained for all King Health Questionnaire subsections is "0" and the worst score is "100".

  3. Sexual function [change from baseline at 4 weeks]

    Sexual function will be assessed with International Index of Erectile Function-5. It includes 5 main topics; erectile function, orgasm function, sexual desire, sexual intercourse satisfaction and general satisfaction are questioned with a total of 5 questions. Each question gets a score between 0-5. Total score; severe (5-7), moderate (8-11), mild-moderate (12-16), mild (17-21), no erectile dysfunction (22-25)

  4. Perception of Subjective Improvement [after treatment (4th week)]

    Patients' subjective perception of improvement will be questioned with a 4-point Likert scale (worse (1), same (2), better (3) and completely cured (4))

  5. Patients Satisfaction [after treatment (4th week)]

    Patient satisfaction will be questioned with a 5-point Likert scale (not at all satisfied (1), dissatisfied (2), undecided (3), satisfied (4), very satisfied (5))

  6. Compliance with Lifestyle Advices [after treatment (4th week)]

    Compliance of patients to the lifestyle advices will be evaluated using a 100-mm visual analog scale.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Being a male individual with stress or stress-dominant mixed urinary incontinence symptoms after undergoing prostatectomy surgery

  • Being over 40 years old

  • 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)

  • Those who have a problem that interferes with cooperation and understanding

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Ankara Yildirim Beyazıt University

Investigators

  • Principal Investigator: Seyda Toprak Celenay, Ankara Yildirim Beyazıt University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
seyda toprak celenay, associate professor, Ankara Yildirim Beyazıt University
ClinicalTrials.gov Identifier:
NCT05432869
Other Study ID Numbers:
  • 2022/06/22
First Posted:
Jun 27, 2022
Last Update Posted:
Jun 27, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 27, 2022