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The Effects of Neuromuscular Electrical Stimulation in Individuals With Urinary Incontinence After Prostatectomy

A

Ankara Yildirim Beyazıt University

Status

Unknown

Conditions

Urinary Incontinence

Treatments

Device: Neuromuscular electrical stimulation application
Device: Sham neuromuscular electrical stimulation application

Study type

Interventional

Funder types

Other

Identifiers

NCT05236088
2022/02/02

Details and patient eligibility

About

The aim of this study is to investigate the effects of neuromuscular electric stimulation on urinary symptoms, quality of life, sexual function, perception of improvement and patient satisfaction in individuals with post-prostatectomy urinary incontinence

Full description

One of the two most common complications after prostatectomy surgeries is urinary incontinence (UI) and the other is erectile dysfunction. There are conservative and surgical treatment options in post-prostatectomy urinary incontinence. One of the conservative treatment options is neuromuscular electrical stimulation application. Since electrical stimulation applications, used in the treatment of post-prostatectomy urinary incontinence, are usually given together with other treatment protocols, there are limitations in clearly demonstrating the effects of neuromuscular electrical stimulation on post-prostatectomy urinary incontinence.

Enrollment

50 estimated patients

Sex

Male

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Being a male individual with stress or stress-dominant mixed urinary incontinence symptoms after undergoing prostatectomy surgery in the urology clinic
  • Being over 40 years old
  • Volunteering to participate in the study

Exclusion criteria

  • Severe cardiovascular disease (unstable angina and arrhythmia patients, heart failure patients ect.)
  • Those with sensory loss
  • Presence of ongoing urinary infection
  • Only urgency urinary incontinence
  • Having a pacemaker
  • Active cancer treatment (radiotherapy, chemotherapy),
  • Those who have undergone Transurethral Prostatectomy (TUR-P) surgery
  • Those who have a problem that interferes with cooperation and understanding

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

NMES group
Experimental group
Description:
Neuromuscular electrical stimulation (NMES) will be applied with INNOVO brand (Atlantic Therapeutics, Galway, Ireland) device for 30 minutes 3 days a week during 4 weeks
Treatment:
Device: Neuromuscular electrical stimulation application
Sham group
Sham Comparator group
Description:
Sham group will be applied from the same device (INNOVO brand (Atlantic Therapeutics, Galway, Ireland)), for 3 days a week for 30 minutes during 4 weeks, but no current will be given from the device.
Treatment:
Device: Sham neuromuscular electrical stimulation application

Trial contacts and locations

0

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Central trial contact

Seyda Toprak Celenay

Data sourced from clinicaltrials.gov

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