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

NCT ID: NCT05236088

Last Updated: 2022-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-31

Study Completion Date

2023-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Urinary Incontinence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

NMES group

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

Group Type EXPERIMENTAL

Neuromuscular electrical stimulation application

Intervention Type DEVICE

It was applied with INNOVO brand (Atlantic Therapeutics, Galway, Ireland) device. It was applied for 30 minutes 3 days a week during 4 weeks

Sham group

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.

Group Type SHAM_COMPARATOR

Sham neuromuscular electrical stimulation application

Intervention Type DEVICE

Sham group will be applied from the same device, again 3 days a week for 30 minutes during 4 weeks, but no current will be given from the device.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Neuromuscular electrical stimulation application

It was applied with INNOVO brand (Atlantic Therapeutics, Galway, Ireland) device. It was applied for 30 minutes 3 days a week during 4 weeks

Intervention Type DEVICE

Sham neuromuscular electrical stimulation application

Sham group will be applied from the same device, again 3 days a week for 30 minutes during 4 weeks, but no current will be given from the device.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ankara Yildirim Beyazıt University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

seyda toprak celenay

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Seyda Toprak Celenay

Role: PRINCIPAL_INVESTIGATOR

Ankara Yildirim Beyazıt University

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Seyda Toprak Celenay

Role: CONTACT

+90312 906 1000

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2022/02/02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Use of Indocyanine Green in Robotic Prostate Surgeries
NCT05960149 NOT_YET_RECRUITING PHASE4
Physical Therapy for Men Undergoing Prostatectomy
NCT02558946 ACTIVE_NOT_RECRUITING NA