NCT05236088

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 11, 2022

Completed
18 days until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

February 11, 2022

Status Verified

February 1, 2022

Enrollment Period

4 months

First QC Date

February 2, 2022

Last Update Submit

February 2, 2022

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

  • Urinary incontinence severity

    Urinary incontinence severity will be assess 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 50 grams is severe stress urinary incontinence.

    change from baseline at 4 weeks

Secondary Outcomes (5)

  • Presence of urinary incontinence symptoms

    change from baseline at 4 weeks

  • Life quality

    change from baseline at 4 weeks

  • Sexual function

    change from baseline at 4 weeks

  • Patients' subjective perception of improvement

    after treatment (4th week)

  • Patient satisfaction

    after treatment (4th week)

Study Arms (2)

NMES group

EXPERIMENTAL

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

Device: Neuromuscular electrical stimulation application

Sham group

SHAM COMPARATOR

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.

Device: Sham neuromuscular electrical stimulation application

Interventions

Neuromuscular electrical stimulation applicationDEVICE

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

NMES group
Sham neuromuscular electrical stimulation applicationDEVICE

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.

Sham group

Eligibility Criteria

Age40 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale with post-prostatectomy urinary incontinence
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Seyda Toprak Celenay

    Ankara Yildirim Beyazıt University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Seyda Toprak Celenay

CONTACT

+90312 906 1000sydtoprak@hotmail.com

Study Design

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

Study Record Dates

First Submitted

February 2, 2022

First Posted

February 11, 2022

Study Start

March 1, 2022

Primary Completion

July 1, 2022

Study Completion

March 1, 2023

Last Updated

February 11, 2022

Record last verified: 2022-02