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Electrical Stimulation in Men With Urinary Incontinence After Radical Prostatectomy

Primary Purpose

Electrical Stimulation

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Perineal electrical stimulation
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Electrical Stimulation focused on measuring perineal electrical stimulation, urinary incontinence, radical prostatectomy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18-80 years old
  2. Men with RP with incontinence over >8 gram / 24 hours and no residual cancer after RP on pathological examination.
  3. Patients within 2 weeks to 1 year after catheter removal
  4. Willingness to complete and do the quality of life scale
  5. Understanding procedures, benefits, and possible side effects
  6. Being able to give written, informed consent

Exclusion Criteria:

  1. UI history before RP
  2. History of conservative treatment after RP including ES
  3. Prolonged indwelling urethral catheterization (more than 15 days)
  4. Previous urological surgery history
  5. Transurethral resection of the prostate due to benign prostatic hyperplasia
  6. Patients receiving radiotherapy
  7. Presence of urethral stricture, and urinary tract infection
  8. Heart failure, presence of a pacemaker, implanted defibrillator
  9. Use of drugs that may affect bladder function (antimuscarinic, duloxetine, a tricyclic antidepressant, etc.)
  10. History of neurogenic bladder, peripheral or central neurological pathology
  11. Inability to attend treatment sessions due to distance or physical limitations

Sites / Locations

  • Hakan AlkanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Perineal electrical stimulation (Stimulation group)

Control group

Arm Description

Perineal electrical stimulation will be performed in lithotomy position via a stimulation device (Enraf Nonius Myomed 632) with perineal surface electrodes. Perineal electrical stimulation will be performed three days a week, 20 minutes a day, a total of 24 sessions for 8 weeks. The stimulation parameters are frequency at 50 Hz, a 5-10s work-rest cycle, and a 300ms pulse width. The symmetric biphasic pulse wave could be delivered over a range of 1-100mA (according to the patient's discomfort level feedback). In this application, three surface electrodes which had 2 cm diameters were used; two electrodes symmetrically at the perianal region (medial to ischial tuberosity); and one electrode at the leg (ground-neutral electrode). Surface electrodes will be used individually for each patient. Perineal electrical stimulation sessions will be performed by an experienced urogynecology rehabilitation nurse.

Subjects in the control group will go through baseline assessment and will not receive treatment or instructions to perform pelvic floor exercises at home. After 8 weeks they will be submitted to the final assessment. After the final evaluation, they will be invited to start treatment in the urogynecological rehabilitation unit.

Outcomes

Primary Outcome Measures

Continence rates
Continence is defined as the loss of 8 grams or less of urine during a 24-hour pad test in patients with urinary incontinence after radical prostatectomy.

Secondary Outcome Measures

The severity of incontinence
The 24-hour pad test will be carried out to evaluate the severity of incontinence
Specific quality of life related to incontinence
The Quality of Life-Incontinence Impact Questionnaire will be used to assess specific QoL related to incontinence (Minumum: 0 maximum:21) higher scores mean worse outcome
The participation in social activities
The Social Activity Index contains, a 10-cm visual analog scale in which men may have problems with participation in social activities (0, impossible to participate;10, no problem to participate) will be used.
The anxiety and depression
The Hospital anxiety and depression scale will be used to evaluate the anxiety and depressive symptoms.It consists of 14 items and two subscales and has been validated previously. It consists of 14 items each of which is scored 0-3 and two subscales each of which is included seven items, and has been validated previously. HADS anxiety and HADS depression scores were derived by summing the subscale items. Higher HADS anxiety and HADS depression scores indicate higher anxiety and depression levels, respectively.
treatment satisfaction
5-point Likert scale higher scores mean better outcome

Full Information

First Posted
January 22, 2022
Last Updated
July 11, 2022
Sponsor
Pamukkale University
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1. Study Identification

Unique Protocol Identification Number
NCT05236140
Brief Title
Electrical Stimulation in Men With Urinary Incontinence After Radical Prostatectomy
Official Title
Efficacy of Perineal Electrical Stimulation in Men With Urinary Incontinence After Radical Prostatectomy. A Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 23, 2022 (Actual)
Primary Completion Date
July 15, 2022 (Anticipated)
Study Completion Date
July 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Aim: In this study, the investigators aimed to assess the efficacy of perineal electrical stimulation on anxiety, depression, quality of life (QOL), and clinical parameters associated with incontinence in men with urinary incontinence after radical prostatectomy. Methods: This study is a prospective, randomized controlled trial. The investigators will recruit men who will be referred to the Urogynecological Rehabilitation Unit from other related outpatient clinics with complaints of urinary incontinence after radical prostatectomy. By using a random number generator, men will be randomized into two groups: as follows: perineal electrical stimulation (Group 1), and a control group. A random allocation sequence will be generated at a 1:1 ratio. The primary outcome measure is the continence rates, according to the literature. Furthermore, the severity of incontinence, incontinence episodes, social activity, anxiety, depression as well as QoL were secondary outcome measures. The 24-hour pad test will be carried out to evaluate the severity of incontinence. The Quality of Life-Incontinence Impact Questionnaire (IIQ7) will use to assess specific QoL related to incontinence. The Social Activity Index (SAI) contains, a 10-cm visual analog scale in which men may have problems with participation in social activities (0, impossible to participate;10, no problem to participate) will be used. The Hospital Anxiety and Depression scale (HADS) will use to evaluate the anxiety and depressive symptoms in men with UI after RP in the present study. In addition, treatment satisfaction will be evaluated. Men will evaluate the change in their urinary incontinence on a 5-point Likert scale (5, very satisfied; 1, very unsatisfied)
Detailed Description
Group 1: Perineal electrical stimulation (ES) Perineal ES will be performed in lithotomy position via a stimulation device (Enraf Nonius Myomed 632) with perineal surface electrodes. Perineal ES will be performed three days a week, 20 minutes a day, a total of 24 sessions for 8 weeks. The stimulation parameters are frequency at 50 Hz, a 5-10s work-rest cycle and a 300ms pulse width. The symmetric biphasic pulse wave could be delivered over a range of 1-100mA (according to the patient's discomfort level feedback). In this application, three surface electrodes which had 2 cm diameters will be used; two electrodes symmetrically at the perianal region (medial to ischial tuberosity); and one electrode at the leg (ground-neutral electrode). Surface electrodes will be used individually for each patient. Perineal ES sessions will be performed by an experienced urogynecology rehabilitation nurse. Men who missed any therapy sessions for the stimulation group will be excluded from the study. Group 2: No-treatment (Control group) Subjects in the control group will through baseline assessment and will not receive treatment or instructions to perform pelvic floor exercises at home. After 8 weeks they will submit to the final assessment. After the final evaluation, they will be invited to start treatment in the urogynecological rehabilitation unit. During the treatment, all men were advised to continue the medical treatment which is not related to incontinence. Evaluation Parameters The primary outcome measure will be accepted as the continence rates, according to literature. Continence was defined as the loss of 8 grams or less of urine during a 24-hour pad test in patients with urinary incontinence after radical prostatectomy. Furthermore, the severity of incontinence, incontinence episodes, social activity, anxiety, depression as well as QoL were secondary outcome measures. The 24-hour pad test will be carried out to evaluate the severity of incontinence. It will be used "incontinence episodes" from data collected with a 3-day bladder diary. Patients with a 50% or greater reduction in incontinence episodes will be considered improvement and absence of incontinence was considered dryness. The Quality of Life-Incontinence Impact Questionnaire (IIQ7) will be used to assess specific QoL related to incontinence. The Social Activity Index (SAI) contains, a 10-cm visual analog scale in which men may have problems with participation in social activities (0, impossible to participate;10, no problem to participate) was used. In addition, treatment satisfaction will be evaluated. Men evaluated the change in their UI on a 5-point Likert scale (5, very satisfied; 1, very unsatisfied). The Hospital Anxiety and Depression scale (HADS) will be used to evaluate the anxiety and depressive symptoms in men with UI after RP in the present study. It consists of 14 items and two subscales and has been validated previously. It consists of 14 items each of which is scored 0-3 and two subscales each of which is included seven items and has been validated previously. HADS anxiety (HADS-A) and HADS depression (HADS-D) scores could be derived by summing the subscale items. Higher HADS anxiety and HADS depression scores indicate higher anxiety and depression levels, respectively. Men with HADS anxiety scores ≥8 were classified as having anxiety, while those with HADS depression scores ≥8 were classified as having depression. The Cronbach's alpha coefficient of the HADS was found to be 0.94, indicating good reliability. All the evaluation tests will be performed by another physician who was blinded to the groups in the initial visit and at the end of the treatment (8th week), except for the continence rate, improvement rate, and the treatment satisfaction parameters which will be evaluated only at the 8th weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Electrical Stimulation
Keywords
perineal electrical stimulation, urinary incontinence, radical prostatectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Perineal electrical stimulation (Stimulation group)
Arm Type
Experimental
Arm Description
Perineal electrical stimulation will be performed in lithotomy position via a stimulation device (Enraf Nonius Myomed 632) with perineal surface electrodes. Perineal electrical stimulation will be performed three days a week, 20 minutes a day, a total of 24 sessions for 8 weeks. The stimulation parameters are frequency at 50 Hz, a 5-10s work-rest cycle, and a 300ms pulse width. The symmetric biphasic pulse wave could be delivered over a range of 1-100mA (according to the patient's discomfort level feedback). In this application, three surface electrodes which had 2 cm diameters were used; two electrodes symmetrically at the perianal region (medial to ischial tuberosity); and one electrode at the leg (ground-neutral electrode). Surface electrodes will be used individually for each patient. Perineal electrical stimulation sessions will be performed by an experienced urogynecology rehabilitation nurse.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Subjects in the control group will go through baseline assessment and will not receive treatment or instructions to perform pelvic floor exercises at home. After 8 weeks they will be submitted to the final assessment. After the final evaluation, they will be invited to start treatment in the urogynecological rehabilitation unit.
Intervention Type
Device
Intervention Name(s)
Perineal electrical stimulation
Intervention Description
Perineal electrical stimulation will be performed in lithotomy position via a stimulation device (Enraf Nonius Myomed 632) with perineal surface electrodes. Perineal electrical stimulation will be performed three days a week, 20 minutes a day, a total of 24 sessions for 8 weeks. The stimulation parameters are frequency at 50 Hz, a 5-10s work-rest cycle, and a 300ms pulse width. The symmetric biphasic pulse wave could be delivered over a range of 1-100mA (according to the patient's discomfort level feedback). In this application, three surface electrodes which had 2 cm diameters were used; two electrodes symmetrically at the perianal region (medial to ischial tuberosity); and one electrode at the leg (ground-neutral electrode). Surface electrodes will be used individually for each patient. Perineal electrical stimulation sessions will be performed by an experienced urogynecology rehabilitation nurse.
Primary Outcome Measure Information:
Title
Continence rates
Description
Continence is defined as the loss of 8 grams or less of urine during a 24-hour pad test in patients with urinary incontinence after radical prostatectomy.
Time Frame
Posttreatment (8th week)
Secondary Outcome Measure Information:
Title
The severity of incontinence
Description
The 24-hour pad test will be carried out to evaluate the severity of incontinence
Time Frame
Posttreatment (8th week)
Title
Specific quality of life related to incontinence
Description
The Quality of Life-Incontinence Impact Questionnaire will be used to assess specific QoL related to incontinence (Minumum: 0 maximum:21) higher scores mean worse outcome
Time Frame
Posttreatment (8th week)
Title
The participation in social activities
Description
The Social Activity Index contains, a 10-cm visual analog scale in which men may have problems with participation in social activities (0, impossible to participate;10, no problem to participate) will be used.
Time Frame
Posttreatment (8th week)
Title
The anxiety and depression
Description
The Hospital anxiety and depression scale will be used to evaluate the anxiety and depressive symptoms.It consists of 14 items and two subscales and has been validated previously. It consists of 14 items each of which is scored 0-3 and two subscales each of which is included seven items, and has been validated previously. HADS anxiety and HADS depression scores were derived by summing the subscale items. Higher HADS anxiety and HADS depression scores indicate higher anxiety and depression levels, respectively.
Time Frame
Posttreatment (8th week)
Title
treatment satisfaction
Description
5-point Likert scale higher scores mean better outcome
Time Frame
Posttreatment (8th week)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-80 years old Men with RP with incontinence over >8 gram / 24 hours and no residual cancer after RP on pathological examination. Patients within 2 weeks to 1 year after catheter removal Willingness to complete and do the quality of life scale Understanding procedures, benefits, and possible side effects Being able to give written, informed consent Exclusion Criteria: UI history before RP History of conservative treatment after RP including ES Prolonged indwelling urethral catheterization (more than 15 days) Previous urological surgery history Transurethral resection of the prostate due to benign prostatic hyperplasia Patients receiving radiotherapy Presence of urethral stricture, and urinary tract infection Heart failure, presence of a pacemaker, implanted defibrillator Use of drugs that may affect bladder function (antimuscarinic, duloxetine, a tricyclic antidepressant, etc.) History of neurogenic bladder, peripheral or central neurological pathology Inability to attend treatment sessions due to distance or physical limitations
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hakan Alkan, Prof
Phone
05322666887
Email
alkangsc@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Necmettin Yıldız, Prof
Organizational Affiliation
Pamukkale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hakan Alkan
City
Denizli
State/Province
None Selected
ZIP/Postal Code
20100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hakan Alkan, Prof
Email
alkangsc@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18381603
Citation
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Results Reference
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10675166
Citation
Van Kampen M, De Weerdt W, Van Poppel H, De Ridder D, Feys H, Baert L. Effect of pelvic-floor re-education on duration and degree of incontinence after radical prostatectomy: a randomised controlled trial. Lancet. 2000 Jan 8;355(9198):98-102. doi: 10.1016/S0140-6736(99)03473-X.
Results Reference
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PubMed Identifier
28464434
Citation
Gomes CS, Pedriali FR, Urbano MR, Moreira EH, Averbeck MA, Almeida SHM. The effects of Pilates method on pelvic floor muscle strength in patients with post-prostatectomy urinary incontinence: A randomized clinical trial. Neurourol Urodyn. 2018 Jan;37(1):346-353. doi: 10.1002/nau.23300. Epub 2017 May 2.
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Moore KN, Valiquette L, Chetner MP, Byrniak S, Herbison GP. Return to continence after radical retropubic prostatectomy: a randomized trial of verbal and written instructions versus therapist-directed pelvic floor muscle therapy. Urology. 2008 Dec;72(6):1280-6. doi: 10.1016/j.urology.2007.12.034. Epub 2008 Apr 2.
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derived

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Electrical Stimulation in Men With Urinary Incontinence After Radical Prostatectomy

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