Clinical trial NCT05236140: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Electrical Stimulation
Keywords: perineal electrical stimulation
urinary incontinence
radical prostatectomy
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2022-02-11
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Continence rates
timeFrame: Posttreatment (8th week)
Secondary outcomes:
measure: The severity of incontinence
timeFrame: Posttreatment (8th week)
measure: Specific quality of life related to incontinence
timeFrame: Posttreatment (8th week)
measure: The participation in social activities
timeFrame: Posttreatment (8th week)
measure: The anxiety and depression
timeFrame: Posttreatment (8th week)
measure: treatment satisfaction
timeFrame: Posttreatment (8th week)
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Hakan Alkan
state: None Selected
Study officials:
affiliation: Pamukkale University
name: Necmettin Yıldız, Prof
role: PRINCIPAL_INVESTIGATOR
References:
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