Electrical Stimulation in Men With Urinary Incontinence After Radical Prostatectomy
NCT ID: NCT05236140
Last Updated: 2022-07-12
Study Results
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Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2022-01-23
2022-07-30
Brief Summary
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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)
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Perineal electrical stimulation (Stimulation group)
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.
Perineal electrical stimulation
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.
Control group
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.
No interventions assigned to this group
Interventions
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Perineal electrical stimulation
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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
80 Years
MALE
No
Sponsors
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Pamukkale University
OTHER
Responsible Party
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Hakan Alkan
Clinical Professor
Principal Investigators
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Necmettin Yıldız, Prof
Role: PRINCIPAL_INVESTIGATOR
Pamukkale University
Locations
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Hakan Alkan
Denizli, None Selected, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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Liu L, Coker AL, Du XL, Cormier JN, Ford CE, Fang S. Long-term survival after radical prostatectomy compared to other treatments in older men with local/regional prostate cancer. J Surg Oncol. 2008 Jun 1;97(7):583-91. doi: 10.1002/jso.21028.
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.
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.
Ficarra V, Novara G, Artibani W, Cestari A, Galfano A, Graefen M, Guazzoni G, Guillonneau B, Menon M, Montorsi F, Patel V, Rassweiler J, Van Poppel H. Retropubic, laparoscopic, and robot-assisted radical prostatectomy: a systematic review and cumulative analysis of comparative studies. Eur Urol. 2009 May;55(5):1037-63. doi: 10.1016/j.eururo.2009.01.036. Epub 2009 Jan 25.
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.
Pedriali FR, Gomes CS, Soares L, Urbano MR, Moreira EC, Averbeck MA, de Almeida SH. Is pilates as effective as conventional pelvic floor muscle exercises in the conservative treatment of post-prostatectomy urinary incontinence? A randomised controlled trial. Neurourol Urodyn. 2016 Jun;35(5):615-21. doi: 10.1002/nau.22761. Epub 2015 Mar 21.
Moore KN, Griffiths D, Hughton A. Urinary incontinence after radical prostatectomy: a randomized controlled trial comparing pelvic muscle exercises with or without electrical stimulation. BJU Int. 1999 Jan;83(1):57-65. doi: 10.1046/j.1464-410x.1999.00894.x.
Hoffmann W, Liedke S, Dombo O, Otto U. [Electrostimulation in therapy of postoperative urinary incontinence. Therapeutic value for quality of life]. Urologe A. 2005 Jan;44(1):33-40. doi: 10.1007/s00120-004-0732-1. German.
Yamanishi T, Mizuno T, Watanabe M, Honda M, Yoshida K. Randomized, placebo controlled study of electrical stimulation with pelvic floor muscle training for severe urinary incontinence after radical prostatectomy. J Urol. 2010 Nov;184(5):2007-12. doi: 10.1016/j.juro.2010.06.103. Epub 2010 Sep 20.
Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78. doi: 10.1002/nau.10052. No abstract available.
Ozlu A, Yildiz N, Oztekin O. Comparison of the efficacy of perineal and intravaginal biofeedback assisted pelvic floor muscle exercises in women with urodynamic stress urinary incontinence. Neurourol Urodyn. 2017 Nov;36(8):2132-2141. doi: 10.1002/nau.23257. Epub 2017 Mar 27.
Moore K, Allen M, Voaklander DC. Pad tests and self-reports of continence in men awaiting radical prostatectomy: establishing baseline norms for males. Neurourol Urodyn. 2004;23(7):623-6. doi: 10.1002/nau.20067.
O'Sullivan R, Karantanis E, Stevermuer TL, Allen W, Moore KH. Definition of mild, moderate and severe incontinence on the 24-hour pad test. BJOG. 2004 Aug;111(8):859-62. doi: 10.1111/j.1471-0528.2004.00211.x.
Yildiz N, Celen S, Ozlulerden Y, Alkan H. Efficacy of perineal electrical stimulation in men with urinary incontinence after radical prostatectomy. A prospective randomized controlled trial. Neurourol Urodyn. 2023 Jan;42(1):340-348. doi: 10.1002/nau.25096. Epub 2022 Nov 15.
Other Identifiers
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E-60116787-020-151348
Identifier Type: -
Identifier Source: org_study_id
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