Electrical Stimulation Clinical Trial
Official title:
Efficacy of Perineal Electrical Stimulation in Men With Urinary Incontinence After Radical Prostatectomy. A Prospective Randomized Controlled Trial
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)
Status | Recruiting |
Enrollment | 60 |
Est. completion date | July 30, 2022 |
Est. primary completion date | July 15, 2022 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Hakan Alkan | Denizli | None Selected |
Lead Sponsor | Collaborator |
---|---|
Pamukkale University |
Turkey,
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. — View Citation
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. Review. — View 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. — View Citation
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. German. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Özlü A, Yildiz N, Öztekin Ö. 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. — View Citation
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. — View 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. — View Citation
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. — View Citation
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Posttreatment (8th week) | |
Secondary | The severity of incontinence | The 24-hour pad test will be carried out to evaluate the severity of incontinence | Posttreatment (8th week) | |
Secondary | 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 | Posttreatment (8th week) | |
Secondary | 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. | Posttreatment (8th week) | |
Secondary | 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. | Posttreatment (8th week) | |
Secondary | treatment satisfaction | 5-point Likert scale higher scores mean better outcome | Posttreatment (8th week) |
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