Electrical Stimulation in Men With Urinary Incontinence After Radical Prostatectomy

NCT05236140 | Unknown DMC

• 1 other identifier: E-60116787-020-151348
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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)

Conditions

Electrical Stimulation

Keywords

perineal electrical stimulation; urinary incontinence; radical prostatectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• The severity of incontinence

  Posttreatment (8th week)

• Specific quality of life related to incontinence

  Posttreatment (8th week)

• The participation in social activities

  Posttreatment (8th week)

• The anxiety and depression

  Posttreatment (8th week)

• treatment satisfaction

  Posttreatment (8th week)

Study Arms (2)

Perineal electrical stimulation (Stimulation group)

EXPERIMENTAL

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.

Device: Perineal electrical stimulation

Control group

NO INTERVENTION

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.

Interventions

Perineal electrical stimulation DEVICE

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 (Stimulation group)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Hakan Alkan

Denizli, None Selected, 20100, Turkey (Türkiye)

RECRUITING

Related Publications (14)

• 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.

  PMID: 18381603 BACKGROUND

• 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.

  PMID: 10675166 BACKGROUND

• 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.

  PMID: 28464434 BACKGROUND

• 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.

  PMID: 19185977 BACKGROUND

• 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.

  PMID: 18384853 BACKGROUND

• 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.

  PMID: 25809925 BACKGROUND

• 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.

  PMID: 10233453 BACKGROUND

• 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.

  PMID: 15580472 BACKGROUND

• 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.

  PMID: 20850831 BACKGROUND

• 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.

  PMID: 11857671 BACKGROUND

• 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.

  PMID: 28345778 BACKGROUND

• 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.

  PMID: 15382185 BACKGROUND

• 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.

  PMID: 15270937 BACKGROUND

• 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.

  PMID: 36378836 DERIVED

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Necmettin Yıldız, Prof

  Pamukkale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hakan Alkan, Prof

CONTACT

05322666887; alkangsc@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 22, 2022
• First Posted: February 11, 2022
• Study Start: January 23, 2022
• Primary Completion: July 15, 2022
• Study Completion: July 30, 2022
• Last Updated: July 12, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)