Electrical StimulationNCT05236140
Electrical Stimulation in Men With Urinary Incontinence After Radical Prostatectomy
A study testing Perineal electrical stimulation in people with Electrical Stimulation, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Electrical Stimulation
- What is being tested?
- Perineal electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Jan 2022to 30 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hakan Alkan
Denizli, None Selected, 20100
Hakan Alkan, Prof, alkangsc@yahoo.com
About this study
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)
Read the 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.
- Conditions
- Electrical Stimulation
- Being tested
- Perineal electrical stimulation
- Keywords
- perineal electrical stimulation, urinary incontinence, radical prostatectomy
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perineal electrical stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Posttreatment (8th week)
Secondary outcomes (5)
The severity of incontinence
The 24-hour pad test will be carried out to evaluate the severity of incontinence
Measured: Posttreatment (8th week)
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
Measured: Posttreatment (8th week)
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.
Measured: Posttreatment (8th week)
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.
Measured: Posttreatment (8th week)
treatment satisfaction
5-point Likert scale higher scores mean better outcome
Measured: Posttreatment (8th week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start23 Jan 2022
- Primary completion15 Jul 2022 (estimated)
- Study completion30 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Electrical StimulationStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakan Alkan, Pamukkale University
- Investigators
- Necmettin Yıldız, Prof, Principal investigator, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05236140
- Sponsor's protocol ID
- E-60116787-020-151348
- Status last verified
- Jul 2022
- First submitted
- 22 Jan 2022
- Last updated
- 12 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18381603Van 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.
PubMed 10675166Gomes 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.
PubMed 28464434Ficarra 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.
PubMed 19185977Moore 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.
PubMed 18384853Pedriali 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.
PubMed 25809925Moore 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.
PubMed 10233453Hoffmann 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.
PubMed 15580472Yamanishi 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.
PubMed 20850831Abrams 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.
PubMed 11857671Ozlu 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.
PubMed 28345778Moore 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.
PubMed 15382185O'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.
PubMed 15270937Yildiz 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.
PubMed 36378836
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Perineal Electrical Stimulation in Men With Urinary Incontinence After Radical Prostatectomy. A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05236140
- Acronym / sponsor ID
- E-60116787-020-151348
- Conditions
- Electrical Stimulation
- Keywords
- perineal electrical stimulation, urinary incontinence, radical prostatectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 23 Jan 2022 (actual)
- Primary completion
- 15 Jul 2022 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 11 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perineal electrical stimulation (Stimulation group) | Experimental | Device: Perineal electrical stimulationPerineal 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 | 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perineal electrical stimulationPerineal 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 (Stimulation group) |
Primary outcome
Continence rates
Time frame: Posttreatment (8th week)
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.
5 secondary outcomes
The severity of incontinence
Time frame: Posttreatment (8th week)
Specific quality of life related to incontinence
Time frame: Posttreatment (8th week)
The participation in social activities
Time frame: Posttreatment (8th week)
The anxiety and depression
Time frame: Posttreatment (8th week)
treatment satisfaction
Time frame: Posttreatment (8th week)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- Background: PubMed 18381603Liu 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.
- Background: PubMed 10675166Van 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.
- Background: PubMed 28464434Gomes 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.
- Background: PubMed 19185977Ficarra 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.
- Background: PubMed 18384853Moore 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.
- Background: PubMed 25809925Pedriali 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.
- Background: PubMed 10233453Moore 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.
- Background: PubMed 15580472Hoffmann 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.
- Background: PubMed 20850831Yamanishi 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.
- Background: PubMed 11857671Abrams 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.
- Background: PubMed 28345778Ozlu 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.
- Background: PubMed 15382185Moore 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Necmettin Yıldız, Prof principal investigator
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perineal electrical stimulation in people with Electrical Stimulation, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hakan Alkan, Prof (05322666887, alkangsc@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continence rates (time frame: Posttreatment (8th week)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05236140, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2022.