Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06200987
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2023-12-29
Brief Title:
Penile Vibratory Stimulation in the Prevention of Sexual Dysfunction and Urinary Incontinence After Radical Prostatectomy
Sponsor:
Herlev and Gentofte Hospital
Organization:
Herlev and Gentofte Hospital
Study Overview
Official Title:
Planned Penile Vibratory Stimulation in the Prevention of Sexual Dysfunction and Urinary Incontinence After Radical Prostatectomy a Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To investigate if post-operative penile vibration stimulation kan be used to reduce or prevent sexual dysfunction and urinary incontinence after radical prostatectomy This will be done in a randomized controlled non-blinded study Men that undergo nerve preserving surgery for prostate cancer is allocated into an intervention group and a control group A total of 100 men will be included for a power of 80 The intervention group will be instructed to use the Ferticare 20 vibrator for at least five minutes a day with an amplitude of 1 mm and frequency of 90 Hz these settings were found in a pilot study for a total of 9 months
Both groups will do the standard pelvic floor training program and both groups will be offered regular phosphodiesterase-5-inhibitor treatment Before surgery 3 6 and 10 months after the patients will have to fill out four different questionnaires regarding sexual and urinary function including IIEF-EF EHS neglected side effects and ICIQ-SF 10 months is due to a wash-out period of 1 month after the intervention
The collected data will be analysed and the primary goal is to see if there is a significant difference in average spontaneous IIEF-EF score in the two groups 10 months after the surgery
Both groups will do the standard pelvic floor training program and both groups will be offered regular phosphodiesterase-5-inhibitor treatment Before surgery 3 6 and 10 months after the patients will have to fill out four different questionnaires regarding sexual and urinary function including IIEF-EF EHS neglected side effects and ICIQ-SF 10 months is due to a wash-out period of 1 month after the intervention
The collected data will be analysed and the primary goal is to see if there is a significant difference in average spontaneous IIEF-EF score in the two groups 10 months after the surgery
Detailed Description:
Hypothesis The studys hypothesis is that vibration therapy using the stimulation parameters found in the pilot study will have a beneficial effect on erectile function orgasm disturbances penile shortening and urinary incontinence both generally and in connection with sexual activity
Methods The study is conducted as a randomized controlled non-blinded study Men undergoing a nerve-sparing operation for prostate cancer are divided into two groups A total of 100 men will be included in the study In case a surgery cannot be performed with nerve preservation or if a participant experiences a recurrence of their prostate cancer requiring additional treatment the participant will be withdrawn from the study
Randomization and Treatment Overall we will investigate the effect of vibration stimulation on erectile function orgasm disturbances penile shortening and urinary incontinence both generally and in connection with sexual activity In accordance with the hypotheses this study will offer vibration therapy for a longer duration than before Both the vibration group and the control group will be offered fixed post-operative treatment with phosphodiesterase-5-inhibitors as per the standard protocol Participants will be randomized into the two groups through drawing lots for either vibration or no vibration Randomization will be done using block randomization via a computer-generated list The Ferticare 20 vibrator produced by the company Reflexonic LLC Leesburg VA USA will be used in the study which is a modernized version of the previously used vibrator and is sold as a sexual aid in Denmark It is safety-approved with European CE marking as a household appliance and is sold as a sexual aid in Denmark Men in the vibration group will be instructed on the stimulation before their prostate surgery Subsequently participants will be able to perform the vibration therapy themselves at home In both groups participants must undergo a standard pelvic floor training program and both groups will be offered fixed PDE-5 inhibitor treatment in the form of daily tadalafil 5 mg as the standard treatment for erectile difficulties after the operation In the vibration group daily stimulation will be directed towards the frenulum for a minimum of 5 minutes with an amplitude of 1 mm and a frequency of 90 Hz as found in the pilot study Participants will start getting used to the vibration 1-4 weeks before the surgery and resume it within 14 days after the operation The daily stimulation will continue for a period of 9 months along with the standard treatment After these 9 months men in both groups will stop taking tadalafil during a 4-week wash-out period after which their spontaneous sexual function will be evaluated This is necessary due to the well-known positive effect of the medication In comparison to the standard treatment in the department offering vibration to half of the participants is an addition Regarding pelvic floor training and medication for erectile difficulties for all study participants the current standard is to offer these to all men who have undergone nerve-sparing radical prostatectomy This will proceed as usual and the only deviation from usual practice is ensuring that the medication offer is consistent for all participants The mentioned 4-week period without tablet treatment wash-out is necessary to assess spontaneous erections This is a deviation from the normal standard as such a wash-out is not conducted for patients who do not participate in research but it will not affect the actual erectile function of the participants in either group
Data Collection
Standard investigations related to prostate cancer will be conducted according to normal guidelines with the registration of
Pre-operative PSA
Clinical and pathological tumor stage
Gleason score
Prostate size
Degree of nerve preservation during the surgery
Any complications during the surgery
Resection margin status positive or negative
PSA measurements at 3 6 and 12 months after the operation This information will be obtained from the patients medical records by the scientific staff after the study participants have given their consent to participate After providing consent the study organizers sponsor sponsors representatives and any regulatory authorities will have direct access to obtain information from the patients medical records including electronic records for the purpose of reviewing information about the research participants health as necessary for conducting the research project and for monitoring including self-monitoring quality control and oversight as they are obligated to perform
Since potential participants are screened and informed about the project during their visits to the outpatient clinic see the section on Recruitment of Study Participants and Informed Consent there is no need to obtain information from the patients medical records before consent is given At this stage the research team only receives the name social security number and contact information for patients who have expressed interest in the project
Additional examinations are carried out before the surgery and at follow-ups at 3 months 6 months and 10 months equivalent to the end of the wash-out period after the surgery with the registration of the following for all participants in both the vibration group and the control group
Before the surgery and at follow-ups
Validated symptom questionnaires for erectile function IIEF-EF and EHS
Specific questionnaire about orgasm disturbances penile shortening and urinary incontinence during sexual activity
Validated symptom questionnaire for incontinence symptoms ICIQ-SF
24-hour pad weighing test only at follow-ups for men who are not fully continent
Additional registrations at follow-ups
Registration of PSA recurrence after the surgery and noting any additional treatment
Any side effects of vibration and standard treatment
Methods The study is conducted as a randomized controlled non-blinded study Men undergoing a nerve-sparing operation for prostate cancer are divided into two groups A total of 100 men will be included in the study In case a surgery cannot be performed with nerve preservation or if a participant experiences a recurrence of their prostate cancer requiring additional treatment the participant will be withdrawn from the study
Randomization and Treatment Overall we will investigate the effect of vibration stimulation on erectile function orgasm disturbances penile shortening and urinary incontinence both generally and in connection with sexual activity In accordance with the hypotheses this study will offer vibration therapy for a longer duration than before Both the vibration group and the control group will be offered fixed post-operative treatment with phosphodiesterase-5-inhibitors as per the standard protocol Participants will be randomized into the two groups through drawing lots for either vibration or no vibration Randomization will be done using block randomization via a computer-generated list The Ferticare 20 vibrator produced by the company Reflexonic LLC Leesburg VA USA will be used in the study which is a modernized version of the previously used vibrator and is sold as a sexual aid in Denmark It is safety-approved with European CE marking as a household appliance and is sold as a sexual aid in Denmark Men in the vibration group will be instructed on the stimulation before their prostate surgery Subsequently participants will be able to perform the vibration therapy themselves at home In both groups participants must undergo a standard pelvic floor training program and both groups will be offered fixed PDE-5 inhibitor treatment in the form of daily tadalafil 5 mg as the standard treatment for erectile difficulties after the operation In the vibration group daily stimulation will be directed towards the frenulum for a minimum of 5 minutes with an amplitude of 1 mm and a frequency of 90 Hz as found in the pilot study Participants will start getting used to the vibration 1-4 weeks before the surgery and resume it within 14 days after the operation The daily stimulation will continue for a period of 9 months along with the standard treatment After these 9 months men in both groups will stop taking tadalafil during a 4-week wash-out period after which their spontaneous sexual function will be evaluated This is necessary due to the well-known positive effect of the medication In comparison to the standard treatment in the department offering vibration to half of the participants is an addition Regarding pelvic floor training and medication for erectile difficulties for all study participants the current standard is to offer these to all men who have undergone nerve-sparing radical prostatectomy This will proceed as usual and the only deviation from usual practice is ensuring that the medication offer is consistent for all participants The mentioned 4-week period without tablet treatment wash-out is necessary to assess spontaneous erections This is a deviation from the normal standard as such a wash-out is not conducted for patients who do not participate in research but it will not affect the actual erectile function of the participants in either group
Data Collection
Standard investigations related to prostate cancer will be conducted according to normal guidelines with the registration of
Pre-operative PSA
Clinical and pathological tumor stage
Gleason score
Prostate size
Degree of nerve preservation during the surgery
Any complications during the surgery
Resection margin status positive or negative
PSA measurements at 3 6 and 12 months after the operation This information will be obtained from the patients medical records by the scientific staff after the study participants have given their consent to participate After providing consent the study organizers sponsor sponsors representatives and any regulatory authorities will have direct access to obtain information from the patients medical records including electronic records for the purpose of reviewing information about the research participants health as necessary for conducting the research project and for monitoring including self-monitoring quality control and oversight as they are obligated to perform
Since potential participants are screened and informed about the project during their visits to the outpatient clinic see the section on Recruitment of Study Participants and Informed Consent there is no need to obtain information from the patients medical records before consent is given At this stage the research team only receives the name social security number and contact information for patients who have expressed interest in the project
Additional examinations are carried out before the surgery and at follow-ups at 3 months 6 months and 10 months equivalent to the end of the wash-out period after the surgery with the registration of the following for all participants in both the vibration group and the control group
Before the surgery and at follow-ups
Validated symptom questionnaires for erectile function IIEF-EF and EHS
Specific questionnaire about orgasm disturbances penile shortening and urinary incontinence during sexual activity
Validated symptom questionnaire for incontinence symptoms ICIQ-SF
24-hour pad weighing test only at follow-ups for men who are not fully continent
Additional registrations at follow-ups
Registration of PSA recurrence after the surgery and noting any additional treatment
Any side effects of vibration and standard treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None