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The influence of pelvic floor muscle training during 3 months in men, who still suffer from erectile dysfunction 12 months after open or robot radical prostatectomy: A randomised controlled trial.


- candidate number10631
- NTR NumberNTR3180
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-dec-2011
- Secondary IDsML7136 
- Public TitleThe influence of pelvic floor muscle training during 3 months in men, who still suffer from erectile dysfunction 12 months after open or robot radical prostatectomy: A randomised controlled trial.
- Scientific TitleThe influence of pelvic floor muscle training during 3 months in men, who still suffer from erectile dysfunction 12 months after open or robot radical prostatectomy: A randomised controlled trial.
- ACRONYM
- hypothesis1. Patients, who still suffer from erectile dysfunction, 12 months after a radical prostatectomy, can improve their erectile function by performing an intensive therapy program for their pelvic floor muscles;
2. Patients after robot surgery have a faster recovery of erectile function then patients after open surgery.
- Healt Condition(s) or Problem(s) studiedProstate cancer, Erectile dysfunction, Pelvic floor muscles, Open radical prostatectomy, Robot radical prostatectomy
- Inclusion criteria1. Male patients, who had an unilateral/bilateral nervesparing open or robot radical prostatectomy at least 12 months earlier and still suffer from erectile dysfunction;
2. Patients who can participate in pelvic floor muslce training during the entire study period;
3. Patients who are willing to quit additional medication, like PDE-5 inhibitors, intracavernous injections during the entire study period.
- Exclusion criteria1. Patients, who didn't have erections and/or sexual intercourse preoperatively;
2. Patients, who underwent a nonnerve sparing radical prostatectomy;
3. Patients , who are not willing to quit additional medication, like PDE-5 inhibitors, intracavernous injections during the entire study period;
4. Patients, who are not able to perform pelvic floor muscle exercises because of cognitive problems;
5. Patients who refuse to participate in the study.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2011
- planned closingdate31-mrt-2013
- Target number of participants40
- InterventionsPatients, who still suffer from erectile dysfunction, 12 months after surgery, will be randomised in group 1 (starting immediately with pelvic floor muscle exercises) or in group 2 (starting 3 months later with pelvic floor muscle exercises). The pelvic floor muscle training program consists of exercises of the pelvic floor manually controlled by the therapist and supplied with EMG biofeedback and electrostimulation. Every patient receives individual treatment on an outpatient basis once a week. Further the patient performs an exercise scheme independently at home.
- Primary outcomeImprovement in erectile function: The patients will be evaluated by filling in the 'International Index of Erectile Function- Questionnaire' and the 'Erectile Hardness Scale' at several time points.
- Secondary outcomeAt the same time points the patient and his partner will be interviewed concerning the quality of the erection, orgasm and relation.
- TimepointsPatients are randomised at the time of inclusion: Group 1 starts immediately with therapy, group 2 only after 3 months.
Patients are evaluated at the time of inclusion, at the time of starting the therapy phase, after 3 months of therapy and 3 months after the end of the therapy.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Inge Geraerts
- CONTACT for SCIENTIFIC QUERIES Inge Geraerts
- Sponsor/Initiator Katholieke Universiteit Leuven, Faculty of Kinesiology and Rehabilitaiton Sciences Respiratory Rehabilitation
- Funding
(Source(s) of Monetary or Material Support)
Katholieke Universiteit Leuven, Faculteit Bewegings- en Revalidatiewetenschappen
- PublicationsN/A
- Brief summaryProstate cancer is the most common cancer in men on this moment. Radical prostatectomy for localized prostate cancer is done via a retropubic (open) or robot radical prostatectomy. Urinary incontinence and erectile dysfunction are the most embarrassing complications after prostatectomy. Twelve months after surgery, many patients still suffer from erectile dysfunction. Pelvic floor muscle exercises can improve erectile function. The purpose of this study is to evaluate the influence of a therapy program (pelvic floor muscle training) during 3 months for erectile dysfunction, 12 months after a radical prostatectomy. Further we also want to compare the recovery of erectile function after both surgical approaches.
- Main changes (audit trail)
- RECORD6-dec-2011 - 17-dec-2011


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