Clinical trial · Interventional
Pelvic Floor Muscles Training in Men Undergoing Radiotherapy for Prostate Cancer: Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Unobtainable sample size
Summary
Brief summary (as posted)
The pelvic floor disorders are a major problem in our current society with manifestations of micturition disorders, defecatory problems and sexual dysfunction. The pelvic floor muscles training arouses interest due the few studies on this subject. Studies are being conducted with emphasis on the post-prostatectomy urinary disorders, however, not associated with radiotherapy. The study of the effect of radiotherapy in these muscles is still uncertain. At right, we do not know if the effect of radiation can trigger important anatomical changes that could lead to pelvic floor disorders manifesting clinically as defecatory and urinary disorders. These issues motivate us to research, focusing on the evaluation of these muscles through magnetic nuclear resonance considering that radiation therapy has been increasingly used as a therapeutic option in the treatment of prostate cancer. The primary objective of this is to verify the effect of pelvic floor muscles training (PFMT) tract symptoms (LUTS), anorectal and sexual complaints in men with prostate cancer (PCa) treated with radiotherapy (RT). Secondly, the objective is to evaluate the effect of PFMT in its function and in the severity of urinary incontinence (UI) and evaluate the quality of life. The assessment of the changes occurred by the effect of radiation separately and jointly to the training of the pelvic floor muscles can help us to better understand some of the dysfunctions presented in this sample of patients as well as understanding the effect and the possible contribution of training of these muscles for treatment and/or prevention of these disorders.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Urologic Diseases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pelvic floor muscles training | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Training group (TG)
- description
- The group of patients undergoing radiotherapy and submitted to pelvic floor muscles training.
- interventionNames
- Other: Pelvic floor muscles training
- type
- NO_INTERVENTION
- label
- Control group(CG)
- description
- The group of patients undergoing radiotherapy only.
Primary outcomes (1)
- measure
- Changes in the in the LUTS, anorectal and sexual complaints in six months.
- timeFrame
- 6 months after radiotherapy.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Men aged equal or higher than 45 years-old with confirmed diagnosis of prostate cancer by biopsy and having clinical indication for radiotherapy who follow-up in the HCFMRP-USP; * No age distinction of race, creed and education; * Men with graduation of PFM function greater than or equal to grade 2 evaluated by anal digital palpation (Oxford Scale Modified); * Men who voluntarily consent to participate in research. Exclusion Criteria: * Men with anatomical abnormalities in perineal region due sequelae of surgery, pathology, trauma or injury sites; * Men with associated neurological pathologies; * Indication for adjuvant or rescue RT (radical prostatectomy); * Men with acquired immune deficiency syndrome; * PFMT carried out previously; * Men with cardiac pacemakers, aneurysm clips, neurostimulators or other factors that preclude the application of review procedures established in this study; * Men who have not completed proposed radiotherapy treatment; * Men who do not accept to participate in this study.
References
Publications (4)
- BACKGROUNDBo K. Pelvic floor muscle strength and response to pelvic floor muscle training for stress urinary incontinence. Neurourol Urodyn. 2003;22(7):654-8. doi: 10.1002/nau.10153. PMID 14595609
- BACKGROUNDCentemero A, Rigatti L, Giraudo D, Lazzeri M, Lughezzani G, Zugna D, Montorsi F, Rigatti P, Guazzoni G. Preoperative pelvic floor muscle exercise for early continence after radical prostatectomy: a randomised controlled study. Eur Urol. 2010 Jun;57(6):1039-43. doi: 10.1016/j.eururo.2010.02.028. Epub 2010 Mar 1. PMID 20227168
- BACKGROUNDDorey G, Glazener C, Buckley B, Cochran C, Moore K. Developing a pelvic floor muscle training regimen for use in a trial intervention. Physiotherapy. 2009 Sep;95(3):199-209. doi: 10.1016/j.physio.2009.03.003. Epub 2009 Jul 8. PMID 19635340
- BACKGROUNDGlazener C, Boachie C, Buckley B, Cochran C, Dorey G, Grant A, Hagen S, Kilonzo M, McDonald A, McPherson G, Moore K, Norrie J, Ramsay C, Vale L, N'Dow J. Urinary incontinence in men after formal one-to-one pelvic-floor muscle training following radical prostatectomy or transurethral resection of the prostate (MAPS): two parallel randomised controlled trials. Lancet. 2011 Jul 23;378(9788):328-37. doi: 10.1016/S0140-6736(11)60751-4. Epub 2011 Jul 7. PMID 21741700