The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: somatosensory interactive pelvic floor muscle training, pelvic floor magnetic stimulation therapy, standard pelvic floor muscle training.
- Who it may be relevant to
- Registry conditions: Prostate Cancer (Post Prostatectomy). Basic parameters: 18 years — 85 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China, Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The study aims to compare the efficacy of different pelvic floor muscle training (PFMT) modes on improving urinary incontinence (UI) recovery in prostate cancer (PCa) patients after radical prostatectomy (RP). The methods being compared include standard PFMT (S-PFMT) , a somatosensory interactive PFMT (SI-PFMT, an enhanced PFMT) , and a standard PFMT combined with pelvic floor muscle magnetic stimulation (S-PFMT+MS). Eligible participants are randomized into either of the groups to receive different modalities of post-operative PFMT. Subjects in the S-PFMT group received traditional verbal instructions and paper-based educational materials. For the SI-PFMT group, an interactive experiential education model was adopted. First, an educational video introduced the importance and basic information of postoperative PFMT. Then, synchronized PFMT guidance through a combination of audio and video would be used. Subjects assigned to the S-PFMT+MS group, on the basis of traditional verbal and paper-based education, pelvic floor magnetic stimulation therapy was applied using a pelvic floor magnetic stimulator, operated by the same experienced rehabilitation physician. Self administered questionnaires and 1-hour pad test would be used to assess the treatment outcomes at 1, 3, and 6 months postoperatively.
Interventions
- Behavioral somatosensory interactive pelvic floor muscle training
synchronized PFMT guidance through a combination of audio and video - Procedure pelvic floor magnetic stimulation therapy
stimulation frequency was set at 10 Hz, with stimulation administered in cycles of 5 seconds on followed by 5 seconds off. Each treatment session lasted 20 minutes, conducted twice a week, for a total of 10-12 sessions - Behavioral standard pelvic floor muscle training
traditional verbal instructions and paper-based educational materials of PFMT are given to participants. All patients would receive PFMT under the guidance of digital rectal examination by nurses, and their pelvic floor muscle function was graded according to the Oxford Grading System (grades 0-5), ensuring the correctness of subsequent PFMT.
Primary outcome measures
- International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) [Time frame: 1, 3, and 6 months postoperatively.]
Secondary outcome measures (1)
- urine leakage volume from the 1-hour pad test [Time frame: 1, 3, and 6 months postoperatively]
Eligibility criteria
Inclusion criteria
- PCa patients aged 18 to 85 years who had undergone laparoscopic radical prostatectomy (RP)
Exclusion criteria
- patients currently participating in other clinical trials and those unable to cooperate with study interventions and follow-up procedures due to specific factors
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Ruijin Hospital — Shanghai
Hong Kong · 1 center
- Queen Mary Hospital — Hong Kong
Identifiers
NCT: NCT06740071 · PFMT-RARP