RecruitingNot ApplicableNCT06740071

The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy


Sponsor

The University of Hong Kong

Enrollment

100 participants

Start Date

May 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 85 Years

Inclusion Criteria1

  • PCa patients aged 18 to 85 years who had undergone laparoscopic radical prostatectomy (RP)

Exclusion Criteria1

  • patients currently participating in other clinical trials and those unable to cooperate with study interventions and follow-up procedures due to specific factors

Interventions

BEHAVIORALsomatosensory interactive pelvic floor muscle training

synchronized PFMT guidance through a combination of audio and video

PROCEDUREpelvic 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

BEHAVIORALstandard 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.


Locations(2)

Ruijin Hospital

Shanghai, Shanghai Municipality, China

Queen Mary Hospital

Hong Kong, Hong Kong, Hong Kong

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NCT06740071


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