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

The University of Hong Kong (HKU)

Status: Enrolling

Conditions: Prostate Cancer (Post Prostatectomy)

Treatments: Behavioral: somatosensory interactive pelvic floor muscle training; Procedure: pelvic floor magnetic stimulation therapy; Behavioral: standard pelvic floor muscle training

Study type: Interventional

Funder types: Other

Identifiers

NCT06740071

PFMT-RARP

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

standard pelvic floor muscle training group

Active Comparator group

Treatment:

Behavioral: standard pelvic floor muscle training

somatosensory interactive pelvic floor muscle training group

Active Comparator group

Treatment:

Behavioral: somatosensory interactive pelvic floor muscle training

standard pelvic floor muscle training combined with pelvic floor magnetic stimulation therapy group

Experimental group

Treatment:

Procedure: pelvic floor magnetic stimulation therapy

Behavioral: somatosensory interactive pelvic floor muscle training