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NCT Number: NCT06740071

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Ruijin Hospital, Shanghai, Shanghai Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

somatosensory interactive pelvic floor muscle training

Behavioral

synchronized PFMT guidance through a combination of audio and video

pelvic floor magnetic stimulation therapy

Procedure

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

standard pelvic floor muscle training

Behavioral

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 outcomes

  1. International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)

    Time frame: 1, 3, and 6 months postoperatively.

    A higher score indicates a more severe urinary incontinence and thus a worse outcome. Reduction in score is expected for subjects with clinical improvement.

    Range of score: 0 - 21 Severity of urinary incontinence: slight (1-5), moderate (6-12), severe (13-18) and very severe (19-21)

Secondary outcomes

  1. urine leakage volume from the 1-hour pad test

    Time frame: 1, 3, and 6 months postoperatively

Study contacts

Contact information is provided by the study sponsor or research team.

Research Assistant, BSc

CONTACT

[email protected]

852-22554852

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Ruijin Hospital

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Dec 18, 2024
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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