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- Publisher Website: 10.1016/j.cct.2022.106991
- Scopus: eid_2-s2.0-85141265968
- PMID: 36332826
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Article: Effectiveness of pelvic floor muscle training alone or combined with either a novel biofeedback device or conventional biofeedback for improving stress urinary incontinence: A randomized controlled pilot trial
Title | Effectiveness of pelvic floor muscle training alone or combined with either a novel biofeedback device or conventional biofeedback for improving stress urinary incontinence: A randomized controlled pilot trial |
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Authors | |
Keywords | Biofeedback NCT04638348 Pelvic floor muscle training Randomized controlled trial Stress urinary incontinence |
Issue Date | 2-Nov-2022 |
Publisher | Elsevier |
Citation | Contemporary Clinical Trials, 2022, v. 123 How to Cite? |
Abstract | Purpose: To (i) compare the acceptance of a newly developed, novel biofeedback device (PelviSense) with that of conventional biofeedback (CB) using an intravaginal probe for the treatment of stress urinary incontinence (SUI) in women, (ii) examine the feasibility and safety of using the PelviSense device as a pelvic floor muscle (PFM) training (PFMT) adjunct, and (iii) compare the PFMT adherence and effectiveness of CB, the PelviSense device, with PFMT alone for women with SUI. Methods: An assessor-blinded, three-arm, randomized controlled pilot trial was conducted among 51 women with SUI. Women were randomly allocated to one of three study groups (PelviSense-assisted PFMT, CB-assisted PFMT, or PFMT alone [control]). Outcome measures included the International Consultation on Incontinence Questionnaire-Short Form, the 1-h pad test, and the Modified Oxford Scale. Results: Participants in the PelviSense-assisted PFMT group expressed good device acceptance. PFMT adherence was greater in the PelviSense-assisted PFMT group than in the unassisted or CB-assisted PFMT groups. Between-groups analysis revealed significant effects on improved SUI symptoms, urine loss severity, and PFM strength for the PelviSense-assisted PFMT group compared with the CB-assisted and PFMT alone groups. Conclusions: The pilot trial results demonstrated moderate to high PFMT adherence in the PelviSense-assisted PFMT group and supported the safety of using the PelviSense device. The preliminary results of the pilot trial showed that PelviSense-assisted PFMT was more effective for reducing SUI symptoms among women than unassisted or CB-assisted PFMT. Trial registration: This trial was registered in http://ClinicalTrials.gov (reference number: NCT04638348) before the recruitment of the first participant. |
Persistent Identifier | http://hdl.handle.net/10722/344933 |
ISSN | 2023 Impact Factor: 2.0 2023 SCImago Journal Rankings: 0.980 |
DC Field | Value | Language |
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dc.contributor.author | Kannan, Priya | - |
dc.contributor.author | Cheing, Gladys LY | - |
dc.contributor.author | Fung, Brigitte Kim Yook | - |
dc.contributor.author | Li, Jess | - |
dc.contributor.author | Leung, Wing Cheong | - |
dc.contributor.author | Chung, Raymond CK | - |
dc.contributor.author | Cheung, Tsz Wing | - |
dc.contributor.author | Lam, Lok Fan | - |
dc.contributor.author | Lee, Wing Yi | - |
dc.contributor.author | Wong, Wai Ching | - |
dc.contributor.author | Wong, Wing Hei | - |
dc.contributor.author | Tang, Pui Yin Grace | - |
dc.contributor.author | Chan, Paddy KL | - |
dc.date.accessioned | 2024-08-14T08:56:20Z | - |
dc.date.available | 2024-08-14T08:56:20Z | - |
dc.date.issued | 2022-11-02 | - |
dc.identifier.citation | Contemporary Clinical Trials, 2022, v. 123 | - |
dc.identifier.issn | 1551-7144 | - |
dc.identifier.uri | http://hdl.handle.net/10722/344933 | - |
dc.description.abstract | Purpose: To (i) compare the acceptance of a newly developed, novel biofeedback device (PelviSense) with that of conventional biofeedback (CB) using an intravaginal probe for the treatment of stress urinary incontinence (SUI) in women, (ii) examine the feasibility and safety of using the PelviSense device as a pelvic floor muscle (PFM) training (PFMT) adjunct, and (iii) compare the PFMT adherence and effectiveness of CB, the PelviSense device, with PFMT alone for women with SUI. Methods: An assessor-blinded, three-arm, randomized controlled pilot trial was conducted among 51 women with SUI. Women were randomly allocated to one of three study groups (PelviSense-assisted PFMT, CB-assisted PFMT, or PFMT alone [control]). Outcome measures included the International Consultation on Incontinence Questionnaire-Short Form, the 1-h pad test, and the Modified Oxford Scale. Results: Participants in the PelviSense-assisted PFMT group expressed good device acceptance. PFMT adherence was greater in the PelviSense-assisted PFMT group than in the unassisted or CB-assisted PFMT groups. Between-groups analysis revealed significant effects on improved SUI symptoms, urine loss severity, and PFM strength for the PelviSense-assisted PFMT group compared with the CB-assisted and PFMT alone groups. Conclusions: The pilot trial results demonstrated moderate to high PFMT adherence in the PelviSense-assisted PFMT group and supported the safety of using the PelviSense device. The preliminary results of the pilot trial showed that PelviSense-assisted PFMT was more effective for reducing SUI symptoms among women than unassisted or CB-assisted PFMT. Trial registration: This trial was registered in http://ClinicalTrials.gov (reference number: NCT04638348) before the recruitment of the first participant. | - |
dc.language | eng | - |
dc.publisher | Elsevier | - |
dc.relation.ispartof | Contemporary Clinical Trials | - |
dc.subject | Biofeedback | - |
dc.subject | NCT04638348 | - |
dc.subject | Pelvic floor muscle training | - |
dc.subject | Randomized controlled trial | - |
dc.subject | Stress urinary incontinence | - |
dc.title | Effectiveness of pelvic floor muscle training alone or combined with either a novel biofeedback device or conventional biofeedback for improving stress urinary incontinence: A randomized controlled pilot trial | - |
dc.type | Article | - |
dc.identifier.doi | 10.1016/j.cct.2022.106991 | - |
dc.identifier.pmid | 36332826 | - |
dc.identifier.scopus | eid_2-s2.0-85141265968 | - |
dc.identifier.volume | 123 | - |
dc.identifier.eissn | 1559-2030 | - |
dc.identifier.issnl | 1551-7144 | - |