Randomized trial of mechanotherapy for the treatment of stress urinary incontinence in women
Background: Stress urinary incontinence (SUI) presents as unintentional urine leakage associated with activities. It significantly affects quality of life (QoL) and is the most common type of incontinence in women. Current treatment options, particularly non-surgical therapies, are lacking. Objectiv...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
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SAGE Publishing
2024-02-01
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| Series: | Therapeutic Advances in Urology |
| Online Access: | https://doi.org/10.1177/17562872241228023 |
| _version_ | 1797321640590180352 |
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| author | Nissrine Nakib Suzette Sutherland Kevin Hallman Marcus Mianulli David R Boulware |
| author_facet | Nissrine Nakib Suzette Sutherland Kevin Hallman Marcus Mianulli David R Boulware |
| author_sort | Nissrine Nakib |
| collection | DOAJ |
| description | Background: Stress urinary incontinence (SUI) presents as unintentional urine leakage associated with activities. It significantly affects quality of life (QoL) and is the most common type of incontinence in women. Current treatment options, particularly non-surgical therapies, are lacking. Objective: To assess the efficacy of mechanotherapy provided by the Flyte ® intra-vaginal device during pelvic floor muscle training (PFMT). Design: This was a randomized, controlled, double-blinded trial. Materials and methods: Flyte is a repeat use device for conditioning and strengthening the pelvic floor muscles (PFMs). It provides two-part mechanotherapy. Part 1 is the stretching and preloading of the PFM from the internal wand. Part 2 integrates mechanical pulses which elicit muscle cellular and tissue level responses that trigger cellular regeneration, improve neuromuscular facilitation and motor learning. Subjects used the device for 5 min/day for 12 weeks. Subjects (144) were randomized and evaluated at 6 and 12 weeks. Arm A (72) received both Part 1 and Part 2 mechanotherapy for 12 weeks, whereas Arm B (72) received Part 1 therapy for 6 weeks, then crossed over to full therapy. Mean age was 50, 49, respectively, prior pelvic/abdominal surgery 26%, 46%, and previous incontinence treatments 13%, 22%. The primary endpoint was 24-h pad weight (24-HR PW) at 6 weeks. Secondary endpoints were 24-HR PW at 12 weeks and QoL [International Consultation on Incontinence Questionnaire (ICIQ), Urinary Incontinence Quality of Life (IQOL)]. Results: Part 1 therapy had a greater than anticipated therapeutic effect. Thus, the study was underpowered to identify differences between study arms. Therefore, data were pooled to assess the effects of mechanotherapy. Twenty four-HR PW was significantly reduced at 6 weeks ( p = <0.0001), with further reduction from 6 to 12 weeks ( p = <0.0001). Data were stratified based on 24-HR PW severity. Significant reductions were noted in all severity groups (mild p = <0.0001, moderate p = <0.0001, severe p = <0.01). QoL was similarly improved at 6 weeks (ICIQ p = <0.0001, IQOL p = <0.0001), and 12 weeks (ICIQ p = <0.0001, IQOL p = <0.0001). Compliance was >80% at 6 weeks and 70% at 12 weeks. Conclusion: Two-part mechanotherapy significantly improved 24-HR PW and QoL across all severities of SUI. Improvements were noted in as little as 2 weeks and appeared to be sustained through 2-year follow up. Trial registration: Registered on ClinTrials.gov (NCT02954042). |
| first_indexed | 2024-03-08T05:02:29Z |
| format | Article |
| id | doaj.art-7b14ac84aa904eb2b980710ab387373e |
| institution | Directory Open Access Journal |
| issn | 1756-2880 |
| language | English |
| last_indexed | 2024-03-08T05:02:29Z |
| publishDate | 2024-02-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | Therapeutic Advances in Urology |
| spelling | doaj.art-7b14ac84aa904eb2b980710ab387373e2024-02-07T11:03:48ZengSAGE PublishingTherapeutic Advances in Urology1756-28802024-02-011610.1177/17562872241228023Randomized trial of mechanotherapy for the treatment of stress urinary incontinence in womenNissrine NakibSuzette SutherlandKevin HallmanMarcus MianulliDavid R BoulwareBackground: Stress urinary incontinence (SUI) presents as unintentional urine leakage associated with activities. It significantly affects quality of life (QoL) and is the most common type of incontinence in women. Current treatment options, particularly non-surgical therapies, are lacking. Objective: To assess the efficacy of mechanotherapy provided by the Flyte ® intra-vaginal device during pelvic floor muscle training (PFMT). Design: This was a randomized, controlled, double-blinded trial. Materials and methods: Flyte is a repeat use device for conditioning and strengthening the pelvic floor muscles (PFMs). It provides two-part mechanotherapy. Part 1 is the stretching and preloading of the PFM from the internal wand. Part 2 integrates mechanical pulses which elicit muscle cellular and tissue level responses that trigger cellular regeneration, improve neuromuscular facilitation and motor learning. Subjects used the device for 5 min/day for 12 weeks. Subjects (144) were randomized and evaluated at 6 and 12 weeks. Arm A (72) received both Part 1 and Part 2 mechanotherapy for 12 weeks, whereas Arm B (72) received Part 1 therapy for 6 weeks, then crossed over to full therapy. Mean age was 50, 49, respectively, prior pelvic/abdominal surgery 26%, 46%, and previous incontinence treatments 13%, 22%. The primary endpoint was 24-h pad weight (24-HR PW) at 6 weeks. Secondary endpoints were 24-HR PW at 12 weeks and QoL [International Consultation on Incontinence Questionnaire (ICIQ), Urinary Incontinence Quality of Life (IQOL)]. Results: Part 1 therapy had a greater than anticipated therapeutic effect. Thus, the study was underpowered to identify differences between study arms. Therefore, data were pooled to assess the effects of mechanotherapy. Twenty four-HR PW was significantly reduced at 6 weeks ( p = <0.0001), with further reduction from 6 to 12 weeks ( p = <0.0001). Data were stratified based on 24-HR PW severity. Significant reductions were noted in all severity groups (mild p = <0.0001, moderate p = <0.0001, severe p = <0.01). QoL was similarly improved at 6 weeks (ICIQ p = <0.0001, IQOL p = <0.0001), and 12 weeks (ICIQ p = <0.0001, IQOL p = <0.0001). Compliance was >80% at 6 weeks and 70% at 12 weeks. Conclusion: Two-part mechanotherapy significantly improved 24-HR PW and QoL across all severities of SUI. Improvements were noted in as little as 2 weeks and appeared to be sustained through 2-year follow up. Trial registration: Registered on ClinTrials.gov (NCT02954042).https://doi.org/10.1177/17562872241228023 |
| spellingShingle | Nissrine Nakib Suzette Sutherland Kevin Hallman Marcus Mianulli David R Boulware Randomized trial of mechanotherapy for the treatment of stress urinary incontinence in women Therapeutic Advances in Urology |
| title | Randomized trial of mechanotherapy for the treatment of stress urinary incontinence in women |
| title_full | Randomized trial of mechanotherapy for the treatment of stress urinary incontinence in women |
| title_fullStr | Randomized trial of mechanotherapy for the treatment of stress urinary incontinence in women |
| title_full_unstemmed | Randomized trial of mechanotherapy for the treatment of stress urinary incontinence in women |
| title_short | Randomized trial of mechanotherapy for the treatment of stress urinary incontinence in women |
| title_sort | randomized trial of mechanotherapy for the treatment of stress urinary incontinence in women |
| url | https://doi.org/10.1177/17562872241228023 |
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