Efficacy of a Food Supplement Based on Collagen and Magnesium Combined with Pelvic Floor Muscle Training Exercises in Women with Urinary Incontinence: A Double-Blind, Randomized, Pilot Clinical Trial
Background/Objectives: Urinary incontinence (UI) is a common condition affecting women worldwide, with pelvic floor muscle training exercises (PFMT) recognized as the first-line treatment for UI. Supplementation with bioactive compounds, such as collagen and magnesium, may enhance the effectiveness...
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MDPI AG
2025-04-01
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| Online Access: | https://www.mdpi.com/2673-4397/5/2/7 |
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| author | Vincenzo Nobile Roberta Villa Mariella Micieli Fabio Amone Erminia D’Ambrosio Giuseppe Pulitano Camilla Schinzari Eleonora Di Campi Davide Carati |
| author_facet | Vincenzo Nobile Roberta Villa Mariella Micieli Fabio Amone Erminia D’Ambrosio Giuseppe Pulitano Camilla Schinzari Eleonora Di Campi Davide Carati |
| author_sort | Vincenzo Nobile |
| collection | DOAJ |
| description | Background/Objectives: Urinary incontinence (UI) is a common condition affecting women worldwide, with pelvic floor muscle training exercises (PFMT) recognized as the first-line treatment for UI. Supplementation with bioactive compounds, such as collagen and magnesium, may enhance the effectiveness of PFMT. This study aimed to evaluate the efficacy of combining a food supplement containing collagen and magnesium with PFMT in women experiencing stress (SUI), urge (UUI), or mixed (MUI) urinary incontinence. Methods: A pilot clinical trial was carried out on 44 women with stress, urge, or mixed urinary incontinence. The improvement in urinary incontinence was assessed, before and after 6 weeks (W6) of product use, by the Questionnaire for Urinary Incontinence Diagnosis (QUID) and the clinical assessment of the gynecologist. Quality of life (QoL) was assessed as a secondary endpoint. Results: At Week 6, the baseline median QUID score in the active group was significantly reduced by 64% (<i>p</i> < 0.001), with 76% finishing the study with a negative diagnosis for UI. In contrast, the placebo group showed a reduction in QUID score by only 10% (<i>p</i> < 0.001), with just 25% of participants achieving a negative diagnosis for UI. QoL statistically significantly (<i>p</i> < 0.001) improved by 76% in the active group, while no changes were observed in the placebo group. Conclusions: Supplementation with the (Dermoxen<sup>®</sup> PelviPlus™/Dermoxen<sup>®</sup> Gynable<sup>®</sup> Urocollagen™) tested product significantly improved urinary symptoms and quality of life, demonstrating a greater effect than pelvic floor muscle training (PFMT) exercises alone. Dermoxen<sup>®</sup> PelviPlus™/Dermoxen<sup>®</sup> Gynable<sup>®</sup> Urocollagen™ demonstrated efficacy across all three subtypes of UI. |
| format | Article |
| id | doaj-art-3ff80d73a1194eec92e88e07ef59fd3d |
| institution | Kabale University |
| issn | 2673-4397 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Uro |
| spelling | doaj-art-3ff80d73a1194eec92e88e07ef59fd3d2025-08-20T03:26:56ZengMDPI AGUro2673-43972025-04-0152710.3390/uro5020007Efficacy of a Food Supplement Based on Collagen and Magnesium Combined with Pelvic Floor Muscle Training Exercises in Women with Urinary Incontinence: A Double-Blind, Randomized, Pilot Clinical TrialVincenzo Nobile0Roberta Villa1Mariella Micieli2Fabio Amone3Erminia D’Ambrosio4Giuseppe Pulitano5Camilla Schinzari6Eleonora Di Campi7Davide Carati8R&D Department, Complife Italia S.r.l., 27028 San Martino Siccomario, ItalyR&D Department, Complife Italia S.r.l., 27028 San Martino Siccomario, ItalyUnit of Obstetrics and Gynecology, “SS. Annunziata” Hospital, 87100 Cosenza, ItalyNutratech S.r.l., Spin-Off of University of Calabria, 87036 Rende, ItalyNutratech S.r.l., Spin-Off of University of Calabria, 87036 Rende, ItalyNutratech S.r.l., Spin-Off of University of Calabria, 87036 Rende, ItalyR&D Department, Ekuberg Pharma, 73020 Carpignano Salentino, ItalyR&D Department, Ekuberg Pharma, 73020 Carpignano Salentino, ItalyR&D Department, Ekuberg Pharma, 73020 Carpignano Salentino, ItalyBackground/Objectives: Urinary incontinence (UI) is a common condition affecting women worldwide, with pelvic floor muscle training exercises (PFMT) recognized as the first-line treatment for UI. Supplementation with bioactive compounds, such as collagen and magnesium, may enhance the effectiveness of PFMT. This study aimed to evaluate the efficacy of combining a food supplement containing collagen and magnesium with PFMT in women experiencing stress (SUI), urge (UUI), or mixed (MUI) urinary incontinence. Methods: A pilot clinical trial was carried out on 44 women with stress, urge, or mixed urinary incontinence. The improvement in urinary incontinence was assessed, before and after 6 weeks (W6) of product use, by the Questionnaire for Urinary Incontinence Diagnosis (QUID) and the clinical assessment of the gynecologist. Quality of life (QoL) was assessed as a secondary endpoint. Results: At Week 6, the baseline median QUID score in the active group was significantly reduced by 64% (<i>p</i> < 0.001), with 76% finishing the study with a negative diagnosis for UI. In contrast, the placebo group showed a reduction in QUID score by only 10% (<i>p</i> < 0.001), with just 25% of participants achieving a negative diagnosis for UI. QoL statistically significantly (<i>p</i> < 0.001) improved by 76% in the active group, while no changes were observed in the placebo group. Conclusions: Supplementation with the (Dermoxen<sup>®</sup> PelviPlus™/Dermoxen<sup>®</sup> Gynable<sup>®</sup> Urocollagen™) tested product significantly improved urinary symptoms and quality of life, demonstrating a greater effect than pelvic floor muscle training (PFMT) exercises alone. Dermoxen<sup>®</sup> PelviPlus™/Dermoxen<sup>®</sup> Gynable<sup>®</sup> Urocollagen™ demonstrated efficacy across all three subtypes of UI.https://www.mdpi.com/2673-4397/5/2/7collagenmagnesiumsupplementationurinary incontinenceclinical trial |
| spellingShingle | Vincenzo Nobile Roberta Villa Mariella Micieli Fabio Amone Erminia D’Ambrosio Giuseppe Pulitano Camilla Schinzari Eleonora Di Campi Davide Carati Efficacy of a Food Supplement Based on Collagen and Magnesium Combined with Pelvic Floor Muscle Training Exercises in Women with Urinary Incontinence: A Double-Blind, Randomized, Pilot Clinical Trial Uro collagen magnesium supplementation urinary incontinence clinical trial |
| title | Efficacy of a Food Supplement Based on Collagen and Magnesium Combined with Pelvic Floor Muscle Training Exercises in Women with Urinary Incontinence: A Double-Blind, Randomized, Pilot Clinical Trial |
| title_full | Efficacy of a Food Supplement Based on Collagen and Magnesium Combined with Pelvic Floor Muscle Training Exercises in Women with Urinary Incontinence: A Double-Blind, Randomized, Pilot Clinical Trial |
| title_fullStr | Efficacy of a Food Supplement Based on Collagen and Magnesium Combined with Pelvic Floor Muscle Training Exercises in Women with Urinary Incontinence: A Double-Blind, Randomized, Pilot Clinical Trial |
| title_full_unstemmed | Efficacy of a Food Supplement Based on Collagen and Magnesium Combined with Pelvic Floor Muscle Training Exercises in Women with Urinary Incontinence: A Double-Blind, Randomized, Pilot Clinical Trial |
| title_short | Efficacy of a Food Supplement Based on Collagen and Magnesium Combined with Pelvic Floor Muscle Training Exercises in Women with Urinary Incontinence: A Double-Blind, Randomized, Pilot Clinical Trial |
| title_sort | efficacy of a food supplement based on collagen and magnesium combined with pelvic floor muscle training exercises in women with urinary incontinence a double blind randomized pilot clinical trial |
| topic | collagen magnesium supplementation urinary incontinence clinical trial |
| url | https://www.mdpi.com/2673-4397/5/2/7 |
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