ORIGINAL ARTICLE

Low-dose Desmopressin and Tolterodine Combination Therapy for Treating Nocturia in Women with Overactive Bladder: A Double-blind, Randomized, Controlled Study

Corresponding Author

Eric S. ROVNER

[email protected]

Department of Urology, Medical University of South Carolina, Charleston, South Carolina, USA

Correspondence: Eric S. Rovner, MD, Department of Urology, Medical University of South Carolina, 96 Jonathan Lucas Street, CSB 620, Charleston, SC 29425, USA. Tel: 843 792 8347; Fax: 843 792 8523. Email: [email protected]Search for more papers by this author

Kyle RAYMOND,

Kyle RAYMOND

Ferring Pharmaceuticals, Copenhagen S, Denmark

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Eugene ANDRUCZYK,

Eugene ANDRUCZYK

Clinical Research of Philadelphia, LLC, Philadelphia, Pennsylvania, USA

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Kristian V. JUUL,

Kristian V. JUUL

Ferring Pharmaceuticals, Copenhagen S, Denmark

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Eric S. ROVNER,

Corresponding Author

Eric S. ROVNER

[email protected]

Department of Urology, Medical University of South Carolina, Charleston, South Carolina, USA

Kyle RAYMOND,

Kyle RAYMOND

Ferring Pharmaceuticals, Copenhagen S, Denmark

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Eugene ANDRUCZYK,

Eugene ANDRUCZYK

Clinical Research of Philadelphia, LLC, Philadelphia, Pennsylvania, USA

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Kristian V. JUUL,

Kristian V. JUUL

Ferring Pharmaceuticals, Copenhagen S, Denmark

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First published: 31 May 2017

https://doi.org/10.1111/luts.12169

Citations: 28

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Abstract

Objective

Evaluation of safety and efficacy of desmopressin/tolterodine combination therapy in women.

Methods

This double-blind, randomized, proof-of-concept study enrolled 106 patients (≥18 years), with overactive bladder (OAB) and nocturia, with ≥2 nocturnal voids, receiving a 3-month once-daily combination (desmopressin 25 µg, orally-disintegrating tablets [ODT]/tolterodine 4 mg [Detrol® LA]; n = 49) or monotherapy (tolterodine 4 mg/placebo ODT; n = 57). Primary endpoint was change from baseline in mean number of nocturnal voids. Secondary endpoints were change from baseline in nocturnal voided volume, time to first nocturnal void, and quality-of-life. Post-hoc exploratory analysis were performed for patients with and without baseline nocturnal polyuria (NP, n = 47 each).

Results

Overall population showed a non-significant reduction in mean number of nocturnal voids with combination versus monotherapy (full analysis set: adjusted treatment contrast [TC], −0.34; P = 0.112). Change in mean nocturnal void volume (TC, −64.16 mL; P = 0.103), mean time to first nocturnal void (TC, 18.00 min; P = 0.385) and Nocturia Impact (NI) Diary^© scores were comparable. In post-hoc analysis, NP patients showed a benefit with combination versus monotherapy for nocturnal void volume (P = 0.034) and time to first nocturnal void (P = 0.045), and a non-significant improvement in NI Diary^© scores. Safety profile was comparable between treatments. A single transient event of asymptomatic clinically significant hyponatremia in combination group resolved subsequently.

Conclusion

Low-dose desmopressin could be safely combined with tolterodine for treating nocturia in women with OAB, with a significant benefit in women with NP. Further, prospective validation studies of combination therapy are warranted in mixed NP/OAB population, based on this favorable proof-of-concept finding.

Supporting Information

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Volume10, Issue3

September 2018

Pages 221-230

Low-dose Desmopressin and Tolterodine Combination Therapy for Treating Nocturia in Women with Overactive Bladder: A Double-blind, Randomized, Controlled Study

Abstract

Objective

Methods

Results

Conclusion

Supporting Information

REFERENCES

Citing Literature

References

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Low-dose Desmopressin and Tolterodine Combination Therapy for Treating Nocturia in Women with Overactive Bladder: A Double-blind, Randomized, Controlled Study

Abstract

Objective

Methods

Results

Conclusion

Supporting Information

REFERENCES

Citing Literature

References

Related

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