Tags

Type your tag names separated by a space and hit enter

Low-dose Desmopressin and Tolterodine Combination Therapy for Treating Nocturia in Women with Overactive Bladder: A Double-blind, Randomized, Controlled Study.
Low Urin Tract Symptoms. 2018 Sep; 10(3):221-230.LU

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.

Authors+Show Affiliations

Department of Urology, Medical University of South Carolina, Charleston, South Carolina, USA.Ferring Pharmaceuticals, Copenhagen S, Denmark.Clinical Research of Philadelphia, LLC, Philadelphia, Pennsylvania, USA.Ferring Pharmaceuticals, Copenhagen S, Denmark.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

28560762

Citation

Rovner, Eric S., et al. "Low-dose Desmopressin and Tolterodine Combination Therapy for Treating Nocturia in Women With Overactive Bladder: a Double-blind, Randomized, Controlled Study." Lower Urinary Tract Symptoms, vol. 10, no. 3, 2018, pp. 221-230.
Rovner ES, Raymond K, Andruczyk E, et al. Low-dose Desmopressin and Tolterodine Combination Therapy for Treating Nocturia in Women with Overactive Bladder: A Double-blind, Randomized, Controlled Study. Low Urin Tract Symptoms. 2018;10(3):221-230.
Rovner, E. S., Raymond, K., Andruczyk, E., & Juul, K. V. (2018). Low-dose Desmopressin and Tolterodine Combination Therapy for Treating Nocturia in Women with Overactive Bladder: A Double-blind, Randomized, Controlled Study. Lower Urinary Tract Symptoms, 10(3), 221-230. https://doi.org/10.1111/luts.12169
Rovner ES, et al. Low-dose Desmopressin and Tolterodine Combination Therapy for Treating Nocturia in Women With Overactive Bladder: a Double-blind, Randomized, Controlled Study. Low Urin Tract Symptoms. 2018;10(3):221-230. PubMed PMID: 28560762.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Low-dose Desmopressin and Tolterodine Combination Therapy for Treating Nocturia in Women with Overactive Bladder: A Double-blind, Randomized, Controlled Study. AU - Rovner,Eric S, AU - Raymond,Kyle, AU - Andruczyk,Eugene, AU - Juul,Kristian V, Y1 - 2017/05/31/ PY - 2016/09/13/received PY - 2016/12/07/revised PY - 2017/01/15/accepted PY - 2017/6/1/pubmed PY - 2018/12/24/medline PY - 2017/6/1/entrez KW - antimuscarinics KW - desmopressin KW - nocturia KW - overactive bladder KW - tolterodine SP - 221 EP - 230 JF - Lower urinary tract symptoms JO - Low Urin Tract Symptoms VL - 10 IS - 3 N2 - 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. SN - 1757-5672 UR - https://www.unboundmedicine.com/medline/citation/28560762/Low_dose_Desmopressin_and_Tolterodine_Combination_Therapy_for_Treating_Nocturia_in_Women_with_Overactive_Bladder:_A_Double_blind_Randomized_Controlled_Study_ L2 - https://doi.org/10.1111/luts.12169 DB - PRIME DP - Unbound Medicine ER -