Efficacy and Safety of Drug Combinations for Chronic Pelvic Pain: Protocol for a Systematic Review

Overview

Journal JMIR Res Protoc

Publisher JMIR Publications

Specialty General Medicine

Date 2021 May 17

PMID 33999006

Authors

Mohammed Mohiuddin

Rex Park

Ursula Wesselmann

Caroline Pukall

Keith Jarvi

Curtis Nickel

Christopher Doiron

Ian Gilron

Affiliations

Soon will be listed here.

Abstract

Background: Chronic pelvic pain with various etiologies and mechanisms affects men and women and is a major challenge. Monotherapy is often unsuccessful for chronic pelvic pain, and combinations of different classes of medications are frequently prescribed, with the expectation of improved outcomes. Although a number of combination trials for chronic pelvic pain have been reported, we are not aware of any systematic reviews of the available evidence on combination drug therapy for chronic pelvic pain.

Objective: We have developed a protocol for a systematic review to evaluate available evidence of the efficacy and safety of drug combinations for chronic pelvic pain.

Methods: This systematic review will involve a detailed search of randomized controlled trials investigating drug combinations to treat chronic pelvic pain in adults. The databases searched will include the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and EMBASE from their inception until the date the searches are run to identify relevant studies. The primary outcome will be pain relief measured using validated scoring tools. Secondary outcomes, where reported, will include the following: adverse events, serious adverse events, sexual function, quality of life, and depression and anxiety. Methodological quality of each included study will be assessed using the Cochrane Risk of Bias Tool.

Results: The systematic review defined by this protocol is expected to synthesize available good quality evidence on combination drug therapy in chronic pelvic pain, which may help guide future research and treatment choices for patients and their health care providers.

Conclusions: This review will provide a clearer understanding of the efficacy and safety of combination pharmacological therapy for chronic pelvic pain.

Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42020192231; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=192231.

International Registered Report Identifier (irrid): PRR1-10.2196/21909.

References

Suskind A, Berry S, Ewing B, Elliott M, Suttorp M, Clemens J . The prevalence and overlap of interstitial cystitis/bladder pain syndrome and chronic prostatitis/chronic pelvic pain syndrome in men: results of the RAND Interstitial Cystitis Epidemiology male study. J Urol. 2012; 189(1):141-5. PMC: 3894747. DOI: 10.1016/j.juro.2012.08.088. View

Gelbaya T . Focus on primary care: chronic pelvic pain in women. Obstet Gynecol Surv. 2001; 56(12):757-64. DOI: 10.1097/00006254-200112000-00002. View

Cheong Y, Stones R . Doctors and the chronic pelvic pain patient. Minerva Ginecol. 2007; 59(6):613-8. View

Mathias S, Kuppermann M, Liberman R, Lipschutz R, Steege J . Chronic pelvic pain: prevalence, health-related quality of life, and economic correlates. Obstet Gynecol. 1996; 87(3):321-7. DOI: 10.1016/0029-7844(95)00458-0. View

Gilron I, Jensen T, Dickenson A . Combination pharmacotherapy for management of chronic pain: from bench to bedside. Lancet Neurol. 2013; 12(11):1084-95. DOI: 10.1016/S1474-4422(13)70193-5. View

Daniels J, Khan K . Chronic pelvic pain in women. BMJ. 2010; 341:c4834. DOI: 10.1136/bmj.c4834. View

Nickel J, Tripp D, Pontari M, Moldwin R, Mayer R, Carr L . Interstitial cystitis/painful bladder syndrome and associated medical conditions with an emphasis on irritable bowel syndrome, fibromyalgia and chronic fatigue syndrome. J Urol. 2010; 184(4):1358-63. DOI: 10.1016/j.juro.2010.06.005. View

Nickel J, Shoskes D, Wagenlehner F . Management of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS): the studies, the evidence, and the impact. World J Urol. 2013; 31(4):747-53. DOI: 10.1007/s00345-013-1062-y. View

Nickel J, Herschorn S, Whitmore K, Forrest J, Hu P, Friedman A . Pentosan polysulfate sodium for treatment of interstitial cystitis/bladder pain syndrome: insights from a randomized, double-blind, placebo controlled study. J Urol. 2014; 193(3):857-62. DOI: 10.1016/j.juro.2014.09.036. View

10.

Jarrell J, Vilos G, Allaire C, Burgess S, Fortin C, Gerwin R . No. 164-Consensus Guidelines for the Management of Chronic Pelvic Pain. J Obstet Gynaecol Can. 2018; 40(11):e747-e787. DOI: 10.1016/j.jogc.2018.08.015. View

11.

Crawford A, Tripp D, Nickel J, Carr L, Moldwin R, Katz L . Depression and helplessness impact interstitial cystitis/bladder pain syndrome pain over time. Can Urol Assoc J. 2019; 13(10):328-333. PMC: 6788912. DOI: 10.5489/cuaj.5703. View

12.

Reiter R . A profile of women with chronic pelvic pain. Clin Obstet Gynecol. 1990; 33(1):130-6. View

13.

Zondervan K, Yudkin P, Vessey M, Dawes M, Barlow D, Kennedy S . Prevalence and incidence of chronic pelvic pain in primary care: evidence from a national general practice database. Br J Obstet Gynaecol. 1999; 106(11):1149-55. DOI: 10.1111/j.1471-0528.1999.tb08140.x. View

14.

Magistro G, Wagenlehner F, Grabe M, Weidner W, Stief C, Nickel J . Contemporary Management of Chronic Prostatitis/Chronic Pelvic Pain Syndrome. Eur Urol. 2015; 69(2):286-97. DOI: 10.1016/j.eururo.2015.08.061. View

15.

Collins M, Stafford R, OLeary M, Barry M . How common is prostatitis? A national survey of physician visits. J Urol. 1998; 159(4):1224-8. View

16.

Capodice J, Bemis D, Buttyan R, Kaplan S, Katz A . Complementary and alternative medicine for chronic prostatitis/chronic pelvic pain syndrome. Evid Based Complement Alternat Med. 2005; 2(4):495-501. PMC: 1297501. DOI: 10.1093/ecam/neh128. View

17.

Maixner W, Fillingim R, Williams D, Smith S, Slade G . Overlapping Chronic Pain Conditions: Implications for Diagnosis and Classification. J Pain. 2016; 17(9 Suppl):T93-T107. PMC: 6193199. DOI: 10.1016/j.jpain.2016.06.002. View

18.

Thilagarajah R, Witherow R, Walker M . Oral cimetidine gives effective symptom relief in painful bladder disease: a prospective, randomized, double-blind placebo-controlled trial. BJU Int. 2001; 87(3):207-12. DOI: 10.1046/j.1464-410x.2001.02031.x. View

19.

Doiron R, Tripp D, Tolls V, Nickel J . The evolving clinical picture of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS): A look at 1310 patients over 16 years. Can Urol Assoc J. 2018; 12(6):196-202. PMC: 5994985. DOI: 10.5489/cuaj.4876. View

20.

Berry S, Elliott M, Suttorp M, Bogart L, Stoto M, Eggers P . Prevalence of symptoms of bladder pain syndrome/interstitial cystitis among adult females in the United States. J Urol. 2011; 186(2):540-4. PMC: 3513327. DOI: 10.1016/j.juro.2011.03.132. View