CLINICAL TRIALS PROFILE FOR METHENAMINE HIPPURATE

All Clinical Trials for methenamine hippurate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01958073 ↗	Vaginal Estrogen for the Prevention of Recurrent Urinary Tract Infection in Postmenopausal Women	Completed	American Urogynecologic Society	Phase 4	2013-10-01	The investigators would like to know if the use of vaginally applied estrogen can prevent the problem of repeated urinary tract infections (UTI) in women who have gone through menopause. The investigators will use two forms of vaginal estrogen that are available by prescription (a ring and a cream) and compare their efficacy to that of a placebo (without any active ingredient). The investigators are going to look at if the vaginal estrogen can prevent UTIs altogether and also the number of UTIs each group experiences over a 6 month period. After 6 months, all subjects will receive vaginal estrogen and the women on the non-active treatment will be able to choose whether they would like to use either the estrogen ring or cream. The investigators will then be able to compare the number of UTIs on and off active vaginal estrogen treatment within those subjects who started on the placebo. The investigators are also going to look at quality of life before and during treatment using questionnaires and whether subjects stop using the treatments or do not use them as directed (compliance).
NCT01958073 ↗	Vaginal Estrogen for the Prevention of Recurrent Urinary Tract Infection in Postmenopausal Women	Completed	New York University Langone Medical Center	Phase 4	2013-10-01	The investigators would like to know if the use of vaginally applied estrogen can prevent the problem of repeated urinary tract infections (UTI) in women who have gone through menopause. The investigators will use two forms of vaginal estrogen that are available by prescription (a ring and a cream) and compare their efficacy to that of a placebo (without any active ingredient). The investigators are going to look at if the vaginal estrogen can prevent UTIs altogether and also the number of UTIs each group experiences over a 6 month period. After 6 months, all subjects will receive vaginal estrogen and the women on the non-active treatment will be able to choose whether they would like to use either the estrogen ring or cream. The investigators will then be able to compare the number of UTIs on and off active vaginal estrogen treatment within those subjects who started on the placebo. The investigators are also going to look at quality of life before and during treatment using questionnaires and whether subjects stop using the treatments or do not use them as directed (compliance).
NCT01958073 ↗	Vaginal Estrogen for the Prevention of Recurrent Urinary Tract Infection in Postmenopausal Women	Completed	NYU Langone Health	Phase 4	2013-10-01	The investigators would like to know if the use of vaginally applied estrogen can prevent the problem of repeated urinary tract infections (UTI) in women who have gone through menopause. The investigators will use two forms of vaginal estrogen that are available by prescription (a ring and a cream) and compare their efficacy to that of a placebo (without any active ingredient). The investigators are going to look at if the vaginal estrogen can prevent UTIs altogether and also the number of UTIs each group experiences over a 6 month period. After 6 months, all subjects will receive vaginal estrogen and the women on the non-active treatment will be able to choose whether they would like to use either the estrogen ring or cream. The investigators will then be able to compare the number of UTIs on and off active vaginal estrogen treatment within those subjects who started on the placebo. The investigators are also going to look at quality of life before and during treatment using questionnaires and whether subjects stop using the treatments or do not use them as directed (compliance).
NCT01958073 ↗	Vaginal Estrogen for the Prevention of Recurrent Urinary Tract Infection in Postmenopausal Women	Completed	University of California, San Diego	Phase 4	2013-10-01	The investigators would like to know if the use of vaginally applied estrogen can prevent the problem of repeated urinary tract infections (UTI) in women who have gone through menopause. The investigators will use two forms of vaginal estrogen that are available by prescription (a ring and a cream) and compare their efficacy to that of a placebo (without any active ingredient). The investigators are going to look at if the vaginal estrogen can prevent UTIs altogether and also the number of UTIs each group experiences over a 6 month period. After 6 months, all subjects will receive vaginal estrogen and the women on the non-active treatment will be able to choose whether they would like to use either the estrogen ring or cream. The investigators will then be able to compare the number of UTIs on and off active vaginal estrogen treatment within those subjects who started on the placebo. The investigators are also going to look at quality of life before and during treatment using questionnaires and whether subjects stop using the treatments or do not use them as directed (compliance).

Clinical Trial Conditions for methenamine hippurate

Condition Name

Condition Name for methenamine hippurate
Intervention	Trials
Urinary Tract Infections	3
Recurrent Urinary Tract Infection	2
UTI	1
UTI - Lower Urinary Tract Infection	1

Condition MeSH

Condition MeSH for methenamine hippurate
Intervention	Trials
Urinary Tract Infections	6
Infection	5
Infections	5
Communicable Diseases	3

Clinical Trial Locations for methenamine hippurate

Trials by Country

Trials by Country for methenamine hippurate
Location	Trials
United States	5
Poland	1
Norway	1
Netherlands	1
Sweden	1

Trials by US State

Trials by US State for methenamine hippurate
Location	Trials
Texas	1
Ohio	1
Pennsylvania	1
New York	1
California	1

Clinical Trial Progress for methenamine hippurate

Clinical Trial Phase

Clinical Trial Phase for methenamine hippurate
Clinical Trial Phase	Trials
Phase 4	4
Phase 2	1
N/A	1

Clinical Trial Status

Clinical Trial Status for methenamine hippurate
Clinical Trial Phase	Trials
Recruiting	2
Completed	2
Not yet recruiting	1

Clinical Trial Sponsors for methenamine hippurate

Sponsor Name

Sponsor Name for methenamine hippurate
Sponsor	Trials
Medical University of Lodz	1
Medical Universtity of Lodz	1
UMC Utrecht	1

Sponsor Type

Sponsor Type for methenamine hippurate
Sponsor	Trials
Other	14

Methenamine hippurate Market Analysis and Financial Projection

Methenamine Hippurate: Clinical Trials, Market Analysis, and Projections

Introduction to Methenamine Hippurate

Methenamine hippurate is a urinary antiseptic that has been used in some Scandinavian countries as a preventive treatment for recurrent urinary tract infections (UTIs). This drug works by creating an acidic environment in the urine, which inhibits the growth of bacteria that cause UTIs.

Clinical Trials Update

Current Studies and Objectives

A significant clinical trial, the ImpresU consortium study, is currently underway to assess the efficacy of methenamine hippurate in reducing the incidence of UTIs in older women. This study is a randomized, controlled, triple-blind phase IV clinical trial involving women aged 70 years and older with a history of recurrent UTIs. The trial is being conducted across Norway, Sweden, Poland, and the Netherlands, aiming to recruit 400 participants, with 100 from each country. Participants are randomized to receive either methenamine hippurate 1 g or placebo tablets twice a day for six months, followed by a six-month drug-free follow-up period. The primary outcome is the number of antibiotic treatments for UTIs during the treatment period, while secondary outcomes include the number of antibiotic treatments during the follow-up period and self-reported symptom severity and duration of UTI episodes[1].

Ethical and Regulatory Aspects

The study has obtained ethical approvals in all participating countries and is registered with ClinicalTrials.gov (NCT04077580) and EudraCT (2018-002235-15). The results will be disseminated through peer-reviewed journals and scientific conferences[1].

Previous Studies and Findings

Previous studies on methenamine hippurate have shown mixed results. A review of six studies involving 557 participants found insufficient evidence to confirm the benefits of methenamine hippurate in preventing UTIs. While there was a non-statistically significant trend of benefit compared to antibiotics over 12 months, further research is needed to definitively establish its efficacy[4].

Market Analysis

Current Market Size and Growth

The methenamine hippurate tablets market has experienced strong growth in recent years. As of 2023, the market size was valued at $8.97 billion and is projected to grow to $9.63 billion in 2024, with a compound annual growth rate (CAGR) of 7.4%. By 2028, the market is expected to reach $12.83 billion, driven by factors such as growing UTI prevalence, rising antibiotic resistance concerns, advancements in UTI management, and a focus on preventive healthcare[2].

Market Segmentation

The market is segmented by type (20 tablets or bottle, 6 tablets or bottle), distribution channel (hospital pharmacy, online pharmacy, retail pharmacy), application (uncomplicated UTIs, healthcare-associated UTIs), and end-user (hospitals, homecare, specialty clinics, others). Europe and North America are key regions, with Europe witnessing the highest growth due to the rise in chronic infections among women and postmenopausal UTIs. North America dominates the market due to growing disposable income and increasing urological procedures[3][5].

Driving Factors

Several factors are driving the growth of the methenamine hippurate market:

• Rising UTI Prevalence: The incidence of UTIs is increasing globally, with reported cases of 50-60% in adult women.
• Antibiotic Resistance: Growing concerns about antibiotic resistance are leading to a preference for non-antibiotic solutions like methenamine hippurate.
• Clinical Validation: Ongoing clinical trials and research are validating the use of methenamine hippurate, enhancing its market appeal.
• Healthcare Focus: There is a growing focus on preventive therapies and non-antibiotic treatments in healthcare, which benefits the market[2][3].

Market Projections

Forecast Period

The methenamine hippurate tablets market is expected to continue its strong growth trajectory. From 2023 to 2030, the market is projected to grow at a CAGR of 6.50%, increasing from $8.9 billion in 2022 to $14.73 billion by 2030. This growth is attributed to the increasing incidence of UTIs, rising antibiotic resistance, and advancements in UTI management[3][5].

Regional Insights

Europe is expected to witness the highest growth due to the constant rise in chronic infections among women and growing cases of postmenopausal UTIs. North America will continue to dominate the market due to growing disposable income and increasing urological procedures. The wide presence of distribution networks for methenamine hippurate tablets in these regions also contributes to their market share[5].

Key Takeaways

• Clinical Trials: Ongoing trials like the ImpresU consortium study aim to establish the efficacy of methenamine hippurate in preventing UTIs in older women.
• Market Growth: The methenamine hippurate market is growing strongly, driven by rising UTI prevalence, antibiotic resistance concerns, and a focus on preventive healthcare.
• Market Segmentation: The market is segmented by type, distribution channel, application, and end-user, with Europe and North America being key regions.
• Future Projections: The market is expected to grow significantly from 2023 to 2030, reaching $14.73 billion by 2030.

FAQs

What is methenamine hippurate used for?

Methenamine hippurate is used to prevent or treat recurring urinary tract infections caused by specific bacteria. It works by creating an acidic environment in the urine that inhibits bacterial growth.

What is the current market size of methenamine hippurate tablets?

As of 2023, the methenamine hippurate tablets market size is valued at $8.97 billion.

What are the driving factors for the growth of the methenamine hippurate market?

The growth is driven by rising UTI prevalence, antibiotic resistance concerns, advancements in UTI management, and a focus on preventive healthcare.

Which regions dominate the methenamine hippurate market?

Europe and North America are the key regions, with Europe witnessing the highest growth due to chronic infections among women and postmenopausal UTIs, and North America dominating due to growing disposable income and urological procedures.

What is the projected CAGR for the methenamine hippurate market from 2023 to 2030?

The projected CAGR is around 6.50%, with the market expected to grow from $8.9 billion in 2022 to $14.73 billion by 2030.

Sources

1. PubMed: "Methenamine hippurate to prevent recurrent urinary tract infections in older women: a protocol for a randomised, controlled, triple-blind phase IV clinical trial" (2022)
2. The Business Research Company: "Methenamine Hippurate Tablets Global Market Report 2024"
3. Data Bridge Market Research: "Global Methenamine Hippurate Tablets Market"
4. BJGP: "Use of methenamine hippurate to prevent urinary tract infections in older women: a systematic review"
5. Data Bridge Market Research: "Global Methenamine Hippurate Tablets Market" (German version)