## Protocol Section
### Identification Module
**NCT ID:** NCT05557279

**Brief Title:** Urinary Microbiome Changes Following Administration of 500 mg of NDS-446 in Women With Dry OAB at 12 Weeks

**Official Title:** Urinary Microbiome Changes Following Administration of 500 mg of NDS-446 in Women With Dry OAB at 12 Weeks - a Single-center Study

#### Organization Study ID Info
**ID:** 215838
#### Organization
**Class:** OTHER
**Full Name:** Loyola University
### Status Module
#### Completion Date
**Date:** 2024-12-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-12-11

**Type:** ACTUAL

**Last Update Submit Date:** 2023-12-08

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-04-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-01-01

**Type:** ACTUAL

**Status Verified Date:** 2023-12

#### Study First Post Date
**Date:** 2022-09-28
**Type:** ACTUAL
**Study First Submit Date:** 2022-09-12
**Study First Submit QC Date:** 2022-09-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Loyola University

#### Responsible Party

**Investigator Affiliation:** Loyola University

**Investigator Full Name:** Elizabeth Mueller MD

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to learn about how the use of 500 mg of dried cranberry powder extract (NDS-446) changes the bacteria that normal reside in the bladder of women who don't have urinary leakage problems but do have problems with urinary urgency and frequency.

**Detailed Description:** While this treatment algorithm is the recommended approach to OAB management, recent research has resulted in the development of a new paradigm that may influence how this condition is treated in the future. This research focuses on the urinary microbiome and for a decade it has been known that urine is not sterile. Expanded Quantitative Urine Culture (EQUC) techniques have allowed for more comprehensive and accurate 16S ribosomal RNA sequencing of the urinary microbiome. Changes in the abundance and diversity of the resident microbiota have been associated with a number of urogenital conditions including interstitial cystitis, urinary incontinence, responses to OAB medications and symptoms of urinary tract infections. These studies provide insight to the fact that the microbiome plays an important role in the maintenance of a healthy urogenital tract. Thus, treatments that target the microbiome for one condition may work for others by similar mechanisms, especially when there is considerable symptom overlap between the two conditions as there is in UTIs and OAB.

One such treatment is cranberry (Vaccinium macrocarpon) extract, which has long been used as complementary therapy for a variety of medical conditions. Health benefits are linked to the presence of phytochemicals present in the fruit- anthocyanins, flavonols, tannins, proanthocyanidins, and phenolic acid derivatives. Cranberry is known to be effective in the prevention of UTIs. In a recent study examining its use in women with dry OAB, daily dried cranberry improved urgency symptoms and number of daytime voids. In addition, the authors reported an improvement in the validated subjective instrument, Patient Perception of Bladder Condition (PPBC). Moderately symptomatic LUTS in men improved following 6 months of daily dried cranberry powder. Therefore, the investigators aim to investigate changes to the female urinary microbiome in women with dry OAB who take daily dried cranberry extract. This study aims to quantify a change in urinary frequency, urinary urgency, and PPBC following the daily use of a cranberry extract called NDS-446. The investigators also have an ancillary hypothesis that women who are post-menopausal will develop a urinary microbiome more similar to pre-menopausal women by the end of the study. Lastly, the investigators will measure the levels of extracellular (eATP) in the urine of participants. It has been previously shown that higher levels of eATP are associated with worsening OAB symptoms.

### Conditions Module

**Conditions:**

- Overactive Bladder

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** All participants will receive 500 mg NDS-446 daily for 12 weeks following a baseline assessment and meeting inclusion/exclusion criteria 20 premenopausal women, 20 postmenopausal women not on estrogen supplementation

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** All participants will receive 500 mg NDS-446 daily for 12 weeks

**Intervention Names:**

- Drug: 500 mg NDS-446

**Label:** Intervention Group

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intervention Group

**Description:** All participants will receive 500 mg NDS-446 daily for 12 weeks following a baseline assessment

**Name:** 500 mg NDS-446

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Vaginal and peri-urethral swabs, as well as voided and catheterized urine specimens, will be obtained.

**Measure:** Compare the UG microbiota (vagina, peri-urethral, catheterized and voided urine) of female participants with urgency-frequency syndrome after 12 weeks of daily use of 500 mg of NDS-446 to the UG microbiota at baseline.

**Time Frame:** 12 week visit

#### Secondary Outcomes

**Description:** The Patient Perception of Bladder Condition (PPBC) score in the study participants.

**Measure:** Compare the baseline and 12 week PPBC score in pre-menopausal and post-menopausal who take 500 mg of NDS-446 daily.

**Time Frame:** 12 week visit

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 18 years, female, ambulatory
* OAB symptoms \> 6 months
* Voiding frequency \> 8 times in 24 hrs and \> 3 episodes of urgency (grade 3 or 4) without incontinence during 3-day diary at baseline

Exclusion Criteria:

* Self-reported urinary incontinence (\> 3 episodes in the month prior)
* UTI \> 3 in last 12 months
* A diagnosis of painful bladder syndrome or interstitial cystitis
* LUT surgery last 6 months
* Drug or non-drug treatment of OAB (previous 60 days) or current meds that affect detrusor activity
* On Warfarin
* Failure to complete 3-day diary
* Aspirin \> 81 mg daily
* Gross hematuria
* Allergy or sensitivity to aspirin
* Subjects taking anti-platelet agents
* Inability to swallow capsules

**Maximum Age:** 99 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** mtulke@luc.edu

**Name:** Mary Tulke, RN

**Phone:** 708-216-2186

**Role:** CONTACT

**Contact 2:**

**Email:** emuelle@lumc.edu

**Name:** Elizabeth Mueller, MD

**Phone:** 708-216-2170

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Maywood

**Contacts:**

***Contact 1:***

- **Email:** mtulke@luc.edu

- **Name:** Mary Tulke, RN

- **Phone:** 708-216-2067

- **Role:** CONTACT

**Country:** United States

**Facility:** Loyola Medical Center

**State:** Illinois

**Status:** RECRUITING

**Zip:** 60153

#### Overall Officials

**Official 1:**

**Affiliation:** Loyola Medical Center

**Name:** Elizabeth Mueller, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

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## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001745

- Term: Urinary Bladder Diseases

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

- ID: D000059411

- Term: Lower Urinary Tract Symptoms

- ID: D000020924

- Term: Urological Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M27167

- Name: Urinary Bladder, Overactive

- Relevance: HIGH

- As Found: Overactive Bladder

- ID: M5026

- Name: Urinary Bladder Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M29464

- Name: Lower Urinary Tract Symptoms

- Relevance: LOW

- As Found: Unknown

- ID: M22659

- Name: Urological Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000053201

- Term: Urinary Bladder, Overactive

### Misc Info Module

- Version Holder: 2024-05-24
