## Protocol Section
### Identification Module
**NCT ID:** NCT06114979

**Brief Title:** Silodosin vs Placebo in the Treatment of Female LUTS

**Official Title:** Silodosin vs Placebo in the Treatment of Female Lower Urinary Tract Symptoms: A Randomized Controlled Trial

#### Organization Study ID Info
**ID:** Silodosin for female LUTS
#### Organization
**Class:** OTHER
**Full Name:** Mansoura University
#### Secondary ID Infos
**Domain:** Research Coordination Committee
**ID:** 937/2018
**Type:** REGISTRY
### Status Module
#### Completion Date
**Date:** 2024-12-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-11-02

**Type:** ACTUAL

**Last Update Submit Date:** 2023-10-30

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-10-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-11-01

**Type:** ESTIMATED

**Status Verified Date:** 2023-10

#### Study First Post Date
**Date:** 2023-11-02
**Type:** ACTUAL
**Study First Submit Date:** 2023-10-20
**Study First Submit QC Date:** 2023-10-30
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER_GOV

**Name:** Amiri Hospital

#### Lead Sponsor

**Class:** OTHER

**Name:** Mansoura University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This trial will be conducted to study the efficacy and safety of Silodosin in the treatment of female lower urinary tract symptoms.

**Detailed Description:** The double blinded randomized controlled trial will evaluate efficacy and safety of silodosin in treatment of female lower urinary tract symptoms by comparing with placebo.

### Conditions Module

**Conditions:**

- Lower Urinary Tract Symptoms

**Keywords:**

- Silodosin

- LUTS

- Female

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 278

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients will receive 8 mg of Silodosin tablet once daily.

**Intervention Names:**

- Drug: Silodosin

**Label:** Silodosin

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Patients will receive placebo pill once daily,

**Intervention Names:**

- Drug: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Silodosin

**Description:** Each patient will receive 8 mg of silodosin tablet once daily.

**Name:** Silodosin

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** Each patient will receive placebo tablet.

**Name:** Placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** International Prostate Symptom Score will be recorded for each patient. The score ranged between 7 and 35. Higher scores means worse outcome.

**Measure:** International Prostate Symptom Score

**Time Frame:** 8 weeks

**Description:** Overactive Bladder Validated 8-question will be recorded for each patient. The score ranged between 2 and 42. Higher scores means worse outcome.

**Measure:** Overactive Bladder Validated 8-question

**Time Frame:** 8 weeks

#### Secondary Outcomes

**Description:** Voided volume , Maximum flow, Voiding time, Post void residual

**Measure:** Uroflometry

**Time Frame:** 8 weeks

**Description:** Side effects of the treatment will be recorded

**Measure:** Adverse events

**Time Frame:** 8 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Females complaining of lower urinary tract symptoms
* IPSS ≥ 8 or OAB - V8 score ≥ 8

Exclusion Criteria:

1. Patients with documented hypersensitivity to Silodosin.
2. Patients receiving alpha blockers or anticholinergic medications for any other reason.
3. Patients with history of orthostatic hypotension.
4. Pregnant or breastfeeding females.
5. Patients with stress urinary incontinence.
6. Patients with active urinary tract infection.
7. History of previous pelvic surgery or radiation.
8. Patient with diabetes mellitus.
9. Patients diagnosed with bladder cancer.
10. Patients with hepatic impairment (Child-Pugh score \>9).
11. Patients with severe renal impairment with creatinine clearance of less than 10 mL/min.
12. Patients planned to undergo any ophthalmic procedure.
13. Patients with history of urinary retention or gastric retention.

**Gender Based:** True

**Maximum Age:** 75 Years

**Minimum Age:** 21 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** majd.qabbani@gmail.com

**Name:** Majd Alkabbani, MD

**Phone:** 0097450322671

**Role:** CONTACT

**Contact 2:**

**Email:** tshaiji@gmail.com

**Name:** Tariq F AL-Shaiji, MD

**Phone:** 0096599099915

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Amiri Hospital

**Name:** Tariq F AL-Shaiji, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020924

- Term: Urological Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M29464

- Name: Lower Urinary Tract Symptoms

- Relevance: HIGH

- As Found: Lower Urinary Tract Symptoms

- ID: M22659

- Name: Urological Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000059411

- Term: Lower Urinary Tract Symptoms

### Intervention Browse Module - Ancestors

- ID: D000058668

- Term: Adrenergic alpha-1 Receptor Antagonists

- ID: D000000317

- Term: Adrenergic alpha-Antagonists

- ID: D000018674

- Term: Adrenergic Antagonists

- ID: D000018663

- Term: Adrenergic Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000064804

- Term: Urological Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Urol

- Name: Urological Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M228332

- Name: Silodosin

- Relevance: HIGH

- As Found: Purchase

- ID: M20746

- Name: Adrenergic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M29194

- Name: Adrenergic alpha-1 Receptor Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M3669

- Name: Adrenergic alpha-Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M20755

- Name: Adrenergic Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000095285

- Term: Silodosin

### Misc Info Module

- Version Holder: 2024-05-24
